Corporate Events

Shionogi & Co., Ltd., Board Meeting, Oct 05, 2026. Agenda: To consider the agreement to acquire IntraBio Inc. (Head Office: Austin, TX; hereinafter “IntraBio”), a biopharmaceutical company developing and commercializing therapies for neurodegenerative diseases. Pursuant to the agreement, which was signed by the parties today, IntraBio would become a wholly owned subsidiary of Shionogi Inc., a New Jersey-based subsidiary of Shionogi. The proposed transaction, which is subject to customary closing conditions, would add AQNEURSA® (levacetylleucine) and IntraBio’s capabilities in the rare disease area to Shionogi’s growing portfolio; and to consider the other matters.

Shionogi & Co., Ltd. (TSE:4507) entered into an equity transfer agreement to acquire remaining 50% stake in Shionogi-Apnimed Sleep Science, LLC from Apnimed, Inc. for $150 million on March 23, 2026. As part of consideration, Shionogi & Co., Ltd will pay $100 million upfront cash payment, and a $50 million in earnout upon the achievement of a development milestone related to SASS-002 (sulthiame) and tiered royalties on future commercial sales of any products arising from SASS intellectual property. Upon completion, Shionogi-Apnimed Sleep Science, LLC will operate as a wholly owned subsidiary of Shionogi & Co., Ltd. The transaction is expected to close on April 6, 2026. Shionogi & Co., Ltd. (TSE:4507) completed the acquisition of remaining 50% stake in Shionogi-Apnimed Sleep Science, LLC from Apnimed, Inc. on April 6, 2026.

Shionogi & Co., Ltd. and Torii Pharmaceutical Co., Ltd. announced that they have obtained manufacturing and marketing approval for VTAMA® Cream 0.5% (generic name: tapinarof; hereafter "the drug"), for the indication of atopic dermatitis in pediatric patients under 12 years of age. The drug is a nonsteroidal, small molecule therapeutic aryl hydrocarbon receptor (AhR) modulating agent that suppresses the production of inflammatory cytokines and induces gene expression of skin barrier function- related and antioxidant molecules through the activation of AhR. In Japan, VTAMA® Cream 1% has obtained manufacturing and marketing approval for atopic dermatitis in adults and pediatric patients aged 12 years and older, as well as for plaque psoriasis in adults. This approval is based on the results of a domestic Phase 3 clinical trial² conducted in pediatric patients with atopic dermatitis (aged 2 to under 12 years). In the trial, the efficacy and safety of the drug administered once daily for 8 weeks were evaluated in comparison with the vehicle cream, and the long-term safety of administration for up to 60 weeks was also evaluated. As a result, the primary efficacy endpoint was met, with the drug showing superiority over the vehicle cream, and favorable tolerability was also confirmed with respect to long-term safety. Atopic dermatitis frequently develops in childhood, and with this approval, the drug is expected to become a new treatment option for pediatric patients. The SHIONOGI Group has identified "Contributing to a healthier and enriched life" as one of its material issues and is advancing initiatives toward realizing a society in which everyone can live longer, more vibrant lives that are true to themselves. Shionogi and Torii will continue to strive to deliver the drug as quickly as possible, in order to contribute to the treatment and quality of life (QOL) of pediatric patients with atopic dermatitis. The impact of this matter on the consolidated financial results for the fiscal year ending March 2027 is expected to be minimal.

Shionogi & Co., Ltd. announced that it has obtained approval for a partial change to the manufacturing and marketing authorization of COVGOZE for Intramuscular Injection (JN.1-Adapted), a recombinant protein vaccine against COVID-19, to add a booster dose indication. The vaccine has been developed to address the continuously evolving SARS-CoV-2 virus. Building on the approvals of its original-strain vaccine and JN.1-adapted vaccine, Shionogi has been advancing the establishment of a platform that enables the rapid development and manufacturing of vaccines tailored to the recommended strains designated for each vaccination season. With this latest approval, the foundation for the platform has now been established. The approved vaccine is different from the strain-adapted vaccine designated for use in Japan during the 2026/2027 vaccination season. Therefore, Shionogi does not plan to supply this vaccine. The impact of this matter on the consolidated financial results for the fiscal year ending March 2027 has already been reflected in the earnings forecast announced on May 12, 2026. COVGOZE for Intramuscular Injection is a recombinant protein vaccine developed using the BEVS technology. The recombinant protein vaccine is formulated with a purified antigen protein, which is expressed and refined using the genetic information of the virus. The vaccine is then administered with an adjuvant. Recombinant protein technology has been used for many years in vaccine development, including influenza vaccines, both in Japan and internationally, and a substantial body of knowledge regarding its efficacy and safety has been accumulated.

Shionogi & Co., Ltd. reported earnings results for the first quarter ended June 30, 2026. For the first quarter, the company reported sales was JPY 163,310 million compared to JPY 99,781 million a year ago. Net income was JPY 97,696 million compared to JPY 39,355 million a year ago. Basic earnings per share from continuing operations was JPY 114.81 compared to JPY 46.26 a year ago. Diluted earnings per share from continuing operations was JPY 114.78 compared to JPY 46.25 a year ago.

Shionogi & Co., Ltd. has commenced sales of its anti-SARS-CoV-2 drug, encitrelvir fumarate (product name in the U.S.: XOCOVA), in the United States. This drug was approved by the U.S. Food and Drug Administration (FDA) in May 2026 for the indication of post-exposure prophylaxis (PEP) for COVID-19. By taking it within 72 hours of contact with an infected person, it is expected to suppress viral replication during the period before symptoms appear and reduce the risk of developing COVID-19. In the global Phase 3 post-exposure prophylaxis trial (SCORPIO-PEP trial), it was the first oral antiviral drug in the world to demonstrate efficacy in preventing the onset of COVID-19, statistically significantly reducing the risk of developing COVID-19 by 67% up to day 10 after administration compared to the placebo group. Post-exposure prophylaxis refers to the practice of administering antiviral drugs before the onset of symptoms occurs when there is a possibility of infection with the virus, such as through contact with a person infected with COVID-19. In the United States, COVID-19 outbreaks have been observed from summer to fall since 2020, and continued efforts to control the infection are required. Since PEP is a preventive measure used for other viral infections such as influenza, it can be a new preventive option for COVID-19. Shionogi & Co., Ltd. ensures a stable supply of this drug for the U.S. market by conducting all processes from manufacturing to distribution within the United States. Furthermore, through Shionogi Inc., we will work to improve access to this drug through awareness campaigns for healthcare professionals and the general public, collaboration with pharmacies, and the provision of co-payment support programs. SARS-CoV-2 remains highly infectious, with reports indicating that up to 47% of family members living with an infected person may become infected. Furthermore, it is estimated that between 4 million and 12.4 million new infections will occur in the United States between October 2025 and June 2026. COVID-19 continues to be a public health burden, with reports of long-term effects on the nervous, cardiovascular, respiratory, and renal systems in addition to acute infection. The risk of severe illness and death remains high among the elderly and those residing in care facilities. The SCORPIO-PEP trial was an international, collaborative Phase 3 clinical trial conducted to evaluate the efficacy and safety of encitrelvir fumarate in the prevention of post-exposure COVID-19 disease. 2,387 family contacts aged 12 years or older living with COVID-19 patients were enrolled. In this trial, encitrelvir fumarate significantly reduced the risk of developing COVID-19 by 67% compared to placebo. Furthermore, in an analysis of subjects with risk factors for severe illness, the risk was reduced by 76%. The results of this trial were published in the New England Journal of Medicine in May 2026.

Shionogi & Co., Ltd., ¥ 38.0, Cash Dividend, Sep-29-2026

Shionogi & Co., Ltd. announced that its Supplemental New Drug Application (sNDA) for cefiderocol (U.S. product name "Fetroja"), a treatment for Gram-negative bacterial infections, has been accepted by the U.S. Food and Drug Administration (FDA) for the addition of indications for pediatric patients, including hospital-acquired pneumonia/ventilator-associated pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs), including pyelonephritis, caused by specific Gram-negative bacteria. This application is being submitted by Shionogi Inc., based on the results of three clinical trials that evaluated the pharmacokinetics, safety, tolerability, and efficacy of cefiderocol in 154 pediatric patients ranging from children born at 26 weeks of gestation to those under 18 years of age, in cases of confirmed or suspected Gram-negative bacterial infections such as HABP/VABP and cUTIs including pyelonephritis. The FDA has set a target date for completion of review (PDUFA date) for this application as February 23, 2027. Cefiderocol is listed on the World Health Organization's (WHO) list of essential medicines and plays an important international role as a treatment option for drug-resistant Gram-negative bacterial infections. Since 2023, it has been included in the WHO's Pediatric Drug Optimization (PADO) priority list, which identifies medicines that require particular development and distribution due to challenges such as dosage setting, safety data, and age-appropriate formulations in children. Efforts to expand the pediatric indication for HABP/VABP are supported through Project BioShield by the Biomedical Advanced Research and Development Authority (BARDA) and receive federal funding under a contract (contract number: 75A50126C00004) between the U.S. Department of Health and Human Services, the Strategic Preparedness and Response Office, and BARDA. Cefiderocol is a drug that effectively penetrates the outer membrane of Gram-negative bacteria, including drug-resistant strains, to exert its antibacterial activity. In the United States, cefiderocol is marketed for the treatment of adult patients with complicated urinary tract infections (cUTIs), including pyelonephritis caused by certain Gram-negative bacteria, and hospital-acquired pneumonia/ventilator-associated pneumonia (HABP/VABP), and is also marketed in several countries and regions, including Japan, Europe, and Taiwan. Preparations are underway to improve access to this new antibacterial agent for patients in many low- and middle-income countries through a tripartite collaboration agreement with The Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI).

Shionogi & Co., Ltd., Q1 2027 Earnings Call, Aug 03, 2026

Shionogi & Co., Ltd., Board Meeting, Jun 24, 2026. Agenda: To consider its current situation and decided on future policies to achieve management that is conscious of capital costs and stock prices. Please refer to the attached document for details.

Shionogi & Co., Ltd. announced that the dosage and administration of its anti-SARS-CoV-2 drug Zocova (generic name: encitrelvir fumarate) for children aged 6 to under 12 years and weighing 20 kg or more in Japan have been newly approved. Along with this, a smaller tablet (25 mg tablet) has been approved as a new formulation. This approval is based on the results of a domestic Phase 3 clinical trial in patients aged 6 to under 12 years with a weight of 20 kg or more who were infected with SARS-CoV-2. The primary objective of this trial was to confirm the safety and pharmacokinetics of Zocova administered orally once daily for 5 days at a dose according to body weight, and 117 patients were enrolled. As a result, no new safety concerns were identified. Furthermore, population pharmacokinetic analysis (PPK analysis) confirmed that the blood concentration profile of Zocova in children in this trial was similar to that of adults administered at a therapeutic dose, demonstrating the appropriateness of the dose setting for children aged 6 to under 12 years. Zocova will become a new treatment option for COVID-19 in children aged 6 years and older and weighing 20 kg or more, in addition to its existing indications in children aged 12 years and older and adults. As an oral anti-SARS-CoV-2 drug that can be used regardless of the presence or absence of risk factors for severe illness, it is expected to contribute to the treatment of more patients. The impact of this matter on consolidated financial results for the fiscal year ending March 2027 is expected to be minor. Encitrelvir, an anti-SARS-CoV-2 drug, is a 3CL protease inhibitor developed through a joint research project between Hokkaido University and Shionogi & Co., Ltd. SARS-CoV-2 possesses an enzyme called 3CL protease, which is essential for viral replication. Encitrelvir selectively inhibits 3CL protease, thereby suppressing SARS-CoV-2 replication. During the Omicron strain epidemic, a Phase 3 part of a Phase 2/3 clinical trial (SCORPIO-SR trial) was conducted, confirming improvement in five symptoms of COVID-19 characteristic of the Omicron strain (primary endpoint). Based on these results, it received emergency approval in Japan in November 2022 and regular approval in March 2024. In March 2026, based on favorable results from a global Phase 3 post-exposure prophylaxis trial (SCORPIO-PEP trial), it received approval in Japan for its efficacy in post-exposure prophylaxis of COVID-19. Overseas, in the United States, Shionogi Inc. received approval from the U.S. Food and Drug Administration (FDA) in May 2026 for the indication of post-exposure prophylaxis of COVID-19. In Europe, the European Medicines Agency (EMA) is reviewing the drug for post-exposure prophylaxis and treatment of COVID-19 in 2025. In Singapore, the drug became available for use in some medical institutions in November 2023 after receiving import authorization based on a Special Access Route (SAR) application. In Taiwan, a new drug application is pending for the indication of post-exposure prophylaxis of COVID-19. Shionogi & Co., Ltd. and Medicines Patent Pool have entered into a licensing agreement aimed at providing this drug to a wider range of low- and middle-income countries (LMICs), and are working to expand global access.

Shionogi & Co., Ltd. announced that it has achieved its primary endpoint in a global Phase 3 clinical trial (hereinafter referred to as the "OASIS trial" or "this trial") of ororofim, a novel antifungal drug being jointly developed with F2G Ltd. in patients with invasive aspergillosis. Orolofim is a novel oral antifungal drug with a novel mechanism of action that exhibits antifungal activity by inhibiting the pyrimidine synthesis pathway, which is essential for fungal growth. The OASIS trial, which yielded favorable results, was conducted to verify the non-inferiority of orolofim to the AmBisome treatment group (a group that received standard treatment after at least 10 days of AmBisome administration) in patients with invasive aspergillosis who were resistant to or for whom the use of azole antifungal drugs was difficult. In the primary endpoint, "all-cause mortality at 42 days after the start of treatment," orolofim demonstrated non-inferiority to the AmBisome treatment group (23.8% in the orolofim group, 24.3% in the AmBisome group, with a difference of -0.5% (95% confidence interval: -13.1% to 10.8%)). No new safety concerns were identified, and the incidence of adverse events that investigators determined to be drug-related was 35.8% in the orolofim group and 63.9% in the AmBisome treatment group. The orolofim group also showed a lower incidence of renal function-related adverse events, which are known side effects of the control drug. The results of the OASIS trial suggest that ororofim may be a new treatment option for invasive aspergillosis. Further details of the test results will be presented at international conferences and other venues in the future. Shionogi & Co., Ltd. is jointly developing Orolofim under an agreement with F2G, and holds the development and exclusive marketing rights in Europe and Asia. Based on the results of this trial, we plan to submit applications for approval in Europe and Asia, and F2G plans to submit a new drug application to the U.S. Food and Drug Administration (FDA). The impact of this matter on our consolidated financial results for the fiscal year ending March 2027 is expected to be minor. The Phase 3 clinical trial OASIS (Olorofim Aspergillus Infection Study, NCT05101187) is a global randomized controlled trial evaluating the efficacy and safety of orolofim and AmBisome compared to standard treatment in patients with invasive aspergillosis who are resistant to or have difficulty using azole antifungal agents. The primary endpoint of this trial is all-cause mortality at 42 days after the start of treatment, and secondary endpoints include clinical efficacy, safety, and quality of life (QOL). Ororofim is the lead compound of the orotomide-based antifungal drug class developed by F2G, and has completed a global Phase 3 clinical trial (OASIS trial). Ororofim has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for coccidioidomycosis, skedosporium disease, and invasive aspergillosis. It has also received Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive skedosporium disease, invasive lomentosporium disease, coccidioidomycosis, invasive infections caused by Scopulariopsis species, and invasive fusariosis. Furthermore, it has received orphan designation from the European Medicines Agency (EMA) for invasive aspergillosis, skedosporium disease, and invasive Scopulariopsis infections. Ororofim is currently an investigational compound and is not yet approved in any country or region.

Shionogi & Co., Ltd. announced that it has received supplemental approval in Japan for the pediatric dosage and administration of XOCOVA (generic name: ensitrelvir fumaric acid), an anti-SARS-CoV-2 drug, for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. New, smaller 25 mg tablets have also been approved. The approval is based on the results of a Phase 3 clinical trial conducted in pediatric patients aged 6 to under 12 years with SARS-CoV-2 infection weighing at least 20 kg in Japan. The trial evaluated the safety and pharmacokinetics of once-daily oral administration of XOCOVA for 5 days at weight-based doses, in a total of 117 participants. No new safety concerns were identified. The pediatric plasma concentration profiles of XOCOVA observed in the trial were confirmed to be comparable to those predicted for adults receiving therapeutic doses, based on a population pharmacokinetic (PPK) analysis. These findings support the appropriateness of the dosing regimen for children aged 6 to under 12 years. With this approval, and in addition to its indication for adults and pediatric patients aged 12 years and older, XOCOVA becomes a new treatment option for pediatric patients aged 6 years and older weighing at least 20 kg, and is expected to contribute to the treatment of a broader pediatric population as an oral anti-SARS-CoV-2 drug that can be used regardless of risk factors for progression to severe disease. Product name: XOCOVA Tablets 125 mg /XOCOVA Tablets 25 mg. Generic name: ensitrelvir fumaric acid. Indication: For the treatment and post-exposure prophylaxis of SARS-CoV-2 infection. Dosage and Administration: The usual dosage is the following amount of ensitrelvir, administered orally once daily. For adults and pediatric patients aged 12 years and older: 375 mg on Day 1, 125 mg on Days 2–5. For pediatric patients aged 6 to under 12 years: =40 kg: 375 mg on Day 1, 125 mg on Days 2–5; =30 kg to <40 kg: 250 mg on Day 1, 125 mg on Days 2–5; =20 kg to <30 kg: 150 mg on Day 1, 75 mg on Days 2–5. For post-exposure prophylaxis: For adults and pediatric patients aged 12 years and older, the usual dosage is 375 mg of ensitrelvir on Day 1, followed by 125 mg once daily on Days 2 to 5, administered orally. Ensitrelvir is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 3 trial conducted in Asia, during the Omicron-dominant phase of the epidemic. In this trial, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (the primary endpoint) and antiviral efficacy (a key secondary endpoint) in patients with mild-to-moderate SARS-CoV-2 infection. Ensitrelvir received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19. In March 2026, based on the positive results from the global Phase 3 post-exposure prophylaxis trial (SCORPIO-PEP), Shionogi obtained approval in Japan for the indication of COVID-19 post-exposure prophylaxis. In the U.S., Shionogi Inc., received approval from the U.S. Food and Drug Administration (FDA) on May 29, 2026 for the indication of post-exposure prophylaxis of COVID-19. In Europe, ensitrelvir has been under review by the European Medicines Agency for the indication of post-exposure prophylaxis and treatment of COVID-19. It became available in Singapore via a Special Access Route application in November 2023, and is currently under regulatory review for the indication of postexposure prophylaxis of COVID-19 in Taiwan. Shionogi has entered into a licensing agreement with the Medicines Patent Pool to enable broad access to the drug in low- and middle-income countries (LMICs), and continues to advance efforts to expand global access. Seven manufacturers sign sublicence agreements with the Medicines Patent Pool to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir to increase access in low- and middle-income countries.

F2G Ltd. and Shionogi & Co., Ltd. announced positive topline results from the global Phase 3 OASIS study (NCT05101187), comparing the investigational oral antifungal drug olorofim versus AmBisome (liposomal amphotericin B for injection) followed by standard of care in patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy. The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome followed by standard of care (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). No new safety findings were observed for olorofim; the rate of drug-related treatment-emergent adverse events (TEAEs) was 35.8% for olorofim and 63.9% for AmBisome followed by standard of care, with the difference mainly driven by the higher rate of renal events in the AmBisome arm. These results expand on the previous Phase 2b study data that led to olorofim’s Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA), reinforcing olorofim’s potential as a treatment for patients with invasive aspergillosis. F2G and Shionogi plan to present pivotal results from the study at a future medical congress. These data will be submitted to regulatory authorities in the U.S. by F2G and in Europe and Asia by Shionogi. Invasive aspergillosis is a life-threatening fungal infection that primarily affects immunocompromised patients and is associated with substantial morbidity and mortality. Treatment options are limited for patients who cannot be treated with available azole antifungal therapies. F2G and Shionogi are collaborating to develop and commercialize olorofim and bring this novel antifungal therapy to patients with invasive fungal infections. F2G has commercial responsibility for olorofim in North America and non-Shionogi territories, and Shionogi has commercial responsibility for olorofim in Europe and Asia. The Phase 3 OASIS (Olorofim Aspergillus Infection Study) trial (NCT05101187) was a global, randomized study that evaluated the efficacy and safety of olorofim versus AmBisome followed by standard of care in adult patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy. OASIS was designed as a non-inferiority study using a non-inferiority margin of 20% comparing outcomes in 225 subjects randomized 2:1 to olorofim or AmBisome-based standard of care. Invasive aspergillosis is a life-threatening fungal infection with limited treatment options due to rising drug resistance and toxicity concerns. The study’s primary endpoint was all-cause mortality at Day 42, with additional measures of clinical response, safety, and quality of life. Olorofim (formerly, F901318) is F2G's leading candidate from the orotomide class and has been studied in a recently completed global Phase 3 trial ("OASIS", NCT05101187). Olorofim is a first-in-class antifungal with a novel mechanism of action, oral dosing, and activity against a wide range of Aspergillus species, including strains that are resistant to currently approved agents. If approved based on the Phase 3 OASIS data, olorofim will be the first novel mechanism agent for invasive aspergillosis in more than 20 years. In the U.S., olorofim has received orphan drug status from the FDA for the treatment of invasive aspergillosis, scedosporiosis, invasive scopulariopsis, and coccidioidomycosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for several invasive fungal infections, including invasive aspergillosis and coccidioidomycosis. Additionally, olorofim has also received two Breakthrough Therapy designations (BTD) from the FDA. The first BTD was for the treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium and Scopulariopsis species. The second BTD was for the treatment of central nervous system (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy. In Europe, olorofim has been granted orphan designation from the European Medicines Agency for the treatment of invasive aspergillosis, scedosporiosis, and invasive scopulariopsis. Olorofim is an investigational therapy and has not been approved by any regulatory authorities.

On June 12, 2026, Dioseve, Inc. closed the transaction. The company amended the terms of the transaction. The company has received ¥1,000,000,000 in it's second and final tranche. The transaction was led by returning investor, Archetype Ventures, and include participation from returning investors, DG Daiwa Ventures Inc., Asuka Innovation Fund, a fund managed by MIRAIDOOR Co., Ltd., new investors, D4V LLC, Pangaea Ventures Ltd. and Shionogi & Co., Ltd. The company has raised ¥2,900,000,000 in total funding till date.

Dioseve, Inc. announced that it has received funding from new investor Shionogi & Co., Ltd. through its corporate venture capital arm on June 12, 2026. The company has issued convertible preferred stock in the transaction.

Shionogi & Co., Ltd. announced that it has commenced sales of ENDEAVORRIDE, a digital therapeutic support app for which the Company has acquired exclusive development and sales rights in Japan and Taiwan from Akili Inc., starting on June 5, 2026. EndeavorRide is the first medical device program (treatment support app) approved in Japan for the purpose of adjunct treatment of attention deficit hyperactivity disorder (ADHD) in childhood. It was approved based on the favorable results of a Phase 3 clinical trial conducted by the company in Japan. This trial was conducted to verify the efficacy and safety of EndeavorRide in 164 pediatric ADHD patients aged 6 to 17 years who were receiving the usual environmental adjustments and psychosocial treatments for ADHD, with the primary endpoint being the change from baseline in the ADHD-RS-IV inattention score, an ADHD severity assessment scale. The EndeavorRide group showed a statistically significant improvement (p < 0.05) at 6 weeks after the start of treatment compared to the usual treatment group (continuation of environmental adjustments and psychosocial treatment), achieving the main objective of this trial. In addition to existing options such as psychosocial therapy and pharmacotherapy, the launch of EndeavorRide expands the options to include a new digital therapeutic support app. EndeavorRide is a digital therapeutic support app for children with ADHD that is expected to improve ADHD symptoms through use on smartphones and tablets. Based on Akili Selective Stimulus Management Engine (SSME (TM)) core technology, EndeavorRide is designed to activate the prefrontal cortex of the brain, which is considered to play a crucial role in cognitive function. SSME (TM) stimulates the cerebral cortex by performing dual tasks optimized for each patient, encouraging improvements in inattention, hyperactivity, and impulsivity.

Shionogi & Co. Ltd. announced that its U.S. group company, Shionogi Inc., has received approval from the U.S. Food and Drug Administration (FDA) for the post-exposure prevention of COVID-19 disease in relation to the anti-SARS-CoV-2 drug encitrelvir fumarate (product name in Japan: Zocova; hereinafter referred to as "ensitrelvir"). The target date for completion of review (PDUFA) was June 16, 2026 .Disclaimer: The Above Content is Auto-Translated. This approval is based on the positive results of the global Phase 3 post-exposure prevention trial (SCORPIO-PEP *2 trial). The primary endpoint of this trial was "post-exposure prevention in cohabitants or family members of patients who developed COVID-19," and encitrelvir was the first oral antiviral drug in the world to demonstrate efficacy. In the encitrelvir group, the risk of developing COVID-19 up to day 10 after administration was statistically significantly reduced by 67% compared to the placebo group. Furthermore, encitrelvir was well-tolerated, and the incidence of adverse events was similar in both groups. The results of this trial were published in The New England Journal of Medicine on May 14, 2026 . With this approval, encitrelvir becomes the first oral antiviral drug in the United States to receive approval for post-exposure prevention of COVID-19.

Shionogi & Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved XOCOVA (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. XOCOVA is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five. The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026. The approval is based on positive results from SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing symptomatic COVID-19 following exposure to an infected individual. XOCOVA significantly reduced the risk of symptomatic COVID-19 by 67% in uninfected individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011). Overall, XOCOVA was generally well tolerated, with similar rates of adverse events across groups (15.1% in the XOCOVA group (n=1,190) and 15.5% in the placebo group (n=1,187)). The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough. There were no reports of altered taste (dysgeusia) attributed to XOCOVA in the trial. Results from the SCORPIO-PEP trial were published in the New England Journal of Medicine on May 14, 2026. COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19. The U.S. Centers for Disease and Control estimates that between October 1, 2025 and May 23, 2026 there were 3,800,000–12,400,000 new cases in the U.S., resulting in 800,000–2,300,000 outpatient visits, 120,000–240,000 hospitalizations and 13,000–42,000 deaths. Beyond acute infection, COVID-19 can have lasting impacts. People diagnosed with COVID-19 had increased rates of both new and worsening neurologic, cardiovascular, respiratory, and renal conditions during the year following infection. COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities. The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of XOCOVA as post-exposure prophylaxis for COVID-19. The study included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test at baseline. The trial was conducted from June 2023–September 2024. More than 99% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both. Study participants were randomly assigned at a 1:1 ratio to receive XOCOVA (375 mg on day 1 and 125 mg on days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Participants then continued XOCOVA (125 mg) or placebo for five days. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual. XOCOVA (ensitrelvir) is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. XOCOVA suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. XOCOVA is approved in the U.S. and Japan for post-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 based on results from SCORPIO-SR, a Phase 3 study conducted in Asia during the Omicron-dominant phase of the pandemic. Results from this study were published in JAMA Network Open. XOCOVA is not approved for the treatment of COVID-19 in the U.S.

Shionogi & Co., Ltd.'s group company Shionogi China Co., Ltd. has received approval from the National Medical Products Administration (NMPA) of China on May 27, 2026, for Naldemedine Tosilate, a treatment for opioid-induced constipation (OIC). OIC is a common adverse effect associated with the use of opioids for the treatment of conditions such as cancer pain, occurring at a high frequency. Symptoms such as difficulty in defecation and abdominal discomfort may lead to deterioration in patients’ quality of life (QOL) and discontinuation or dose reduction of opioid therapy, thereby significantly affecting the continuation of appropriate pain management. Current treatment options for OIC primarily consist of symptomatic therapies such as laxatives; however, these approaches may not provide sufficient relief. Naldemedine is a peripherally acting µ-opioid receptor antagonist discovered by Shionogi. Opioids used for pain management exert their analgesic effects by acting on opioid receptors in the central nervous system; however, they also act on µ-opioid receptors in the gastrointestinal tract, which can lead to constipation. Naldemedine selectively binds to µ-opioid receptors in the gastrointestinal tract and directly addresses the underlying cause of opioid-induced constipation (OIC) without affecting the analgesic effects of opioids. As a result, it improves constipation symptoms and contributes to enhanced patient quality of life (QOL) as well as better pain management. Naldemedine is recommended as a treatment for OIC in guidelines issued by the American Gastroenterological Association (AGA) and the European Society for Medical Oncology (ESMO), and the approval of naldemedine in China is expected to contribute to the treatment of OIC in the country. This approval is based on favorable results from Phase 3 clinical trials conducted in China and outside China. Naldemedine is already marketed in Japan, the United States, Europe and other regions. In China, the product will be marketed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and the company will work in collaboration with its partner to promote the broader adoption of this product. Naldemedine is a peripherally acting µ-opioid receptor antagonist that binds to µ-opioid receptors in the gastrointestinal tract and counteracts the peripheral effects of opioids, thereby improving OIC. Naldemedine has been approved in Japan, the United States, and Europe, and is marketed under the brand names Symproic®, Rizmoic®, and others. This trial was a multicenter Phase 3 trials consisting of a double-blind, placebo-controlled period followed by an open-label extension period. The treatment period comprised two phases: 2-week double-blind, placebo-controlled treatment period and 10-week open-label treatment period. The primary endpoint was the proportion of patients achieving at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM per week from baseline. Naldemedine showed a statistically significant improvement compared with placebo.

Annual General Meeting of Shareholders

Shionogi & Co., Ltd. provided consolidated earnings guidance for the Six months ending September 30, 2026 and Year ending March 31, 2027. For the six months period, the company expects Revenue to be JPY 340,000 million, operating profit to be JPY 96,000 million, Profit attributable to owners of parent to be JPY 108,000 million and Basic earnings per share to be 126.91 per share. For the year, the company expects Revenue to be JPY 700,000 million, operating profit to be JPY 220,000 million, Profit attributable to owners of parent to be JPY 210,000 million and Basic earnings per share to be 246.79 per share.

Shionogi & Co., Ltd. provided year end dividend guidance for the Year ending March 31, 2027. For the year end, the company expects dividend of JPY 38.00 per share against JPY 38.00 per share a year ago.

Shionogi & Co., Ltd. proposed the year end dividend of JPY 38.00 per share for the Year ended March 31, 2026, payable on June 25, 2026 against JPY 33.00 per share a year ago. Provided dividend guidance for the second quarter of Year ending March 31, 2027. For the period, the company expects dividend of JPY 38.00 per share against JPY 33.00 per share a year ago.

Shionogi & Co., Ltd. announced that results from its global, double-blind, randomized, placebo-controlled Phase 3 study,SCORPIO-PEP, were published in the New England Journal of Medicine [1]. A five-day course of ensitrelvir significantly reduced the risk of symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared to placebo.1 Among participants in the primary analysis population (n=2,041) who received ensitrelvir, 2.9% developed symptomatic COVID-19, compared to 9.0% of those who received placebo through Day 10 (risk ratio: 0.33; 95% confidence interval [CI]: 0.22-0.49; pAbout SCORPIO-PEP The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of ensitrelvir as post-exposure prophylaxis. The study included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test. The trial was conducted from June 2023–September 2024. More than 98% of household contacts tested positive for SARS-CoV-2 N and/or S antibodies, indicating that nearly all had evidence previous SARS-CoV-2 infection or vaccination, or both. Study participants were randomly assigned at a 1:1 ratio to receive ensitrelvir (375 mg on day 1 and 125 mg on days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 (index patient) began showing symptoms. Participants then continued ensitrelvir (125 mg) or placebo for five days. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual. Ensitrelvir is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. Ensitrelvir is under review by the U.S. FDA for post-exposure prophylaxis (PEP) of COVID-19, with a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026. Ensitrelvir, known as XOCOVA® in Japan, received emergency regulatory approval [2] in Japan in November 2022 and full approval [3] in March 2024 for the treatment of COVID-19 based on results [4] from SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the pandemic. Results from this study were published [5] in JAMA Network Open. In 2025, Shionogi submitted a supplemental New Drug Application for COVID-19 treatment in pediatric patients aged 6 to under 12 years in Japan. In March 2026, XOCOVA received approval in Japan for the prevention of COVID-19 following exposure [6]. Ensitrelvir is currently under regulatory review in Taiwan [7] for post-exposure prophylaxis of COVID-19.

Shionogi & Co., Ltd. reported earnings results for the full year ended March 31, 2026. For the full year, the company reported sales was JPY 499,677 million compared to JPY 438,268 million a year ago. Net income was JPY 205,159 million compared to JPY 170,435 million a year ago. Basic earnings per share from continuing operations was JPY 241.11 compared to JPY 200.36 a year ago. Diluted earnings per share from continuing operations was JPY 241.04 compared to JPY 200.29 a year ago.

Shionogi & Co., Ltd., Annual General Meeting, Jun 24, 2026, at 10:00 Tokyo Standard Time. Location: Grand Hall, Congrès Square Grand Green Osaka Grand Green Osaka South Building 4F, 5-54 Ofuka-cho, Kita-ku, Osaka Japan Agenda: To consider the business report, consolidated financial statements and non-consolidated financial statements for the 161st fiscal term commenced april 1, 2025 and ended march 31, 2026; to consider the audit report of the consolidated financial statements for the 161st fiscal term year ended march 31, 2026 by the accounting auditor and the audit and supervisory committee; and to transact such other business matters.

Shionogi & Co., Ltd. announced that they will report Q1, 2027 results on Aug 03, 2026

Shionogi & Co., Ltd., Board Meeting, Apr 27, 2026. Agenda: To consider Notice Regarding the Absorption-Type Merger of Torii Pharmaceutical Co., Ltd., a Wholly Owned Subsidiary.

Shionogi & Co., Ltd. announced that they will report fiscal year 2026 results on May 12, 2026

Shionogi & Co., Ltd., 2026 Earnings Call, May 13, 2026

Restore Vision Inc. announced that it has raised ¥1,300 million a round of funding on April 15, 2026. The transaction included participation from returning investors Higin Capital Co., Ltd., Kyoto University Innovation Capital Co., Ltd., JIC Venture Growth Investments Co., Ltd., Japan Science And Technology Agency, Remiges Ventures, Astellas Venture Management LLC, Ajinomoto Co., Inc., Nippon Venture Capital Co., Ltd., Shionogi & Co., Ltd. The company will issue Convertible Preferred Stock in the transaction. The transaction brings the total amount raised by the company to exceeds ¥5.8 Billion.

Shionogi & Co., Ltd. presented new real-world data evaluating Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin, in adults with confirmed MBL-producing Enterobacterales infections at the 36th Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, 17th-21st April, 2026. Cefiderocol is for the treatment of seriously ill adult patients with complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain Gram-negative bacterial infections. The CIRCE study was a retrospective, observational, multicenter chart review study conducted in Spain between January 2023 and April 2025, designed to describe the effectiveness and safety of real-world cefiderocol use in 232 adult patients with infections caused by MBL-producing Enterobacterales. The analysis found 68% of patients who received cefiderocol were considered clinically cured at day 14 and 82% of patients achieved clinical response at day 14. The overall rates of survival at days 14 and 28 were 90% and 83%, respectively, in this population. At baseline, 29% of patients were immunosuppressed, 27% were in intensive care and 13% presented with septic shock. Drug associated adverse events were collected through routine chart review with no new identified safety signals beyond the established safety profile of cefiderocol. MBL-producing Enterobacterales inactivate almost all beta-lactam antibiotics, including carbapenems - agents typically reserved for severe or high-risk infections, thereby limiting therapeutic options. In the CIRCE study, the most frequently identified pathogens were carbapenem-resistant Klebsiella pneumoniae and Enterobacter spp. respectively, both classified by the World Health Organization as critical priority pathogens due to their high levels of resistance to currently available therapies. Among patients with available follow-up cultures, microbiological eradication rates were reported as 85% in bloodstream infections and 82% in urinary tract infections (UTIs). Approximately half of patients received cefiderocol based on susceptibility testing. Additional data presented at ESCMID 2026 evaluated the in vitro activity of cefiderocol against more than 4,000 Stenotrophomonas maltophilia clinical isolates collected through the multinational SIDERO-WT (2014–2019) and SENTRY (2020–2024) surveillance programmes. Across this 10-year period, there was no significant change in cefiderocol susceptibility observed before or after market introduction. Stenotrophomonas maltophilia is an opportunistic pathogen with high intrinsic resistance to multiple antimicrobial classes, often limiting treatment options in high-risk patients. Data presented at the same congress reinforced cefiderocol’s effectiveness against Stenotrophomonas maltophilia, with a subgroup analysis of 119 patients from the PROVE study demonstrating clinical cure in approximately two-thirds of patients, the majority of whom were critically ill and receiving care in intensive care units. In the U.S., cefiderocol is commercially available under the brand name Fetroja and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Europe, cefiderocol is commercially available under the brand name Fetcroja for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. In Japan, cefiderocol is commercially available under the brand name Fetroja and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species. Fetroja (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja. An increase in 28-day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.

On April 1, 2026, ViiV Healthcare Limited closed the transaction.

Shionogi & Co., Ltd. (TSE:4507) entered into an equity transfer agreement to acquire 50% stake in Shionogi-Apnimed Sleep Science, LLC from Apnimed, Inc. for $150 million on March 23, 2026 The transaction is expected to close in the second quarter of 2026.

Shionogi & Co., Ltd. announced that it has received approval in Japan for an expanded indication of XOCOVA (generic name: ensitrelvir fumaric acid), an anti SARS-CoV-2 drug, for post-exposure prophylaxis of COVID-19. The approval is based on the positive results from the Global Phase 3 Study, SCORPIO-PEP. COVID-19 remains a public health threat. While vaccination is considered the foundation of COVID-19 prevention, declining vaccination rates, waning immunity following vaccination, and the potential emergence of new variants make it difficult to fully prevent SARS-CoV-2 infection, symptom onset, or disease severity through vaccination alone. Under these circumstances, post-exposure prophylaxis with an antiviral agent represents an important option for the prevention of COVID-19, particularly for individuals with risk factors for severe disease who have been exposed to a person with COVID-19. Ensitrelvir, known as XOCOVA in countries where it is approved, received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19. Furthermore, in 2025, based on the positive results from the global Phase 3 post-exposure prophylaxis study (SCORPIO-PEP), Shionogi submitted a supplemental New Drug Application in Japan for an expanded indication of ensitrelvir for the post-exposure prophylaxis of COVID-19. In addition, a Phase 3 study in Japan in pediatric patients demonstrated favorable safety and tolerability, and showed that the pharmacokinetics of ensitrelvir in pediatric patients were similar to those observed in adults. Based on these results, Shionogi also submitted an application to expand the approved dosage and administration from the current treatment indication for patients aged 12 years and older to include pediatric patients aged 6 years and older weighing 20 kg or more. It became available in Singapore via a Special Access Route application in 2023, and it is currently under regulatory review for the treatment of COVID-19 in Taiwan. Ensitrelvir is currently under review by the U.S. Food and Drug Administration for the prevention of COVID-19 following exposure, with a Prescription Drug User Fee Act target action date of June 16, 2026. Ensitrelvir is also under regulatory review with the European Medicines Agency for COVID-19 post-exposure prophylaxis and treatment. Product name XOCOVA Tablets 125mg Generic Name ensitrelvir fumaric acid Indication Treatment and post-exposure prophylaxis of SARS-CoV-2 infection Dosage Regimen The usual dosage for children aged 12 years or older and adults is 375 mg of ensitrelvir orally on Day 1 and 125 mg once daily from Days 2 to 5. Drug price JPY 7,090 per 125mg tablet Marketing Authorization Holder Shionogi & Co., Ltd. The dosage and administration of this product are the same for both treatment and post-exposure prophylaxis. Ensitrelvir is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease. Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the epidemic. In this study, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in a predominantly vaccinated population of patients with mild-to-moderate SARS-CoV-2 infection, regardless of risk factors. Regarding safety, most adverse events were mild in severity and no deaths were seen in the study. Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies. The data from this study were published in JAMA Network Open. Additionally, the Phase 3 SCORPIO-HR study assessed ensitrelvir in a broad range of symptomatic, non-hospitalized participants with COVID-19, regardless of past SARS-CoV-2 infection. The study did not meet its primary endpoint of a statistically significant reduction in time to sustained resolution (symptom resolution sustained for at least 48 hours) of 15 common COVID-19 related symptoms for once-daily ensitrelvir compared to placebo. No new safety concerns were identified in the study, and treatment with ensitrelvir was well tolerated, with a similar adverse event profile as placebo. Shionogi recently announced that its global, double-blind, randomized, placebo-controlled Phase 3 study (SCORPIO-PEP) assessing ensitrelvir as oral post-exposure prophylaxis met the primary endpoint of preventing COVID-19. SCORPIO-PEP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19. SCORPIO-PEP assessed 2,387 study participants aged 12 years and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. Study participants were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo, once daily, and began treatment within three days of when the household member with COVID-19 began showing symptoms. Participants then continued ensitrelvir or placebo for five days. Overall, ensitrelvir was generally well tolerated, with similar rates of adverse events in the ensitrelvir group and the placebo group (15.1% and 15.5%, respectively). There were no COVID-19 related hospitalizations or deaths.

Shionogi & Co., Ltd. announced the first patients were enrolled in Esprit, a global Phase 2 clinical trial evaluating S-606001, an investigational drug for the treatment of late-onset Pompe disease (LOPD). Esprit is a multicenter, randomized, placebo-controlled, double-blind study evaluating the safety, pharmacodynamics and preliminary efficacy of S-606001 as an oral substrate reduction therapy (SRT) in addition to standard of care enzyme replacement therapy (ERT) in adults with a confirmed diagnosis of LOPD. This 52-week study will enroll participants across the U.S., European Union and United Kingdom. Pompe disease is a rare genetic metabolic disorder that presents in children and adults. In people with Pompe disease, a deficiency of the acid alpha-glucosidase (GAA), an enzyme necessary for the breakdown of glycogen, results in the accumulation of glycogen in tissues throughout the body, especially in muscles. In LOPD, GAA activity is partially reduced. This can cause severe weakness and respiratory issues leading to respiratory insufficiency, wheelchair dependency and a shortened lifespan. LOPD affects about one in every 22,000 people worldwide and may be identified at any age. Despite significant progress in diagnosis in countries with newborn screening programs, identifying LOPD in people who are not screened at birth remains challenging. Its rarity, wide range of clinical presentations, and overlap with other neuromuscular disorders often lead to delays in diagnosis. S-606001 is an investigational SRT that is believed to work by limiting glycogen buildup in muscle lysosome by inhibiting glycogen synthase (GYS1). ERT, the current approved treatment for Pompe disease, infuses more GAA enzyme to increase glycogen breakdown. SRT blocks the GYS1 enzyme to slow down glycogen buildup. Because SRT targets the opposite side of the glycogen buildup problem from ERT, it has the potential to work alone or in combination with ERT. Shionogi acquired exclusive worldwide rights for S-606001 (previously known as MZE001) from Maze Therapeutics Inc. in 2024. In 2025, S-606001 received a rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the treatment of Pompe disease, a designation granted for serious and life-threatening diseases that primarily affect children ages 18 years or younger with fewer than 200,000 people in the U.S. The FDA also granted Orphan Drug Designation to the compound in 2022. S-606001 is currently under investigation in clinical trials for the treatment of late-onset Pompe disease. The safety and effectiveness of S-606001 have not been established, nor has it been approved by FDA or any health authority.

Shionogi & Co., Ltd., Board Meeting, Feb 20, 2026. Agenda: To discuss a basic policy, to implement an absorption-type merger, effective April 1, 2027, with TORII PHARMACEUTICAL Co., Ltd.

Shionogi & Co., Ltd. reported earnings results for the nine months ended December 31, 2025. For the nine months, the company reported sales was JPY 360,684 million compared to JPY 333,600 million a year ago. Net income was JPY 158,225 million compared to JPY 133,803 million a year ago. Basic earnings per share from continuing operations was JPY 185.95 compared to JPY 157.3 a year ago. Diluted earnings per share from continuing operations was JPY 185.91 compared to JPY 157.25 a year ago.

ViiV Healthcare Limited announced that it will issue shares for total proceeds of $2.125 billion on January 20, 2026. The transaction is participated returning investor, Shionogi & Co., Ltd. The company will issue additional new common shares to Shionogi & Co., Ltd., increasing its voting stake in the company to 21.7% from 10%. The acquisition of additional shares is expected to be completed by the end of March 2026.

Shionogi & Co., Ltd. expected to report Fiscal Year 2026 results on May 8, 2026. This event was calculated by S&P Global (Created on January 30, 2026).

Shionogi & Co., Ltd., Q3 2026 Earnings Call, Jan 30, 2026

Shionogi & Co., Ltd., Board Meeting, Dec 22, 2025. Agenda: To acquire a newly established company that Tanabe Pharma Corporation will create to hold the rights to RADICAVA ORS® and IV RADICAVA. Tanabe Pharma plans to form this new entity, and Shionogi intends to purchase 100 percentage of its shares. The agreement between Shionogi and Tanabe Pharma was signed this afternoon. As part of the transaction, a new business company established by Tanabe for RADICAVA in the U.S. will become a wholly owned subsidiary of Shionogi Inc; and to consider other business matters.

2025 Sustainability Meeting

Shionogi & Co., Ltd. (TSE:4507) agreed to acquire Pharmaceutical business of Japan Tobacco Inc from Japan Tobacco Inc. (TSE:2914) on May 7, 2025. Negotiations on the Tender Offer Price have taken place consistently between the Target Company and the Tender Offeror from the beginning, without the involvement of Japan Tobacco. In light of these circumstances, the Special Committee does not believe that the terms and conditions of the Absorption-type Split have had any adverse impact on the terms and conditions of the Tender Offer, including the Tender Offer Price. In addition, the Special Committee has confirmed, from sources including answers received from the Tender Offeror and Japan Tobacco, that, in regard to the proposed acquisition of the JT Pharmaceutical Business the Tender Offeror through the Absorption-type Split in connection with the Transaction. After consideration, the Tender Offeror concluded that acquiring the JT Pharmaceutical Business and making the Target Company a wholly-owned subsidiary of the Tender Offeror was highly significant to realizing the vision. For the period ending December 31, 2024, Pharmaceutical business of Japan Tobacco Inc reported total revenue of ¥44.94 billion. The expected completion of the transaction is December 1, 2025 to December 31, 2025. The effective date of Absorption-type Split of Pharmaceutical business of Japan Tobacco Inc has been set as December 1, 2025. Shionogi & Co., Ltd. (TSE:4507) completed the acquisition of Pharmaceutical business of Japan Tobacco Inc from Japan Tobacco Inc. (TSE:2914) on May 7, 2025.

Shionogi & Co., Ltd. announced it will implement a corporate reorganization and several personnel reassignments, effective December 1, 2025, in line with the upcoming absorption-type merger of Japan Tobacco Inc.'s pharmaceutical business. As part of the reorganization, Shionogi will establish the Central Pharmaceutical Research Institute and the Development Business Division under its R&D Supervisory Unit. The Venture Alliance Management Office, under the same unit will also be renamed the Alliance Management Office.

Shionogi & Co., Ltd. announced it will implement a corporate reorganization and several personnel reassignments, effective December 1, 2025, in line with the upcoming absorption-type merger of Japan Tobacco Inc.'s pharmaceutical business. As part of the reorganization, Shionogi will establish the Central Pharmaceutical Research Institute and the Development Business Division under its R&D Supervisory Unit. The Venture Alliance Management Office, under the same unit will also be renamed the Alliance Management Office. In connection with the changes, Makoto Kakutani has been appointed Senior Vice President of the Central Pharmaceutical Research Institute, while Takayuki Yamaguchi will serve as Senior Vice President of the Development Business Division.

Shionogi & Co., Ltd., ¥ 33.0, Cash Dividend, Mar-30-2026

Shionogi & Co., Ltd. announced dividend of JPY 33.0 per share for the second quarter ended September 30, 2025 against JPY 85.00 per share paid a year ago. Scheduled date of dividend payments on December 01, 2025.

Shionogi & Co., Ltd. revised consolidated earnings guidance for the fiscal year ending March 31, 2026. For the period, the company now expects revenue of JPY 500,000 million, operating profit of JPY 185,000 million, profit attributable to owners of parent of JPY 188,000 million and basic earnings per share of JPY 220.94 compared to previous guidance for revenue of JPY 530,000 million, operating profit of JPY 175,000 million, profit attributable to owners of parent of JPY 180,000 million and basic earnings per share of JPY 211.59. Reasons for revisions to consolidated earnings forecasts: Regarding revenue, while the company anticipates an increase due to steady progress in the overseas and HIV businesses, full- year results are expected to fall short of the previous forecast due to delays in the progress of domestic prescription drugs, including acute respiratory infection drugs, during the interim consolidated fiscal period ended September 30, 2025. On the profit side, the company expects operating profit, profit before tax, and profit attributable to owners of parent to all be higher than the previous forecasts. This is because cost reduction through thorough company-wide cost management is likely to offset the decrease in revenue and an increase in other income is expected to drive profit expansion. Reflecting the above outlook, the company has revised earnings forecast upward.

Shionogi & Co., Ltd., Board Meeting, Oct 27, 2025. Agenda: To consider the company analyzed its current situation and decided on future policies to achieve management that is conscious of capital costs and stock prices.

Shionogi & Co. Ltd. presents new data at IDWeek 2025, demonstrating broad activity of Fetroja®?/F etcroja®? (cefiderocol) across infection types and adult patient populations. Results from the PROVE (Retrospective Cefiderocol Chart Review) study showed the effectiveness of earlier appropriate cefiderocol use in real-world settings, while data from the SENTRY Antimicrobial Surveillance Program further demonstrated the effectiveness of a broad range of clinically significant Gram-negative (GN) pathogens to cefiderocol. PROVE is a five-year, international, retrospective, observational medical chart review study, conducted between November 2020 and July 2024 in >1000 patients in the U.S. and EU. The study is designed to evaluate the effectiveness and safety of real-world cefiderocol use in adult patients with serious infections caused by GN pathogens, the majority of which were resistant to carbapenem antibiotics. The analysis of the U.S. cohort of the PROVE study assessed clinical cure rate (defined as resolution or improvement of signs or symptoms with no subsequent signs of relapse or mortality) in mostly seriously ill patients treated with cefiderocol. In the study, 57.3% of patients were in the intensive care unit and 47.6% were receiving organ support (such as mechanical ventilation or use of vasopressor medication) at cefiderocol initiation. The overall clinical cure rate for infections across different infection sites was 70.1%. Clinical cure rate was 73.7% among patients who received cefiderocol before the causative bacteria had been identified (empiric treatment), while the clinical cure rate was lower (54.3%) when cefiderocol was used as salvage therapy.

Shionogi & Co., Ltd., Q2 2026 Earnings Call, Oct 28, 2025