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2025-08-04
Shionogi & Co., Ltd. Presents at 9th Tokyo International Conference on African Development, Aug-20-2025 through Aug-22-2025. Venue: Pacifico Yokohama, Hall D, Yokohama, Japan. Presentation Date & Speakers: Aug-20-2025, Takuko Sawada, Vice Chairperson.
2025-08-04
Ministry of Foreign Affairs, Japan, African Union Commission, The World Bank Group, United Nations, United Nations Development Programme, 9th Tokyo International Conference on African Development, Aug 20, 2025 through Aug 22, 2025. Venue: Pacifico Yokohama, Hall D, Yokohama, Japan.
2025-07-10
Stibo Systems K.K. announced that Shionogi & Co. Ltd. has implemented its master data management (MDM) solution, "Stibo Systems MDM," in collaboration with Hitachi Ltd. (headquartered in Chiyoda-ku, Tokyo; hereinafter "Hitachi"). This initiative is part of Shionogi's ongoing efforts to strengthen its data management framework, as outlined in its press release dated January 22, 2025, "Shionogi and Hitachi Launch Strategic Partnership to Create Innovative Services for the Pharmaceutical and Healthcare Industries Leveraging Data and Generative AI. It represents a key step in advancing data-driven management at the company. Stibo Systems' multi-domain MDM platform enables integrated management of a wide range of master data--including product, organization, location and calendar--thereby contributing to enhanced operational efficiency and data governance. Hitachi supported the design and implementation of the solution in alignment with Shionogi's business requirements, working closely with Stibo Systems throughout the process. Stibo Systems will continue to strengthen their collaboration to further evolve and expand MDM capabilities, supporting Shionogi's sustainable growth and global digital transformation.
2025-07-03
Stallergenes Greer, Shionogi & Co. Ltd. and CEOLIA Pharma Co. Ltd. announced the transition of promotional activities for Actair®? in Japan. Actair®? is Stallergenes Greer's sublingual immunotherapy tablet for the treatment of patients suffering from house dust mite induced allergic rhinitis. After ending the license agreement established in 2010 with Shionogi, which had been responsible for developing, registering, and commercialising Actair®? in Japan, Stallergenes Greer has appointed CEOLIA as its new promotional partner in the country starting July 3. To ensure the continuity of both patient care and support for healthcare professionals, Shionogi will continue during a transition period to serve as the Marketing Authorization Holder (MAH) in Japan and remain responsible for the importation, manufacturing and distribution of Actair®?. Shionogi will also provide active support to CEOLIA by transferring knowledge and offering operational assistance.
2025-07-02
BioVersys AG announced a research and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co. Ltd., to jointly develop novel ansamycin leads from BioVersys' BV500 program into clinical candidates. Under the terms of the agreement, BioVersys will receive an upfront payment and near-term research payments totaling CHF 5.0 million. Once clinical candidates have been selected, Shionogi may exercise a license option for which BioVersys would be eligible to receive up to CHF 479 million in regulatory and sales milestones, as well as tiered royalties on global sales. The BV500 NTM program is derived from the company's proprietary Ansamycin Chemistry platform. Shionogi is an ideal partner for this programme, given its expertise and commitment in infectious diseases and the company's global reach. Partnerships like this one strongly benefit patients and other stakeholders. Beyond the BV500 program, BioVersys remains on track to initiate the Phase 3 trial for most advanced asset BV100 later this year and look forward to updating stakeholders on the progress. The joint research teams aim to deliver clinical candidates and back-up molecules during the research collaboration period. Shionogi will have the exclusive option to license a selected number of molecules for further clinical development and global commercialization. The BV500 program arose from a successful collaboration within the SmartLab public private partnership with the University of Lille (France) as an incubator for early-stage idea generation, underlining that efficient research in the field of antibiotics works best in collaboration. The BV500 program has also received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM programme. Where applicable, these partnerships will continue during the ongoing research and development of BV500.
2025-06-30
Shionogi & Co., Ltd. announced that it has submitted a supplemental New Drug Application (sNDA) in Japan to expand the indication of its investigational oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter "ensitrelvir") for the treatment of COVID-19, from the current approval for patients aged 12 years and older to include pediatric patients aged 6 years and older weighing 20 kg or more. Additionally, Shionogi has filed for approval of a new formulation (25mg tablet) to facilitate easier administration for pediatric patients. The sNDA is based on the positive results from the Phase 3 study in pediatric patients aged 6 to under 12 years in Japan (jRCT:2031230140). The primary objective of this study was to evaluate the safety, tolerability, and pharmacokinetics of ensitrelvir once daily for 5 days in pediatric subjects aged 6 to 12 years. One hundred and seventeen patients were enrolled in this study. The study confirmed safety and tolerability and found the pharmacokinetics of ensit Relvir in this age group was similar to adults. There is a need for the development of safe and convenient oral antiviral treatments for this population. If this application is approved, ensitrelvir is expected to be a new treatment option available for pediatric patients aged 6 years and old weighing 20 kg or more. Ensitrelvir was granted Fast Track designation by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19 and was granted Fast Track designation by The FDA in 2023 for the treatment of COVID -19. Shionogi initiated the rolling submission of a new drug application (NDA) with the FDA for Post-Exposure Prophylaxis of COVID -19 in 2025. 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. In 2025, based on the favorable outcomes of the SCORPIO-PEP trial, a global Phase 3 post-exposure prevention study1, Shionogi submitted a supplemental New Drug Application for ensitrelvir in Japan for the post-ex exposure prophyl axis of COVID-19 in 2025. It became available in Singapore via a Special Access Route application in 2023, and it is currently under regulatory review in Taiwan. Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova®? has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore. 4. 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 symptomatic COVID-19 through day 101. SCORPIO-P EP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophphylaxis to meet the primary endpoint of preventing COVID-19. An investigator-initiated research study with ensitrelvir is ongoing in hospitalized patients for the management of COVID-19 as part of the Strategies and Treatments for Respiratory Infections & Viral Emer Emer emergencies (STRIVE) platform protocol. STRIVE was developed under the auspices of NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. Shionogi also recently released preliminary results from a multicenter, randomized, double-blind, placebo-controlled trial of ensitrelvir in mild to moderate COVID-19 patients aged 6 to under 12 months in Japan. The study confirmed safety and tolerated and found the pharmacokinetic of ensitrelvir in this age group similar to adults. R risks and uncertainties include general domestic and international economic conditions such as general domestic and market conditions such as general industry and market conditions such as general international economic conditions such as general industry and changes of interest rate and currency exchange rate and currency exchange rate.
2025-06-27
Shionogi & Co., Ltd., Q1 2026 Earnings Call, Jul 28, 2025
2025-06-19
Shionogi & Co., Ltd. (TSE:4507) proposed to acquire 44.1% stake in Torii Pharmaceutical Co., Ltd. (TSE:4551) from group of sellers for ¥80.7 billion on May 1, 2025. A cash consideration valued at ¥6350 per share will be paid by Shionogi & Co., Ltd. In related transaction Shionogi & Co., Ltd. (TSE:4507) will purchase Japan Tobacco's stake via an agreement. The Board of Directors of Torii Pharmaceutical Co., Ltd. formed a special committee for the transaction. The expected completion of the transaction is June 25, 2025. As of May 28, 2025, Amendment to “Notice of Commencement of Tender Offer for Shares of TORII PHARMACEUTICAL. The Tender Offer may be withdrawn or otherwise canceled upon the occurrence of any of the events listed in Article 14, paragraph (1), item (i), sub-items (a) through (j) and (m) through (s), item (ii), sub-items (a) through (h) and (j), and Article 14, paragraph (2), items (iii) through (vi) of the Order for Enforcement of the Financial Instruments and Exchange Act (Cabinet Order No. 321 of 1965, as amended thereafter; hereafter, the “Enforcement Order”). The Tender Offer may be withdrawn or otherwise canceled upon the occurrence of any of the events listed in Article 14, paragraph (1), item (i), sub-items (a) through (j) and (m) through (s), item (iii), sub-items (a) through (h) and (j), and Article 14, paragraph (2), items (iii) through (vi) of the Order for Enforcement of the Financial Instruments and Exchange Act (Cabinet Order No. 321 of 1965, as amended thereafter; the “Enforcement Order”). The transaction is subject to minimum tender of 3,342,000 shares. Mizuho Securities Co., Ltd. acted as financial advisor for Torii Pharmaceutical Co., Ltd. SMBC Nikko Securities Inc. acted as financial advisor for Shionogi & Co., Ltd. Nagashima Ohno & Tsunematsu acted as legal advisor for Torii Pharmaceutical Co., Ltd. Nishimura & Asahi acted as legal advisor for Shionogi & Co., Ltd. Shionogi & Co., Ltd. (TSE:4507) completed the acquisition of 44.1% stake in Torii Pharmaceutical Co., Ltd. (TSE:4551) from group of sellers on June 18, 2025. Shionogi & Co., Ltd. was able to tender 10,977,091 shares which is more than the minimum shares condition, hence it will acquire all the shares.
2025-06-18
Shionogi & Co., Ltd., Board Meeting, Jun 18, 2025. Agenda: To consider notice of Disposal of Treasury Shares as Restricted Stock Compensation Plan.
2025-05-30
Shionogi & Co., Ltd. announced that the New Drug Application (NDA) for naldemedine tosilate (hereinafter "naldemedine"), a treatment for opioid-induced constipation (OIC), has been accepted in China. Naldemedine is a peripherally acting u-opioid receptor antagonist (PAMORA) originally developed by company. It has been launched in countries and regions such as Japan, the United States, Europe, and Taiwan, contributing to the improvement of symptoms in many patients suffering from opioid-induced constipation (OIC). In cancer pain management, opioid analgesics play a central role; however, their side effects can sometimes make continued treatment difficult. Among these, constipation is a common adverse effect observed in 40- 80% of patients using opioid analgesics. It imposes a significant physical burden and greatly affects patients' quality of life (QOL), making it a major challenge in pain management. In China, treatment options for OIC are limited, and current approaches mainly involve symptomatic treatments such as dose adjustments of opioids or the use of laxatives. Therefore, there is a strong need for new therapeutic options to achieve better pain management. The approval of naldemedine in China is expected to contribute to improving the QOL of patients suffering from OIC. This new drug application is based on favorable results from a Phase III clinical trial conducted in China targeting patients with OIC. The application was submitted through group company, Shionogi China Co., Ltd. (Head Office: Shanghai, China; Chairman and CEO: Tatsumori Yoshida.; hereafter "SCN"), Following approval, the sales of naldemedine inChina will be handled by SCN which has entered into an exclusive license agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ((Head Office: Jiangsu Province, China; CEO: Eric Tse.; hereinafter "CTTQ") for the import and domestic distribution of the product.CTTQ will be responsible for sales in mainland China, and company will receive a certain amount of revenue based on sales volume. Shionogi has identified "contributing to a healthier and more prosperous life" as a key material issue and is committed to creating a society where everyone can live longer, more vibrant lives in their own way. The company will continue to contribute to improving the Qol of patients suffering from various types of pain. Naldemedine is an peripherally acting u-opIOid receptor antagonist that binds to u-opioid receptors in the gastrointestinal tract and counteracts the peripheral effects of opioids, thereby improving OIC. Naldemedine has been approved in countries and regions including Japan, the United States, European, and Taiwan. It is marketed under the brand name Symproic®? in Japan, the United States, and Taiwan, and as Rizmoic®? in Europe. This Phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled study conducted in China to evaluate the efficacy and safety of naldemedine in adult patients with opioid-induced constipation (PAMORA) who were receiving opioid analgesic therapy. The primary endpoint of the study was the proportion of patients who achieved three or more spontaneous bowel movements (SBMs) per week, along with an increase of at least one SBM per week from baseline. The naldemedine treatment group demonstrated a statistically significant improvement compared to the placebo group.
2025-05-27
Shionogi & Co., Ltd. and Veritas In Silico Inc. are conducting joint drug discovery research of mRNA-targeted small molecules to create small molecule drugs targeting mRNA based on the "Joint Drug Discovery Research Agreement" dated November 16, 2021. The Companies have announced that it has reached a milestone in the progress of the Joint Drug Discovery Research. In the Joint Drug Discovery Research, Shionogi and VIS utilize VIS's proprietary drug discovery platform, ibVIS®?, to target mRNAs corresponding to several genes related to infectious diseases and psychiatric and neurological disorders that Shionogi has been focusing on. The Joint Drug Discovery Research covers everything from identifying target structures on the mRNAs to discovering novel drug candidates that act on those structures and exhibit efficacy in animal models.
2025-05-20
Shionogi & Co., Ltd. announced that, at a meeting of its Board of Directors held on May 12, 2025, it resolved to propose the Amendments to Articles of Incorporation to the 160th Annual General Meeting of Shareholders to be held on June 18, 2025. Purpose and Reason for Amendments to the Articles of Incorporation: As has already been announced in the press release1) made on March 24, 2025, Shionogi has decided to transition to a company with an Audit and Supervisory Committee, subject to approval at the 160th Annual General Meeting of Shareholders, in order to further enhance and strengthen the corporate governance system and to realize sustainable improvement of enterprise value. By becoming a company with an Audit and Supervisory Committee, we will further strengthen oversight over the Representative Director within the Board of Directors, and on that basis, establish a framework that enables the Board of Directors to determine and distinguish between proposals that should be left to the executive side and proposals that should be discussed by the Board of Directors, thereby enabling the Board to focus on discussing medium- to long-term company-wide strategies with an emphasis on maintaining a balance with each stakeholder and to delegate authority to expedite decision-making. The Audit and Supervisory Committee will use its authority and the internal auditing division to further strengthen the monitoring and oversight of the overall executive decision-making process. While ensuring diversity of skills, etc., we will develop a framework to facilitate the election of additional executive directors with knowledge and experience of SHIONOGI's business, while maintaining a Board of Directors with a majority of Outside Directors, with a view to promote globalization and business model transformation. Accordingly, the necessary amendments will be made, including the establishment of new provisions regarding Audit and Supervisory Committee Members and the Audit and Supervisory Committee, the deletion of provisions regarding auditors and the Board of Auditors and the establishment of new provisions regarding changes in the number of Directors and the delegation of important business execution decisions. Other necessary amendments, such as the addition, deletion or revision of necessary wording, and adjustments of the number of articles, will be made. Schedule of Amendments: These amendments to the Articles of Incorporation shall take effect at the conclusion of the 160th Annual General Meeting of Shareholders to be held on June 18, 2025.
2025-05-17
Shionogi & Co., Ltd. announced that they will report Q1, 2026 results on Jul 28, 2025
2025-05-16
Shionogi & Co., Ltd., Board Meeting, May 12, 2025. Agenda: To propose the Amendments to Articles of Incorporation at the upcoming AGM.
2025-05-12
Shionogi & Co., Ltd., Annual General Meeting, Jun 18, 2025, at 10:00 Tokyo Standard Time. Location: HERBIS HALL (HERBIS OSAKA B2F) 5-25, Umeda 2-chome, Kita-ku, Osaka 530-0001 Osaka Japan Agenda: To consider appropriation of surplus; to consider amendments to Articles of Incorporation; to elect six directors (other than those who are Audit and Supervisory Committee members); to elect five directors who are Audit and Supervisory Committee members; to elect one substitute director who is an Audit and Supervisory Committee member; to consider setting of amount of remuneration for directors other than those who are Audit and Supervisory Committee members; to consider setting of amount of remuneration for directors who are Audit and Supervisory Committee members; and to consider determination of remuneration for the granting of restricted shares to directors (other than those who are Audit and Supervisory Committee members and outside directors).
2025-05-12
Shionogi & Co., Ltd. expected to report Q1 2026 results on July 29, 2025. This event was calculated by S&P Global (Created on May 12, 2025).
2025-05-12
Shionogi & Co., Ltd. provided consolidated earnings guidance for the Six months ending September 30, 2025 and Year ending March 31, 2026. For the six months period, the company expects Revenue to be JPY 233,000 million, operating profit to be JPY 82,000 million, Profit attributable to owners of parent to be JPY 86,000 million and Basic earnings per share to be 101.09 per share. For the year, the company expects Revenue to be JPY 530,000 million, operating profit to be JPY 175,000 million, Profit attributable to owners of parent to be JPY 180,000 million and Basic earnings per share to be 211.59 per share.
2025-05-12
Shionogi & Co., Ltd. announced dividend of JPY 33.0 per share for the year ended March 31, 2025 against JPY 85.00 per share paid a year ago. Scheduled date of dividend payments June 19, 2025. For the second quarter of 2026, the company expects a dividend of JPY 33.0 per share against JPY 85.0 per share last year.
2025-05-12
Shionogi & Co., Ltd. provided dividend guidance for the fiscal year ending March 31, 2026. For the year, the company expects to pay a dividend of of JPY 33.0 per share against the same amount paid a year ago.
2025-05-07
Shionogi & Co., Ltd., Board Meeting, May 07, 2025. Agenda: To consider commencement of Tender Offer for Shares of TORII PHARMACEUTICAL CO., LTD; and to consider notice of the execution of an agreement for Company Split of the Pharmaceutical Business of Japan Tobacco Inc. and for Acquisition of Shares in Akros Pharma Inc. by Shionogi Inc.
2025-04-24
Shionogi & Co., Ltd. announced that it has made the following revisions to its dividend forecasts for the fiscal year ending March 31, 2025 (fiscal 2024; April 1, 2024 - March 31, 2025). For the year, the company now expects year end dividend of JPY 33.00 per share against previous guidance of JPY 29.00 per share.
2025-04-01
Shionogi & Co., Ltd., 2025 Earnings Call, May 13, 2025
2025-03-31
Shionogi & Co., Ltd. announced that it has initiated the rolling submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter "ensitrelvir"). The rolling submission of ensitrelvir for Post-Exposure Prophylaxis is being made based on the positive results from the Global Phase 3 Study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment - Post-Exposure Prophylaxis (SCORPIO-PEP). COVID-19 continues to pose a health risk for many people and remains a public health threat, with thousands of hospitalizations and hundreds of deaths each week in the U.S. It can impact quality of life, lead to absence from work, cause long COVID, and progress to severe disease, hospitalization and death. With continually decreasing vaccination rates, waning immunity after vaccination, and the potential for new variants to emerge, additional treatment and preventive options for COVID-19 are needed. If this application is approved, ensitrelvir is expected to be the first orally-administered option for the post-exposure prophylaxis of COVID-19 Ensitrelvir was granted Fast Track designation by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19 and was granted Fast Track designation by the FDA in 2023 for the treatment of COVID-19. Shionogi is also in discussions with FDA regarding the treatment indication for COVID-19 with ensitrelvir. 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. In 2025, based on the favorable outcomes of the SCORPIO-PEP trial, a global Phase 3 post-exposure prevention study, an application was submitted in Japan to include additional benefits and efficacy related to the prevention of COVID-19. Shionogi submitted a supplemental New Drug Application for ensitrelvir in Japan for the post-exposure prophylaxis of COVID-19 in 2025. It became available in Singapore via a Special Access Route application in 2023, and it is currently under regulatory review in Taiwan. Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore.
2025-03-27
Shionogi & Co., Ltd. submitted supplemental New Drug Application (sNDA) in Japan for its investigational, oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter "ensitrelvir") for post-exposure prophylaxis of COVID-19. The sNDA is based on the positive results from the Global Phase 3 Study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment - Post-Exposure Prophylaxis (SCORPIO-PEP). COVID-19 remains a public health threat, with the disease exhibiting a high degree of risk as reflected by hospitalizations roughly six times that of influenza, and deaths approximately fifteen times higher in Japan. Vaccination is said to be the basis for preventing COVID-19 . Nonetheless, with continually decreasing vaccination rates, waning immunity after vaccination, and the potential for new variants to emerge, it is challenging to fully prevent viral infection, symptom onset, or the severity of COVID-19 through vaccination alone. Therefore, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed. If this application is approved, ensitrelvir is expected to be the first orally-administered option for the post- exposure prophylaxis of 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. It became available in Singapore via a Special Access Route application in 2023, and it is currently under regulatory review in Taiwan. Ensitrelvir was granted Fast Track designation by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19 and was granted Fast Track designation by the FDA in 2023 for the treatment of COVID-19. Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore.
2025-03-24
Shionogi & Co., Ltd., Board Meeting, Mar 24, 2025. Agenda: To resolve that it will transition from the company with the board of corporate auditors to a company with an audit and supervisory committee; and to consider the other matters.
2025-01-22
Shionogi & Co., Ltd. Presents at IDWeek 2024, Oct-16-2024 . Venue: Los Angeles Convention Center, Los Angeles, California, United States.
2025-01-16
Shionogi & Co., Ltd. Presents at BIO Partnering @JPM Week, Jan-13-2025 . Venue: San Francisco Marriott Marquis, San Francisco, California, United States.
2024-12-24
Shionogi & Co., Ltd., Board Meeting, Dec 23, 2024. Agenda: To consider acquire all shares of the Ping An-Shionogi Co., Ltd. and Ping An-Shionogi (Hong Kong) Limited. joint ventures with subsidiaries of Ping An Insurance (Group) Company of China, Ltd. (Headquarters: Guangdong Province, China; hereinafter "Ping An"), thereby dissolving the joint ventures and making both companies wholly-owned subsidiaries.
2024-12-06
Shionogi & Co., Ltd., Q3 2025 Earnings Call, Jan 31, 2025
2024-10-29
Shionogi & Co., Ltd. announced that they will report Q3, 2025 results at 1:00 PM, Tokyo Standard Time on Jan 31, 2025
2024-10-29
Shionogi & Co., Ltd. announced that they will report fiscal year 2025 results at 1:00 PM, Tokyo Standard Time on May 12, 2025
2024-10-29
Shionogi & Co., Ltd., ¥ 29.0, Cash Dividend, Mar-28-2025
2024-10-29
Shionogi & Co., Ltd. announced that its double-blind, randomized, placebo-controlled global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment - Post Exposure Prophylaxis (SCORPIO-PEP), met its primary endpoint. Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter ensitrelvir) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified. Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV- 2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 for the treatment of COVID-19. In Japan, ensitrelvir, known as Xocova®?, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID -19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore. SCORPIO-PEP included approximately 2,400 participants aged 12 years and older across the U.S. as well as several countries in South America, Africa and Asia. Study participants with a negative screening test for SARS-CoV-2 infection and no symptoms, who were exposed to a person living in their household with symptomatic COVID-19, were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo once daily. Study participants 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. Additional details on the study are available on clinicaltrials.gov (NCT05897541).
2024-10-29
Shionogi & Co., Ltd. expected to report Q3 2025 results on January 29, 2025. This event was calculated by S&P Global (Created on October 29, 2024).
2024-10-29
FY2024 Sustainability Meeting
2024-10-28
Shionogi & Co., Ltd. announced dividend for the second quarter of year Ending March 31,2025 and provided dividend guidance for the full year ending March 31,2025. For the quarter company announced dividend of JPY 85.00 per share for the second quarter of year ending March 31,2025 as compared to JPY 75.00 per share for the previous period, payable on December 2, 2024. For the full year ending, company expected to pay dividend of JPY 29.00 per share as compared to JPY 85.00 for the previous period. The Company conducted a 3-for-1 stock split of shares of common stock, effective October 1, 2024.
2024-10-28
Shionogi & Co., Ltd. revised earnings guidance for the Full Year Ending March 31, 2025. For the year, the company expects Revenue of JPY 460,000, Operating profit to be JPY 165,000. Profit attributable to owners of parent to be JPY 171,000. Basic earnings per share to be 201.03 per share as compared to previous guidance Revenue of JPY 455,000, Operating profit of JPY 160,000. Profit attributable to owners of parent of JPY 163,000. Basic earnings per share of 191.66 per share.
2024-10-07
Next Gen Diagnostics announced an agreement with Shionogi & Co. Ltd. (Shionogi) to develop models to predict susceptibility to cefiderocol. Cefiderocol is an antibiotic that is used to treat infections caused by certain resistant Gram-negative bacteria. Due to cefiderocol's unique mode of cell entry, a special growth medium is required to assess its activity with certain testing methodologies making it less amenable to conventional, automated phenotypic testing devices. With sequence-based determinations of susceptibility, the need for the special medium would be eliminated, allowing for a differentiated test for cefiderocol susceptibility. NGD has built methods and infrastructure to develop and validate whole genome sequencing-based machine learning models to determine antibiotic susceptibility in Gram-negative bacteria. NGD has demonstrated these models to be useful tools to show plausible potential resistance pathways, which can help guide healthcare professionals' approach to antibiotic use. In the U.S., 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 Serratia marcescens.
2024-09-30
Shionogi & Co., Ltd., Q2 2025 Earnings Call, Oct 29, 2024
2024-09-27
Shionogi & Co., Ltd. announced that Shionogi submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). Through a strategic collaboration with Sage Therapeutics, Inc, Shionogi has been granted exclusive development and commercialization rights in Japan, Taiwan, and South Korea1. The NDA submission is based on data from the Phase 3 program conducted by Shionogi in Japan. A Phase 3 validation trial in Japan was conducted to evaluate the efficacy, safety, and tolerability of zuranolone in 412 patients with moderate to severe MDD who were not on other anti-depressant medications. In that study, a statistically-significant improvement in the change from baseline in the HAM-D total score, a measure of MDD severity, was observed in the zuranolone group compared to the placebo group at day 15, achieving the primary endpoint. Additionally, zuranolone showed a statistically significant improvement in MDD symptoms as early as day 3 as measured by the HAM-D total score, demonstrating its rapid onset of action. It is estimated that there are approximately 5 million patients with depression in Japan, making it the most prevalent non-fatal health condition. Existing treatments often take several weeks to become effective, highlighting the need for fast-acting therapies. Zuranolone, which has demonstrated rapid efficacy in previous clinical trials, has the potential to be a novel and much-needed treatment option for MDD, if approved.
2024-08-31
Shionogi & Co., Ltd., 3.0000300003 : 1, Stock Split or Significant Stock Dividend, Sep-27-2024
2024-08-30
Shionogi & Co., Ltd. revised dividend guidance for the fiscal year Ending March 31, 2025. For the year end, the company expects dividend of JPY 87.00 per share against previous guidance of JPY 85.00 per share. As of the record date of September 30, 2024, the common shares held by shareholders listed in the final shareholder register on that date will be split at a ratio of 3 shares for every 1 share.
2024-08-30
Shionogi & Co., Ltd. provided dividend guidance for the second quarter Ending March 31, 2025. For the second quarter ending March 2025, the company expects dividend to be JPY 85.00 per share. Since the effective date of stock split announced by company is October 1, 2024, the dividend for the second quarter of the fiscal year ending March 2025, with a record date of September 30, 2024, will be based on the number of shares before the stock split.
2024-08-30
Shionogi & Co., Ltd. announced that, at the Board of Directors meeting held on August 30, 2024, a resolution was passed regarding a stock split, partial amendment to the articles of incorporation and revision of the dividend forecast for the fiscal year ending March 31, 2025. In accordance with Article 184, Paragraph 2 of the Companies Act, Shionogi will amend a part of their Articles of Incorporation, effective October 1, 2024, due to the stock split. Current articles of incorporation: Article 6 (The total number of shares authorized to be issued): The total number of shares authorized to be issued by the Company shall be 1 billion shares. Articles of incorporation after amendment: Article 6 (The total number of shares authorized to be issued): The total number of shares authorized to be issued by the Company shall be 3 billion shares. Effective Date: October 1, 2024.
2024-08-30
Shionogi & Co., Ltd., Board Meeting, Aug 30, 2024. Agenda: To consider Stock split; to consider Partial amendment of articles of incorporation; and to consider Revision of dividend forecast.
2024-08-28
Shionogi & Co., Ltd. announced that they will report Q2, 2025 results on Oct 28, 2024
2025Q2 | 2025Q1 | 2024Q4 | 2024Q3 | 2024Q2 | 2024Q1 | 2023Q4 | 2023Q3 | |
---|---|---|---|---|---|---|---|---|
Total Revenues | 440,495 | 438,268 | 456,869 | 418,510 | 423,356 | 435,081 | 425,157 | 506,446 |
Pretax Income Excl.Unusual Items | 210,503 | 209,229 | 214,681 | 196,510 | 179,103 | 218,280 | 196,277 | 278,200 |
Total Assets | 1,538,284 | 1,535,349 | 1,516,585 | 1,456,729 | 1,448,677 | 1,416,918 | 1,359,864 | 1,409,593 |
Total Liabilities | 159,801 | 172,853 | 153,979 | 145,930 | 157,745 | 164,357 | 145,522 | 178,161 |
Cash & Cash Equivalents | 254,826 | 374,795 | 305,579 | 303,405 | 281,957 | 358,090 | 284,787 | 252,371 |
Total Common Equity | 1,378,257 | 1,361,924 | 1,345,590 | 1,292,792 | 1,273,606 | 1,235,325 | 1,192,334 | 1,209,378 |
Book Value Per Share (BVPS) | 1,619.98 | 1,600.97 | 1,581.77 | 1,672.86 | 1,497.52 | 1,452.51 | 1,383.22 | 1,383.97 |
Net Change in Cash | -27,132 | 16,704 | 20,791 | 51,034 | -7,119 | 48,866 | 66,118 | 54,328 |
Capital Expenditure | -18,683 | -17,126 | -12,134 | -12,572 | -12,746 | -12,693 | -12,222 | -12,615 |
As of July 28, 2025, Shionogi & published financial results for the second quarter of 2025, having revenues of 99.78B yen and net income of 39.35B yen, reflecting a 2.2% uptick in revenue, coupled with a substantial increase of about 28.4% in EPS relative to the corresponding quarter last year.
In addition, the EBITDA margin improved from 33.8% in the corresponding quarter last year to 40.2%. Another figure worth noting is the free cash flow for the quarter, which was 36.54B yen, an increase of 5.99B yen from the previous year's corresponding period. Following the improvement in cash flow, the company's management returned an impressive amount of 28.11B yen which was paid as a dividend. The dividend yield for this stock is approximately 2.6%, and it trades at 12.3x times current year's earnings, which is higher than the sector average (P/E 9.6x).