Cefiderocol Sulfate Tosylate

OSAKA, Japan, January 22, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that the Taiwan Food and Drug Administration has accepted our new drug application (NDA) for ensitrelvir fumaric acid (hereafter “ensitrelvir”) for the treatment of COVID-19. This NDA was submitted by Taiwan Shionogi & Co., Ltd., (hereafter “Taiwan Shionogi”), the Taiwan subsidiary of Shionogi. Additionally, Taiwan Shionogi and Taiwan Centers for Disease Control have concluded a contract for the purchase of ensitrelvir for stockpiling by the Taiwanese government. Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.  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. COVID-19 continues to mutate and impact the health and lives of many people worldwide, necessitating the ongoing development of effective and safe treatments. It is estimated that there are approximately 1.7 million COVID-19 patients in Taiwan annually*, and ensitrelvir is expected to contribute as a new treatment option for COVID-19. * Cumulative number of patients visiting outpatient and emergency departments in 2024 (Source: Taiwan Centers for Disease Control website) About ensitrelvir 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. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to ensitrelvir for COVID-19. FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need. Known as Xocova® in Japan, ensitrelvir received emergency regulatory approval in 2022 and full approval in March 2024. Ensitrelvir was made available in Singapore in November 2023 based on the Special Access Route application. Ensitrelvir remains 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. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. About the ensitrelvir Clinical Development Program Shionogi has a robust clinical development program for ensitrelvir and is committed to making it available to populations worldwide. In addition to SCORPIO-HR and SCORPIO-PEP, Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 2/3 study conducted in Asia, during the Omicron-dominant phase of the epidemic. The data from this study were published in JAMA Network Open. Additionally, an investigator-initiated research study is ongoing in hospitalized patients for the management of COVID-19 as part of the new Strategies and Treatments for Respiratory Infections & Viral 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 is also studying the safety and efficacy of ensitrelvir in Japan for children between the ages of 6 to 11 years old. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

OSAKA, Japan, December 23, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that, at a meeting held on December 23, 2024, its Board of Directors, resolved to 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. I. Reason for Dissolution of the Joint Venture On July 24, 2020, Shionogi entered into an agreement to establish a joint venture with two subsidiaries of Ping An: Ping An Life Insurance Company of China, Ltd. (headquartered in Guangdong, China, hereinafter "Ping An Life") and Tutum Japan Healthcare Limited (headquartered in the Cayman Islands, hereinafter "Ping An Overseas"), an indirect subsidiary of Ping An and a subsidiary of China Ping An Insurance Overseas (Holdings) Limited. The agreement was made between these entities and our subsidiary, Shionogi (Hong Kong) Co., Ltd. (headquartered in Hong Kong, hereinafter "Shionogi (Hong Kong)"). The joint ventures, Ping An-Shionogi Co., Ltd. and Ping An-Shionogi (Hong Kong) Limited., were established in Shanghai and Hong Kong to engage in joint business activities in Asia, including China 1, 2, 3. In China, Ping An-Shionogi Co., Ltd. and Ping An-Shionogi (Hong Kong) Limited., since their establishment, have made progress with certain Shionogi original drugs such as a New Drug Application and early use in medical special zones of cefiderocol, an antibiotic for Gram-negative bacterial infections 4, 5, and in Singapore, the approval of ensitrelvir (product name in Japan: Xocova® Tablets 125 mg) and cefiderocol based on SAR* applications 6, 7. Regarding our initial goal of utilizing AI for drug discovery in China, we have achieved significant results through our collaboration with Ping An. By combining Ping An’s advanced AI technology with Shionogi’s expertise in drug discovery, we have generated multiple development candidates. After reviewing the joint venture business plan in the context of the business strategies of both Shionogi and Ping An, it was concluded that it would enhance the corporate value of both companies and contribute more to society if Shionogi focused on the research, development, sales, and manufacturing of new drugs in China and Ping An concentrated on its core businesses. Therefore, it was agreed to amicably dissolve the joint venture business. Shionogi will continue to strive to contribute to patients and healthcare in China and Asia and will work to promote its business in these regions. * SAR (Special Access Route): A pharmaceutical system unique to Singapore for importing and supplying unapproved therapeutic drugs. II. Details of the Dissolution of the Joint Ventures i. Content of the Dissolved Joint Venture Business and Method of Transfer of Shares Shionogi and Ping An have agreed to dissolve their two joint ventures. Shionogi (Hong Kong) will acquire the 49% share held by Ping An Life in Ping An-Shionogi Co., Ltd., which conducts pharmaceutical research, development, manufacturing, and sales in China. Additionally, through this transfer agreement, Shionogi (Hong Kong) will acquire the 49% share held by Ping An Overseas Holdings in Ping An-Shionogi (Hong Kong) Limited., which handles IP license management and product import/export operations across Asia. ii. Outline of the Joint Ventures (1) Outline of Ping An-Shionogi Co., Ltd., (1) Name of Company Ping An-Shionogi Co., Ltd. (2) Location Room 602 Kaibin Centre, No. 199 Kaibin Road, Xuhui District, Shanghai, China (3) Representative Tatsumori Yoshida, Chairman and CEO (4) Business Description Investment, pharmaceuticals, clinical-laboratory drugs/instruments research, development, sale, etc., IT-related technology development, services (5) Registered Capital JPY 63,180 million (6) Date of Founding November 2020 (7) Fiscal-year End December (8) Net Assets JPY 24,791 million (Consolidated) (9) Total Assets JPY 28,249 million (Consolidated) (10) Shareholders Shionogi (Hong Kong) 51%, Ping An Life 49% (1) Name of Company Ping An-Shionogi Co., Ltd. (2) Location Room 602 Kaibin Centre, No. 199 Kaibin Road, Xuhui District, Shanghai, China (3) Representative Tatsumori Yoshida, Chairman and CEO (4) Business Description Investment, pharmaceuticals, clinical-laboratory drugs/instruments research, development, sale, etc., IT-related technology development, services (5) Registered Capital JPY 63,180 million (6) Date of Founding November 2020 (7) Fiscal-year End December (8) Net Assets JPY 24,791 million (Consolidated) (9) Total Assets JPY 28,249 million (Consolidated) (10) Shareholders Shionogi (Hong Kong) 51%, Ping An Life 49% Exchange rates are based on the interim rate of JPY 100 = RMB 4.6549 as of December 31, 2023, as announced by the Bank of China. (2) Outline of Ping An- Shionogi (Hong Kong) Limited., (1) Name of Company Ping An-Shionogi (Hong Kong) Limited. (2) Location Room 802, The Gateway Tower 1, Harbour City, 25 Canton Road, Tsim Sha Tsui, Kowloon, Hong Kong, China (3) Representative Tatsumori Yoshida, Chairman and CEO (4) Business Description Equity investment, financial services, IP license management, import/export of products from/to Asian countries (5) Capital JPY 6,220 million (6) Date of Founding August 2020 (7) Fiscal-year End March (8) Net Assets JPY 7,061 million (9) Total Assets JPY 14,055 million (10) Shareholders Shionogi (Hong Kong) 51%, Ping An Overseas 49% (1) Name of Company Ping An-Shionogi (Hong Kong) Limited. (2) Location Room 802, The Gateway Tower 1, Harbour City, 25 Canton Road, Tsim Sha Tsui, Kowloon, Hong Kong, China (3) Representative Tatsumori Yoshida, Chairman and CEO (4) Business Description Equity investment, financial services, IP license management, import/export of products from/to Asian countries (5) Capital JPY 6,220 million (6) Date of Founding August 2020 (7) Fiscal-year End March (8) Net Assets JPY 7,061 million (9) Total Assets JPY 14,055 million (10) Shareholders Shionogi (Hong Kong) 51%, Ping An Overseas 49% Exchange rates are based on the interim rate of JPY 100 = HKD 5.82 as of December 31, 2023, as announced by the Hong Kong Monetary Authority. III. Outline of the Other Parties to the Joint Ventures (1) Ping An Shionogi Co., Ltd., (as of December 31, 2023) (1) Name of Company Ping An Life Insurance Company of China, Ltd. (2) Location 14th, 15th, 16th, 37th, 41st, 44th, 45th and 46th Floors, Ping An Finance Center, No.5033 Yi Tian Road, Futian District, Shenzhen, Guangdong Province, China (3) Representative Yang Zheng, Chairman (4) Business Description Life insurance (5) Capital JPY 527,416 million (6) Date of Founding December 17, 2002 (7) Number of Shares Issued 33,800,000,000 shares (8) Fiscal-year End December (9) Number of Employees 48,556 (10) Main Customers Private individuals (11) Main Banks Bank of China, Industrial and Commercial Bank of China, China Construction Bank, Ping An Bank (12) Major Shareholders and Shareholding Ratios Ping An Insurance (Group) Company of China, Ltd. 99.51% (13) Relationship Between the Parties Capital Relationship The company holds 6,356,000 shares of Shionogi’s common stock, which represents 2.21% of the issued shares. Personal Relationship There is no relationship to be disclosed between the parties. Transactional Relationship There is no relationship to be disclosed between the parties. Status as Related Party There is no relationship to be disclosed between the parties. (14) The consolidated financial performance and financial position of the company for the past three years. (million JPY) Fiscal-year End December, 2021 December, 2022 December, 2023 Net Sales 13,707,480 6,597,054 7,583,173 Operating Income 1,082,838 1,576,940 1,452,113 (1) Name of Company Ping An Life Insurance Company of China, Ltd. (2) Location 14th, 15th, 16th, 37th, 41st, 44th, 45th and 46th Floors, Ping An Finance Center, No.5033 Yi Tian Road, Futian District, Shenzhen, Guangdong Province, China (3) Representative Yang Zheng, Chairman (4) Business Description Life insurance (5) Capital JPY 527,416 million (6) Date of Founding December 17, 2002 (7) Number of Shares Issued 33,800,000,000 shares (8) Fiscal-year End December (9) Number of Employees 48,556 (10) Main Customers Private individuals (11) Main Banks Bank of China, Industrial and Commercial Bank of China, China Construction Bank, Ping An Bank (12) Major Shareholders and Shareholding Ratios Ping An Insurance (Group) Company of China, Ltd. 99.51% (13) Relationship Between the Parties Capital Relationship The company holds 6,356,000 shares of Shionogi’s common stock, which represents 2.21% of the issued shares. Personal Relationship There is no relationship to be disclosed between the parties. Transactional Relationship There is no relationship to be disclosed between the parties. Status as Related Party There is no relationship to be disclosed between the parties. (14) The consolidated financial performance and financial position of the company for the past three years. (million JPY) Fiscal-year End December, 2021 December, 2022 December, 2023 Net Sales 13,707,480 6,597,054 7,583,173 Operating Income 1,082,838 1,576,940 1,452,113 Exchange rates are based on the interim rate of JPY 100 = RMB 4.6549 as of December 31, 2023, as announced by the Bank of China. (2) Other Party to Ping An Shionogi (Hong Kong) Co., Ltd., (as of December 31, 2023) (1) Name of Company Tutum Japan Healthcare Limited (2) Location 4th Floor, Harbour Place, 103 South Church Street, P.O. Box 10240, Grand Cayman KY1-1002, Cayman Islands (3) Representative KUI Kaipin, Director (4) Business Description Investment Holding (5) Capital JPY 4,000,000,000 (6) Date of Founding March 29, 2019 (7) Number of Shares Issued 3 (8) Fiscal-year End December (9) Number of Employees N/A (10) Main Customers N/A (11) Main Banks Bank of China (12) Major Shareholders and Shareholding Ratios 100% held by China Ping An Insurance Overseas (Holdings) Limited (13) Relationship Between the Parties Capital Relationship There is no relationship to be disclosed between the parties. Personal Relationship There is no relationship to be disclosed between the parties. Transactional Relationship There is no relationship to be disclosed between the parties. Status as Related Party There is no relationship to be disclosed between the parties. (1) Name of Company Tutum Japan Healthcare Limited (2) Location 4th Floor, Harbour Place, 103 South Church Street, P.O. Box 10240, Grand Cayman KY1-1002, Cayman Islands (3) Representative KUI Kaipin, Director (4) Business Description Investment Holding (5) Capital JPY 4,000,000,000 (6) Date of Founding March 29, 2019 (7) Number of Shares Issued 3 (8) Fiscal-year End December (9) Number of Employees N/A (10) Main Customers N/A (11) Main Banks Bank of China (12) Major Shareholders and Shareholding Ratios 100% held by China Ping An Insurance Overseas (Holdings) Limited (13) Relationship Between the Parties Capital Relationship There is no relationship to be disclosed between the parties. Personal Relationship There is no relationship to be disclosed between the parties. Transactional Relationship There is no relationship to be disclosed between the parties. Status as Related Party There is no relationship to be disclosed between the parties. (3) Outline of Parent Company of Other Parties to the Joint Ventures (as of December 31, 2023) (1) Name of Company Ping An Insurance (Group) Company of China, Ltd. (2) Location Ping An Finance Center, No. 5033 Yi Tian Road, Futian District, Shenzhen, Guangdong Province, China (3) Representative Ma Mingzhe, Chairman (4) Business Description Insurance Business, Banking Business, Asset Management Business, Technology Business (5) Capital JPY 391,205 million (6) Date of Founding March 21, 1988 (7) Number of Shares Issued 10,762,657,695 A-Shares, 7,447,576,912 H-Shares (8) Fiscal-year End December (9) Number of Employees 288,751 (10) Main Customers ― (11) Main Banks ― (12) Major Shareholders and Shareholding Ratios CP Group Ltd. 5.84% (H-Shares) Shenzhen Investment Holdings Co., Ltd. 5.29% (A-Shares) (13) Relationship Between the Parties Capital Relationship There is no relationship to be disclosed between the parties. Personal Relationship There is no relationship to be disclosed between the parties. Transactional Relationship There is no relationship to be disclosed between the parties. Status as Related Party There is no relationship to be disclosed between the parties. (14) The consolidated financial performance and financial position of the company for the past three years. (million JPY) Fiscal-year End December, 2021 December, 2022 December, 2023 Net Sales 25,359,169 18,912,436 19,630,690 Operating Income 3,000,816 3,068,572 2,596,253 (1) Name of Company Ping An Insurance (Group) Company of China, Ltd. (2) Location Ping An Finance Center, No. 5033 Yi Tian Road, Futian District, Shenzhen, Guangdong Province, China (3) Representative Ma Mingzhe, Chairman (4) Business Description Insurance Business, Banking Business, Asset Management Business, Technology Business (5) Capital JPY 391,205 million (6) Date of Founding March 21, 1988 (7) Number of Shares Issued 10,762,657,695 A-Shares, 7,447,576,912 H-Shares (8) Fiscal-year End December (9) Number of Employees 288,751 (10) Main Customers ― (11) Main Banks ― (12) Major Shareholders and Shareholding Ratios CP Group Ltd. 5.84% (H-Shares) Shenzhen Investment Holdings Co., Ltd. 5.29% (A-Shares) (13) Relationship Between the Parties Capital Relationship There is no relationship to be disclosed between the parties. Personal Relationship There is no relationship to be disclosed between the parties. Transactional Relationship There is no relationship to be disclosed between the parties. Status as Related Party There is no relationship to be disclosed between the parties. (14) The consolidated financial performance and financial position of the company for the past three years. (million JPY) Fiscal-year End December, 2021 December, 2022 December, 2023 Net Sales 25,359,169 18,912,436 19,630,690 Operating Income 3,000,816 3,068,572 2,596,253 Exchange rates are based on the interim rate of JPY 100 = RMB 4.6549 as of December 31, 2023, as announced by the Bank of China. IV. Schedule Dissolution Date (Stock Acquisition Date) Ping An-Shionogi Co., Ltd.: March 2025 (planned) Ping An-Shionogi (Hong Kong) Limited.: January 2025 (planned) V. Future Outlook Following the dissolution of the joint ventures and the acquisition of all shares in the joint venture companies by Shionogi (Hong Kong), Ping An Shionogi Co., Ltd. and Ping An-Shionogi (Hong Kong) Limited. will become 100% subsidiaries of Shionogi. In the future, we will fully integrate the two joint ventures as wholly owned subsidiaries, while accelerating our focus on the new drug business. At the same time, we will establish a new structure that can contribute to the globalization of the SHIONOGI Group. Additionally, Shionogi Healthcare Co., Ltd. (currently a 100% subsidiary of Ping An-Shionogi (Hong Kong) Limited. is expected to become a 100% subsidiary of Shionogi. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html References 1. Press Release: March 30, 2020 Notice Regarding the Signing of the Basic Agreement with Ping An Insurance for a Capital and Business Alliance including the Disposal of Treasury Shares by Way of Third-Party Allotment 2. Press Release: July 13, 2020 Notice Regarding the Signing of the Agreements on the Establishment of the Joint Ventures with Ping An Insurance, the Establishment of a New Subsidiary, the Signing of the Agreements on Transfer of Subsidiary Shares and Equity Stakes, and the Disposal of Treasury Shares by Way of Third-Party Allotment 3. Press Release: July 27, 2020 Notice Regarding the Execution of the Agreements on the Establishment of the Joint Ventures with Ping An and the Disposal of Treasury Shares by Way of Third-Party Allotment 4. Press Release: January 31, 2024 Cefiderocol is approved for clinical use in Boao Lecheng International Medical Tourism Pilot Zone, Hainan, China 5. Press Release: August 5, 2024 New Drug Application of Novel Siderophore Cephalosporin Antibiotics, Cefiderocol, Accepted in China 6. Press Release: December 19, 2023 Execution of Sub-license Agreement from Ping An-Shionogi Hong Kong to Juniper Therapeutics and SAR approval in Singapore regarding ensitrelvir fumaric acid, a treatment drug for the novel coronavirus infection (COVID-19) 7. 1st Quarter of Fiscal 2024 Financial Results, page 9