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VOLUNTARY ANNOUNCEMENT - REGULAR APPROVAL OF XIANNUOXIN, AN ANTI-SARS-COV-2 INNOVATIVE DRUG APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION OF CHINA

2024-07-11 00:00:00

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.Simcere Pharmaceutical Group Limited先声药业集团有限公司 (Incorporated in Hong Kong with limited liability) (Stock code: 2096) VOLUNTARY ANNOUNCEMENT REGULAR APPROVAL OF XIANNUOXIN AN ANTI-SARS-COV-2 INNOVATIVE DRUG APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION OF CHINA This announcement is made by Simcere Pharmaceutical Group Limited (the “Company” together with its subsidiaries the “Group”) on a voluntary basis to inform shareholders and potential investors of the Company about the latest business development of the Group.The board (the “Board”) of directors (the “Directors”) of the Company is pleased to announce that on July 8 2024 XIANNUOXIN (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)) an innovative drug of the Group has been reviewed and approved by the National Medical Products Administration of China (国家药品监督管理局) (the “NMPA”) for conversions from conditional approval to regular approval. The indication is to treat adult patients infected with mild to moderate novel coronavirus (COVID-19). XIANNUOXIN became the first oral anti-SARS-CoV-2 drug which has obtained regular approval in China.– 1 –ABOUT XIANNUOXIN XIANNUOXIN (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)) is an oral small molecule anti-SARS-CoV-2 innovative drug. Simnotrelvir targets 3CL protease which is essential for SARS-CoV-2 virus replication and its combination with low-dose Ritonavir helps to slow down the metabolism and clearance of Simnotrelvir in body in order to improve the antiviral effect. On November 17 2021 the Group entered into a technology transfer contract with Shanghai Institute of Materia Medica and Wuhan Institute of Virology Chinese Academy of Sciences pursuant to which the Group obtained the development production and commercialization rights on an exclusive basis of Simnotrelvir worldwide. The results of phase II/III clinical studies (NCT05506176) show that XIANNUOXIN can accelerate the recovery from symptoms shorten the duration of the disease reduce viral load of 96.9% rapidly and significantly and demonstrate good safety.On January 28 2023 XIANNUOXIN was conditionally approved for marketing by the NMPA and became the first domestic 3CL anti-SARS-CoV-2 innovative drug. On December 13 2023 XIANNUOXIN was officially included in the 2023 New National Reimbursement Drug List (2023年新版国家医保药品目录).ABOUT THE COMPANY The Company is an innovation and R&D-driven pharmaceutical company and has established a “State Key Laboratory of Neurology and Oncology Drug Development”. The Company focuses on the therapeutic areas of oncology nervous system autoimmune and anti-infection with forward-looking layout of disease areas that may have significant clinicalneeds in the future aiming to achieve the mission of “providing today’s patients withmedicines of the future”. Driven by its in-house R&D efforts and synergistic innovation the Company has established strategic cooperation partnerships with many innovative companies and research institutes.By order of the Board Simcere Pharmaceutical Group Limited Mr. Ren Jinsheng Chairman and Chief Executive Officer Hong Kong July 10 2024 As at the date of this announcement the Board comprises Mr. REN Jinsheng as the Chairman and executive Director Mr. TANG Renhong Mr. WAN Yushan and Ms. WANG Xi as the executive Directors; and Mr. SONG Ruilin Mr. WANG Jianguo Mr. WANG Xinhua and Mr. SUNG Ka Woon as the independent non-executive Directors.–2–