PHASE II/III CLINICAL TRIAL OF SIMCERE'S 3CL-TARGETING ANTI-SARS-COV-2 DRUG CANDIDATE COMPLETE ALL PATIENTS ENROLLMENT

NANJING, China, Dec. 20, 2022 /PRNewswire/ -- Simcere Pharmaceutical Group (2096.HK) announced today that, XIANNUOXIN (SIM0417), an anti-SARS-CoV-2 drug candidate jointly developed by Simcere with Shanghai Institute of Materia Medica (the "SIMM") and Wuhan Institute of Virology (the "WIV"), Chinese Academy of Sciences (the "CAS"), has achieved a major clinical milestone: A multi-centered, randomized, double-blind, placebo-controlled phase II/III clinical study (the "Study") to evaluate the efficacy and safety of XIANNUOXIN in symptomatic adult participants with mild to moderate COVID-19 has completed all enrollment of 1,208 patients.

Simcere will accelerate the analysis of clinical study results and actively prepare for New Drug Application (NDA), while speeding up the expansion of production capacity to meet urgent clinical needs. This is to fulfill the Group's corporate mission of "providing today's patients with medicines of the future".

"COVID-19 poses a great threat to human health and lives. The development of a home-grown effective anti-SARS-CoV-2 drug has special significance for reducing fatality and fear among our people, controlling the epidemic and return a sense of normalcy to our lives. Clinical experts and biomedical companies should make unremitting efforts to this ultimate task." said Academician Wang Chen, leading investigator, Chinese Academy of Medical Sciences and the National Center for Respiratory Medicine, at the SIM0417 clinical project initiation meeting.

"Thanks to the synergistic efforts of researchers from all over the country, the clinical development of XIANNUOXIN is able to advance rapidly," said Dr. Tang Renhong, Ph.D. Executive Director of the Board, Simcere Pharmaceutical Group, "We wish to give many thanks to the Phase I clinical centers: Shandong Qianfoshan Hospital, Shenzhen Third People's Hospital, the Phase II clinical centers, Fudan Zhongshan Hospital, as well as the 43 Phase III clinical centers across the nation, including China Japan Friendship Hospital, Shenzhen Third People's Hospital, Wuhan Jinyintan Hospital, Hainan Sanya Central Hospital，as well as the dedicated work of hundreds of respectable researchers."

ABOUT THE STUDY

The Study, led by Academician Wang Chen, Chinese Academy of Medical Sciences and the National Center for Respiratory Medicine and Professor Cao Bin, China Japan Friendship Hospital, is so far the first clinical study in the world to carry out in Chinese patient population infected with the SARS-CoV-2 Omicron strain that has entered the pivotal phase III clinical trial and has completed patient enrollment. The trial design is guided by the international prevailing standard. The Study has established a total of 43 clinical research centers in 20 provinces, municipalities and autonomous regions in China. Since the First Patient In (FPI) on August 19, 2022, all 1,208 patients were enrolled within only four months. The trial is designed to compare XIANNUOXIN vs. placebo control, being orally administrated for 5 consecutive days. The clinical endpoints includes the time until recovery from COVID-19 symptoms, the reduction of viral load, etc.

ABOUT XIANNUOXIN

XIANNUOXIN is a combination packaged drug of a small molecule anti- SARS-CoV-2 drug candidate and Ritonavir, this candidate is targeted 3CL protease which is essential for SARS-CoV-2 viral replication. In pre-clinical trials, XIANNUOXIN has demonstrated highly potent and broad spectrum antiviral activity. On November 17, 2021, the Group entered into a technology transfer contract with the SIMM and the WIV of the CAS, pursuant to which the Group obtained development, production and commercialization rights on an exclusive basis of the inhibitor of 3CL protease XIANNUOXIN worldwide. On March 28 and May 13, 2022, XIANNUOXIN obtained two Clinical Trial Approvals issued by the National Medical Products Administration for the treatment of patients with mild to moderate COVID-19, and post-exposure prophylaxis for close contacts of individuals who test positive for SARS-CoV-2.

ABOUT SIMM

Founded in 1932, SIMM, CAS is the oldest comprehensive innovative drug research institute in China. In line with frontiers in life sciences and aiming at solving key scientific problems in drug discovery, SIMM carries out research on innovative drug basis and application basis, developing new theories, methods and technologies. The institute has focused on the research and development of innovative drugs for the treatment of malignant tumors, cardiovascular and cerebrovascular diseases, neuropsychiatric diseases, metabolic diseases, autoimmune diseases and infectious diseases.

ABOUT WIV

Founded in 1956, WIV, CAS is the comprehensive research institution specializing in basic research on virology and related technological innovation. Regarding the significant demands in the areas of national population health and biosafety, WIV focuses on basic and applied basic research in virology, immunology, emerging biotechnology, etc. WIV has 5 research centers and a high-level research team mainly composed of middle-aged and young people, to develop cooperation with the global partners in scientific research, capacity building, talents training and other areas.

ABOUT SIMCERE

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future，aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. 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.

www.simcere.com

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