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Innovative, Potential Best-in-Class, Anti-COVID-19 Drug, XIANNUOXIN® has Received an Accepted New Drug Application from the NMPA

Release time:2023-01-16

On January 16, 2023, New Drug Application (NDA) of the innovative drug, XIANNUOXIN® (simnotrelvir tablets/ ritonavir tablets (co-packaged)), jointly developed by Simcere Pharmaceutical Co., Ltd. (2096.HK, hereinafter referred to as Simcere), Shanghai Institute of Materia Medica under Chinese Academy of Sciences, and Wuhan Institute of Virology has been accepted by the National Medical Products Administration (NMPA) and will be reviewed in special drug approval procedures. The intended indication is mild to moderate novel coronavirus infection (COVID-19) of adults.

XIANNUOXIN® is a new oral small molecule drug against COVID-19 in a combination therapy regimen of simnotrelvir and ritonavir tablets. Simnotrelvir targets the 3CL protease that is essential for SARS-CoV-2 viral replication. Coupled with low-dosage ritonavir, it can help slow simnotrelvir metabolism and thus improve anti-COVID-19 effect. In preclinical animal experiments, XIANNUOXIN® showed its highly effective and broad-spectrum activity against coronavirus with no genotoxicity identified.

On November 17, 2021, Simcere entered into a technology transfer contract with the Shanghai Institute of Materia Medica (SIMM) and Wuhan Institute of Virology (WIV) of the Chinese Academy of Sciences (CAS), pursuant to which the Group obtained global development, production, and commercialization rights on an exclusive basis of simnotrelvir worldwide. On March 28 and May 13, 2022, XIANNUOXIN® obtained two Clinical Trial Approvals issued by the National Medical Products Administration. On August 19, 2022, A multi-centered, randomized, double-blind, placebo-controlled phase II/III clinical study to evaluate the efficacy and safety of XIANNUOXIN® in adult participants with mild to moderate COVID-19 achieved the First Patient In (FPI) milestone. On December 16, 2022, all 1,208 patients were enrolled.

Clinical evaluation of XIANNUOXIN® was 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 and was conducted under the joint guidance of Academician Fan Jia, president of Zhongshan Hospital, Fudan University and Professor Hu Bijie, director of Infectious Diseases Department of Zhongshan Hospital, Fudan University. It is the first mega-trial that targeted Chinese patients infected with the Omicron variant of COVID-19 and the first registered phase III clinical study that set "continuous recovery of 11 symptoms including cough, nasal obstruction, rhinorrhea, pharynx pain, pyrexia, headache, and muscle or generalized pain" of Omicron-infected patients as the primary endpoint both at home and abroad. The registered clinical study has established a total of 43 clinical research centers in 20 provinces, municipalities, and autonomous regions in China. With strong support from many clinical experts like Professor Lu Hongzhou, president of the Third People's Hospital of Shenzhen and Professor Huang Chaolin, president of Wuhan Jinyintan Hospital, the study has been completed on all 1,208 subjects in a rapid and high-quality manner.

Detailed data on the efficacy and safety of the registered clinical study will be released after the product is approved to market. Phase I clinical trials of the XIANNUOXIN® were completed under the guidance of Professor Zhao Wei, Shandong Qianfoshan Hospital.

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 also focused on the research and development of innovative drugs.

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.