Simcere Pharmaceutical's application for anti-new crown innovative drug was accepted, and it is a Pfizer Paxlovid drug with the same target

On January 16, 2023, Simcere Pharmaceutical Group Co., Ltd. announced that the new drug marketing application (NDA), an innovative drug jointly developed with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences and the Wuhan Institute of Virology, has been accepted by the National Medical Products Administration (NMPA) through the special drug ® approval process, and is intended to be used to treat adult patients with mild to moderate novel coronavirus infection (COVID-19).

Senoxin ® is an oral small molecule anti-new coronavirus innovative drug, which is a combination of prenotovir tablets and ritonavir tablets, in which prenortevir targets the 3CL protease necessary for SARS-CoV-2 virus replication, and low-dose ritonavir helps slow down the metabolism or decomposition of prenotovir in the body and improve the antiviral effect. In preclinical animal tests, Synoxin ® showed highly potent, broad-spectrum anti-novel coronavirus activity, and no genetic toxicity was found.

On November 17, 2021, Simcere Pharmaceutical entered into a technology transfer contract with Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Wuhan Institute of Virology, and obtained the exclusive right to develop, manufacture and commercialize Synthegravir globally. On March 28 and May 13, 2022, Sinoxin ® received two drug clinical trial approval notices issued by the State Medical Products Administration. On August 19, 2022, a multicenter, randomized, double-blind, placebo-controlled phase II/III clinical study evaluating the efficacy and safety of Synoxin ® in the treatment of adults with mild to moderate COVID-19 infection reached the first patient enrollment, and all 1208 patients were enrolled on December 16, 2022.

The registered clinical research of Xiannoxin is led by Academician Wang Chen of the Chinese Academy of Medical Sciences, National Center for Respiratory Medicine, Professor Cao Bin ® of China-Japan Friendship Hospital, and jointly supervised by Academician Fan Jia of Zhongshan Hospital affiliated to Fudan University and Professor Hu Bijie, director of the Department of Infectious Diseases of Zhongshan Hospital affiliated to Fudan University Chinese. Sustained recovery of 11 symptoms such as muscle or general pain" as the primary endpoint of the Phase III Registered Clinical Study. This registered clinical study was included in 43 clinical research centers in 20 provinces, municipalities and autonomous regions across the country, and with the strong support of many clinical experts such as Professor Lu Hongzhou, President of Shenzhen Third People's Hospital, Professor Huang Chaolin, President of Wuhan Jinyintan Hospital, all 1208 patients were completed with rapid and high quality.

Detailed data on the efficacy and safety of this registered clinical study will be published or published after the product is approved for marketing. The phase I clinical trial of this project was completed under the guidance of Professor Zhao Wei of Shandong Qianfoshan Hospital.