政府新闻
中国批准再销售两种国产口服新冠肺炎药物 2023-01-31
China Approves Sale of Two More Homegrown Oral COVID-19 Drugs
China has granted conditional sales approval for two more oral COVID-19 treatments, both developed in the country, bringing the total to five.
Simcere Pharmaceutical Group's Xiannuoxin and Junshi Biosciences' Mindewei have been added to the list of coronavirus treatments approved for marketing in China, according to a notice the National Medical Products Administration issued yesterday.
The drug and medical devices regulator has now approved three oral COVID-19 drugs developed in China and two from overseas. The others are Pfizer's Paxlovid, Genuine Biotech's Azvudine, and Merck's Molnupiravir.
Xiannuoxin, a simnotrelvir and ritonavir combination, received conditional marketing approval on Jan. 28, Nanjing-based Simcere said in a filing yesterday. The drug was co-developed with the Shanghai Institute of Materia Medica, Wuhan Institute of Virology, and Chinese Academy of Sciences, it added.
Mindewei, also known as deuremidevir hydrobromide and VV116, was approved on Jan. 28, Junshi Bio said in a filing today. It was developed in collaboration with Vigonvita Life Science, the Chinese Academy of Science, and others, the Shanghai-based firm said.
Both are oral small-molecule drugs used to treat adults with mild coronavirus symptoms, the NMPA's notice said. Xiannuoxin is a 3CL treatment. 3CL is an enzyme that breaks down proteins and peptides. Mindewei is a ribonucleic acid-dependent RNA polymerase inhibitor. Despite their different mechanisms, the two drugs prevent COVID-19 replicating in patients.
Simcere will start producing Xiannuoxin immediately and provide it through hospitals, online medical centers, and other channels, the company told Yicai Global. As an innovative drug with independent intellectual property rights, Xiannuoxin will be much cheaper than Paxlovid, which is priced at CNY2,300 (USD341) a box.
Source: Yicai
