Simcere’s Covid-19 Pill Is First in China to Get Nod for General Use
Lin Zhiyin
DATE:  Jul 11 2024
/ SOURCE:  Yicai
Simcere’s Covid-19 Pill Is First in China to Get Nod for General Use Simcere’s Covid-19 Pill Is First in China to Get Nod for General Use

(Yicai) July 11 -- Chinese drugmaker Simcere Pharmaceutical Group’s Covid-19 tablets have been granted general approval, in the first such instance in the country, which will allow patients more convenient access. All other such tablets have been given conditional approval, which limits their availability and application.

The National Medical Products Administration has approved the conversion of Simnotrelvir tablets from conditional use to general use for the treatment of mild to moderate cases of Covid-19 in adults, the Hong Kong-based company said today.

Most Covid-19 tablets have been given conditional approval, which means they can be used in the case of emergencies and still need to undergo research and to collect real-world use data to establish the effectiveness and safety of the drug, market insiders told Yicai.

Once the pills are granted general approval, it means that they can be sold in ordinary pharmacies, which increases their availability and means patients can get treatment quickly.

China currently has six Covid-19 orally taken drugs on the market, two of which are imported and four of which are made locally. These include 3CL protease inhibitors, namely Simcere’s Simnotrelvir, Raynovent’s Leritrelvir and US pharma giant Pfizer’s Paxlovid. The other group is RdRp inhibitors, namely Genuine Biotech’s Azvudine, Junshi Biosciences’ Deuremidevir Hydrobromide and German drugmaker Merck’s Molnupiravir.

Simnotrelvir tablets, co-developed by Simcere, the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology, first received conditional approval in January last year and they have since been included in the national medical insurance scheme. It is the first home-made 3CL Covid drug with independent intellectual property rights.

Sincere carried China’s first large-scale clinical research of a Covid-19 pill already on the market in May 2023 using its Simnotrelvir tablets. Forty-two medical institutions participated, studying more than 3,300 cases of Covid-19.

Simcere’s share price [HKG:2096] closed up 1.45 percent at HKD5.60 (USD0.72) today.

Editor: Kim Taylor

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Keywords:   Simcere Pharmaceutical Group,Covid-19