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Monthly Report: New Drug Approvals in China | August 2022
In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022
INDUSTRY
China CDE to Grant Priority Review Designation to Sanofi's Avaglucosidase Alfa, a Rare Disease Therapy
Sanofi's avalglucosidase alfa entered the preliminary list of priority review designation on August 15, as shown on China CDE's website. If no objections are filed to CDE by August 22, the drug will officially be granted the priority review and can complete the technical review within 70 workdays, much shorter than 200 workdays for drugs without the priority review.
Aug 18, 2022
INDUSTRY
China's First Homegrown COVID-19 Pill, Azvudine, is Priced at 270 Yuan Per Bottle
China's first domestic oral drugs for COVID-19 treatment, Genuine Biotech's Azuvidine Tablets, is priced at no more than 300 yuan for each bottle, which contains 35 tablets (1mg/tablet). The recommended dosage is 5 mg (five 1mg tablets) per day for a course no longer than 14 days. Thus, a course of Azvudine costs no more than 600 yuan.
Aug 12, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | July 2022
In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
Aug 05, 2022
INDUSTRY
China's Pharmaceutical Industry Expected to Be the World's Largest in Less Than 10 Years
As of 2021, China holds 12% of the global pharmaceutical market, following the United States, responsible for 40% of the total revenue worldwide. Chinese pharma market is reported to have generated 708.75 billion yuan in 2021, while Chinese domestic pharma companies amassed 502 billion USD (3.37 trillion RMB) in revenue.
Jul 28, 2022
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