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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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Monthly Report: New Drug Approvals in China | September 2022
In September 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products.
Oct 08, 2022
REGULATION
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COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
INDUSTRY
MAH
Marketing Approval
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Innovative Drug
Generic Drug
Biological Product
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New Drug
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