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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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INDUSTRY

INDUSTRY
Top 10 CROs Using China's Human Genetic Resources in International Clinical Trials
From Jan. to Oct. 2022, among the 3,632 international clinical trials approved by China to use the its human genetic resources outside China, about 52% are conducted by contract research organizations (CROs) and about 48% by the applicants themselves.
Nov 23, 2022

INDUSTRY
China Inhalation Drug Market: Nearly 5 Billion USD in 2021 and Still Growing
China is a huge inhalation drug market, whose value reached 35.48 billion yuan in 2021. The market shows two trends:
1. Though nebulizers take the highest market share, dry powder inhalers and metered-dose inhalers' shares are expected to increase.
2. Overseas inhalation drugs account for the most shares, while Chinese generics seek to improve shares via volume-based procurement.
Oct 17, 2022

INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Drug Registration
New Drug
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

INDUSTRY
MAH
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Diabetes
Rare Disease
Drug Registration
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