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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 | 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
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
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
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New Drug
Monthly Report: New Drug Approvals in China | March 2022
In March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.
Apr 07, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | February 2022
In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer’s Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China.
Mar 11, 2022
INDUSTRY
Biogen's Drug for Rare Disease SMA Gets Access to More Patients in China Due to NRDL
In December 2021, Biogen cut the price of Spinraza (Nusinersen Sodium Injection) from 700,000 yuan per dose to 33,000 yuan per dose to get a place in China’s National Reimbursement Drug List (NRDL). The move makes Spinraza gain access to more spinal muscular atrophy (SMA) patients in China.
Feb 14, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Biosimilar
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | Oct. 2021
In Oct. 2021, China's NMPA granted marketing authorization approvals to 11 new drugs, including Takeda's VOCINTI and Sanofi's Clopidogrel Bisulfate and Aspirin Tablets.
Nov 08, 2021