CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s...
Priority reviews
Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab...
Everest Medicines’ Nefecon Receives Priority Review Recommendation from CDE
China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of...
NMPA Approves Viatris’ Symfi Lo for HIV-1 Treatment in China
The National Medical Products Administration (NMPA) website indicates that US-based Viatris Inc.’s (NASDAQ: VTRS) Symfi...
Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276)...
CDE Prioritizes Review for Jiedi Pharma’s Mitotane and Other Key Drugs
The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs,...
Innovent’s Parsaclisib Filed for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics...
ScienCare Pharma’s Naltrexone Implant Prioritized for Review by CDE
The Center for Drug Evaluation (CDE) website indicates that the market filing by China-based Shenzhen...
Fosun Kite’s Yescarta Gains Priority Review Status for r/r LBCL
China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group)...
CARsgen’s BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China
The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell...
Tris Pharma and Pediatrix Therapeutics’ ADHD Drug Gains Priority Review in China
The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry...
Hengrui Medicine’s Dexmedetomidine Nasal Spray Gains Priority Review
China’s Center for Drug Evaluation (CDE) has indicated that Hengrui Medicine Co., Ltd’s (SHA: 600276)...
CDE Prioritizes Review of Pearl Bio’s Breatinib for NSCLC Treatment
The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101/PLB1001...
InnoCare Pharma and CStone Pharmaceuticals’ Drugs Receive Prioritized CDE Review
The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG:...
Viatris Pharmaceuticals’ HIV/AIDS Drug Prioritized for CDE Review
The Center for Drug Evaluation (CDE) has indicated that Viatris Pharmaceuticals Co., Ltd’s efavirenz/lamivudine/tenofovir is...
Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG:...
CDE Prioritizes Review for Sanofi’s Nexviazyme and WinHealth’s Ravicti
The Center for Drug Evaluation (CDE) website indicates that two drugs have been selected for...
Tris Pharma and Pediatrix’s Methylphenidate Tablet, Ipsen’s Triptorelin Injection Awarded Priority Review by CDE
The Center for Drug Evaluation (CDE) website shows that US-based Tris Pharma and Pediatrix Therapeutics’...
CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou...
Sobi’s Anakinra (Kineret) Prioritized for Review in China for FMF Treatment
The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV:...