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...
Drug
LianBio Cancels Phase III Trial for Truseltiq in China Amid Global Halt
China-based LianBio (OTCMKTS: LIANY) revealed in an SEC filing that it is canceling work on...
Accutar Biotechnology Initiates Phase I Trial for ERα Targeting Degradation Molecule AC0682
New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the...
RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD)...
BeiGene’s Brukinsa Outperforms Imbruvica in Phase III ALPINE Study
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its Bruton’s...
Aosaikang’s Neratinib Maleate API Market Filing Accepted by NMPA
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its...
Azvudine Included in China’s COVID-19 Treatment Protocol
The National Healthcare Commission and the National Administration of Traditional Chinese Medicine have released a...
NMPA Approves IND Filing for Henan Genuine Biotech’s Long-Acting HIV Drug CL-197
China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting...
Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
NMPA Introduces Electronic Certificates for Biologics and Narcotic Drugs
The National Medical Products Administration (NMPA) has released a notification regarding the initiation of electronic...
Pfizer’s Zavicefta Approved in China for Pediatric Complex Intra-Abdominal Infections
US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from...
HutchMed Initiates Phase II/III Study of Sovleplenib for Warm AIHA
China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initiation of a...
Guangdong Zhongsheng Receives USPTO Patent for FGFR4 Inhibitor ZSP1241
China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced receiving a patent award from...
Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its...
Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing...
NMPA Approves JW Therapeutics’ Carteyva for Recurrent Follicular Lymphoma
The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’...
Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for...
Sciwind Biosciences Initiates US Phase I Study for GLP-1 Agonist XW014
China-based Sciwind Biosciences Co., Ltd has announced the initiation and first patient dosing of a...
Fujian Cosunter Doses First Patient in Phase I Study of COVID-19 Drug GST-HG171
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has...
Salubris Pharmaceuticals’ First-in-Class Anti-Tumor Drug SAL008 Accepted by NMPA
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing...