US FDA Issues Warning Letter to Chengdu KeCheng Fine Chemicals Over Communication Failures
The US FDA’s Center for Drug Evaluation (CDE) issued a warning letter to China-based Chengdu...
Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the...
Teva Pharmaceutical’s Copaxone Approved by NMPA for Multiple Sclerosis Treatment in China
The National Medical Products Administration (NMPA) website has indicated that Israel-based Teva Pharmaceutical Industries’ (NYSE:...
Fosun Pharmaceutical’s Sisram Opens Wellness Center in Chicago for Beauty and Health
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the establishment of...
Sanyou Biopharmaceuticals and Huadong Medicine Expand Partnership on Macromolecule Therapeutics
China-based Sanyou Biopharmaceuticals Co., Ltd has announced a licensing deal with compatriot firm Huadong Medicine...
Daewoong Pharmaceutical Files NDA in China for Potassium-Competitive Acid Blocker Fexuclu
South Korea-based Daewoong Pharmaceutical (KRX: 069620) has revealed that a new drug application (NDA) has...
Insilico Medicine’s AI-Discovered Drug INS018_055 Reaches Phase II Clinical Trial Milestone
China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has announced that its lead pipeline candidate,...
Biomm Secures Late-Stage Biosimilar Candidate BAT2206 from Bio-Thera Solutions
Brazil-based biotechnology company Biomm (BVMF: BIOM3) has announced that it has in-licensed the late-stage biosimilar...
CDE Issues Guidelines for New Drug Benefit-Risk Assessment in Market Approval Filings
The Center for Drug Evaluation (CDE) has released a notice outlining the guidelines for “New...
CNIPA Launches Pilot for Priority Patent Review for Macau Applicants in Mainland China
The China National Intellectual Property Administration (CNIPA) has announced the commencement of a pilot program...
AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval...
Lion TCR Secures RMB 300 Million in Series B2 Financing to Advance Clinical Studies and Facility Construction
Singapore-based clinical-stage biotechnology company Lion TCR has announced the successful completion of its Series B2...
LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm...
CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from...
NMPA Releases 69th Batch of Reference Drugs for Generic Quality Consistency Evaluation
The National Medical Products Administration (NMPA) has released the 69th batch of reference drugs for...
BDgene Technology Secures Over RMB 200 Million in Series B Financing Led by Lapam Capital
Gene therapy specialist Shanghai BDgene Technology Co., Ltd has successfully raised over RMB 200 million...
WuXi Biologics Partners with Pharmadule Morimatsu AB for CRDMO Expansion in Singapore
China-based WuXi Biologics (HKG: 2269) has announced a strategic partnership with Sweden-headquartered Pharmadule Morimatsu AB...
CStone Pharmaceuticals’ Gavreto Approved for First-Line RET Fusion-Positive NSCLC Treatment in China
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) of...
CSPC Pharmaceutical’s Biosimilar Omalizumab Accepted for Review by China’s NMPA
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that the National Medical Products Administration...
Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial
Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National...