Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received...
Drug
Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration...
S-Evans Biosciences Receives NMPA Tacit Approval for Stem Cell Therapy in ARDS
S-Evans Biosciences, a stem cell specialist based in Hangzhou, has obtained tacit clinical trial approval...
Hopstem Biotechnology’s hNPC01 Receives Tacit Approval for Stroke Sequelae Treatment from CDE
Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by neuroscientists and stem-cell biologists...
CDE Releases Guidelines for Clinical Trials of Stem Cell Therapies and Derived Products
The Center for Drug Evaluation (CDE) has released a set of “Guidelines for Clinical Trial...
Sciwind Biosciences Leads China’s Anti-Obesity Drug Market with GLP-1 Analog Ecnoglutide
Sino-US biotech Sciwind Biosciences Co., Ltd has positioned itself as a frontrunner in China’s race...
CDE Releases Draft Guidelines for Antibody Drug Conjugate Research and Evaluation
The Center for Drug Evaluation (CDE) has released a draft set of “Guiding Principles for...
Jiangsu Hengrui’s Camrelizumab Earns Full Approval for Advanced Hepatocellular Carcinoma in China
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the transition of its programmed death-1 (PD-1)...
Biocytogen Pharmaceuticals Receives CNIPA Patent for RenMab Human Antibody Mice Platform
China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced receiving a prestigious patent award...
BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in...
Jiangsu Hengrui Pharmaceutials’ SHR-1209 for Hypercholesterolemia Accepted for NMPA Review
China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category...
Minghui Pharmaceutical Achieves First Dosing Milestone in Phase I Studies for ADC Candidates
China-based biotech Minghui Pharmaceutical Inc. has reported that the first dosing has been completed in...
CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s...
Fujian Cosunter Pharmaceutical’s COVID-19 Drug GST-HG171 Meets Primary Endpoint in Phase II/III Study
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the pivotal Phase II/III...
Boehringer Ingelheim’s Spevigo on Track for Priority Review for GPP Flare Prevention in China
Germany-based Boehringer Ingelheim’s (BI) interleukin-36 receptor (IL-36R)-targeted orphan drug, Spevigo (spesolimab), in subcutaneous injection form,...
Bio-Thera Solutions’ PD-1 Inhibitor BAT1308 Approved for Cervical Cancer Clinical Trials in China
Bio-Thera Solutions Ltd (SHA: 688177) has announced that its programmed death-1 (PD-1) inhibitor, BAT1308, has...
Sinocelltech Group Launches Biosimilar Version of AbbVie’s Humira in China
China-based Sinocelltech Group Ltd (SHA: 688520) has officially commercialized its biosimilar version of AbbVie’s (NYSE:...
Grand Pharmaceutical Initiates Phase II STARBURST Study for TLX250-CDx in Indication Expansion
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the...
Shanghai Pharmaceuticals’ SPH3127 for Hypertension Gets MNPA Review Acceptance
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products...
WinHealth Pharma Receives NMPA Approval for Glycerol Phenylbutyrate for Urea Cycle Disorders
China-based Hong Kong WinHealth Pharma Group Ltd has announced receiving market approval from the National...