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...
Kite Pharma’s Yescarta Marketing Rights Transferred to Gilead Sciences K.K. in Japan
US immunotherapy specialist Kite Pharma, Inc. has announced that the Marketing Authorization for Yescarta (axicabtagene...
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...
Edding Pharma Aims for Fifth IPO Attempt on Hong Kong Stock Exchange
China-based Edding Pharma is gearing up for its fifth attempt to hold an initial public...
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...
Aureka Biotechnologies Secures $10 Million in Seed Funding for AI-Driven Biotechnology
Aureka Biotechnologies Inc., a California-based artificial intelligence (AI)-empowered biotech company, has successfully raised USD 10...
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...
Xiamen ITG Group and Fosun Health Collaborate on Big Health Industry Fund and Medical Device Commercialization
China-based Xiamen ITG Group Co., Ltd. (SHA: 600755) and Shanghai Fosun Health Technology (Group) Co.,...
Australian Scleral Lens Epicon A Approved by China’s NMPA as 10th Novel Product
Ruitai Bio’s Epicon A, a scleral lens product from Australia, has been approved by the...
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...