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...
Drug
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...
Nanjing Leads Biolabs Receives FDA IND Approval for LBL-033 Phase I/II Clinical Trial
China-based Nanjing Leads Biolabs Co., Ltd has revealed that it has received Investigational New Drug...
TG ImmunoPharma Receives FDA Approval for Phase I Clinical Study of TGI-6 Bispecific Antibody
China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the US...
IASO Bio Receives FDA IND Approval for IASO-782 for Autoimmune Disorders
China-based IASO Bio has announced that the US Food and Drug Administration (FDA) has approved...
Aosaikang Pharmaceutical’s ASKB589 Shows Promising Results in Solid Tumor Treatment Study
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed the latest results from a Phase...
Roche’s Evrysdi Receives NMPA Approval for Wider SMA Patient Age Range
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that its blockbuster nervous system drug Evrysdi...
MicuRx Pharmaceuticals’ MRX-4/Contezolid Combo Receives Clinical Trial Approvals for Diabetic Foot Infection
Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced receiving clinical trial approvals for its...