China’s CDE Releases Draft Guidelines for Biosimilar Drug Labeling
On September 29, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products...
Legend Biotech Corporation to Establish Advanced R&D Center in Philadelphia for Next-Generation Cell Therapies
Legend Biotech Corporation (NASDAQ: LEGN), a leading chimeric antigen receptor (CAR) T cell therapy specialist...
BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab)...
Unixell Advances in Cell Therapy with CDE IND Acceptance
Shanghai-based Unixell Biotechnology Co., Ltd. has announced that its Investigational New Drug (IND) application for...
Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
Duality Biologics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered...
BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I...
BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS,...
InnoCare Pharma’s Orelabrutinib Achieves Milestone in SLE Clinical Trial Enrollment
InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a...
Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma...
FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC...
Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug...
Hengrui Pharmaceuticals’ HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently...
NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a...
Jiangsu Alphamab Biopharmaceuticals Partners with Shanghai Jinmant Biotech for JSKN003 ADC
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced that its wholly-owned...
CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs,...
Zephyrm Bioscience Aims for HKEX Main Board with Innovative Cell Therapy Products
Zephyrm Bioscience Limited (hereinafter referred to as “Zephyrm Bio”) officially submitted its prospectus to the...
Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104),...
Alphamab Oncology Strikes Licensing Deal with CSPC Pharma for HER2 Targeted ADC in China
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing...
Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its...
J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial...