Alphamab Oncology Doses First Patient in JSKN027 Phase I Trial – First‑in‑Class PD‑L1/VEGFR2 Bispecific ADC Enters Clinic
Alphamab Oncology (HKG: 9966) has successfully dosed the first patient in the Phase I clinical...
Clinical trial approval / initiation
Sino Biopharm’s TRD221 Wins NMPA Approval – Novel Polysaccharide Drug Targets Osteoarthritis via Complement Inhibition
Sino Biopharmaceutical Limited (HKG: 1177) announced that TRD221, a Category 1 innovative polysaccharide drug co-developed...
Hengrui’s Irinotecan Liposome (II) Wins NMPA Phase II Approval – Adjuvant Pancreatic Cancer Study vs. Gemcitabine/Capecitabine
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
Chipscreen Biosciences’ CS08399 Wins NMPA Approval – PRMT5-MTA Inhibitor Targets MTAP-Deficient Solid Tumors and Lymphomas
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced NMPA clearance to initiate a clinical study...
Cutia Therapeutics’ CU-40105 Wins NMPA Approval – Topical Dutasteride Targets Androgenetic Alopecia with Reduced Systemic Exposure
Cutia Therapeutics announced NMPA clearance to initiate a clinical study for CU-40105, a topical dutasteride...
BeBetter Medicine’s Ifupinostat Wins NMPA Approval for PTCL Trial – First HDAC/PI3Kα Dual Inhibitor Enters First-Line Lymphoma Study
Guangzhou BeBetter Medicine Technology Co., Ltd (SHA: 688759) announced NMPA clearance to initiate a clinical...
Abbisko’s Irpagratinib Doses First Patient in Phase II HCC Trial – FGFR4 Inhibitor Plus Toripalimab/Bevacizumab Targets First-Line Liver Cancer
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced first patient dosing in a Phase II clinical...
YolTech’s YOLT-202 Wins FDA Phase II/III Approval – In Vivo Base Editing Gene Therapy Targets Alpha-1 Antitrypsin Deficiency
YolTech Therapeutics announced FDA clearance to initiate an open-label, single-dose expansion Phase II/III clinical study...
Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic
Shanghai Essight Biotechnology Co., Ltd. announced that ES502 Injection has received FDA approval to proceed...
Sino Biopharm’s TQB3205 Wins NMPA Approval – First China-Developed Pan-KRAS Inhibitor Enters Clinic for Advanced Cancers
Sino Biopharmaceutical Limited (HKG: 1177) announced that TQB3205, an orally administered Pan-KRAS inhibitor independently developed...
Hengrui’s SHR-2524 Wins NMPA Phase I Approval – Novel Subcutaneous Formulation Plus Bevacizumab Targets First-Line Liver Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
Huadong Medicine’s HDM2024 Wins FDA Phase I Approval – First-in-Class EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors
Huadong Medicine Co., Ltd (SHE: 000963) announced that HDM2024, a Category 1 innovative bispecific antibody-drug...
AstraZeneca Initiates CLARITY-Gastric 02 Phase III – Sonesitatug Vedotin Combo Triggers $45 Million Milestone from KYM Biosciences
AstraZeneca (AZ, NASDAQ: AZN) announced the initiation of CLARITY-Gastric 02, a multi-center, randomized, controlled Phase...
SicaGene’s SG12 ASO Wins NMPA Approval – Antisense Oligonucleotide Targets Hepatitis B Functional Cure
SicaGene (Beijing) Biotechnology Co., LTD announced that SG12 injection, a self-developed antisense oligonucleotide (ASO), has...
Kelun-Biotech’s SKB575/HBM7575 Wins NMPA Approval – Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575/HBM7575, a long-acting bispecific antibody (bsAb)...
Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3...
Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel...
Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS9531, a novel dual...
Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance for two pivotal...
Leads Biolabs’ Opamtistomig Enters Phase II in First-Line Esophageal Cancer – PD-L1/4-1BB Bispecific with BTD/ODD Designations
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced first patient enrollment in a Phase II...