Merck Initiates Phase 3 Trial for Calderasib + KEYTRUDA QLEX in KRAS G12C NSCLC
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of KANDLELIT‑007, a Phase 3 clinical...
Clinical trial approval / initiation
Imunopharm’s IM19 CAR‑T Wins NMPA IND for Second‑Line NHL Therapy
Beijing Imunopharm Technology Co., Ltd. announced that its independently developed CD19‑targeted CAR‑T cell therapy, IM19,...
XtalPi’s RTX-117 Wins NMPA IND for CMT Therapy
ReviR Therapeutics, an incubated company of XtalPi (HKG: 2228), announced that RTX-117 has received Investigational...
Ascentage’s PROTAC BTK Degrader APG-3288 Wins FDA IND for B-Cell Malignancies
Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) announced that the U.S. Food and Drug Administration (FDA)...
Yifan Pharmaceutical’s F-652 Wins NMPA IND for GVHD Therapy
Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that its Recombinant Human Interleukin‑22‑Fc Fusion Protein for...
Hengrui’s HRS9531 and AR‑PROTAC Win NMPA IND Approval for Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that four drug candidates—HRS9531 (GLP‑1R/GIPR...
Genhouse Bio’s MAT2A Inhibitor GH31 Wins NMPA and FDA Clinical Trial Approvals
Genhouse Bio (Suzhou) Co., Ltd. (invested in and incubated by Viva Biotech) announced that China’s...
Humanwell Healthcare’s HW221043 Receives NMPA Approval for Advanced Solid Tumor Trials
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that its independently developed HW221043 tablets have...
Kelun-Biotech’s ITGB6 ADC SKB105 Wins NMPA IND Approval
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its Investigational New Drug (IND) application...
GenEditBio’s GEB-101 Wins FDA IND Approval as World’s First Corneal Gene Therapy
GenEditBio announced that GEB-101, its self‑developed in vivo genome editing investigational drug, has received Investigational...
Sirius Therapeutics Doses First Phase II Patient for SRSD216 siRNA Hyperlipoproteinemia Therapy
Sirius Therapeutics announced that the first patient has been dosed in a Phase II clinical trial...
CSPC Pharmaceutical Receives IND Approvals for GLP-1/GIP Agonist and Triple-Combo Diabetes Drug
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that three drug candidates—SYH2072 (aldosterone synthase inhibitor), Priglitin/Dapagliflozin/Metformin...
Hengrui’s HRS-6257 Receives IND Approval for Novel Pain Therapy in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its drug candidate HRS-6257...
Easton Pharmaceutical Doses First Patient in Phase I/II Trial of HP‑001 for Relapsed Multiple Myeloma
Easton Pharmaceutical Co., Ltd. (SHA: 688513) announced that the first subject has been dosed in...
Sino Biopharmaceutical’s TDI01 Enrolls First IPF Patient in World’s First ROCK2 Inhibitor Phase III Trial
Sino Biopharmaceutical Limited (HKG: 1177) announced that TDI01, the world’s first highly selective ROCK2 inhibitor...
BDgene Doses First Patient with BD920 CRISPR Gene Therapy for HPV-16 HSIL
Shanghai BDgene Technology Co., Ltd. announced that BD920, its in vivo CRISPR gene editing therapy,...
Jemincare JMX-2005 PAD Injection Secures NMPA Clinical Trial Approval
Jiangxi Jemincare Group (SHA: 603222) announced that its Class 2.2 and Class 2.4 new drug application for...
EPI-003 Wins FDA IND as First LNP Epigenetic Therapy for Hepatitis B
Epigenic Therapeutics (Shanghai) Biotechnology Co., Ltd., a clinical‑stage biotech focused on epigenetic modulation therapies, announced...
SanegeneBio’s INHBE siRNA Wins China IND for Obesity as First RNAi Target
SanegeneBio, a clinical‑stage RNAi therapeutics company, announced that China’s National Medical Products Administration (NMPA) approved...
Grand Pharmaceutical RDC GPN01530 Wins FDA Phase I/II Nod for FAP Tumor Diagnosis
Grand Pharmaceutical Group Limited (HKG: 0512) announced that its self‑developed, globally innovative Radionuclide Drug Conjugate...