TransThera NDA Accepted for Tinengotinib in Cholangiocarcinoma After FGFR Inhibitor
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) formally...
Bio‑Thera NDA for VEGF‑A165 Antibody Targets $2B Wet AMD Market in China
Bio‑Thera Solutions (SHA: 688177) submitted a New Drug Application (NDA) to China’s National Medical Products...
Novo Nordisk Submits CagriSema NDA for 20% Weight Loss in Obesity
Novo Nordisk A/S (NYSE: NVO) submitted a New Drug Application (NDA) to the U.S. FDA...
Neurodawn’s Y-4 Wins FDA Fast Track for First‑in‑Class Neuropathic Pain Combo
Neurodawn Pharmaceutical Co., Ltd. announced that its Y‑4 tablet received Fast Track Designation (FTD) from...
Baiyunshan to Acquire Zhejiang Pharma‑Industry for $500.5M, Expanding Distribution Network
Guangzhou Baiyunshan Pharmaceutical Co., Ltd (SHA: 600332) announced its intention to acquire 100% equity of...
Rona Therapeutics siRNA RN5681 Submitted to Australian Ethics Committee
Rona Therapeutics announced the submission of RN5681 to the Australian Human Research Ethics Committee (HREC),...
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...
DualityBio’s DB-1310 Wins FTD as First HER3‑ADC for HR+/HER2‑ Breast Cancer
Duality Biotherapeutics, Inc. (HKG: 9606) announced that the U.S. FDA granted Fast Track Designation (FTD)...
Yabao’s GLX002 Wins NMPA Approval for PAH Clinical Trial, First Modified Bosentan
Yabao Pharmaceutical Group Co., Ltd. (SHA: 600351) announced that China’s National Medical Products Administration (NMPA)...
Biostar Technologies Doses First Patient in US Pivotal Trial for Utedelone in Breast Cancer Brain Mets
Beijing Biostar Technologies Ltd (HKG: 2563) announced that its wholly‑owned U.S. subsidiary, Biostar Pharma, Inc.,...
Asieris’ APL-2401 FGFR2/3 Inhibitor Wins NMPA Nod for Phase 1 Solid Tumor Trial
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that China’s National Medical Products Administration (NMPA)...
InnoCare’s Soficitinib Wins NMPA Approval for Phase 2/3 TYK2 Urticaria Study
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that China’s National Medical Products Administration (NMPA)...
InSilico Medicine Debuts on HKEX in $2.3B IPO, Valuing AI Drug Platform at $1.5B
InSilico Medicine Cayman TopCo (HKG: 3696) officially listed on the Hong Kong Stock Exchange, offering...
China Mandates Specialty Departments in Primary Care by 2030
The National Health Commission issued Guiding Opinions on Strengthening Construction of Characteristic Departments in Primary...
Sirnaomics Partners on $42M Small Nucleic Acid Fund in Hangzhou
Xinyuan Zhenghe (Hangzhou) Private Equity Fund Management Co., Ltd., Sirnaomics, and the Fuyang Economic and...
Hainan Opens First Wholly Foreign-Owned Hospital Ahead of Free Trade Port Launch
Boao Fullerton Hospital, the first wholly foreign‑owned hospital in Hainan, held its unveiling ceremony today...
Hutchmed’s HMPL-A251 ATTC Dosed in Global Phase 1 for HER2 Tumors
Chinese pharmaceutical company HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a...
HBM BMS Multi-Specific Antibody Deal Targets $1 Billion Milestones
HBM Holdings Limited (HKG: 2142) announced it has entered into a long-term global strategic collaboration...
Antengene Xpovio sNDA Malaysia Approval Expands DLBCL Indication
Antengene Corporation Limited (HKG: 6996) announced that the Malaysian National Pharmaceutical Regulatory Agency has approved...
Everest lerodalcibep PCSK9 FDA Approval Targets China Launch
Everest Medicines Limited (HKG: 1952) announced that the U.S. FDA has approved the Biologics License...