FDA Releases Draft Guidance on NAMs – Accelerating Shift from Animal Testing to Human‑Relevant Drug Safety Assessment
The US Food and Drug Administration (FDA) has advanced its “Roadmap to Reducing Animal Testing...
Jiuyuan Gene Engineering Secures NMPA Approval for JY47 – SIRPα Antibody Enters MASH Clinical Development
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (HKG: 2566) announced receiving tacit clinical approval from China’s...
Alebund Pharma Licenses AP306 to R1 Therapeutics – USD 100 Million Deal for First‑in‑Class Hyperphosphatemia Drug
Alebund Pharmaceuticals has entered into an exclusive licensing agreement with R1 Therapeutics, Inc. (UK) for...
Ark Biopharma Files Hong Kong IPO – Roche‑Licensed RSV and IPF Pipeline Targets Respiratory and Pediatric Markets
Shanghai Ark Biopharmaceutical Co., Ltd. has submitted an initial public offering (IPO) filing to the...
Everest Medicines Signs LOI to Acquire Haisen Pharmaceutical – RMB 200 Million Deposit for 14‑Product APAC Commercial Platform
Everest Medicines Limited (HKG: 1952) announced the signing of a letter of intent to acquire...
Pfizer Reports Positive FOURLIGHT-1 Results for Atirmociclib – CDK4 Inhibitor Shows PFS Benefit in Post-CDK4/6 Breast Cancer
Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase II FOURLIGHT-1 study, demonstrating...
AstraZeneca Secures EU Approval for Imfinzi in Gastric Cancer – Perioperative Regimen Cuts Death Risk 22% in MATTERHORN Trial
AstraZeneca PLC (NASDAQ: AZN) announced European Union marketing approval for Imfinzi (durvalumab) in combination with...
Kintor Pharma Partners with Chicmax to Accelerate KT‑939 Commercialization – Active Cosmetic Ingredient Targets Whitening Market
Kintor Pharmaceutical Limited (HKG: 9939) has entered into a strategic partnership with Shanghai Shangmei Cosmetics...
UniXell Bio Secures FDA Approval for UX‑GIP001 – First iPSC Allogeneic Cell Therapy for Epilepsy Enters US Clinical Trials
Shanghai UniXell Biotechnology Co., Ltd. announced that its iPSC‑derived allogeneic cell therapy UX‑GIP001 has received...
Simcere Pharma Reports Positive SIM0237 Phase I/II Data – 80% CR Rate in BCG‑Unresponsive Bladder Cancer
Simcere Pharmaceutical Group Limited (HKG: 2096) announced positive Phase I/II results for SIM0237, its PD‑L1/IL‑15...
Bio-heart Bio Expands Iberis RDN Registration to Thailand – World’s Only Dual‑Access Renal Denervation System
Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced Thailand regulatory registration of its Iberis...
Eli Lilly Rolls Out USD 299 Zepbound KwikPen via LillyDirect – Self‑Pay Pricing for Dual‑Target Obesity Drug
Eli Lilly and Company (NYSE: LLY) announced that patients can now access the single‑patient‑use Zepbound...
Peijia Medical Secures First FDA 510(k) Clearance for DCwire Micro Guidewire – US Market Entry Milestone
Peijia Medical Ltd (HKG: 9996) announced that its DCwire micro guidewire has received 510(k) clearance...
Shanghai Pharmaceuticals and Henlius Forge Strategic Alliance – Hospital Market Expansion and Global Commercial Collaboration Targeted
Shanghai Pharmaceuticals Holding Co., Ltd. (SPH; HKG: 2607, SHA: 601607) and Henlius (HKG: 2696) announced...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
CSPC Pharma Secures Dual NMPA‑FDA Approval for PDE4B Inhaler SYH2059 – First‑in‑Class ILD Candidate Enters Global Clinical Development
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its highly selective PDE4B inhibitor SYH2059 powder...
Basecare Medical Secures NMPA Approval for First Domestic‑Platform PGT‑A Kit – Milestone for China IVF Genetic Testing Independence
Suzhou Basecare Medical Corporation Limited (HKG: 2170) announced that its Embryo Pre‑implantation Chromosomal Aneuploidy Testing...
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...
China Unveils NHSA Grassroots Healthcare Reform – 14‑Point Guidance Targets RMB Fund Flow Shift to Primary Care Institutions
China’s National Healthcare Security Administration (NHSA), jointly with the National Development and Reform Commission and...
PegBio Inks RMB10 Billion Paidakang Commercialization Deal with Tenry Pharma – Exclusive China Partnership for Weekly GLP‑1 Diabetes Drug
PegBio Co., Ltd. (HKG: 2565) has entered into a strategic cooperation agreement with Shanghai Tenry...