NMPA Issues Export Drug Certification Rules, Expanding Scope and Validity
China’s National Medical Products Administration (NMPA) released the “Regulations on Inspection and Export Certification Management...
Bayer’s HYRNUO Wins FDA Approval for HER2-Mutated Lung Cancer
Bayer AG (ETR: BAYN) announced that sevabertinib (trade name HYRNUO) received U.S. FDA approval for...
Johnson & Johnson China PINS Head Alex He to Depart, Driving Leadership Transition Amid Key NRDL Product Success
Johnson & Johnson (J&J, NYSE: JNJ) China confirmed a significant leadership change today, announcing that...
3SBio’s Mandi Spin-Off Targets HKEX IPO as Hair Health Leader
3SBio Inc. (HKG: 1530) announced plans to spin off its consumer healthcare subsidiary Mandi International...
GE HealthCare to Acquire Intelerad for $2.3B, Expanding Cloud-Enabled Imaging
GE HealthCare (NASDAQ: GEHC) announced a definitive agreement to acquire Intelerad Medical System for USD...
Sinovac Receives Nasdaq Delisting Notice Over Late 20-F Filing
Sinovac Biotech Ltd. (NASDAQ: SVA) announced it received a delisting determination letter from Nasdaq for...
Pien Tze Huang’s PZH2108 Cancer Pain Drug Enrolls First Phase IIa Patient
Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436) announced the enrollment of the first...
Abbott to Acquire Exact Sciences for $21B, Entering Cancer Diagnostics Leadership
Abbott Laboratories (NYSE: ABT) and Exact Sciences Corp. (NASDAQ: EXAS) announced a definitive agreement under...
Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its anti‑PD‑1 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly...
FDA Pilot Program Offers Meeting Minute Clarification to Drug Sponsors
The U.S. Food and Drug Administration (FDA) announced a pilot program designed to streamline post‑meeting...
Reprogenix Closes RMB 500M Series A+ to Advance Diabetes Cell Therapy Pipeline
Reprogenix Bioscience Inc. announced the completion of an oversubscribed RMB 500 million Series A+ financing round led...
Pfizer’s Hympavzi Wins China Approval as First Weekly Non‑Factor Hemophilia Therapy
Pfizer Inc. (NYSE: PFE) announced that Hympavzi (marstacimab), the world’s first non‑factor hemophilia therapy requiring...
Freenome Roche Cancer Screening Deal Worth Over $200M
Freenome, a California‑based early cancer detection company, announced a strategic collaboration with Roche (SWX: ROG,...
Nona Biosciences Licenses HCAb Platform to Pfizer for Antibody Discovery
Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), announced a non‑exclusive licensing...
Rock Roc’s CAR-M Platform Secures RMB 50M Series A for Macrophage Therapy
Rock Roc Biotechnology Co., Ltd completed an oversubscribed RMB 50 million (≈ US$7 million) Series A financing to...
Kelun-Biotech’s Trastuzumab Botidotin HER2 ADC Launches in China After Phase 3 Win vs T-DM1
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced the official China launch of trastuzumab botidotin,...
Regeneron’s Libtayo Wins EC Approval for Adjuvant CSCC, 68% Risk Reduction
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the European Commission (EC) approved Libtayo (cemiplimab) as adjuvant...
Novartis Builds $23B North Carolina Manufacturing Hub, Adding 700 Jobs
Novartis (NYSE: NVS) announced plans to establish a flagship manufacturing hub in North Carolina as...
Lynk’s LNK01004 Pan-JAK Inhibitor Shows EASI-75 Win in Phase 2 Atopic Dermatitis Trial
Lynk Pharmaceuticals Co., Ltd. announced positive Phase II data for its self‑developed Class 1 innovative drug LNK01004,...
Acotec’s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions
Acotec Scientific Holdings Limited (HKG: 6669) announced that China’s National Medical Products Administration (NMPA) has...