Lundbeck’s Vyepti Secures Chinese NDA, Expands Asian Footprint
CompanyDrug

Lundbeck’s Vyepti Secures Chinese NDA, Expands Asian Footprint

Suzhou Zelgen Biopharma to Deregister U.S. Subsidiary Gensun to Sharpen R&D Focus
CompanyDeals

Suzhou Zelgen Biopharma to Deregister U.S. Subsidiary Gensun to Sharpen R&D Focus

Akeso Secures NMPA Approval for AK152 – First Bispecific Antibody Targeting Alzheimer’s in China
CompanyDrug

Akeso Secures NMPA Approval for AK152 – First Bispecific Antibody Targeting Alzheimer’s in China

MSD Acquires Cidara Therapeutics in $9.2‑Billion Deal to Expand Antiviral Portfolio
CompanyDeals

MSD Acquires Cidara Therapeutics in $9.2‑Billion Deal to Expand Antiviral Portfolio

Abbisko Therapeutics Reports Durable Response in Phase 3 MANEUVER Study for Pimicotinib (ABSK021) in TGCT
CompanyDrug

Abbisko Therapeutics Reports Durable Response in Phase 3 MANEUVER Study for Pimicotinib (ABSK021) in TGCT

Zhejiang Jianfeng Group Secures NMPA Approval for JFAN‑1001/ Vinorelbine Combination in Advanced NSCLC
CompanyDrug

Zhejiang Jianfeng Group Secures NMPA Approval for JFAN‑1001/ Vinorelbine Combination in Advanced NSCLC

Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma
CompanyDrug

Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma

PegBio’s PB‑119 (Paidakang) Wins NMPA Approval for Type 2 Diabetes Treatment
CompanyDrug

PegBio’s PB‑119 (Paidakang) Wins NMPA Approval for Type 2 Diabetes Treatment

Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
CompanyDrug

Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications

Hangzhou Bio‑Sincerity Pharma‑Tech Secures NMPA Approval for BIOS2242 Oral Solution in Acute Ischemic Stroke
CompanyDrug

Hangzhou Bio‑Sincerity Pharma‑Tech Secures NMPA Approval for BIOS2242 Oral Solution in Acute Ischemic Stroke

NMPA Launches Pilot Program to Cut Review Time for Overseas‑Manufactured Drug Supplementary Applications
Others

NMPA Launches Pilot Program to Cut Review Time for Overseas‑Manufactured Drug Supplementary Applications

FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
Policy / Regulatory

FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+