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GenEditBio's GEB-101 Granted FDA Fast Track Designation – First‑in‑Class Genome‑Editing Therapy for TGFBI Corneal Dystrophies
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GenEditBio’s GEB-101 Granted FDA Fast Track Designation – First‑in‑Class Genome‑Editing Therapy for TGFBI Corneal Dystrophies

CBMG Wins FDA Clearance for C-CAR168 Phase Ib/II Trial – Bispecific CAR‑T Targets Progressive Multiple Sclerosis
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CBMG Wins FDA Clearance for C-CAR168 Phase Ib/II Trial – Bispecific CAR‑T Targets Progressive Multiple Sclerosis

Santo Therapeutics and PolyGene Sign Strategic Partnership – Joint Gene Therapy Delivery Push Targets NF1 Skin Disease
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Santo Therapeutics and PolyGene Sign Strategic Partnership – Joint Gene Therapy Delivery Push Targets NF1 Skin Disease

NMPA Issues Medical Device GMP Inspection Guidelines – Revised Production Quality Standards Take Effect November 1, 2026
Medical DevicePolicy / Regulatory

NMPA Issues Medical Device GMP Inspection Guidelines – Revised Production Quality Standards Take Effect November 1, 2026

Hengrui Pharma's Recaticimab Cleared by NMPA for Phase 3 Trial – Targeting Stroke Recurrence in Intracranial Atherosclerotic Stenosis
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Hengrui Pharma’s Recaticimab Cleared by NMPA for Phase 3 Trial – Targeting Stroke Recurrence in Intracranial Atherosclerotic Stenosis

FDA Approves Imdelltra Label Update – Monitoring Time for First Two Doses Cut to 6–8 Hours from 22–24, Easing Delivery of Amgen's First‑in‑Class SCLC Immunotherapy
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FDA Approves Imdelltra Label Update – Monitoring Time for First Two Doses Cut to 6–8 Hours from 22–24, Easing Delivery of Amgen’s First‑in‑Class SCLC Immunotherapy

FDA Accepts Takeda's NDA for Zasocitinib with Priority Review – Next‑Generation Oral TYK2 Inhibitor Nears Decision in Moderate‑to‑Severe Plaque Psoriasis
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FDA Accepts Takeda’s NDA for Zasocitinib with Priority Review – Next‑Generation Oral TYK2 Inhibitor Nears Decision in Moderate‑to‑Severe Plaque Psoriasis

NMPA Approves Expanded Indication for Merck's Winrevair (Sotatercept) – First‑in‑Class Activin Signaling Inhibitor Now Covers WHO Functional Class II–IV PAH in China
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NMPA Approves Expanded Indication for Merck’s Winrevair (Sotatercept) – First‑in‑Class Activin Signaling Inhibitor Now Covers WHO Functional Class II–IV PAH in China

Bio‑heart Partners with Shenqi Medical to Commercialize BioHeart Bioabsorbable Stent – Advancing "Interventional Treatment Without Implantation" in China's Coronary Market
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Bio‑heart Partners with Shenqi Medical to Commercialize BioHeart Bioabsorbable Stent – Advancing “Interventional Treatment Without Implantation” in China’s Coronary Market

Cheplapharm and Sanofi Move to Forge Strategic Partnership – Lovenox/Clexane Anchors 20‑Medicine Portfolio and Three‑Site Transfer in Exchange for 26.4 % Equity Stake
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Cheplapharm and Sanofi Move to Forge Strategic Partnership – Lovenox/Clexane Anchors 20‑Medicine Portfolio and Three‑Site Transfer in Exchange for 26.4 % Equity Stake

Hengrui's SHR‑2004 Marketing Application Accepted by NMPA – First‑in‑Class FXI Antibody Nears Approval for VTE Prevention in Knee Replacement
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Hengrui’s SHR‑2004 Marketing Application Accepted by NMPA – First‑in‑Class FXI Antibody Nears Approval for VTE Prevention in Knee Replacement

China Medical System Wins NMPA Clinical Trial Approval for CMS‑D001 – Highly Selective Oral TYK2 Inhibitor Targeting Systemic Lupus Erythematosus
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China Medical System Wins NMPA Clinical Trial Approval for CMS‑D001 – Highly Selective Oral TYK2 Inhibitor Targeting Systemic Lupus Erythematosus