IASO Bio's In Vivo CAR‑T IASO208 Receives FDA Implicit IND Approval – Off‑the‑Shelf CD20 Therapy Targets Relapsed/Refractory B‑NHL
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IASO Bio’s In Vivo CAR‑T IASO208 Receives FDA Implicit IND Approval – Off‑the‑Shelf CD20 Therapy Targets Relapsed/Refractory B‑NHL

Chia Tai Tianqing's Dual Category 1 Biologics Applications Accepted by NMPA – TQB2102 HER2‑Low ADC and TQH2722 IL‑4Rα Antibody Advance Toward Approval
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Chia Tai Tianqing’s Dual Category 1 Biologics Applications Accepted by NMPA – TQB2102 HER2‑Low ADC and TQH2722 IL‑4Rα Antibody Advance Toward Approval

CSPC's SYS6010 Granted NMPA Breakthrough Therapy Designation – EGFR‑Targeting ADC for Refractory Non‑Squamous NSCLC
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CSPC’s SYS6010 Granted NMPA Breakthrough Therapy Designation – EGFR‑Targeting ADC for Refractory Non‑Squamous NSCLC

Gilead and PAHO Sign Agreement to Expand Twice-Yearly Lenacapavir PrEP Access Across Latin America and the Caribbean
CompanyDeals

Gilead and PAHO Sign Agreement to Expand Twice-Yearly Lenacapavir PrEP Access Across Latin America and the Caribbean

China's NHSA Pilots Pre-Project Approval System for Medical Service Pricing – Fast Lane for Innovative Technologies
Policy / Regulatory

China’s NHSA Pilots Pre-Project Approval System for Medical Service Pricing – Fast Lane for Innovative Technologies

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
CompanyDeals

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