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

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

Cellular Biomedicine Group (CBMG) announced that the US Food and Drug Administration (FDA) has approved the initiation of a Phase Ib/II clinical trial of C‑CAR168, a CD20/BCMA bispecific CAR‑T therapy,…

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
CompanyDrug

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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CSPC Pharmaceutical’s Megalith Subsidiary Enters $1.77 Billion siRNA Collaboration with AstraZeneca for Novel RNAi Therapeutics

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Bio-sincerity Secures NMPA Clinical Trial Approval for BIOS0629-109, Novel XPO1 Inhibitor for Advanced Malignant Tumors

Novartis Secures EU Approval for Itvisma, First Gene Replacement Therapy for Broad SMA Population Including Patients Two Years and Older
CompanyDrug

Novartis Secures EU Approval for Itvisma, First Gene Replacement Therapy for Broad SMA Population Including Patients Two Years and Older

CompanyDrug

Ocumension Therapeutics Secures NMPA Approval for OT-502, China’s First Single-Dose Sustained-Release Intraocular Steroid for Postoperative Inflammation

Hotgen Biotech Launches AI Subsidiary to Transform Small Nucleic Acid Drug Discovery
Company

Hotgen Biotech Launches AI Subsidiary to Transform Small Nucleic Acid Drug Discovery

Hangzhou Adamerck's Aom0498 Receives NMPA Approval as China's First Homegrown Neuromuscular Blockade Reversal Agent – Completing Decade-Long National Innovation Program
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Hangzhou Adamerck’s Aom0498 Receives NMPA Approval as China’s First Homegrown Neuromuscular Blockade Reversal Agent – Completing Decade-Long National Innovation Program

CompanyDeals

Junshi Biosciences Licenses Anti-IL-17A Antibody Roconkibart to Fosun Wanbang for Greater China – $1.34B Deal Secures Commercialization of Phase III-Ready Psoriasis Therapy

CompanyDrug

Jingxin Pharmaceutical Secures NMPA Approval for China’s First Generic Cariprazine in Schizophrenia – Capturing Market Opportunity as Reference Product Remains Unlaunched

CompanyDrug

TransThera Completes Patient Enrollment in Global Phase III Trial of Tinengotinib for Advanced Cholangiocarcinoma – Multi-Kinase Inhibitor Backed by Multiple Regulatory Designations

CompanyDrug

TransThera Advances Phase II Trial of Selective BTK Inhibitor TT-01488 with Anti-CD20 Antibodies for Mantle Cell Lymphoma – Novel Non-Covalent Approach Shows Enhanced Safety Profile

CompanyDeals

Insilico Medicine and Takeda Launch $600M Strategic AI Drug Discovery Collaboration – Pharma.AI Platform to Drive Candidate Identification for High-Potential Therapeutic Targets

CompanyDeals

Nona Biosciences and Lonza Forge Strategic Alliance to Develop Best-in-Class Blood-Brain Barrier Penetration Technology for CNS Therapeutics

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