Shanghai Ark Biopharmaceutical's AK0406 Receives FDA IND Clearance for Phase 2 Trial – Long‑Acting Antiviral‑Fc Conjugate Advances Toward Influenza Prevention
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Shanghai Ark Biopharmaceutical’s AK0406 Receives FDA IND Clearance for Phase 2 Trial – Long‑Acting Antiviral‑Fc Conjugate Advances Toward Influenza Prevention

Shanghai Ark Biopharmaceutical Co., Ltd. (Ark Biosciences) announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AK0406, a long‑acting antiviral drug‑Fc…

T-MAXIMUM's MT027 Wins FDA Clearance for Phase 2 Study – Non‑Viral Allogeneic B7‑H3 CAR‑T Targets Advanced Solid Tumor Brain Metastases
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T-MAXIMUM’s MT027 Wins FDA Clearance for Phase 2 Study – Non‑Viral Allogeneic B7‑H3 CAR‑T Targets Advanced Solid Tumor Brain Metastases

Five Innovative Therapies Enter the Rare Disease R&D Pilot Initiative – Spanning Blau Syndrome, Angelman Syndrome, ALS and Charcot‑Marie‑Tooth Disease
Policy / Regulatory

Five Innovative Therapies Enter the Rare Disease R&D Pilot Initiative – Spanning Blau Syndrome, Angelman Syndrome, ALS and Charcot‑Marie‑Tooth Disease

Suzhou Rigerna Therapeutics' RG002C0106 Injection Supplemental Application Accepted by China's CDE – Class 1 Chemical Drug Enters Regulatory Review
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Suzhou Rigerna Therapeutics’ RG002C0106 Injection Supplemental Application Accepted by China’s CDE – Class 1 Chemical Drug Enters Regulatory Review

Hyperway Pharmaceutical Closes Series B+ Financing Round – Penglai Private Fund and Hengdian Capital Back the Chengdu Biotech's CNS and Brain‑Penetrant Drug Pipeline
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Hyperway Pharmaceutical Closes Series B+ Financing Round – Penglai Private Fund and Hengdian Capital Back the Chengdu Biotech’s CNS and Brain‑Penetrant Drug Pipeline

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Merck's Subcutaneous Pembrolizumab Approved by China's NMPA Across 19 Solid Tumor Indications – First and Only Subcutaneous PD‑1 Inhibitor in China
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Merck’s Subcutaneous Pembrolizumab Approved by China’s NMPA Across 19 Solid Tumor Indications – First and Only Subcutaneous PD‑1 Inhibitor in China

Atavistik Bio Strikes CVRM Collaboration with Roche – USD 70 Million Upfront, up to USD 1.9 Billion in Milestones for Allosteric Small‑Molecule Discovery
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Atavistik Bio Strikes CVRM Collaboration with Roche – USD 70 Million Upfront, up to USD 1.9 Billion in Milestones for Allosteric Small‑Molecule Discovery

HUTCHMED Initiates Phase Ia Global Trial of HMPL-A830 – First‑in‑Class KRAS‑Payload Antibody‑Targeted Conjugate Licensed to GSK for up to USD 1.295 Billio
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HUTCHMED Initiates Phase Ia Global Trial of HMPL-A830 – First‑in‑Class KRAS‑Payload Antibody‑Targeted Conjugate Licensed to GSK for up to USD 1.295 Billion

FDA Approves AbbVie's Tavapadon as Juvmo for Parkinson's Disease – Once‑Daily Dopamine Mimetic Joins $8.7 Billion Cerevel Portfoli
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FDA Approves AbbVie’s Tavapadon as Juvmo for Parkinson’s Disease – Once‑Daily Dopamine Mimetic Joins $8.7 Billion Cerevel Portfolio

Biokin Scores Triple NMPA Breakthrough Therapy Designation – BL-M07D1, BL-M05D1, and Iza‑Bren Recognized Across Biliary Tract and Gastric Cancers
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Biokin Scores Triple NMPA Breakthrough Therapy Designation – BL-M07D1, BL-M05D1, and Iza‑Bren Recognized Across Biliary Tract and Gastric Cancers

Biokin's BL-M12D1 Wins NMPA Clinical Trial Approval – ADC Candidate to Be Evaluated as Monotherapy in Relapsed or Refractory Hematologic Malignancies
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Biokin’s BL-M12D1 Wins NMPA Clinical Trial Approval – ADC Candidate to Be Evaluated as Monotherapy in Relapsed or Refractory Hematologic Malignancies

Haisco's HSK42360-Na Granted NMPA Breakthrough Therapy Designation – BRAF Paradoxical Breaker Targets High‑Grade Glioma with BRAF V600 Mutation
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Haisco’s HSK42360-Na Granted NMPA Breakthrough Therapy Designation – BRAF Paradoxical Breaker Targets High‑Grade Glioma with BRAF V600 Mutation

Neurorevix Completes Tens of Millions RMB Angel Round Led by HSG – BCI and Neuromodulation Pioneer Advances "Closed‑Loop Nerve Bundle Modulation" Platform
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Neurorevix Completes Tens of Millions RMB Angel Round Led by HSG – BCI and Neuromodulation Pioneer Advances “Closed‑Loop Nerve Bundle Modulation” Platform

Boehringer Ingelheim and WHO Foundation Launch Three‑Year, USD 5 Million Collaboration to Tackle Obesity in Resource‑Limited Settings
CompanyDeals

Boehringer Ingelheim and WHO Foundation Launch Three‑Year, USD 5 Million Collaboration to Tackle Obesity in Resource‑Limited Settings

Three Oncology Assets Join CDE Pilot Programs – ICP‑B794 and Aponermin Enter "Care Program – Extension" While GH56 Advances Pediatric Development
Policy / Regulatory

Three Oncology Assets Join CDE Pilot Programs – ICP‑B794 and Aponermin Enter “Care Program – Extension” While GH56 Advances Pediatric Development

Leads Biolabs' LBL-024 Granted Orphan Drug Designation by Japan's MHLW – Anti‑PD‑L1/4‑1BB Bispecific Antibody Advances in Extrapulmonary Neuroendocrine Carcinoma
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Leads Biolabs’ LBL-024 Granted Orphan Drug Designation by Japan’s MHLW – Anti‑PD‑L1/4‑1BB Bispecific Antibody Advances in Extrapulmonary Neuroendocrine Carcinoma

Evive Biotech Doses First Participant in Phase II Study of F-652 for Acute GVHD – Yifan Pharmaceutical's First‑in‑Class IL-22 Fusion Protein Advances Post‑HSCT Treatment
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Evive Biotech Doses First Participant in Phase II Study of F-652 for Acute GVHD – Yifan Pharmaceutical’s First‑in‑Class IL-22 Fusion Protein Advances Post‑HSCT Treatment

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