Haisco's HSK42360‑Na Proposed for CDE Breakthrough Therapy Designation – Next‑Generation BRAF Inhibitor Targets V600‑Mutant High‑Grade Glioma
CompanyDrug

Haisco’s HSK42360‑Na Proposed for CDE Breakthrough Therapy Designation – Next‑Generation BRAF Inhibitor Targets V600‑Mutant High‑Grade Glioma

Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced, via listing on the website of China's Center for Drug Evaluation (CDE) of the NMPA, that its Class 1 investigational new drug…

Astellas' PADCEV Plus Keytruda Receives Positive CHMP Opinion – Perioperative Muscle‑Invasive Bladder Cancer Regimen Nears EU Approval
CompanyDrug

Astellas’ PADCEV Plus Keytruda Receives Positive CHMP Opinion – Perioperative Muscle‑Invasive Bladder Cancer Regimen Nears EU Approval

Novo Nordisk's FREHEMGO (Denecimig) Receives Positive CHMP Opinion – Next‑Generation Hemophilia A Prophylaxis Nears EU Authorization
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Novo Nordisk’s FREHEMGO (Denecimig) Receives Positive CHMP Opinion – Next‑Generation Hemophilia A Prophylaxis Nears EU Authorization

Nutshell Therapeutics' NTS231 Clears FDA IND – First NRF2 Molecular Glue Degrader from China and Second Globally to Enter Clinical Development, Targeting KEAP1 to Block NRF2
CompanyDrug

Nutshell Therapeutics’ NTS231 Clears FDA IND – First NRF2 Molecular Glue Degrader from China and Second Globally to Enter Clinical Development, Targeting KEAP1 to Block NRF2

Simcere Pharmaceutical Files IND for SIM0688 – First B7‑H3/c‑Met Bispecific ADC to Enter Clinical Development
CompanyDrug

Simcere Pharmaceutical Files IND for SIM0688 – First B7‑H3/c‑Met Bispecific ADC to Enter Clinical Development

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Alibaba Health Reports Strong FY2026 Results with 35.2% Profit Growth and Launches Medical LLM "H+"
CompanyDigital

Alibaba Health Reports Strong FY2026 Results with 35.2% Profit Growth and Launches Medical LLM “H+”

Amgen's Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration
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Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration

Policy / Regulatory

China Issues National Guidelines for Home Hospital Bed Services to Address Healthcare Access for Vulnerable Populations

CompanyDrug

Chongqing Genrix Bio Receives NMPA Clinical Approval for GR1803 Bispecific Antibody in Relapsed/Refractory Multiple Myeloma

AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer
CompanyDrug

AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer

CompanyDrug

Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes

CompanyDrug

Biogen Reports Positive Phase II CELIA Results for Diranersen, First-in-Class Tau-Targeting ASO Therapy in Early Alzheimer’s Disease

CompanyDrug

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for RSS0393 Latex in Atopic Dermatitis Treatment

CompanyDeals

Eli Lilly Commits $50M to UNICEF USA Alliance Targeting Non-Communicable Disease Prevention in Children Across 21 LMICs

CompanyDrug

Sichuan Biokin Receives NMPA Go-Ahead for SI-B036 Bispecific Antibody Clinical Study in Advanced Solid Tumors

CompanyDrug

Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors

CompanyMedical Device

Basecare Medical Device Secures NMPA Approval for Gems Embryo Culture Medium – Chinese IVF Specialist Completes Global Regulatory Triad

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