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NMPA Proposes Optimized Process Validation Requirements for Innovative Chemical Drugs – Draft Policy Incentivizes Global Simultaneous Filing and Launch in China
Policy / Regulatory

NMPA Proposes Optimized Process Validation Requirements for Innovative Chemical Drugs – Draft Policy Incentivizes Global Simultaneous Filing and Launch in China

Eli Lilly Completes Acquisition of AtaiBeckley for up to USD 3.8 Billion – Deal Secures BPL‑003 Rapid‑Acting Neuroplastogen for Treatment‑Resistant Depression
CompanyDeals

Eli Lilly Completes Acquisition of AtaiBeckley for up to USD 3.8 Billion – Deal Secures BPL‑003 Rapid‑Acting Neuroplastogen for Treatment‑Resistant Depression

AstraZeneca's Etcamah (Camizestrant) Misses SERENA‑4 Primary PFS Endpoint in First‑Line Advanced Breast Cancer – Next‑Generation Oral SERD Falls Short Against Anastrozole Plus Palbociclib
CompanyDrug

AstraZeneca’s Etcamah (Camizestrant) Misses SERENA‑4 Primary PFS Endpoint in First‑Line Advanced Breast Cancer – Next‑Generation Oral SERD Falls Short Against Anastrozole Plus Palbociclib

GSK's ROS1 Inhibitor Jideytro (Zidesamtinib) Posts 94 % Response Rate in TKI‑Naïve ROS1‑Positive NSCLC – Phase I/II ARROS‑1 Delivers Durable Responses With 90 % 12‑Month PFS
CompanyDrug

GSK’s ROS1 Inhibitor Jideytro (Zidesamtinib) Posts 94 % Response Rate in TKI‑Naïve ROS1‑Positive NSCLC – Phase I/II ARROS‑1 Delivers Durable Responses With 90 % 12‑Month PFS

Merck's KEYTRUDA (Pembrolizumab) Wins NMPA Approval in Early‑Stage High‑Risk TNBC – Label Expansion Beyond PD‑L1 CPS ≥ 20 for China's Only Approved PD‑1 Perioperative Breast Cancer Therapy
CompanyDrug

Merck’s KEYTRUDA (Pembrolizumab) Wins NMPA Approval in Early‑Stage High‑Risk TNBC – Label Expansion Beyond PD‑L1 CPS ≥ 20 for China’s Only Approved PD‑1 Perioperative Breast Cancer Therapy

Diagens Biotechnology and AntAngelMed Forge Three‑Year Pact on Medical Imaging AI – iMedImage Platform Anchors Zhejiang's Provincial "Digital and Intelligent Imaging" Build‑Out
CompanyDeals

Diagens Biotechnology and AntAngelMed Forge Three‑Year Pact on Medical Imaging AI – iMedImage Platform Anchors Zhejiang’s Provincial “Digital and Intelligent Imaging” Build‑Out

MediLink's Roche‑Partnered B7‑H3 ADC Tambotatug Pelitecan Cuts Death Risk 54 % vs. Topotecan in Relapsed Small‑Cell Lung Cancer – Phase III TAISHAN‑302 Meets Primary OS Endpoint
CompanyDrug

MediLink’s Roche‑Partnered B7‑H3 ADC Tambotatug Pelitecan Cuts Death Risk 54 % vs. Topotecan in Relapsed Small‑Cell Lung Cancer – Phase III TAISHAN‑302 Meets Primary OS Endpoint

Hengrui's HER3 ADC Ruzaltatug Rezetecan Wins China Breakthrough Therapy Designation – A New Option for EGFR‑Mutant NSCLC After TKI Failure
CompanyDrug

Hengrui’s HER3 ADC Ruzaltatug Rezetecan Wins China Breakthrough Therapy Designation – A New Option for EGFR‑Mutant NSCLC After TKI Failure

Peijia Medical Wins NMPA Approval for GeminiOne TEER System – A Novel Transcatheter Edge‑to‑Edge Repair Device for Mitral Regurgitation in China
CompanyMedical Device

Peijia Medical Wins NMPA Approval for GeminiOne TEER System – A Novel Transcatheter Edge‑to‑Edge Repair Device for Mitral Regurgitation in China

Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption
Policy / Regulatory

Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption

CompanyDrug

BRL Medicine’s Allogeneic CD19 CAR‑T Included in CDE’s “Care Program‑Extension” – Rare Disease Fast Track for Relapsed/Refractory Systemic Sclerosis

CompanyDrug

Walvax’s Third‑Generation COVID‑19 mRNA Vaccine Wins NMPA Approval – JN.1‑Based Shot Clears Regulatory Bar for Adults in China