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

Merck & Co., Inc. (MSD; NYSE: MRK) announced that its PD‑1 inhibitor KEYTRUDA (pembrolizumab) has been approved by China's National Medical Products Administration (NMPA) in combination with chemotherapy as neoadjuvant…

NMPA Approves Expanded Indication for Merck's Winrevair (Sotatercept) – First‑in‑Class Activin Signaling Inhibitor Now Covers WHO Functional Class II–IV PAH in China
CompanyDrug

NMPA Approves Expanded Indication for Merck’s Winrevair (Sotatercept) – First‑in‑Class Activin Signaling Inhibitor Now Covers WHO Functional Class II–IV PAH in China

CompanyDrug

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

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

Allergan Aesthetics' JUVÉDERM VOLBELLA Wins NMPA Approval for Infraorbital Hollowing – Hyaluronic Acid Filler Expands China Label Beyond Lips
CompanyDrug

Allergan Aesthetics’ JUVÉDERM VOLBELLA Wins NMPA Approval for Infraorbital Hollowing – Hyaluronic Acid Filler Expands China Label Beyond Lips

GSK's Shingrix Wins Japan Approval for Prefilled Syringe Presentation – Recombinant Zoster Vaccine Gains Administration Flexibility
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GSK’s Shingrix Wins Japan Approval for Prefilled Syringe Presentation – Recombinant Zoster Vaccine Gains Administration Flexibility

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

CDE Includes Beijing Toll Biotech's TollB‑001 Tablets in Rare Disease Pilot Scheme – Novel Oral TLR8 Inhibitor Targets Systemic Sclerosis with First Specific Treatment Potential
CompanyDrug

CDE Includes Beijing Toll Biotech’s TollB‑001 Tablets in Rare Disease Pilot Scheme – Novel Oral TLR8 Inhibitor Targets Systemic Sclerosis with First Specific Treatment Potential

NMPA Grants Priority Review to Everest Medicines' Manufacturing‑Transfer NDA for VELSIPITY (Etrasimod) – Localizing Production of Its Approved Ulcerative Colitis Therapy in China
CompanyDrug

NMPA Grants Priority Review to Everest Medicines’ Manufacturing‑Transfer NDA for VELSIPITY (Etrasimod) – Localizing Production of Its Approved Ulcerative Colitis Therapy in China

Hengrui’s SHR‑2004 Marketing Application Accepted by NMPA – First‑in‑Class FXI Antibody Nears Approval for VTE Prevention in Knee Replacement

Hengrui's SHR‑2004 Marketing Application Accepted by NMPA – First‑in‑Class FXI Antibody Nears Approval for VTE Prevention in Knee Replacement

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China's National Medical Products Administration (NMPA) has accepted the marketing authorization application for SHR‑2004 injection, a Category 1 innovative drug and novel humanized monoclonal antibody targeting Factor XI (FXI),…

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

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

GenScript Biotech Collaborates with Lilly TuneLab – Pairing Large‑Scale Wet‑Lab Validation with Eli Lilly's AI/ML Drug Discovery Platform
CompanyDeals

GenScript Biotech Collaborates with Lilly TuneLab – Pairing Large‑Scale Wet‑Lab Validation with Eli Lilly’s AI/ML Drug Discovery Platform

Novo Nordisk and Anthropic Announce AI Collaboration – Claude Science to Accelerate Drug Discovery and AI‑Driven Software Development
CompanyDeals

Novo Nordisk and Anthropic Announce AI Collaboration – Claude Science to Accelerate Drug Discovery and AI‑Driven Software Development

Novartis Exercises Exclusive Option to Acquire Global Rights to Sironax Brain Delivery Platform – USD 125 Million Transaction Targets Blood‑Brain Barrier Breakthrough for CNS Diseases
CompanyDeals

Novartis Exercises Exclusive Option to Acquire Sironax Brain Delivery Platform in USD 125 Million Transaction

China Resources Pharmaceutical and Sino Biopharmaceutical Sign Strategic Pact Spanning R&D, Distribution and DTP Channels Toward RMB 10 Billion Target
CompanyDeals

China Resources Pharmaceutical and Sino Biopharmaceutical Sign Strategic Pact Spanning R&D, Distribution and DTP Channels Toward RMB 10 Billion Target

Tempest Therapeutics Secures Exclusive Option to License Senlang's CD7‑Targeted In Vivo CAR‑T Platform – Lead Bispecific BCMA/GPRC5D Candidate in Phase I for Relapsed/Refractory Multiple Myeloma
CompanyDeals

Tempest Therapeutics Secures Exclusive Option to License Senlang’s CD7‑Targeted In Vivo CAR‑T Platform – Lead Bispecific BCMA/GPRC5D Candidate in Phase I for Relapsed/Refractory Multiple Myeloma

Where biopharma's biggest deals take shape!

Your front-row seat to the deals reshaping the pharmaceutical landscape — mergers and acquisitions, licensing agreements, venture investments, and strategic partnerships. We track every major transaction, from blockbuster M&As to early-stage funding rounds, breaking down what each deal means for the companies, the pipeline, and the market.
M&A and Licensing
ACROBiosystems and MediumBank Forge Strategic Partnership on AI‑Designed Proteins – Closed‑Loop Program Targets Thermostable bFGF and High‑Activity Cytokines for Cell Culture Media
CompanyDeals

ACROBiosystems and MediumBank Forge Strategic Partnership on AI‑Designed Proteins – Closed‑Loop Program Targets Thermostable bFGF and High‑Activity Cytokines for Cell Culture Media

ACROBiosystems Co., Ltd. and Shanghai MediumBank Biotechnology Co., Ltd. (MediumBank) announced that the two companies have entered into a strategic cooperation centered on AI‑designed proteins developed by ACROBiosystems — beginning…

Escugen and Sovran Bio Sign Co‑Development Agreement for First‑in‑Class Pan‑Tumor Bispecific ADC – EZWi‑Fit Platform Powers Tumor‑Selective Payload Delivery
CompanyDeals

Escugen and Sovran Bio Sign Co‑Development Agreement for First‑in‑Class Pan‑Tumor Bispecific ADC – EZWi‑Fit Platform Powers Tumor‑Selective Payload Delivery

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

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

Bio‑heart Partners with Shenqi Medical to Commercialize BioHeart Bioabsorbable Stent – Advancing "Interventional Treatment Without Implantation" in China's Coronary Market
CompanyDeals

Bio‑heart Partners with Shenqi Medical to Commercialize BioHeart Bioabsorbable Stent – Advancing “Interventional Treatment Without Implantation” in China’s Coronary Market

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Inno Medicine Completes Nearly RMB 800 Million Series D Led by YuanBio – Funds to Drive International Multi‑Center Trials of Nanomedicine Targeted‑Delivery Pipeline
CompanyDeals

Inno Medicine Completes Nearly RMB 800 Million Series D Led by YuanBio – Funds to Drive International Multi‑Center Trials of Nanomedicine Targeted‑Delivery Pipeline

CompanyDeals

HBM Partner Solstice Oncology Launches with US$225 Million Series A Led by RA Capital – Advancing Second‑Generation CTLA‑4 Antibody Porustobart in Neoadjuvant Oncology

HepaBio Therapeutics Raises Series A Strategic Funding From TriApex to Advance Organoid Technology and Next‑Generation Drug R&D Systems
CompanyDeals

HepaBio Therapeutics Raises Series A Strategic Funding From TriApex to Advance Organoid Technology and Next‑Generation Drug R&D Systems

CompanyDeals

NeuShen Therapeutics Closes Oversubscribed Series B Exceeding USD 80 Million to Accelerate Global CNS Pipeline

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

The Hainan Boao Lecheng International Medical Tourism Pilot Zone has released the "Implementation Rules for the Exit Mechanism of Clinical Translation and Application of New Biomedical Technologies" (the "Rules"), aiming…

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

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

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

More News

NMPA Accepts Qilu Pharmaceutical's Marketing Application for Meropenem/Pralurbactam for Injection – First Independently Developed Novel β‑Lactamase Inhibitor Combination in China for cIAI
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NMPA Accepts Qilu Pharmaceutical’s Marketing Application for Meropenem/Pralurbactam for Injection – First Independently Developed Novel β‑Lactamase Inhibitor Combination in China for cIAI

Hengrui's HRS-4139 Wins NMPA Clinical Trial Approval – Class 1 First‑in‑Target Candidate Targets Moderate‑to‑Severe Plaque Psoriasis
CompanyDrug

Hengrui’s HRS-4139 Wins NMPA Clinical Trial Approval – Class 1 First‑in‑Target Candidate Targets Moderate‑to‑Severe Plaque Psoriasis

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

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
CompanyDrug

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

GenEditBio's GEB-101 Granted FDA Fast Track Designation – First‑in‑Class Genome‑Editing Therapy for TGFBI Corneal Dystrophies
CompanyDrug

GenEditBio’s GEB-101 Granted FDA Fast Track Designation – First‑in‑Class Genome‑Editing Therapy for TGFBI Corneal Dystrophies

Hengrui Pharma's Recaticimab Cleared by NMPA for Phase 3 Trial – Targeting Stroke Recurrence in Intracranial Atherosclerotic Stenosis
CompanyDrug

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

FDA Accepts Takeda's NDA for Zasocitinib with Priority Review – Next‑Generation Oral TYK2 Inhibitor Nears Decision in Moderate‑to‑Severe Plaque Psoriasis
CompanyDrug

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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