China's CDE Launches "Pioneer Plan" Pilot to Advance New Approach Methodologies (NAMs) in Non‑Clinical Drug Evaluation – Aiming to Reduce, Refine, and Replace Animal Testing
Policy / Regulatory

China’s CDE Launches “Pioneer Plan” Pilot to Advance New Approach Methodologies (NAMs) in Non‑Clinical Drug Evaluation – Aiming to Reduce, Refine, and Replace Animal Testing

The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) issued the Pilot Plan for Promoting the Research and Application of New Approach Methodologies (the "Pioneer Plan"),…

BioMarin's Vosoritide Wins NMPA Approval in China – First CNP-Analog Therapy for Pediatric Achondroplasia Enters the World's Largest Rare Bone Disease Market
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BioMarin’s Vosoritide Wins NMPA Approval in China – First CNP-Analog Therapy for Pediatric Achondroplasia Enters the World’s Largest Rare Bone Disease Market

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
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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

Novo Nordisk's Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China's Broadest‑Label Long‑Acting Growth Hormone
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Novo Nordisk’s Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China’s Broadest‑Label Long‑Acting Growth Hormone

Novo Nordisk's Wegovy Wins NMPA Approval for MASH in China – First and Only GLP‑1 Receptor Agonist Indicated for Metabolic Dysfunction‑Associated Steatohepatitis with F2–F3 Fibrosis
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Novo Nordisk’s Wegovy Wins NMPA Approval for MASH in China – First and Only GLP‑1 Receptor Agonist Indicated for Metabolic Dysfunction‑Associated Steatohepatitis with F2–F3 Fibrosis

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

Taienkang Pharma Subsidiary HABKSON Wins NMPA Approval for Diquafosol Sodium Eye Drops – Generic Dry Eye Therapy Enters RMB 228 Million Chinese Ophthalmic Market
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Taienkang Pharma Subsidiary HABKSON Wins NMPA Approval for Diquafosol Sodium Eye Drops – Generic Dry Eye Therapy Enters RMB 228 Million Chinese Ophthalmic Market

Livzon Pharma Wins Approval for China's First 3‑Month Leuprorelin Microsphere – Long‑Acting GnRH Agonist Cuts Injection Frequency by 70% Across Breast Cancer, Prostate Cancer, and Precocious Puberty
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Livzon Pharma Wins Approval for China’s First 3‑Month Leuprorelin Microsphere – Long‑Acting GnRH Agonist Cuts Injection Frequency by 70% Across Breast Cancer, Prostate Cancer, and Precocious Puberty

Hybio Pharmaceutical's AI‑Designed Triple Agonist HY3003 Clears FDA IND Filing for Obesity – GLP‑1/GIP/Glucagon Tri‑Target Drug Outperforms Tirzepatide and Retatrutide in Preclinical Weight Loss
CompanyDrug

Hybio Pharmaceutical’s AI‑Designed Triple Agonist HY3003 Clears FDA IND Filing for Obesity – GLP‑1/GIP/Glucagon Tri‑Target Drug Outperforms Tirzepatide and Retatrutide in Preclinical Weight Loss

Gan & Lee's Insulin Aspart Wins Ethiopian Registration – First Rapid‑Acting Insulin Analogue Approved in Africa's Second‑Most‑Populous Nation
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Gan & Lee’s Insulin Aspart Wins Ethiopian Registration – First Rapid‑Acting Insulin Analogue Approved in Africa’s Second‑Most‑Populous Nation

Defand Therapeutics Enters Research Collaboration with Roche – Novel Molecular Glue Degrader Platform Targets Oncology and Immunology

Defand Therapeutics Enters Research Collaboration with Roche – Novel Molecular Glue Degrader Platform Targets Oncology and Immunology

Hangzhou Defand Therapeutics Co., Ltd. (Defand) announced that it has entered into a research collaboration and licensing agreement with Roche (SWX: ROP; OTCMKTS: RHHBY) to jointly discover and develop novel molecular glue degraders (MGDs) targeting multiple therapeutic targets in oncology…

Jiangsu Nhwa Signs Exclusive Global Licensing Deal with Somnivera – Clinical‑Stage Sleep‑Disorder Asset Backed by Up to US$517.5 Million in Potential Value

Jiangsu Nhwa Signs Exclusive Global Licensing Deal with Somnivera – Clinical‑Stage Sleep‑Disorder Asset Backed by Up to US$517.5 Million in Potential Value

Zhongsheng Pharma's RAY1225 Achieves 22.2% Weight Loss in Phase III REBUILDING‑2 Trial – Biweekly GLP‑1/GIP Dual Agonist Outperforms Tirzepatide Response Rates on Key Thresholds
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Zhongsheng Pharma’s RAY1225 Achieves 22.2% Weight Loss in Phase III REBUILDING‑2 Trial – Biweekly GLP‑1/GIP Dual Agonist Outperforms Tirzepatide Response Rates on Key Thresholds

Lifotronic Technology's H100Plus HbA1c Testing System Receives FDA 510(k) Clearance – Chinese IVD Company Gains U.S. Market Access for Diabetes Diagnostics
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Lifotronic Technology’s H100Plus HbA1c Testing System Receives FDA 510(k) Clearance – Chinese IVD Company Gains U.S. Market Access for Diabetes Diagnostics

Hinova Pharmaceuticals' HP515 Phase IIa MASH Data Accepted as AASLD 2026 Late‑Breaking Abstract – THR‑β Agonist Achieves >50% Liver Fat Reduction With No SAEs
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Hinova Pharmaceuticals’ HP515 Phase IIa MASH Data Accepted as AASLD 2026 Late‑Breaking Abstract – THR‑β Agonist Achieves >50% Liver Fat Reduction With No SAEs

Easton Pharmaceutical Wins NMPA Approval for Vitamin K1 Injection Pediatric Spec – Third Generic to Achieve Bioequivalence for Infant Hemorrhagic Disease Prevention
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Easton Pharmaceutical Wins NMPA Approval for Vitamin K1 Injection Pediatric Spec – Third Generic to Achieve Bioequivalence for Infant Hemorrhagic Disease Prevention

Lepu Medical Subsidiary Secures FDA IND Clearance for MWN117 siRNA Targeting INHBE – Novel Obesity Drug Shows Synergy With GLP‑1 and Muscle Preservation in Primate Studies
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Lepu Medical Subsidiary Secures FDA IND Clearance for MWN117 siRNA Targeting INHBE – Novel Obesity Drug Shows Synergy With GLP‑1 and Muscle Preservation in Primate Studies

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
CompanyDeals

GeneScience Acquires Global Rights to Megestrol Acetate Oral Suspension from TWi Pharmaceuticals – $100M Deal Transforms Distributor into MAH for Cachexia Therapy

Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its controlled subsidiary Changchun GeneScience Pharmaceutical Co., Ltd. — through its wholly‑owned subsidiary GENSCI Singapore Pte. Ltd. —…

Sanofi and Regeneron Expand Alliance with $8B Next‑Generation Antibody Collaboration – Four Long‑Acting Type 2 Inflammation Programs Added Alongside Dupixent
CompanyDeals

Sanofi and Regeneron Expand Alliance with $8B Next‑Generation Antibody Collaboration – Four Long‑Acting Type 2 Inflammation Programs Added Alongside Dupixent

Shionogi to Acquire IntraBio for $2.0B – Rare Neurodegenerative Disease Platform Anchored by FDA‑Approved AQNEURSA Expands Global Portfolio
CompanyDeals

Shionogi to Acquire IntraBio for $2.0B – Rare Neurodegenerative Disease Platform Anchored by FDA‑Approved AQNEURSA Expands Global Portfolio

Foghorn Therapeutics and Lilly Discontinue FHD‑909 and SMARCA2 Programs – Gene Traffic Control Collaboration Ends After Phase 1 Review
CompanyDeals

Foghorn Therapeutics and Lilly Discontinue FHD‑909 and SMARCA2 Programs – Gene Traffic Control Collaboration Ends After Phase 1 Review

GE HealthCare to Acquire SOFIE Biosciences for $945M – Bolstering PET Radiopharmaceutical Manufacturing and Securing Phase III FAPI‑74 Asset
CompanyDeals

GE HealthCare to Acquire SOFIE Biosciences for $945M – Bolstering PET Radiopharmaceutical Manufacturing and Securing Phase III FAPI‑74 Asset

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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
CompanyDeals

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

Tangzhi Pharma Secures Nearly RMB 100 Million Exclusive Financing from Fengnian Capital – Glyco Raw‑Material Platform Targets ADC and Nucleic‑Acid Drug Boom
CompanyDeals

Tangzhi Pharma Secures Nearly RMB 100 Million Exclusive Financing from Fengnian Capital – Glyco Raw‑Material Platform Targets ADC and Nucleic‑Acid Drug Boom

Medicovestor Completes Seed Funding Round to Advance Next-Generation Antibody and ADC Pipeline – MC004 Naked Antibody Targets FDA IND Filing by Early 2027
CompanyDeals

Medicovestor Completes Seed Funding Round to Advance Next-Generation Antibody and ADC Pipeline – MC004 Naked Antibody Targets FDA IND Filing by Early 2027

Medinno Pharmaceutical Closes Over RMB 200 Million Series A Led by Sunshine Ronghui Capital – MDI‑1228, World's First Topical Pan‑JAK/Pan‑Trk Inhibitor, Advances Global Clinical Development
CompanyDeals

Medinno Pharmaceutical Closes Over RMB 200 Million Series A Led by Sunshine Ronghui Capital – MDI‑1228, World’s First Topical Pan‑JAK/Pan‑Trk Inhibitor, Advances Global Clinical Development

MIIT and Nine Departments Issue China's "15th Five‑Year Plan for Pharmaceutical Industry Development" – Innovative Drug Sector Targeted to Grow Over 20 % Annually Through 2030
Policy / Regulatory

MIIT and Nine Departments Issue China’s “15th Five‑Year Plan for Pharmaceutical Industry Development” – Innovative Drug Sector Targeted to Grow Over 20 % Annually Through 2030

The Ministry of Industry and Information Technology (MIIT), together with nine other departments, formulated and issued the "15th Five‑Year Plan for Pharmaceutical Industry Development" (the "Plan"), setting quantitative industry targets…

China's NMPA Unveils Draft Regulations on Radiopharmaceuticals – Public Consultation Open Through October 20 With Priority Review for Urgent‑Demand Products
Policy / Regulatory

China’s NMPA Unveils Draft Regulations on Radiopharmaceuticals – Public Consultation Open Through October 20 With Priority Review for Urgent‑Demand Products

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

China Orders Whole‑Class Listing of "Orphine‑Type Substances" in Non‑Medicinal Narcotic and Psychotropic Catalogue – Tri‑Agency Control Takes Effect 1 October 2026
Policy / Regulatory

China Orders Whole‑Class Listing of “Orphine‑Type Substances” in Non‑Medicinal Narcotic and Psychotropic Catalogue – Tri‑Agency Control Takes Effect 1 October 2026

More News

Humanwell Healthcare Subsidiary Wins FDA ANDA Approval for Diltiazem Hydrochloride Tablets – Expanding U.S. Generic Cardiovascular Portfolio
Others

Humanwell Healthcare Subsidiary Wins FDA ANDA Approval for Diltiazem Hydrochloride Tablets – Expanding U.S. Generic Cardiovascular Portfolio

CSPC Pharma Presents SYS6002 Phase I Data at IGCS 2026 – Nectin‑4 ADC Shows 35.9% ORR in Previously Treated Advanced Cervical Cancer; Phase III Underway
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CSPC Pharma Presents SYS6002 Phase I Data at IGCS 2026 – Nectin‑4 ADC Shows 35.9% ORR in Previously Treated Advanced Cervical Cancer; Phase III Underway

Tong Ren Tang's Dingzhi Wan Receives Hong Kong Proprietary Chinese Medicine Registration – HKCMP Certificate Expands Neurological Wellness Product Line
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Tong Ren Tang’s Dingzhi Wan Receives Hong Kong Proprietary Chinese Medicine Registration – HKCMP Certificate Expands Neurological Wellness Product Line

Sino Biopharmaceutical Completes Phase III Enrollment for TQC3721 Inhaled PDE3/4 Inhibitor in COPD – Dual‑Target Therapy Eyes First‑in‑China Approval
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Sino Biopharmaceutical Completes Phase III Enrollment for TQC3721 Inhaled PDE3/4 Inhibitor in COPD – Dual‑Target Therapy Eyes First‑in‑China Approval

Huadong Medicine's Oral GLP‑1 Agonist HDM1002 Delivers Positive Phase III Results for Weight Management – Pre‑NDA Complete, China Marketing Application Imminent
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Huadong Medicine’s Oral GLP‑1 Agonist HDM1002 Delivers Positive Phase III Results for Weight Management – Pre‑NDA Complete, China Marketing Application Imminent

Dezhan Healthcare Subsidiary Secures FDA IND Clearance for WYY026B Injection in Acute Ischemic Stroke – First‑in‑Class Neuroprotective Agent Advances to U.S. Clinical Trials
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Dezhan Healthcare Subsidiary Secures FDA IND Clearance for WYY026B Injection in Acute Ischemic Stroke – First‑in‑Class Neuroprotective Agent Advances to U.S. Clinical Trials

Sunshine Lake Pharma Wins NMPA Approval for Dual Insulin Analogue Injection – Fixed‑Ratio Degludec/Aspart Targets Fasting and Postprandial Glucose in One Formulation
CompanyDrug

Sunshine Lake Pharma Wins NMPA Approval for Dual Insulin Analogue Injection – Fixed‑Ratio Degludec/Aspart Targets Fasting and Postprandial Glucose in One Formulation

Hengrui Pharma's Fluzoparib Enters EMA Review for Prostate Cancer – First China‑Developed PARP Inhibitor Targets European mCRPC Market
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Hengrui Pharma’s Fluzoparib Enters EMA Review for Prostate Cancer – First China‑Developed PARP Inhibitor Targets European mCRPC Market

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