Insight, China's Pharmaceutical Industry

Hotgen Biotech Doses First Patient in AA001 Phase Ib – Anti‑Aβ mAb Targets Early Alzheimer’s Disease

Hotgen Biotech Co., Ltd (SHA: 688068) announced first subject dosing in a Phase Ib clinical study...

Novo Nordisk Invests €432M in Ireland Facility – Expands Oral GLP‑1 Manufacturing for Global Markets

Fineline Cube Mar 3, 2026

Novo Nordisk (NYSE: NVO) announced a €432 million (approx. DKK 3.2 billion) investment in its Monksland, Athlone, Ireland facility...

Company Drug

Lynk Pharma’s Zemprocitinib Hits Phase III Endpoints in Atopic Dermatitis – Best‑in‑Class JAK1 Inhibitor Shows Superior Efficacy

Fineline Cube Mar 2, 2026

Lynk Pharmaceuticals Co., Ltd. announced positive topline results from a Phase III study for zemprocitinib...

Company Drug

HealZen’s BTK Inhibitor HZ-A-018 Wins NMPA Approval for CSU Phase II – Expands Autoimmune Pipeline

Fineline Cube Mar 2, 2026

Hangzhou HealZen Therapeutics Co., Ltd. announced that its self‑developed Category 1 innovative drug, HZ‑A‑018 capsules, has...

Company Drug

Ribo Life Science’s PCSK9 siRNA RBD7022 Enters Phase III – Qilu Pharma Advances Cholesterol‑Lowering Drug

Fineline Cube Mar 2, 2026

Suzhou Ribo Life Science Co., Ltd. (HKG: 6938) announced that RBD7022 Injection, its independently developed siRNA...

Company Drug

GenFleet’s GFH375 Wins CDE Breakthrough Therapy Designation – Oral KRAS G12D Inhibitor for NSCLC

Fineline Cube Mar 2, 2026

GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that GFH375, an oral KRAS G12D (ON/OFF) inhibitor, has...

Company Drug

InnoCare’s Zurletrectinib Wins Priority Review for Pediatric NTRK Tumors – Next‑Gen TRK Inhibitor Expands Label

Fineline Cube Mar 2, 2026

InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that the Center for Drug Evaluation (CDE) of China’s...

Company Drug

Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis

Fineline Cube Mar 2, 2026

Sino Biopharmaceutical Limited (HKG: 1177) announced that the National Medical Products Administration (NMPA) has approved rovadicitinib...

Company Drug

Antengene’s XPOVIO Secures Second South Korea Reimbursement – Selinexor Combo Approved for Multiple Myeloma

Fineline Cube Mar 2, 2026

Antengene Corporation Limited (HKG: 6996) announced that South Korea’s National Health Insurance Service (NHIS) has approved...

Company Drug

Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China

Fineline Cube Mar 2, 2026

Zhejiang Hangyu Pharmaceutical Co., Ltd., a subsidiary of Jemincare, announced that China’s National Medical Products...

Policy / Regulatory

NMPA CDE Launches “Caring Program – Extension” Pilot – Accelerates Rare Disease Drug Development Pathway

Fineline Cube Mar 2, 2026

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...

Company Deals

QL Biopharma Raises 500M+ RMB Series C – OrbiMed Leads Round for Monthly GLP‑1 Zovigrutide

Fineline Cube Mar 2, 2026

Beijing QL Biopharmaceutical Co., Ltd. announced the completion of a Series C financing round raising...

Company Drug

Hansoh Pharma’s Mirdametinib Plus Almonertinib NDA Accepted by NMPA – Dual‑Target Combination for EGFR‑Mutant NSCLC

Fineline Cube Mar 2, 2026

Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that China’s National Medical Products Administration (NMPA) has...

Policy / Regulatory

China‑SCO Metabolic Disease Cooperation Center Established at Ruijin Hospital – First National‑Level SCO Platform in Shanghai

Fineline Cube Mar 2, 2026

The China‑Shanghai Cooperation Organization (SCO) Metabolic Disease Cooperation Center was officially established at Ruijin Hospital,...

Company Drug

Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion

Fineline Cube Feb 28, 2026

Sanofi (NASDAQ: SNY) announced that Dupixent (dupilumab) has been approved by China’s National Medical Products Administration...

Company Drug

Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA

Fineline Cube Feb 28, 2026

Eli Lilly (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the European Medicines Agency’s (EMA) Committee for...

Company Drug

Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer

Fineline Cube Feb 28, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...

Company Drug

Shionogi Files CORECTIM Lotion for Japan Approval – Expands Topical JAK Inhibitor Franchise in Atopic Dermatitis

Fineline Cube Feb 28, 2026

Shionogi & Co., Ltd. and subsidiary Torii Pharmaceutical Co., Ltd. announced the submission of a...

Company Drug

Dupixent Wins CHMP Positive Opinion for Pediatric CSU – EU Approval Nears for Children Aged 2–11 Years

Fineline Cube Feb 28, 2026

Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human...

Company Drug

Asieris’ APL-1702 MAA Accepted by EMA – First Photodynamic Therapy for Cervical HSIL Nears EU Approval

Fineline Cube Feb 28, 2026

Asieris Pharmaceuticals (SHA: 688176) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...

Insight, China's Pharmaceutical Industry

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

Hengrui’s Hetrombopag Wins China Approval for CTIT and Pediatric ITP – Oral TPO‑RA Expands Across Thrombocytopenia Indications

Roche’s Enspryng Granted FDA Priority Review for MOGAD – First IL‑6 Inhibitor Poised to Expand Beyond NMOSD

Boji Medical and Zhejiang Maiyata Sign Strategic Partnership – Leading China CRO Joins Microbiome Innovator to Advance Live Biotherapeutic Products

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

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

Hotgen Biotech Doses First Patient in AA001 Phase Ib – Anti‑Aβ mAb Targets Early Alzheimer’s Disease

Novo Nordisk Invests €432M in Ireland Facility – Expands Oral GLP‑1 Manufacturing for Global Markets

Lynk Pharma’s Zemprocitinib Hits Phase III Endpoints in Atopic Dermatitis – Best‑in‑Class JAK1 Inhibitor Shows Superior Efficacy

HealZen’s BTK Inhibitor HZ-A-018 Wins NMPA Approval for CSU Phase II – Expands Autoimmune Pipeline

Ribo Life Science’s PCSK9 siRNA RBD7022 Enters Phase III – Qilu Pharma Advances Cholesterol‑Lowering Drug

GenFleet’s GFH375 Wins CDE Breakthrough Therapy Designation – Oral KRAS G12D Inhibitor for NSCLC

InnoCare’s Zurletrectinib Wins Priority Review for Pediatric NTRK Tumors – Next‑Gen TRK Inhibitor Expands Label

Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis

Antengene’s XPOVIO Secures Second South Korea Reimbursement – Selinexor Combo Approved for Multiple Myeloma

Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China

NMPA CDE Launches “Caring Program – Extension” Pilot – Accelerates Rare Disease Drug Development Pathway

QL Biopharma Raises 500M+ RMB Series C – OrbiMed Leads Round for Monthly GLP‑1 Zovigrutide

Hansoh Pharma’s Mirdametinib Plus Almonertinib NDA Accepted by NMPA – Dual‑Target Combination for EGFR‑Mutant NSCLC

China‑SCO Metabolic Disease Cooperation Center Established at Ruijin Hospital – First National‑Level SCO Platform in Shanghai

Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion

Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA

Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer

Shionogi Files CORECTIM Lotion for Japan Approval – Expands Topical JAK Inhibitor Franchise in Atopic Dermatitis

Dupixent Wins CHMP Positive Opinion for Pediatric CSU – EU Approval Nears for Children Aged 2–11 Years

Asieris’ APL-1702 MAA Accepted by EMA – First Photodynamic Therapy for Cervical HSIL Nears EU Approval

You Missed

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

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

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

China’s Seventh National VBP Round for Medical Consumables Concludes in Tianjin – 517 Digestive Intervention Products Selected Across 23 Categories