Market approval filings

Company Drug

Ocumension’s OT‑301 NDA Accepted by China’s CDE – Dual‑Mechanism Glaucoma Therapy Advances Toward Approval in Open‑Angle Glaucoma and Ocular Hypertension

Ocumension Therapeutics (HKG: 1477) announced that the new drug application (NDA) for its key drug...

Company Drug

NMPA Accepts Hengrui’s New Drug Application for Ribupatide Injection – Dual GLP‑1/GIP Receptor Agonist Nears Approval for Type 2 Diabetes in China

Fineline Cube Sep 10, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the New Drug Application...

Company Drug

NMPA Accepts Yantai Dongcheng’s Marketing Application for Bemiparin Sodium Injection – Potential First Generic of Ultra‑Low Molecular Weight Heparin in China

Fineline Cube Sep 10, 2026

Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that China’s National Medical Products Administration...

Company Drug

NMPA Accepts MediLink Therapeutics’ NDA for Tam‑Peli, Self‑Developed B7‑H3‑Targeting ADC for Relapsed Small Cell Lung Cancer

Fineline Cube Sep 7, 2026

MediLink Therapeutics announced that the New Drug Application (NDA) for Tam‑Peli (tamatanmab pelidotin for injection;...

Company Drug PIC

Santen’s Atropine Eye Drops RYJUSEA Wins NDA Acceptance From China’s NMPA for Myopia Progression

Fineline Cube Sep 7, 2026

Santen Pharmaceutical (TYO: 4536) announced that the New Drug Application (NDA) for its atropine sulfate...

Company Drug

Hengrui’s drotokibart BLA Accepted by NMPA for Moderate-to-Severe Atopic Dermatitis

Fineline Cube Sep 4, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...

Company Drug

Hengrui Pharmaceuticals’ Oral GLP‑1R Agonist HRS‑7535 NDA Accepted by NMPA for Type 2 Diabetes, Joining China’s Incretin Race

Fineline Cube Sep 3, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its New Drug Application...

Company Drug

Cutia Therapeutics’ CU‑20101 BLA Accepted by NMPA for Moderate to Severe Glabellar Lines, Advancing a Safer Botulinum Toxin Type A

Fineline Cube Sep 3, 2026

Cutia Therapeutics (HKG: 2487) announced that the Biologics License Application (BLA) for CU‑20101 has been...

Company Drug

Hansoh’s HS‑20093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7‑H3 ADC

Fineline Cube Sep 3, 2026

Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS‑20093...

Company Drug

AbbVie Submits EMA Application for SKYRIZI Subcutaneous Induction in Crohn’s Disease

Fineline Cube Aug 28, 2026

AbbVie (NYSE: ABBV) announced that it has submitted an application to the European Medicines Agency...

Company Drug

Hengrui’s NMPA Accepts NDA for HRG2010, a Novel Levodopa/Carbidopa Combination for Parkinson’s Disease

Fineline Cube Aug 25, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...

Company Drug

Leads Biolabs Files NDA for Opamtistomig in EP-NEC — World’s First 4-1BB Bispecific Nears Potential First Approval

Fineline Cube Aug 24, 2026

Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that it has submitted a New Drug...

Company Drug

LongBio Pharma’s LP‑003 BLA Accepted by NMPA for Seasonal Allergic Rhinitis, Advancing Novel Anti‑IgE Antibody Toward China Approval

Fineline Cube Aug 21, 2026

LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China

Fineline Cube Aug 19, 2026

CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...

Company Drug

CanSino Biologics Files NDA in China for Td5cp, a First-In-Nation Adolescent and Adult DTaP Booster Vaccine

Fineline Cube Aug 17, 2026

CanSino Biologics (HKG: 6185) announced that it has submitted a New Drug Application (NDA) in...

Company Drug

Pfizer and Valneva See EMA Validate MAA for PF‑07307405, the First‑Potential Blockbuster Lyme Disease Vaccine

Fineline Cube Aug 17, 2026

Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency...

Company Drug

Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms

Fineline Cube Aug 11, 2026

Astellas Pharma Inc. (TYO: 4503) announced that it has submitted a New Drug Application (NDA)...

Company Drug

Alebund’s AP301 NDA Accepted by NMPA for Hyperphosphatemia in CKD Dialysis Patients

Fineline Cube Aug 10, 2026

Alebund Pharmaceuticals (Jiangsu) Limited (HKG: 9637) announced that the New Drug Application (NDA) for its core...

Company Drug

Hybio Files First tirzepatide Generic ANDA in China, Challenging Eli Lilly’s GLP-1 Dominance

Fineline Cube Aug 10, 2026

Shenzhen Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced it has submitted a Class 4 Chemical Abbreviated New...

Company Drug

Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint

Fineline Cube Aug 6, 2026

Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application...

Market approval filings

Ocumension’s OT‑301 NDA Accepted by China’s CDE – Dual‑Mechanism Glaucoma Therapy Advances Toward Approval in Open‑Angle Glaucoma and Ocular Hypertension

NMPA Accepts Hengrui’s New Drug Application for Ribupatide Injection – Dual GLP‑1/GIP Receptor Agonist Nears Approval for Type 2 Diabetes in China

NMPA Accepts Yantai Dongcheng’s Marketing Application for Bemiparin Sodium Injection – Potential First Generic of Ultra‑Low Molecular Weight Heparin in China

NMPA Accepts MediLink Therapeutics’ NDA for Tam‑Peli, Self‑Developed B7‑H3‑Targeting ADC for Relapsed Small Cell Lung Cancer

Santen’s Atropine Eye Drops RYJUSEA Wins NDA Acceptance From China’s NMPA for Myopia Progression

Hengrui’s drotokibart BLA Accepted by NMPA for Moderate-to-Severe Atopic Dermatitis

Hengrui Pharmaceuticals’ Oral GLP‑1R Agonist HRS‑7535 NDA Accepted by NMPA for Type 2 Diabetes, Joining China’s Incretin Race

Cutia Therapeutics’ CU‑20101 BLA Accepted by NMPA for Moderate to Severe Glabellar Lines, Advancing a Safer Botulinum Toxin Type A

Hansoh’s HS‑20093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7‑H3 ADC

AbbVie Submits EMA Application for SKYRIZI Subcutaneous Induction in Crohn’s Disease

Hengrui’s NMPA Accepts NDA for HRG2010, a Novel Levodopa/Carbidopa Combination for Parkinson’s Disease

Leads Biolabs Files NDA for Opamtistomig in EP-NEC — World’s First 4-1BB Bispecific Nears Potential First Approval

LongBio Pharma’s LP‑003 BLA Accepted by NMPA for Seasonal Allergic Rhinitis, Advancing Novel Anti‑IgE Antibody Toward China Approval

CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China

CanSino Biologics Files NDA in China for Td5cp, a First-In-Nation Adolescent and Adult DTaP Booster Vaccine

Pfizer and Valneva See EMA Validate MAA for PF‑07307405, the First‑Potential Blockbuster Lyme Disease Vaccine

Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms

Alebund’s AP301 NDA Accepted by NMPA for Hyperphosphatemia in CKD Dialysis Patients

Hybio Files First tirzepatide Generic ANDA in China, Challenging Eli Lilly’s GLP-1 Dominance

Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint

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