Insight, China's Pharmaceutical Industry

CSPC Wins NMPA Clinical Trial Approvals for Two Long‑Acting Injections – Weekly Rotigotine (SYH9087) for Parkinson’s Disease and World’s First Ready‑to‑Use Monthly Goserelin (SYH9102) for Solid Tumours

CSPC Pharmaceutical Group Limited (HKG: 1093) announced that two long‑acting injection products have obtained approval...

Company Deals

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

Fineline Cube Sep 10, 2026

HBM Holdings Limited (HKG: 2142) announced that its partner company, Solstice Oncology, has completed a...

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 Deals

Moonwalk Biosciences Closes Oversubscribed USD 70 Million Series B – Eli Lilly Joins Alpha Wave and YK Bioventures to Back First‑in‑Class Adipose‑Targeted siRNA Candidate MW101

Fineline Cube Sep 10, 2026

Moonwalk Biosciences, a partner of Siran Bio, announced the completion of an oversubscribed USD 70...

Company Drug

Full-Life Technologies Secures FDA IND Clearance for [²²⁵Ac]Ac‑FL‑261 – Potential First‑in‑Class c‑MET Alpha Radionuclide Conjugate Enters Phase I in Non‑Squamous NSCLC

Fineline Cube Sep 10, 2026

Full-Life Technologies Limited announced that its Investigational New Drug (IND) application for Ac‑FL‑261 has been...

Company Deals PIC

CellStore Signs Strategic Partnership Memorandum With Shanghai Cell Therapy Group – Deepening Cooperation in Cell Cryopreservation, Product Application Validation, and Industrial Synergy Across Cell and Gene Therapy

Fineline Cube Sep 10, 2026

CellStore signed a Memorandum of Strategic Partnership with Shanghai Cell Therapy Group, under which the...

Company

BD Opens Tianjin Life Health Innovation Center With Seven Clinical Training Centers – Establishing a Northern China Hub Built on an “Experience – Training – R&D” Trinity for High‑End Medical Devices

Fineline Cube Sep 9, 2026

The Becton, Dickinson and Co. (BD) (Tianjin) Life Health Innovation Center officially opened its doors...

Company Drug

CSPC Pharmaceutical Wins NMPA Clinical Trial Approval for SYH2083 Eye Drops – A Class 1 Innovative Small‑Molecule Ophthalmic Drug Targeting Ocular Surface Inflammation via T‑Cell Adhesion and Activation

Fineline Cube Sep 9, 2026

CSPC Pharmaceutical Group Limited (HKG: 1093) announced that SYH2083 eye drops, its Class 1 innovative...

Company

Gilead Sciences Opens 182,000‑Square‑Foot Research Center at Foster City Headquarters – Expanding Oncology, Inflammation, and Research Data Science Capabilities as Part of a Three‑Project US Investment Program Through 2030

Fineline Cube Sep 9, 2026

Gilead Sciences, Inc. (NASDAQ: GILD) announced the opening of its 182,000‑square‑foot Research Center at the...

Company Drug

Windward Bio Reports Positive POLARIS‑1 Phase 2 Interim Results for HBM9378/WIN378 – An Ultra‑Long‑Acting TSLP Antibody in Asthma – as the Phase 3 Portion Begins

Fineline Cube Sep 9, 2026

HBM Holdings Limited (HKG: 2142) announced that Windward Bio AG, the company’s partner, has reported...

Policy / Regulatory

China’s NHC Issues Eye Health Services Work Plan for 2026–2030 – Setting 2030 Targets on Cataract Surgery Rates, Ophthalmologist Workforce Density, and County‑Level Vision Care Capacity

Fineline Cube Sep 9, 2026

China’s National Health Commission (NHC) issued the Work Plan to Accelerate the Provision of High‑Quality...

Company Drug

Ascletis Pharma Initiates US Phase 1 Study of ASC36 Oral Tablets – An Oral Amylin Receptor Agonist for Obesity, Advancing a Dual‑Format Program Alongside Its Once‑Monthly Injectable

Fineline Cube Sep 9, 2026

Ascletis Pharma Inc. (HKG: 1672) announced the initiation of a US Phase 1 study of...

Company Drug

Guangzhou Baiyunshan Pharma Wins Registration and Marketing Approval in Macau for Its Freeze‑Dried Rabies Vaccine (Vero Cells) – Joining a Highly Concentrated Supplier Landscape

Fineline Cube Sep 9, 2026

Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (SHA: 600332) announced that its freeze‑dried rabies vaccine (Vero cells)...

Company Drug

Alebund Pharma Secures US FDA Clinical Trial Approval for AP308 – A First‑in‑Class Recombinant IgA Protease Aimed at a Functional Cure for IgA Nephropathy

Fineline Cube Sep 9, 2026

Alebund Pharma (HKG: 9637) announced that its lead drug candidate, AP308, has received U.S. Food...

Company Drug

InnoCare Pharma Secures NMPA Clinical Trial Approval for ICP‑B381 – First Bispecific PSMA/STEAP1 ADC From Its Proprietary Platform, Targeting Prostate Cancer and Other Solid Tumors

Fineline Cube Sep 9, 2026

InnoCare Pharma Limited (HKG: 9969; SHA: 688428) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

Accropeutics’ Oral TYK2 Inhibitor AC-201 Cleared for Vitiligo Phase II/III

Fineline Cube Sep 9, 2026

Accro Bioscience (Suzhou) Limited, better known as Accropeutics, announced on Sept 8, 2026 that its...

Policy / Regulatory

China’s CDE Releases 110th Batch of Reference Preparations for Generic Quality and Consistency Evaluation – 27 New Drugs Added in Draft Open for Public Feedback

Fineline Cube Sep 8, 2026

China’s Center for Drug Evaluation (CDE) announced on September 7, 2026 the selection of the...

Company Deals

Shanghai Pharmaceuticals Signs Strategic Framework Pact with CAS Institute of Materia Medica to Bridge Drug Discovery and Industrial Translation

Fineline Cube Sep 8, 2026

Shanghai Pharmaceuticals Holding Co., Ltd. (HKG: 2607; SHA: 601607) and the Shanghai Institute of Materia...

Company Deals

CanSino Biologics Signs Strategic Pact with DeepGeneAI to Co‑Develop mRNA Personalized Therapeutic Cancer Vaccines – Targeting GI and Rare Tumors Globally

Fineline Cube Sep 8, 2026

CanSino Biologics (HKG: 6185) announced on August 25, 2026 the signing of a strategic cooperation...

Company Deals

Insilico Medicine Partners with Byterna Therapeutics to Build Next‑Generation mRNA AI‑Native R&D Engine – Targeting Circular mRNA Personalized Cancer Vaccines

Fineline Cube Sep 8, 2026

Insilico Medicine (HKG: 3696) announced on August 20, 2026 a research collaboration with Byterna Therapeutics...

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

CSPC Wins NMPA Clinical Trial Approvals for Two Long‑Acting Injections – Weekly Rotigotine (SYH9087) for Parkinson’s Disease and World’s First Ready‑to‑Use Monthly Goserelin (SYH9102) for Solid Tumours

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

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

Moonwalk Biosciences Closes Oversubscribed USD 70 Million Series B – Eli Lilly Joins Alpha Wave and YK Bioventures to Back First‑in‑Class Adipose‑Targeted siRNA Candidate MW101

Full-Life Technologies Secures FDA IND Clearance for [²²⁵Ac]Ac‑FL‑261 – Potential First‑in‑Class c‑MET Alpha Radionuclide Conjugate Enters Phase I in Non‑Squamous NSCLC

CellStore Signs Strategic Partnership Memorandum With Shanghai Cell Therapy Group – Deepening Cooperation in Cell Cryopreservation, Product Application Validation, and Industrial Synergy Across Cell and Gene Therapy

BD Opens Tianjin Life Health Innovation Center With Seven Clinical Training Centers – Establishing a Northern China Hub Built on an “Experience – Training – R&D” Trinity for High‑End Medical Devices

CSPC Pharmaceutical Wins NMPA Clinical Trial Approval for SYH2083 Eye Drops – A Class 1 Innovative Small‑Molecule Ophthalmic Drug Targeting Ocular Surface Inflammation via T‑Cell Adhesion and Activation

Gilead Sciences Opens 182,000‑Square‑Foot Research Center at Foster City Headquarters – Expanding Oncology, Inflammation, and Research Data Science Capabilities as Part of a Three‑Project US Investment Program Through 2030

Windward Bio Reports Positive POLARIS‑1 Phase 2 Interim Results for HBM9378/WIN378 – An Ultra‑Long‑Acting TSLP Antibody in Asthma – as the Phase 3 Portion Begins

China’s NHC Issues Eye Health Services Work Plan for 2026–2030 – Setting 2030 Targets on Cataract Surgery Rates, Ophthalmologist Workforce Density, and County‑Level Vision Care Capacity

Ascletis Pharma Initiates US Phase 1 Study of ASC36 Oral Tablets – An Oral Amylin Receptor Agonist for Obesity, Advancing a Dual‑Format Program Alongside Its Once‑Monthly Injectable

Guangzhou Baiyunshan Pharma Wins Registration and Marketing Approval in Macau for Its Freeze‑Dried Rabies Vaccine (Vero Cells) – Joining a Highly Concentrated Supplier Landscape

Alebund Pharma Secures US FDA Clinical Trial Approval for AP308 – A First‑in‑Class Recombinant IgA Protease Aimed at a Functional Cure for IgA Nephropathy

InnoCare Pharma Secures NMPA Clinical Trial Approval for ICP‑B381 – First Bispecific PSMA/STEAP1 ADC From Its Proprietary Platform, Targeting Prostate Cancer and Other Solid Tumors

Accropeutics’ Oral TYK2 Inhibitor AC-201 Cleared for Vitiligo Phase II/III

China’s CDE Releases 110th Batch of Reference Preparations for Generic Quality and Consistency Evaluation – 27 New Drugs Added in Draft Open for Public Feedback

Shanghai Pharmaceuticals Signs Strategic Framework Pact with CAS Institute of Materia Medica to Bridge Drug Discovery and Industrial Translation

CanSino Biologics Signs Strategic Pact with DeepGeneAI to Co‑Develop mRNA Personalized Therapeutic Cancer Vaccines – Targeting GI and Rare Tumors Globally

Insilico Medicine Partners with Byterna Therapeutics to Build Next‑Generation mRNA AI‑Native R&D Engine – Targeting Circular mRNA Personalized Cancer Vaccines

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