Insight, China's Pharmaceutical Industry

Company Drug

Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC

China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for...

Company Drug

Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE

Fineline Cube Jan 30, 2023

China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its...

Company Drug

Grand Pharma’s Jext Auto-Injector Approved for Import into Greater Bay Area

Fineline Cube Jan 30, 2023

China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced receiving official approval from the Guangdong...

Company Drug

Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT

Fineline Cube Jan 30, 2023

Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD)...

Company Drug

CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment

Fineline Cube Jan 30, 2023

The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to...

Company Drug

NMPA Approves Two China-Developed COVID-19 Small-Molecule Therapies

Fineline Cube Jan 29, 2023

The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered...

Policy / Regulatory

China’s NHC Issues Guidelines to Improve Pediatric Medication Management

Fineline Cube Jan 29, 2023

The National Health Commission (NHC) has released a notification aimed at refining management measures for...

Policy / Regulatory

China’s Multi-Bureau Plan Aims to Eradicate Cervical Cancer by 2030

Fineline Cube Jan 29, 2023

The National Health Commission (NHC), Ministry of Education, Ministry of Civil Affairs, and six other...

Company Drug

JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911

Fineline Cube Jan 29, 2023

Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by...

Company Deals

Akeso Receives First $300M Installment from Summit for Bispecific Antibody Ivonescimab

Fineline Cube Jan 29, 2023

Akeso Inc. (HKG: 9926) has announced receiving the first installment of USD 300 million as...

Policy / Regulatory

NMPA Proposes Emergency Use Management Measures for Medical Devices

Fineline Cube Jan 29, 2023

The National Medical Products Administration (NMPA) has released the “Medical Device Emergency Use Management Measures”...

Company Drug

InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023

Fineline Cube Jan 29, 2023

Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune...

Company Drug

Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD

Fineline Cube Jan 29, 2023

Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US...

Company Drug

Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition

Fineline Cube Jan 29, 2023

China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for...

Policy / Regulatory

China Updates Export Controls on Technologies, Adds Gene Editing to List

Fineline Cube Jan 29, 2023

The Ministry of Finance (MOF) has released an updated notification regarding technologies banned and restricted...

Company Drug

Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer

Fineline Cube Jan 28, 2023

Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical...

Company Drug

Fosun Pharma’s Comirnaty Bivalent Vaccine Approved in Macau for Booster Shots

Fineline Cube Jan 28, 2023

Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its Comirnaty...

Company Drug

HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004

Fineline Cube Jan 28, 2023

China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from...

Company Deals

Yinghe Brain Science Raises RMB 100 Million in Angel Financing Round

Fineline Cube Jan 28, 2023

Shenzhen Yinghe Brain Science Co., Ltd, a China-based neurotechnology firm, has reportedly raised over RMB...

Company Deals

HutchMed Signs Licensing Deal with Takeda for Global Fruquintinib Development

Fineline Cube Jan 28, 2023

Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced a licensing deal with Japanese...

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

Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC

Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE

Grand Pharma’s Jext Auto-Injector Approved for Import into Greater Bay Area

Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT

CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment

NMPA Approves Two China-Developed COVID-19 Small-Molecule Therapies

China’s NHC Issues Guidelines to Improve Pediatric Medication Management

China’s Multi-Bureau Plan Aims to Eradicate Cervical Cancer by 2030

JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911

Akeso Receives First $300M Installment from Summit for Bispecific Antibody Ivonescimab

NMPA Proposes Emergency Use Management Measures for Medical Devices

InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023

Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD

Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition

China Updates Export Controls on Technologies, Adds Gene Editing to List

Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer

Fosun Pharma’s Comirnaty Bivalent Vaccine Approved in Macau for Booster Shots

HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004

Yinghe Brain Science Raises RMB 100 Million in Angel Financing Round

HutchMed Signs Licensing Deal with Takeda for Global Fruquintinib Development

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