Product approvals

Explore the landscape of product approvals in China’s pharmaceutical industry. Fineline Info & Tech delivers reliable data and insights on product approvals to help you navigate complexities with precision and clarity. Stay informed and enhance your decision-making at flcube.com.

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

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

Huadong Medicine Co., Ltd. (SHE: 000963) announced positive topline results from its Phase III clinical study (HDM1002‑301) evaluating HDM1002 tablets (Conveglipron Trometamol Tablets), a Class 1 oral small‑molecule GLP‑1 receptor…

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

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

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

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Shanghai Junshi Biosciences' Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
CompanyDrug

Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma

Lepu Medical Receives Approval for Noninvasive Blood Glucose Meter NeoGlu 01 in China
CompanyMedical Device

Lepu Medical Receives Approval for Noninvasive Blood Glucose Meter NeoGlu 01 in China

Roche's Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
CompanyDrug

Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China

Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
CompanyDrug

Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases

AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
CompanyDrug

AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China

Bristol-Myers Squibb's Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
CompanyDrug

BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China

Junshi Biosciences' Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
CompanyDrug

Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment

Pfizer's Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
CompanyDrug

Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B

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