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.

AnnJi Advances AJ201 into Pivotal Phase 3 ROMA‑KD Trial – The Only Investigational Therapy for SBMA in Late‑Stage Development Worldwide
CompanyDrug

AnnJi Advances AJ201 into Pivotal Phase 3 ROMA‑KD Trial – The Only Investigational Therapy for SBMA in Late‑Stage Development Worldwide

AnnJi Pharmaceutical Co., Ltd. (TPEx: 7754), a clinical‑stage drug development company focused on innovative small molecules, announced that it is proceeding with the U.S. portion of its pivotal Phase 3…

Asymchem's Tianjin Macromolecule Site Passes First FDA Pre‑Approval Inspection – EIR Issued for Commercial API Facility

Asymchem’s Tianjin Macromolecule Site Passes First FDA Pre‑Approval Inspection – EIR Issued for Commercial API Facility

Pfizer's Oral Ritlecitinib Meets Primary Endpoints in Phase III Nonsegmental Vitiligo Trials – Largest‑Ever Oral Systemic Program Clears Path for Global Filings

Pfizer’s Oral Ritlecitinib Meets Primary Endpoints in Phase III Nonsegmental Vitiligo Trials – Largest‑Ever Oral Systemic Program Clears Path for Global Filings

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Sanofi’s Teizeild Wins EU Approval as First Disease‑Modifying Therapy for Type 1 Diabetes

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FDA Approves Zycubo as First Therapy for Pediatric Menkes Disease, Targeting Ultra‑Rare Copper Deficiency Disorder

Lifetech Scientific Secures NMPA Approval for G‑iliac Pro – Upgraded Iliac Branch Device for Aortic Aneurysm Repair
CompanyMedical Device

Lifetech Scientific Secures NMPA Approval for G‑iliac Pro – Upgraded Iliac Branch Device for Aortic Aneurysm Repair

CompanyDrug

Santen’s UPNEEQ Wins Japan Approval for Acquired Ptosis

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Shanghai Pharma Receives NMPA Approval for Myasthenia Gravis Oral Solution

Boan Biosimilar Prolia Wins Bolivia Approval, Targets Global Markets
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Boan Biosimilar Prolia Wins Bolivia Approval, Targets Global Markets

CompanyDrug

Hansoh Pharmaceutical’s Ameile Wins Fifth NMPA Indication for EGFR‑Mutated NSCLC

Hengrui's Retlirafusp α Wins NMPA Approval for First-Line Gastric Cancer
CompanyDrug

Hengrui’s Retlirafusp α Wins NMPA Approval for First-Line Gastric Cancer

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