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.

Allist's Firmonertinib Misses Primary PFS Endpoint in Phase 3 FURVENT Trial – 60% Response Rate and OS Trend Keep EGFR Exon 20 Insertion NSCLC Program Alive
CompanyDrug

Allist’s Firmonertinib Misses Primary PFS Endpoint in Phase 3 FURVENT Trial – 60% Response Rate and OS Trend Keep EGFR Exon 20 Insertion NSCLC Program Alive

Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that the Phase 3 FURVENT trial (NCT05607550) evaluating firmonertinib monotherapy in previously untreated, locally advanced or metastatic non‑squamous NSCLC harboring EGFR exon 20…

anatlas Pharmaceuticals Doses First Patient in Phase II Trial of DAT‑2645 – Novel Targeted Therapy for BRCA‑Mutant, HRD‑Positive Ovarian Cancer

Danatlas Pharmaceuticals Doses First Patient in Phase II Trial of DAT‑2645 – Novel Targeted Therapy for BRCA‑Mutant, HRD‑Positive Ovarian Cancer

Danatlas Pharmaceuticals Wins NMPA IND Approval for DAT‑6618 – China's First PPARγ Inhibitor to Enter Clinical Development

Danatlas Pharmaceuticals Wins NMPA IND Approval for DAT‑6618 – China’s First PPARγ Inhibitor to Enter Clinical Development

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Cryofocus Biotechnology's Malignant Stenosis Cryoablation System Approved by NMPA for Chinese Market
CompanyMedical Device

Cryofocus Medtech’s Malignant Stenosis Cryoablation System Approved by NMPA for Chinese Market

Antengene's Xpovio Receives Marketing Approval in Indonesia
CompanyDrug

Antengene’s Xpovio Receives Marketing Approval in Indonesia

Sino Medical Sciences' HT Supreme Stent System Gains Vietnamese Marketing Approval
CompanyMedical Device

Sino Medical Sciences’ HT Supreme Stent System Gains Vietnamese Marketing Approval

BeiGene's Tevimbra Receives FDA Approval for ESCC Treatment
CompanyDrug

BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment

Genentech's TNKase Approved by FDA for Acute Ischemic Stroke Treatment
CompanyDrug

Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment

Waters and Kehua's LC-MS Systems Gain NMPA Approval for IVD Use
CompanyMedical Device

Waters and Kehua’s LC-MS Systems Gain NMPA Approval for IVD Use

Zai Lab's Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
CompanyDrug

Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors

Zeiss Group's VISUMAX 800 with SMILE pro Software Approved by China's NMPA
CompanyMedical Device

Zeiss Group’s VISUMAX 800 with SMILE pro Software Approved by China’s NMPA

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