Market approval filings

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

Bayer's Sunharbo (Asundexian) Secures NMPA Approval in China – World's First‑in‑Class FXIa Inhibitor to Reduce Stroke Risk After Ischemic Stroke or High‑Risk TIA
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Bayer’s Sunharbo (Asundexian) Secures NMPA Approval in China – World’s First‑in‑Class FXIa Inhibitor to Reduce Stroke Risk After Ischemic Stroke or High‑Risk TIA

Bayer AG (ETR: BAYN) announced that China's National Medical Products Administration (NMPA) has approved Sunharbo (asundexian tablets), the world's first (first‑in‑class) activated Factor XI (FXIa) inhibitor, for reducing the risk…

Hansoh Pharma Pledges RMB 100 Million Donation to the China Foundation for Science and Technology Development – Strategic Partnership to Fund Scientific Innovation, Talent Development and Health Communication

Hansoh Pharma Pledges RMB 100 Million Donation to the China Foundation for Science and Technology Development – Strategic Partnership to Fund Scientific Innovation, Talent Development and Health Communication

AbbVie Launches Epkinly (Epcoritamab) in China – First Bispecific Antibody Approved by NMPA for Relapsed/Refractory Follicular Lymphoma in the Second‑Line and Beyond

AbbVie Launches Epkinly (Epcoritamab) in China – First Bispecific Antibody Approved by NMPA for Relapsed/Refractory Follicular Lymphoma in the Second‑Line and Beyond

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Visen Pharmaceuticals’ TransCon hGH Accepted for Review by China’s NMPA

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EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma

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Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter

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EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications

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Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA

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Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA

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Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC

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AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study

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