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.

Sinocelltech's SCT810 Injection Wins NMPA Clearance for Phase I/II Study – Anti‑TFPI Antibody Offers Factor‑Independent Prophylaxis for Hemophilia A and B With or Without Inhibitors
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Sinocelltech’s SCT810 Injection Wins NMPA Clearance for Phase I/II Study – Anti‑TFPI Antibody Offers Factor‑Independent Prophylaxis for Hemophilia A and B With or Without Inhibitors

Beijing Sinocelltech Group Ltd. (SHA: 688520) announced that SCT810 Injection has been approved by China's National Medical Products Administration (NMPA) to initiate a Phase I/II clinical study in patients with…

Insilico Medicine Nominates ISM9546 as Preclinical Candidate – Oral, Peripherally Restricted VAV1 Molecular Glue Degrader Targets IBD and Rheumatoid Arthritis

Insilico Medicine Nominates ISM9546 as Preclinical Candidate – Oral, Peripherally Restricted VAV1 Molecular Glue Degrader Targets IBD and Rheumatoid Arthritis

Lepu Scientech's MemoCarna Oxide Film Single‑Rivet PFO Occluder Approved for Market Launch by NMPA – Novel Design Targets Residual Shunts in Patent Foramen Ovale Closure

Lepu Scientech’s MemoCarna Oxide Film Single‑Rivet PFO Occluder Approved for Market Launch by NMPA – Novel Design Targets Residual Shunts in Patent Foramen Ovale Closure

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Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Included in China’s Emergency Use Program

CompanyMedical Device

Microport EP Medtech’s Pressure Monitoring Catheter Approved by NMPA

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NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer

CompanyMedical Device

Sansure Biotech’s Pertussis Detection Kit Approved by NMPA

CompanyMedical Device

Assure Tech Wins Japanese PDMA Approval for Pen-Type COVID-19 Antigen Test

CompanyDrug

Fosun Pharma’s Human Interferon Gamma Approved for New Indication by NMPA

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InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore

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Hengrui Pharmaceuticals Receives FDA ANDA Approval for Gadobutrol Generic

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