-
Beijing Aosaikang’s ASKG915 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the National Medical Products Administration (NMPA). The study will initially assess the therapy in patients with general advanced solid tumors. ASKG915: A Bifunctional Fusion Protein Targeting PD-1 and IL-15ASKG915…
-
InnoCare Pharma’s Orelabrutinib Gains NMPA Approval for Recurrent/Refractory MZL Treatment
•
China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib. The drug can now be used to treat recurrent/refractory marginal zone lymphoma (MZL), marking it as the first BTK inhibitor for that…
-
Walvax Biotechnology’s RQ3013 mRNA Vaccine Shows Efficacy in Phase III Study
•
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the efficacy interim results of a Phase III clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The study provides crucial data on the vaccine’s performance as a sequential booster in…
-
NMPA’s 2022 Drug Supervision Report: Clinical Trials and Market Filings on the Rise
•
The National Medical Products Administration (NMPA) has released its “Annual Drug Supervision and Administration Statistics (2022)”, offering insights into the drug and device administrative system for the 2022 calendar year. Yearly Increase in Clinical Trials and Market FilingsDuring the period, the NMPA accepted a total of 2,403 clinical trial filings,…
-
Alcon Laboratories’ Innovative Intraocular Lens Approved by China’s NMPA
•
The National Medical Products Administration (NMPA) has granted import approval to US firm Alcon Laboratories, Inc. for its innovative intraocular lens, marking it as the 197th innovative medical device to be approved by the bureau. Product Features and BenefitsThe product in question is a one-piece posterior chamber intraocular lens that…
-
Biosyngen Receives US FDA IND Approval for T-Cell Redirection Therapy for EBV-Positive Lymphoma
•
Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…
-
EOC Pharma Group Partners with China National Accord Medicines for Distribution Rights
•
China-based EOC Pharma Group has announced a strategic partnership with compatriot firm China National Accord Medicines Corporation Ltd, granting the latter distribution and importing rights to its Vascepa (ethyl Icosapentate) and Mulpleta (lusutrombopag). The collaboration aims to enhance the commercialization of both products within the Chinese market. Vascepa: A FDA-Approved…
-
Ubrigene Secures RMB 150 Million in Series C+ Financing to Expand Global CGT CDMO Platform
•
Yiming Cell Biotechnology Co., Ltd, known as Ubrigene Biosciences Inc., a leading gene and cell therapy contract development and manufacturing organization (CDMO) based in Beijing, has reportedly raised RMB 150 million (USD 21.8 million) in a Series C+ financing round. The funding was led by Guotai Junan Innovation Investment and…
