Humanwell Healthcare's Recombinant Plasmid Hepatocyte Growth Factor Injection Accepted for NMPA Review

Humanwell Healthcare’s Recombinant Plasmid Hepatocyte Growth Factor Injection Accepted for NMPA Review

China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for review of its Category 1 therapeutic biologic product, the recombinant plasmid hepatocyte growth factor injection. This development signifies a step forward in the potential approval process for a novel treatment option in China.

Potential Treatment for Limb Rest Pain Caused by Severe Lower Limb Ischemic Disease
The drug candidate from Humanwell Healthcare is indicated for the treatment of limb rest pain caused by severe lower limb ischemic disease. This condition has seen limited treatment options in China, with no similar product currently approved for marketing. The acceptance of Humanwell’s filing by the NMPA indicates the potential for a new therapeutic approach to address this unmet medical need.

Market Competition and Innovation
While there are no similar products approved in China, local firm Northland Bio has submitted a market filing for its NL003, a recombinant human hepatocyte growth factor naked plasmid injection. This highlights a growing interest and innovation in the field of biologic treatments for lower limb ischemic disease. The competition in the market may drive further advancements and provide more options for patients suffering from this condition.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry