Northland
Innovative Biopharmaceutical Manufacturer
2025Year12Month3Date: Humanwell Healthcare Group Co. Ltd. (Stock Code:600079, Stock Abbreviation: Humanwell Healthcare) released a significant announcement, declaring that its holding subsidiary, Wuhan Optics Valley Humanwell Biopharmaceutical Co., Ltd. (hereinafter referred to as“Optics Valley Humanwell”, Humanwell Healthcare Group Co. Ltd. holds shares81.30%) Received the "Notice of Termination of Drug Registration Application" issued by the National Medical Products Administration. The National Medical Products Administration has officially agreed to the withdrawal of the recombinant plasmid application by Guanggu Humanwell.-Hepatocyte Growth Factor Injection (referred to as“pUDK-HGF”) Registration Application.
As a therapeutic biological product1New drug class,pUDK-HGFThe dosage form is injection, and this application is for the marketing authorization of domestically produced drugs in China. The core indication is for the treatment of limb rest pain caused by severe lower limb ischemic disease.
It is reported that there are currently no similar products of this type of drug available on the market in China, and the competitive landscape in the industry is relatively clear. Its research and development progress has been closely watched by the industry.
Reviewing the development process of this project, Humanwell Healthcare Group Co. Ltd. of Optics Valley2024Year12In the same month, the company officially submitted the marketing registration application for the drug to the National Medical Products Administration (NMPA) and it was successfully accepted. However, during the project advancement, based on the latest review status, after internal careful research and evaluation, the company ultimately decided to voluntarily withdraw this registration application.
It is worth noting that,The announcement clearly stated that this withdrawal does not mean the termination of the R&D project.Subsequently, Optics Valley Humanwell will strictly comply with regulatory requirements and technical specifications to comprehensively and fully evaluate and improve existing research materials. Once preparations are complete, they will resubmit the drug's marketing registration application.
In terms of investment scale, the importance Humanwell Healthcare Group Co. Ltd. places on the development of this new drug is evident. As of now,pUDK-HGFThe cumulative R&D investment in the R&D project has reached approximately1.6100 million yuan; In addition,追溯至2021Year, Humanwell Healthcare Group Co. Ltd. acquired Guanggu Humanwell20.33%When equity is included and consolidated into the financial statements, the allocated amount of identifiable assets for this R&D project has already reached a high level.2.38100 million yuan. The total investment in the project has exceeded3.9100 million yuan, close to4The 100 Million Yuan Mark.
Affected by this news, the share price of Humanwell Healthcare Group Co. Ltd. showed a volatile downward trend today, once falling to18.44Near the dollar, finally closed at18.57Yuan, a decrease from yesterday0.64Yuan, decline3.33%。
Although there are currently no similar products on the market in China, the market competition in this field has quietly begun. It is reported that a therapeutic biological product developed by Beijing Northland Biotechnology Co., Ltd.1A New Drug: Sedoming Base Injection (Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection, Code NameNL003) has been accepted for marketing authorization application. Its indications not only include limb ulcers caused by severe lower limb ischemia, but also target resting pain indications.IIIThe Phase clinical trial has been successfully completed, becomingpUDK-HGFDirect competitor.
Subsequently,pUDK-HGFThe progress of improving R&D materials, the specific timeline for re-filing, and the dynamic changes in the competitive landscape of new drug development in this field will continue to receive widespread attention from the pharmaceuticals industry.
