China Securities Intelligent Financial News — CSPC NovaWise (300765.SZ) announced on the evening of December 23 that its majority-owned subsidiary, CSPC Megalith Biopharmaceutical Co., Ltd., recently received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) for its Daratumumab Injection. The drug will commence domestic clinical trials in the near future.
According to the announcement, the injection is a recombinant all-human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38). As a biosimilar to the originator drug DARZALEX®, it was filed under Category 3.3 for therapeutic biological products and is indicated for the treatment of adult patients with multiple myeloma. The development of this product follows the guiding principles for biosimilar research. Results from pharmaceutical and non-clinical studies demonstrate that the product is highly similar to the reference originator drug in terms of quality, safety, and efficacy, supporting the progression to subsequent clinical studies.
Public records show that CSPC NovaWise primarily engages in the R&D, production, and sales of biopharmaceuticals, functional foods, and ingredients. Its biopharmaceutical division focuses on cutting-edge fields such as ADCs (Antibody-Drug Conjugates), mRNA vaccines, and antibody drugs, having established a professional innovative biomedical industrial platform. Its functional foods and ingredients portfolio includes caffeine and Vitamin C chewable tablets.
The company cautioned that while the drug has received clinical trial approval, it must still undergo clinical trials as required and obtain further approval from national regulatory authorities before it can be marketed and sold.

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