Lunan Pharmaceutical's Anti-CD47 Monoclonal Antibody Receives NMPA Approval for Clinical Trials in Relapsed or Refractory Lymphoma

On November 12, Lunan Pharmaceutical Group Corporation announced that the innovative biologic product, recombinant humanized anti-CD47 monoclonal antibody injection, developed by Shandong New Time Pharmaceutical Co., Ltd., has received clinical trial approval from the NMPA.

Data Source: PharmData

Recombinant Humanized Anti-CD47 Monoclonal Antibody Injection for clinical application in relapsed or refractory lymphoma. Lymphoma is a group of highly heterogeneous neoplastic diseases. Due to the varying functions of clonally proliferating lymphocytes and their widespread distribution in the human body, lymphoma can affect any organ, exhibiting diverse morphological features, immunophenotypes, biological behaviors, clinical manifestations, as well as varied treatment responses and prognoses. Some patients present significant treatment challenges with poor therapeutic responses. Currently, lymphoma is one of the top ten malignant tumors with the highest mortality rates in China.

CD47 is a glycoprotein widely expressed on the surface of various cancer cells and is one of the key targets in the field of anti-tumor immunotherapy. CD47 is a crucial member of the immune inhibitory signaling pathway, targeting macrophages and inhibiting their phagocytic function by interacting with and activating the inhibitory receptor signal regulatory protein α (SIRPα). The recombinant humanized anti-CD47 monoclonal antibody injection blocks the CD47-SIRPα signaling pathway, restoring the ability of macrophages to recognize tumor cells and present antigens, achieving an anti-tumor effect through both innate and adaptive immunity.

It is reported that Lunan Pharmaceutical Group Corporation has currently built a full industrial chain platform, which focuses on biological macromolecule drugs such as monoclonal antibodies and bispecific antibodies. This platform integrates drug research and development, technology transformation, and large-scale production. It holds unique advantages in the new biopharmaceutical technology field of utilizing animal cell expression systems to express products, with both upstream and downstream technologies reaching maturity. Lunan Pharmaceutical Group has established a product pipeline covering areas such as cancer, metabolic diseases, and autoimmune diseases. Among these, PEG-G-CSF has been commercially launched, recombinant insulin glargine injection is about to be approved for production, PD-1 monoclonal antibody and CD20 monoclonal antibody are undergoing clinical trials; BCMA/CD3 bispecific antibody is preparing for clinical trials; and more than 20 innovative first-class biological drugs are under development.

Editor: Liuli

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