CSPC Pharmaceutical Group Limited announce that the biologic license application for the class 1 new drug JMT103 (Narlumosbart for Injection) developed by Shanghai JMT-Bio Technology Co. Ltd., a subsidiary of the Company, has been accepted by the National Medical Products Administration of the People's Republic of China, and the Center for Drug Evaluation has agreed to the submission of application for priority review. At present, the application is in progress.

The indication for this application is for the treatment of unresectable or surgically difficult giant cell tumor of bone. The Product is the first IgG4 subtype fully human monoclonal antibody against RANKL filing BLA in the world. At present, denosumab, an IgG2 subtype, is the only marketed drug against the same target in the world.

Compared with denosumab, the Product has significant enhancement in uniformity and quality controllability. Subcutaneous injection is used to administer the Product. It can block the binding of RANKL to the membrane RANK receptors of cells such as osteoclast precursor cells, osteoclasts and osteoclast-like giant cells so as to inhibit the differentiation, maturation and functional activity of the above cells mediated by RANKL-RANK signaling pathway.

It is expected to treat diseases associated with the activation of RANKL-RANK signaling pathway, such as giant cell tumor of bone, osteoporosis, tumor bone metastasis. The BLA for JMT103 is mainly based on two pivotal clinical studies in the treatment of unresectable or surgically difficult giant cell tumor of bone. The clinical studies demonstrated that JMT103 had a better clinical efficacy in the treatment of unresectable or surgically difficult giant cell tumor of bone with a tumor response rate of 93.5%, and a trend higher than that of the denosumab group.

At the same time, JMT103 showed a good safety profile with controllable safety risks.