Fu Hong Han Lin (02696): The marketing registration application for the desumab antibiotic analogue HLX14 120mg (1.7ml) /bottle was accepted by the NMPA

Zhitong Finance App News, Fu Hong Han Lin (02696) announced that recently, the desulumab biosimilar drug HLX14 (recombinant anti-RANKL whole human monoclonal antibody injection) (HLX14) developed independently by the group was accepted by the National Drug Administration (NMPA) Drug Evaluation Center for the 120mg (1.7ml) /bottle specification.

Indications covered by this marketing registration application (NDA) include: (1) solid tumor bone metastasis and multiple myeloma: used to treat patients with solid tumor bone metastases or multiple myeloma patients to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiotherapy, or bone surgery); and (2) bone giant cell tumors: used to treat bone macrocytomas that cannot be surgically removed or surgical excision may cause serious functional impairment, including adults and young patients with mature bone development (defined as patients with at least 1 mature bone length and body weight greater than 45 kg).

The current marketing registration application (NDA) for HLX14 is mainly based on data generated by HLX14 comparing its reference drug, including analytical similarity studies, non-clinical and clinical comparative studies. These data demonstrate that the 120mg (1.7 ml) /vial size of HLX14 is highly similar to its reference drug in terms of quality, safety, and efficacy.