Chinese official approval of PD-1 antibody drug market

The reporter was informed by the State Administration of Drugs on the 15th that the Food and Drug Administration approved the registration application for import of Nivolumab Injection. The drug is the first monoclonal antibody to be approved by PD-1 in China, and it has positive significance for solving the accessibility of clinical drugs for Chinese cancer patients.

At present, research hotspots in the field of tumor immunotherapy mainly focus on inhibitors such as anti-programmed death-1 (PD-1) receptors, which are different from traditional chemotherapy and targeted therapy, mainly by overcoming the body of patients. Immunosuppression, reactivation of the patient's own immune cells to kill the tumor, is a new anti-tumor treatment concept.

It is understood that Navulithumab injection is used for the treatment of epidermal growth factor receptor gene mutation-negative and anaplastic lymphoma kinase-negative, previously undergoing platinum-based chemotherapy after disease progression or intolerable local advanced or metastatic non- Small cell lung cancer in adult patients.

Bristol-Myers Squibb first developed and completed a clinical trial of the drug in patients with advanced non-small cell lung cancer who developed disease after treatment with platinum-containing double-drug chemotherapy, and submitted an application for registration of imported drugs accordingly. In accordance with the priority review procedure, the State Drug Administration speeded up the on-site verification of the technical review and clinical trial data of Navoliuduzumab injection, and approved the import registration on June 15, 2018.

Lung cancer is a malignant tumor that is highly prevalent worldwide. In recent years, some targeted therapeutic drugs have achieved good results in the field of lung cancer treatment, but for advanced non-small cell lung cancer with no driver gene mutation, chemotherapy is still the main, and the overall survival of patients is usually shorter. The clinical trial data of Navulithumab injection showed that the median overall survival of patients with advanced non-small cell lung cancer was extended by about 3 months compared with the existing second-line standard treatment. (Finish)