Hengrui Pharmaceutical PD-1 single anti-new drug another listing application was accepted

Screenshot source: CDE official website Karelli pearl monoantigen is a humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceuticals, and is also a key research and development product of Hengrui Pharmaceuticals.
Since it was first approved for market in China in May 2019, the drug has been approved in China with four adaptive disorders: 1) for the treatment of patients with relapsed or incurable classic Hodgkin's lymphoma after at least second-line system chemotherapy; 3) First-line treatment of patients with local advanced or metastatic non-squamous non-small cell lung cancer with EGFR gene mutation-negative and APK-negative, non-surgical removal; 4) for the treatment of patients with local advanced or metastatic esophageal scale cancer who have previously received first-line standard chemotherapy.
In addition, The application for the treatment of patients with advanced nasopharyngeal cancer who have previously received progression or insufferable advanced nasopharyngeal cancer after second-line and above chemotherapy has been included in the CDE's priority review in September this year for "qualified approved drugs".
applications for first-line treatment in patients with local recurrence or metastatic nasopharyngeal cancer were included in the proposed priority review on 6 November.
China Drug Clinical Trial Registration and Information Disclosure Platform, Hengrui Pharmaceuticals has registered 15 clinical trials of Karelli pearl monoantigen.
In addition to the above-mentioned adaptations, Karelli-Pearl monoantigen is also being developed in clinical trials to treat cancerous species such as triple-negative breast cancer, stomach cancer, PD-L1-positive non-small cell lung cancer, advanced urinary system tumors, gynaecological tumors, stage IV KRAS mutation non-squamous non-small cell lung cancer.
phase 3 clinical studies of triple-negative breast cancer, stomach cancer, and PD-L1-positive non-small cell lung cancer are under way.
Screenshot Source: China Drug Clinical Trial Registration and Information Disclosure Platform Reference: China's State Drug Administration Drug Review Center. Retrieved Nov 12, 2020, from the first-line treatment of advanced nasopharyngeal cancer Phase III clinical studies of Henri Pharmaceuticals Erika ® (Karelli Pearl Monoantigen) reached the end of the main study. Retrieved Aug 13,2020, from the Chinese drug clinical trial registration and information disclosure platform. From Source: Medical Mission Hills