Zhitong Finance App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. Recently, Suzhou Shengdia Biomedical Co., Ltd., a subsidiary of the company, received approval from the State Drug Administration (hereinafter referred to as the “State Drug Administration”) to issue a “Drug Clinical Trial Approval Notice” for injectable carelizumab and will conduct clinical trials in the near future.
Injectable carelizumab has been approved for nine domestic indications, namely: approved for the treatment of recurrent or refractory classic Hodgkin lymphoma with at least second-line chemotherapy in May 2019; approved for the treatment of advanced hepatocellular carcinoma patients who have previously received sorafenib and/or oxaliplatin-containing systemic chemotherapy; approved in June 2020 for use with pemetrexed and carboplatin for negative epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) Locally advanced or metastatic non-squamous shape that cannot be surgically removed First-line treatment for non-small cell lung cancer (NSCLC) and treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma who have previously received first-line chemotherapy; approved in April 2021 for the treatment of patients with advanced nasopharyngeal cancer who have previously received second-line chemotherapy or are intolerable; approved for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal cancer in June 2021; approved in combination with paclitaxel and cisplatin for patients with locally recurrent or metastatic nasopharyngeal cancer in December 2021 First-line treatment for patients with esophageal squamous cell carcinoma It is also used in combination with paclitaxel and carboplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer; in January 2023, apatinib mesylate was approved for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.
According to reports, injectable carelizumab is a humanized anti-PD-1 monoclonal antibody that binds to human PD-1 receptors and blocks the PD-1/PD-L1 pathway to restore the body's anti-tumor immunity, thus forming the basis for cancer immunotherapy. A number of PD-1 monoclonal antibodies have been approved for marketing abroad, including pabolizumab (MSD, trade name Coreda), navulimab (Bristolimab, trade name Odivo), cemiplimab (regenerative pharmaceutical, trade name Libtayo), and dostarlimab (GlaxoSmithKline, trade name Jemperli), etc. A number of similar products have also been approved for sale in China. According to the EvaluatePharma database, total global sales of anti-PD-1 antibodies in 2022 were approximately US$33.277 billion. Up to now, projects related to injectable carelizumab have invested a total of about 2,377 billion yuan in R&D expenses.