Hengrui Pharmaceutical (01276): Innovative drug injectable carelizumab combined with famitinib malate capsules for first-line treatment of patients with recurrent or metastatic cervical cancer approved for marketing

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, the company and its subsidiary Suzhou Shengdia Biomedical Co., Ltd. received a notice from the State Drug Administration to approve the marketing of the company's innovative injectable carrilizumab combined with famitinib malate capsules for first-line treatment of patients with recurrent or metastatic cervical cancer. At this point, this target-free combination therapy has officially completed the upgrade of the layout from second-line treatment to first-line treatment for advanced cervical cancer.

Injectable carelizumab has been approved for several domestic indications, namely: 1. This product is used for the treatment of advanced hepatocellular carcinoma patients who have previously received sorafenib and/or lenvatinib and/or oxaliplatin-containing systemic chemotherapy. 2. This product combined with pemetrexed and carboplatin is suitable for first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) gene mutation and negative anaplastic lymphoma kinase (ALK), which cannot be surgically resected. 3. This product is used for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma who have previously received first-line chemotherapy or are intolerable. 4. This product is used to treat patients with advanced nasopharyngeal cancer who have previously received second-line chemotherapy or are intolerable after receiving second-line chemotherapy. 5. This product is used in combination with cisplatin and gemcitabine for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal cancer. 6. This product is used in combination with paclitaxel and cisplatin for first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma. 7. This product is used in combination with paclitaxel and carboplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer. 8. This product in combination with apatinib mesylate is used for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma. 9. This product in combination with famitinib malate is used in patients with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy but have not received bevacizumab treatment.

Famitinib malate capsules were approved in May 2025. The indication is for patients with recurrent or metastatic cervical cancer who have previously failed platinum-containing chemotherapy but have not received bevacizumab treatment. The indication was changed from conditional approval to full approval in July 2026.