By Fineline Cube 
China’s Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its trastuzumab rezetecan (SHR-A1811), famitinib, and HR20013, all Category I drugs. These approvals mark significant milestones in the company’s pipeline, expanding its therapeutic reach across multiple indications.
Trastuzumab Rezetecan: A Breakthrough in Lung Cancer Treatment
Trastuzumab rezetecan is an in-house developed HER2-targeted antibody-drug conjugate (ADC) therapy. It is authorized to treat adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy. The approval was supported by results from the pivotal HORIZON-Lung study, which demonstrated an IRC-confirmed objective response rate (ORR) of 74.5% and a median progression-free survival (mPFS) of 11.5 months.
Famitinib: Expanding Treatment Options in Cervical Cancer
Famitinib is a multi-kinase inhibitor now approved for use in combination with camrelizumab for the second-line treatment of patients with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy but have not received bevacizumab. The combination is also being investigated in multiple clinical studies for non-small cell lung cancer, urinary, and gynecological system tumors, among others.
HR20013: A Novel Antiemetic Combination
HR20013 is a fixed-dose combination of fosrolapitant and palonosetron (PALO), designed to simultaneously activate NK-1 receptor and 5-HT3 receptor dual pathways to inhibit the vomiting reflex. It is approved for the prevention of acute and delayed nausea/vomiting induced by highly emetogenic chemotherapy (HEC) in adult patients. With an ultra-long half-life of nearly 8 days, HR20013 only needs to be administered once per chemotherapy cycle, providing comprehensive coverage for acute, delayed, and extended-delayed phases of chemotherapy-induced nausea and vomiting (CINV). This approval marks a significant advancement in China’s home-grown ultra-long-acting combination antiemetic injections.-Fineline Info & Tech