China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch repair proficient (pMMR) or non-MSI-H endometrial cancer in patients with disease progression following prior systemic anti-tumor therapy, particularly those unsuitable for curative surgery or radiotherapy. Notably, this combination previously received breakthrough therapy designation (BTD) in China.
Since its launch in December 2018, Tyvyt has been approved for seven indications in mainland China, all included in the National Reimbursement Drug List (NRDL). These indications encompass: 1) recurrent or refractory classical Hodgkin lymphoma (cHL) after at least second-line systemic chemotherapy; 2) first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with negative mutations in the epidermal growth factor receptor (EGFR) gene and negative anaplastic lymphoma kinase (ALK); 3) locally advanced or metastatic NSCLC in EGFR-positive patients who have failed EGFR-targeted tyrosine kinase inhibitors (TKIs); 4) first-line treatment of unresectable locally advanced or metastatic squamous NSCLC; 5) first-line treatment of unresectable metastatic hepatocellular carcinoma (HCC) with no prior systemic treatment; 6) first-line treatment of unresectable locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC); and 7) first-line treatment of unresectable locally advanced recurrent or metastatic gastric adenocarcinoma and gastroesophageal junction (GC/GEJ) cancers.
Elunate, a highly selective oral inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, was approved by the NMPA in September 2018 and launched commercially in November of the same year for metastatic colorectal cancer (mCRC) patients previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who had received anti-VEGF and/or anti-EGFR therapies (RAS wild type). In March 2023, HutchMed entered into a USD 1.13 billion licensing agreement with Takeda, granting the latter global development, commercialization, and manufacturing rights for Elunate, excluding mainland China, Hong Kong, and Macau.- Flcube.com
