Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This would mark the 9th indication for the PD-1 inhibitor in China.
Phase III RENOTORCH Study Results Support Filing
The filing is supported by the results of the multi-center, randomized, open, positive controlled Phase III RENOTORCH study. The study demonstrated that compared with sunitinib, the first-line treatment of toripalimab combined with axitinib significantly reduced the risk of disease progression or death in patients with advanced RCC. Additionally, the combination therapy improved objective response rates (ORR) and other secondary endpoints. The safety data was consistent with known risks, and no new safety signals were identified.
Tuoyi’s Track Record and Ongoing Filings
Tuoyi was the first domestic PD-1 inhibitor approved in China in December 2018 for second-line treatment of melanoma. To date, it has received six indication approvals in China. Multiple market filings for the drug are currently under review in the US, EU, and UK. In April and May of this year, Junshi filed for the 7th and 8th indications for the drug in China, including perioperative treatment combined with chemotherapy for resectable stage III non-small cell lung cancer (NSCLC) and combined with paclitaxel (albumin bound) for PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic triple negative breast cancer.-Fineline Info & Tech
