Shanghai Junshi Biosciences supplemental new drug application (sNDA) for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (RCC), has been accepted by the National Medical Products Administration (NMPA). Following the approval, the drug is expected to get a first-mover advantage in the first-line treatment setting within the PD-1 market in RCC for China, says GlobalData, a leading data and analytics company.

The sNDA was based on the Phase III RENOTORCH (NCT04394975) study of toripalimab in combination with axitinib for first-line treatment of RCC. Toripalimab met the primary endpoint in combination with axitinib by reducing the risk of disease progression when compared to sunitinib monotherapy and is consistent with known risks, with no new safety signals identified in the subjects.

The current marketed drugs space for RCC in China is dominated by tyrosine kinase inhibitors (TKIs) – axitinib and sunitinib from Pfizer and Novartis’s pazopanib. There is no PD-1 inhibitor yet approved for RCC in China.

Nelluri Geetha, Pharma Analyst at GlobalData, comments: “As the current treatment approach for advanced RCC in China has its own limitations, like heavily depending on targeted monotherapy using tyrosine kinase inhibitors (TKIs), which has minimal benefits for patients; there exists a substantial need for novel therapies like PD-1 inhibitors.

According to GlobalData’s Pharmaceutical Intelligence Center, the number of 10-year diagnosed prevalent cases of RCC in China is expected to increase at an annual growth rate (AGR) of 2.59% from 268,991 in 2023 to 300,525 in 2028.

The other PD-1 inhibitor combination trials for RCC in China include Phase III studies for Merck & Co.’s pembrolizumab (first-line therapy), Bristol Myers Squibb’s nivolumab (first and second line), and Phase II studies for BeiGene’s tislelizumab (first-line), and Eli Lilly’s sintilimab (first-line). In addition, domestic companies in China are also focused on in-house R&D for RCC: Xynomic Pharmaceuticals’ abexinostat (first or second line) in Phase III and BeiGene’s sitravatinib (second line) in Phase I development.

Geetha concludes: “Toripalimab is already approved in China for other indications like metastatic melanoma, metastatic nasopharyngeal carcinoma (NPC), metastatic urothelial carcinoma, esophageal squamous-cell carcinoma (ESCC), metastatic non-squamous non-small cell lung cancer (NSCLC). In addition, melanoma, mestastatic NPC and urothelial carcinoma have been included in the National Reimbursement Drug List (NRDL) (2022 Edition). Moreover, physician familiarity with toripalimab efficacy in other approved indications and inclusion in NRDL is expected to contribute to its market success post-approval for RCC.”