Shanghai Junshi Biosciences Co. received its 13th Chinese approval for the anti-PD-1 drug toripalimab, now cleared in combination with RemeGen’s disitamab vedotin for advanced urothelial carcinoma.
"We were able to combine two locally-developed innovations to create a powerful synergistic treatment that significantly improves both PFS and OS," Junshi Biosciences CEO Dr. Jianjun Zou, said in a statement.
The approval by China's National Medical Products Administration is for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma. It's based on the RC48-C016 Phase 3 study, where the combination achieved a median overall survival of 31.5 months, compared to 16.9 months for standard chemotherapy. The hazard ratio for overall survival was 0.54.
The combination therapy also more than doubled progression-free survival to 13.1 months from 6.5 months for chemotherapy. Urothelial carcinoma is a major health issue in China, with over 40,000 deaths in 2022, representing a significant unmet clinical need for which the new combination offers a superior treatment option.
The objective response rate for the toripalimab-disitamab vedotin arm was 76.1 percent, a significant increase from the 50.2 percent observed in the chemotherapy arm. The median duration of response was also nearly tripled, at 14.6 months versus 5.6 months. The therapy also demonstrated a superior safety profile.
Toripalimab, an anti-PD-1 monoclonal antibody, is the first domestically-developed PD-1 inhibitor approved in China. It is also approved for marketing in over 40 countries, including the United States and the European Union. Disitamab vedotin is an antibody-drug conjugate developed by RemeGen; Pfizer holds rights to the drug in the US through its acquisition of Seagen.
This approval solidifies Junshi's leadership in China's oncology market and highlights the success of its collaborative R&D strategy. Investors will watch for sales uptake and the potential inclusion of this new indication in China's National Reimbursement Drug List, which already covers toripalimab's first 12 indications.
This article is for informational purposes only and does not constitute investment advice.
