JUNSHI BIO announced that its Trelagliptin monoclonal antibody (trade name: Tuoyi®) for the treatment of unresectable or metastatic melanoma in patients who have previously failed systemic therapy has been converted from conditional approval to regular approval. This approval is primarily based on the results of the MELATORCH study, which showed that Trelagliptin significantly prolongs progression-free survival compared to dacarbazine and reduces the risk of disease progression or death by 29.2%. Trelagliptin is the first domestically approved PD-1 monoclonal antibody in China and has currently been approved for 10 indications in mainland China, all of which are included in the national health insurance catalog. In terms of international expansion, the drug has been approved for marketing in multiple countries and regions including...Show More

JUNSHI BIO announced that its Trelagliptin monoclonal antibody (trade name: Tuoyi®) for the treatment of unresectable or metastatic melanoma in patients who have previously failed systemic therapy has been converted from conditional approval to regular approval. This approval is primarily based on the results of the MELATORCH study, which showed that Trelagliptin significantly prolongs progression-free survival compared to dacarbazine and reduces the risk of disease progression or death by 29.2%. Trelagliptin is the first domestically approved PD-1 monoclonal antibody in China and has currently been approved for 10 indications in mainland China, all of which are included in the national health insurance catalog. In terms of international expansion, the drug has been approved for marketing in multiple countries and regions including the USA and the EU. Furthermore, the company is conducting over 40 clinical studies covering more than 15 indications globally and has submitted a new indication application for Trelagliptin for first-line treatment of unresectable or metastatic melanoma.It is worth noting that although melanoma is relatively rare in China, the mortality rate is high, with approximately 0.009 million new cases and about 0.005 million deaths recorded in 2022. The regular approval of Trelagliptin provides a new treatment option for these patients. However, the commercialization of the Pharmaceutical may still be affected by local policies and changes in the market environment, presenting certain uncertainties.