JUNSHI BIO announced that its product Trastuzumab (brand name: Tuoyi®) for the treatment of unresectable or metastatic melanoma, in patients who have previously failed systemic therapy, has transitioned from conditional approval to regular approval. This regular approval is primarily based on the MELATORCH study, which is the first domestic key registration clinical trial of a PD-(L)1 inhibitor achieving positive results for first-line treatment of advanced melanoma. The results show that the progression-free survival of the Trastuzumab group was significantly extended compared to the Dacarbazine group, with a 29.2% reduction in the risk of disease progression or death.Trastuzumab is China's first domestically approved PD-1 monoclonal antibody drug, and it has been approved for 10 indications in mainland China...Show More

JUNSHI BIO announced that its product Trastuzumab (brand name: Tuoyi®) for the treatment of unresectable or metastatic melanoma, in patients who have previously failed systemic therapy, has transitioned from conditional approval to regular approval. This regular approval is primarily based on the MELATORCH study, which is the first domestic key registration clinical trial of a PD-(L)1 inhibitor achieving positive results for first-line treatment of advanced melanoma. The results show that the progression-free survival of the Trastuzumab group was significantly extended compared to the Dacarbazine group, with a 29.2% reduction in the risk of disease progression or death.Trastuzumab is China's first domestically approved PD-1 monoclonal antibody drug, and it has been approved for 10 indications in mainland China, all included in the National Medical Insurance catalogue. The drug has also made progress internationally, with approvals granted in the USA, EU, and several other countries and regions. In addition, the application for a new indication for the first-line treatment of unresectable or metastatic melanoma has been accepted by the National Medical Products Administration in August 2024, further expanding its application scope in the field of melanoma treatment.