Release date：2024-12-23 Browse：168
Junshi Biological Triprolizumab (US trade name LOQTORZI) ™） Approved by the FDA in October 2023, it became the first domestically produced PD-1 to be launched in the United States, covering the entire treatment of nasopharyngeal carcinoma and filling a gap in this field in the United States. Its pricing is 30 times the domestic price, highlighting a premium of 4 in overseas markets. In March 2024, BeiGene Trastuzumab (TEVIMBRA) ®） Obtained FDA approval again for esophageal cancer and plans to launch in the United States in the second half of the year.
Triprolizumab adopts a fully humanized design to reduce the risk of immunogenicity; Teralizumab reduces side effects through Fc segment modification. Both were approved based on data from international multicenter Phase III trials, such as the RATIONALE 302 trial which showed that trastuzumab significantly prolonged patient survival compared to chemotherapy.
Junshi Biotechnology promotes commercialization in the United States through its partner Coherus, but has encountered approval delays due to on-site FDA inspections. BeiGene has established its own global sales team and replicated the successful path of its BTK inhibitor Zebutinib. The "internal competition" of domestic PD-1 forces enterprises to go global, but they need to cope with international regulatory differences and market competition.
