On June 28, 2024 Sumgen Biotech reported its enlonstobart for Injection (Trade Name: Enshuxin) received marketing approval from the National Medical Products Administration (NMPA) (Approval Number: S20240028) (Press release, Sumgen Biotech, JUN 28, 2024, View Source;a=nav&id=364 [SID1234656270]). This marks a significant milestone in Sumgen Biotech’s new drug development process, signifying the company’s entry into a new era.
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According to the latest announcement on the official website of the National Medical Products Administration (NMPA), Enlonstobart for Injection (Trade Name: Enshuxin) has formally obtained marketing authorization approval, intended for the treatment of relapsed or metastatic cervical cancer patients with positive PD-L1 expression who have failed to respond to first-line platinum-based chemotherapy. Enlonstobart for injection (SG001) was originally developed by Hangzhou Sumgen Biotech Co., Ltd. (referred to as "Sumgen Biotech"). Its first clinical trial was approval in September 2018, soon afterwards Sumgen Biotech entered into a strategic partnership with CSPC in November 2018. In March 2023, the application for marketing authorization was submitted and it was granted conditional marketing approval.