On June 28, 2024, Enlonstobart for Injection (Trade Name: Enshuxin®), which was initially developed by Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech"), received marketing approval from the National Medical Products Administration (NMPA) (Approval Number: S20240028). This marks a significant milestone in Sumgen Biotech's new drug development process, signifying the company's entry into a new era.
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.
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