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On November 16th, 2024, Hasten announced that the first subject was enrolled and dosed in the Phase III clinical trial of the new third-generation PCSK9 inhibitor, Lerodalcibep (hereinafter referred to as HST101), which is jointly developed by Hasten and LIB. This marks a significant new milestone in Hasten's research and development journey, following the obtaining of clinical trial approval by NMPA earlier this year.
This study is a randomized, double-blind, placebo-controlled phase III clinical trial (CTR20242095/NCT06568471) aimed at evaluating the efficacy and safety of HST101 in Chinese patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The study is led by Professor Huo Yong from Peking University First Hospital and is planned to be conducted at a total of 35 research centers across the country.
Prof. Xiao Shen, CMO of Hasten, said: "Following the positive results of the Phase III clinical trials announced by LIB at EAS conference this year, Hasten has made every effort to actively promote its clinical development process in China. On September 18, the first patient in the phase I clinical trial of HST101 was enrolled and dosed successfully. We are very looking forward to witnessing the same excellent performance of the phase I and phase III clinical trials among Chinese patients, so as to providing new treatment options with more clinical value for doctors and patients, and helping more hyperlipidemia patients achieve LDL-C target as soon as possible."
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