On May. 17^th, 2024, Hasten Biopharmaceutical Limited Co., Ltd. (hereinafter as Hasten) announced that the clinical trial application (IND) for Lerodalcibep(hereinafter as the code：HST101), a novel third-generation PCSK9 inhibitor, has been approved by the Center for Drug Evaluation(CDE) of the National Medical Products Administration (NMPA) for the treatment of patients with hypercholesterolemia. The Company will accelerate domestic clinical trial preparations and initiate recruitment of subjects with hypercholesterolaemia.

Summer XIA, CEO of Hasten, said：“We are very pleased that HST101 clinical trial application has received the approval from the CDE of NMPA, which not only marks the birth of Hasten’s first IND approval, but also means that our first product under development has officially entered the clinical development stage in China. This also further manifests that Hasten’s pipeline development capability is becoming more mature, which will surely assist our R&D progress dashing forward with an ‘accelerated pace’.

Dr. Shen Xiao, MD., Ph.D., Chief Medical Officer of Hasten, said: “Based on our partner LIB's overseas clinical trial data, HST101 has manifested convincing clinical efficacy and patient-friendly characters. We are looking forward to the clinical performance among Chinese patients during the IND. Hasten will accelerate the clinical development pace of HST101 at full speed to provide an innovative and efficient treatment for patients suffering from hypercholesterolaemia.”

The IND application approved by CDE includes two clinical trials, Phase 1 and Phase 3, which will be mainly managed by Hasten to conduct trials covering pharmacokinetic, pharmacodynamic, and efficacy and safety evaluations among Chinese healthy study participants (Phase 1) and patients with hypercholesterolaemia including heterozygous familial hypercholesterolaemia (HeFH) (Phase 3) respectively. Following the completion and positive results of the HST101 global Phase 3 overseas clinical trial project, the two upcoming registrational clinical trials in Chinese patients are expected to support the faster approval of Lerodalcibep, providing healthcare professionals and patients with new therapeutic choices, as well as helping more hyperlipidaemia patients to achieve LDL-C targets as early as possible.

Lerodalcibep(HST101) is the first in-licensing innovative medicine in development of Hasten, which synergies with the company’s seven existing original medicines to strengthen its portfolio in the chronic and acute critical diseases. LIB is planning to submit a Biologics License Application to the Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency successively. In the future, Hasten will work closely with LIB to provide innovative products landing quickly and benefit more patients around the world.

Notification: The drug under development related to this article has not yet been approved in China. Hasten Biopharma does not recommend the use of any unapproved drugs.