Hansoh Pharma Initiates Phase I Clinical Trial of Oral Small Molecule PCSK9 Inhibitor HS-10510

▎Armstrong

On May 30, 2025, Hansoh Pharma registered the Phase I clinical trial of HS-10510 on the Drug Clinical Trial Registration and Information Disclosure Platform website.

According to clinical trial registration information, HS-10510 is likely a small molecule PCSK9 inhibitor.

Currently, there are two oral PCSK9-targeted drugs that have entered Phase III clinical trials globally: Merck's PCSK9 macrocyclic peptide MK-0616 and AstraZeneca's small-molecule PCSK9 inhibitor AZD-0780.

According to the patent information of Hansoh Pharma's PCSK9 inhibitor, its structure is a cyclopentane derivative, the same as AZD0780.

Summary

PCSK9 is the most complex target in the cardio-renal metabolism competitive landscape. In 2014, Amgen and Sanofi's PCSK9 antibodies were approved for marketing, with Amgen's Repatha achieving sales of $2.2 billion in 2024. In 2021, Novartis' PCSK9 siRNA was approved, requiring only one injection every six months, with Q1 2025 sales reaching $333 million. Merck's oral PCSK9 cyclic peptide has entered phase III clinical trials, and AstraZeneca’s small-molecule PCSK9 inhibitor has also advanced to phase III clinical trials. Additionally, in vivo gene editing for PCSK9 is actively progressing. This ultimately creates a competitive landscape where multiple drug formats such as small molecules, antibodies, siRNA, cyclic peptides, and in vivo gene editing compete simultaneously.