Haichuang Pharmaceutical disclosed after trading on November 4 that the first batch of participants were recently enrolled in the Phase II clinical trial of its independently developed HP515 drug, which is intended to treat metabolic-associated steatohepatitis (MASH). Currently, there are no similar target products approved for marketing in China.

The announcement indicates that HP515 tablets are an orally administered, highly selective THR-β (thyroid hormone receptor β subtype) agonist independently developed by Haichuang Pharmaceuticals. HP515 tablets directly act on THR-β to activate downstream gene transcription, thereby enhancing hepatocyte lipid metabolism activity, improving liver fat metabolism, and reducing lipotoxicity to improve metabolic-associated steatohepatitis (MASH). HP515 was approved by the China National Medical Products Administration (NMPA) for the treatment of metabolic steatohepatitis (MASH) in August 2024 and by the U.S. Food and Drug Administration (FDA) for the same purpose in September 2024.

Recently, Haichuang Pharmaceuticals has completed the Phase I clinical trial of HP515. Preliminary data show that HP515 met expectations in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics. The Phase II clinical trial, which evaluates the efficacy, safety, pharmacokinetics, and pharmacodynamics of HP515 in participants with metabolic-associated fatty liver disease (MASH), has recently successfully enrolled its first batch of participants.

The company is conducting research on HP515 in combination with a GLP-1R agonist for obesity. In May 2025, preclinical research data on HP515 in combination with a GLP-1R agonist for obesity was presented orally at the 32nd European Congress on Obesity (ECO) in 2025, and was selected for poster presentation at The 3rd Obesity & Weight Loss Drug Development Summit in June 2025.

According to Frost & Sullivan data, the global MASH market is projected to reach $10.7 billion by 2025 and $32.2 billion by 2030, representing a CAGR of 24.6%. The Chinese MASH drug market is expected to reach RMB 3.2 billion by 2025 and RMB 35.5 billion by 2030, with a CAGR of 61.4%. Haichuang Pharmaceutical stated that it will actively promote the aforementioned R&D projects and strictly comply with relevant regulations to promptly disclose information regarding the subsequent progress of the projects.

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