Chengdu, China, March 27, 2025 -- HUITAI Biomedicine (HUITAI), a clinical stage biotechnology company specialized in the development and commercialization of anti-fibrosis peptide novel medicine, today announced that its inhaled HTPEP-001 has successfully completed Phase I clinical trial and achieved positive topline data, meeting all primary and secondary endpoints.

“The global anti-pulmonary fibrosis drug competitive landscape is undergoing a structural transformation.” said Mr Wei Yijun, Chief Ｅxecutive Officer of HUITAI. “HUITAI's HTPEP-001, which features an ultra-high safety window, clear target mechanism, and delivery advantage, has taken the lead in validating a new competitive dimension through this Phase I clinical trial.”

The Phase I clinical trial of HTPEP-001 was conducted in a randomized, double-blinded, placebo-controlled study to assess the safety and tolerability of HTPEP-001 in healthy subjects at escalating doses from 1mg to 24mg.

The study data showed that the pharmacokinetic (PK) characteristics of HTPEP-001 in healthy subjects, as well as the local irritation tests related to inhaled administration, were consistent with the results from the preclinical models. In addition, all dosage groups demonstrated good safety and tolerability. All treatment-related adverse events (AEs) during the study were mild and had recovered by the end of the study. There were no adverse reactions related to nebulized inhalation, nor were there any adverse reactions reported from other drugs targeting in the same signaling pathway.

It is worth noting that the the highest dose used in the trial, 24mg, was much higher than the theoretical effective dose.

“HTPEP-001 has shown good safety and tolerability in this Phase I clinical study.” said Mr. Yu Jian, Head of Clinical Development of HUITAI. “This candidate has the potential for anti-inflammatory and anti-fibrotic effects and is targeted in the key signaling pathway. We look forward to further verifying its safety and efficacy in the upcoming trials.”

*For more information, please visit: cdhuitai.cn

About HUITAI Biomedicine

Chengdu Huitai Biomedicine Co., Ltd. was established in 2017. As a clinical stage biotechnology company focused on the anti-fibrosis drugs with core intellectual property rights, HUITAI is dedicated to the development and global commercialization of innovative drugs for fibrotic diseases and solid tumors closely related to fibrosis. HUITAI has established five global first-in-class drug development pipelines dedicated to lung, liver, kidney fibrosis, and solid tumors. Preliminary data has been accepted and presented at international conferences by the American Thoracic Society (ATS) and the American Society of Clinical Oncology (ASCO) twice in a row, receiving high praise from the authors of fibrotic clinical guidelines from both China and the United States. HUITAI is a member of "American Thoracic Society (ATS)" and "Hong Kong Biotechnology Association (HKBIO)", and has been honored as one of the "Top 50 Innovative Biotech Companies in China by KPMG" and one of the "Top 100 Potential Enterprises in the Medicine and Health Industry in Chengdu Hi-tech Zone".