Idiopathic pulmonary fibrosis (IPF) is a special manifestation of chronic progressive fibrotic pneumonia of unknown etiology. Idiopathic pulmonary fibrosis is a rare disease, and on May 11, 2018, idiopathic pulmonary fibrosis was designated as one of 121 rare diseases in China's First Rare Disease Catalog. IPF is most common in the elderly, with a median age of 65 years, and is characterized by progressive and worsening dyspnea, accompanied by restrictive ventilation dysfunction and gas exchange disorders, leading to hypoxemia and even respiratory failure. The lesions were confined to the lungs and presented histopathologically and/or radiographically as Usual Interstitial Pneumonia (UIP). The onset of IPF is insidious, and the course of the disease continues to progress, is unpredictable and irreversible. At present, there is a lack of effective treatment, and the prognosis is usually poor. The median survival time of patients is only 3-5 years, and the five-year survival rate is estimated to be about 20%, even lower than the survival rate of many types of cancer. Between 2015 and 2022, the number of people with IPF worldwide increased from 1.4 million to 1.7 million, a compound annual growth rate of 3.0%. Due to the impact of the COVID-19 pandemic, the number of people with IPF worldwide is expected to reach 3 million by 2023. However, at present, there is a shortage of means to treat IPF, and there is a lack of sufficient safety window for either listed drugs or drugs under research, resulting in a huge clinical demand that cannot be met.

   HTPEP-001 is an innovative drug of CD36 simulated polypeptide inhalation preparation, which is a TGF-β activation inhibitor with specific pharmacological effects at the molecular level, and can selectively block the activation process of TGF-β under pathological conditions to achieve the purpose of anti-pulmonary fibrosis.

HTPEP-001 can not only block, even reverse the process of tissue fibrosis, in the safety window index can reach 52.7 times the level, much more than the existing and research drugs at home and abroad. HTPEP-001 preclinical data has been accepted and presented publicly at the annual meeting of the American Thoracic Society and the American Society of Clinical Oncology, and has been highly praised by many clinical guideline writers in the relevant field in the United States.

Equity financing, the expected financing amount of 50 million yuan.

Investment budget: RMB 25 million for clinical Phase 1a, 1b and 2a trials of inhaled HTPEP-001, RMB 10 million to support 52-week toxicity trials of inhaled HTPEP-001 clinical phase 3, RMB 10 million for HTPEP-001 US clinical trials, and RMB 5 million for company operations.