Reverse pulmonary fibrosis 1.1 new drugs
Pulmonary fibrosis is a respiratory disease with great clinical need, affecting the quality of life of tens of millions of people worldwide. At present, there is a shortage of therapeutic means, 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. Therefore, if there is a high safety window of anti-fibrosis drugs will be favored by all parties. 01 Project introduction 1 01.Project introduction HTPEP-001 is an innovative drug developed by a company to simulate CD36 polypeptide inhalation preparations. The drug is a molecular level specific action of TGF-β activation inhibitor, can selectively block the activation process of TGF-β under pathological conditions. 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. 02.Technical introduction The efficacy study of HTPEP-001 adopts the efficacy evaluation protocol recommended by the American Thoracic Society (ATS) with high technical threshold (the international authoritative guide for efficacy evaluation of pulmonary fibrosis), constructs a high-precision disease animal model with minimally invasive technology, and uses Micro-CT and 3D reconstruction technology for the first time. Dynamic stereoscopic display of pulmonary fibrosis in living animals and quantitative measurement of fibrosis treatment effect. HTPEP-001 has a new target, a new mechanism of action and a new structure. It is an inhibitor of transforming growth factor (TGF-β) activation, which can specifically target and inhibit TGF-β activation under pathological conditions. At the same time, HTPEP-001 has the characteristics of specific target, high safety, aerosol inhalation, anti-inflammatory and anti-fibrosis. 03.R&d stage HTPEP-001 has been distributed in 15 countries and regions at home and abroad, and has obtained 2 Chinese invention patent licenses and 5 PCT international patent licenses. At present, both intravenous injection and aerosol inhalation of HTPEP-001 have been approved by the China Food and Drug Administration. Clinical trials will follow. 02 Market competitive advantage 01 Market value HTPEP-001 is a new molecular entity, which meets the registration classification requirements of national chemical drugs Class 1, is an innovative drug that is not listed at home and abroad, and its research and development results are at the international leading level, which can solve the problem of TGF-β target druggability in the world. HTPEP-001, as a TGF-β activation inhibitor, only plays an inhibitory role in abnormal TGF-β signaling pathway, which can avoid the impact on normal physiological processes. It has the characteristics of specific target, high safety, aerosol inhalation, anti-inflammatory and anti-fibrosis, etc., and has excellent safety. Based on the results of preclinical safety pharmacological studies, toxicological studies and clinical trials, the efficacy is better than that of the same mechanism products. Currently marketed specific drugs for pulmonary fibrosis are lacking in safety and efficacy. Therefore, polypeptide HTPEP-001 has the core competitiveness with developed countries and is expected to enjoy a high market share. 02 Core team The company's R & D team is composed of domestic and foreign experts. Our overseas experts have more than 25 years of senior experience in new drug research and development, covering new drug research and development, mechanism of action research, peptide drug development, clinical application transformation and commercial promotion at home and abroad. The top clinical expert consultant team in the field of respiratory diseases such as China West, Concorde and China-Japan Friendship Hospital participated in the whole project research and development process. The first-line scientific research personnel are composed of the young generation of doctors and masters with high education and high level, solid professional theory, strong scientific interest, and rising scientific and technological level. Their specialties cover clinical and basic medicine, animal medicine, pharmacy, life science and technology, biomedical engineering and other disciplines. 03 Cooperation need Equity financing, the expected financing amount of 50 million yuan. Investment budget: 50 million RMB. Of these, 25 million yuan will be used for clinical 1a, 1b and 2a trials of inhaled HTPEP-001, 10 million will be used to support clinical 2b and 3 animal long toxicity tests, 7 million will be used for FDA declaration, and 8 million will be used for daily operations of the company.
