Field | Indication | Product code | Regulatory pathway | Registered country | Progress | ||||
Preclinical | IND | Phase Ⅰ | Phase Ⅱ | Phase Ⅲ | |||||
Fibrosis & tumor | |||||||||
Idiopathic pulmonary fibrosis | HNC1058 | 505(b)(1) | CN、US | ||||||
Pancreatic cancer | HNC664 | 505(b)(1) | CN | ||||||
Infectious diseases | |||||||||
Influenza | HNC042 | 505(b)(1) | CN、US | ||||||
HBV | HNC280 | 505(b)(2) | CN、US | ||||||
CNS | |||||||||
Parkinson | HNC364 | 505(b)(2) | US | ||||||
Parkinson | HNC1798 | 505(b)(2) | CN、US |
Henovcom has established a comprehensive and robust technology platform for NMEs R&D, including discovery and synthesis, pharmacodynamics and pharmacokinetics and non-GLP safety evaluation, quality study, API process and formulation development, and GMP-like process development and manufacturing. Furthermore, Henovcom has assembled a clinical operation team and a global regulatory/registration team. For chronic diseases requiring long-term medication, Henovcom has pioneered a world-leading prodrug technology platform and developed long-acting suspension injections utilizing microcrystalline technology. Long-acting prodrugs offer advantages such as enhancing patients' medication compliance and mitigating potential side effects. Indications encompass Parkinson's disease, Alzheimer's disease (AD), hepatitis B infection, organ rejection and cerebral vasospasm.
Currently, multiple projects have entered clinical stage:
Anti-fibrosis and anti-tumor drugs
Autotaxin (ATX) is a secreted hemolytic Phospholipase D (lysoPLD) that converts lysophosphatidylcholine (LPC) into lysophosphatidic acid (LPA), which is a biologically active phospholipid derivative LPA exerts its biological activity through specific G protein-coupled receptor (LPAR1-6) signaling. ATX-LPA biological axis is involved in many physiological and pathophysiological processes, and plays an important role in the occurrence and development of many diseases, such as cancer (thyroid cancer, pancreatic cancer, breast cancer, etc.), multiple sclerosis, fibrosis, inflammation, pain, cardiovascular disease, etc.
HNC1058 is a potential best-in-class ATX inhibitor developed by Henovcom for the treatment of Idiopathic pulmonary fibrosis (IPF), which has completed Phase I a clinical trials in the United States.
HNC664 is an ATX inhibitor to target the mechanism of fibrosis and affect the cancer microenvironment to direct antitumor as well as increase local chemotherapy’s concentration. A Phase Ib/IIa trial in patients with solid tumor is ongoing in China.
HNC042 is a new broad-spectrum anti-influenza neuraminidase inhibitor, which is effective against Tamiflu resistant strains. Its phase I clinical trial and bridging trial have been completed in the United States and China, respectively. Phase II clinical trials will be conducted soon.
HNC280 is a long-acting (once 3-6 month administration) microcrystal suspension injectable indicated for anti-HBV. It is expected to file an IND application in 2025. The compound's structural patent has been authorized.
HNC364, a prodrug of the MAO-B inhibitor Rasagiline, is a long-acting (once 1-3 month administration) microcrystal suspension injectable indicated for Parkinson’s disease, which has completed Phase I clinical trials in the United States.