Sungening Biotechnology and Lizhu Pharmaceutical jointly released a new class 1 antifungal drug, which successfully completed phase 1 clinical trials in April 2025. The results showed that SG1001 exhibited excellent performance in terms of human safety and pharmacokinetic properties, laying a solid foundation for subsequent clinical development. SG1001, as a new class 1 drug with a novel mechanism of action, innovatively targets fungal dihydroorotate dehydrogenase (DHODH), which is expected to solve the problem of drug resistance and poor first-line treatment efficacy in invasive aspergillosis infections. At present, there are no approved drugs targeting the same target globally, and SG1001 is a potential First in class drug targeting this target.
Invasive aspergillosis: clinical mortality rate of 30% -80%, no innovative drugs have been launched in the past decade
SG1001, jointly developed by Lizhu Pharmaceutical and Sungening Biotechnology, is China's first Class 1.1 innovative drug targeting DHODH. It is expected to solve the current problem of invasive Aspergillus resistance and poor first-line treatment efficacy. The mechanism of action of SG1001 is different from that of existing triazoles (which interfere with cell membrane sterol synthesis) and amphotericin B (which binds to ergosterol in the cell membrane and destroys the cell membrane). It mainly selectively blocks DHODH enzyme activity, cuts off the synthesis pathway of fungal pyrimidine nucleotides, and inhibits both cell wall construction and genetic material replication processes. The synergistic effect of this' double blow 'can effectively inhibit fungal growth and reproduction. Meanwhile, due to the lack of cell wall structure in human cells, SG1001 has stronger target specificity and lower off target effects.
The Phase I clinical trial aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of SG1001 in healthy subjects. The results showed that SG1001 exhibited good safety and tolerability after single and multiple administrations, with no reported serious adverse reactions; The pharmacokinetic parameters (such as Cmax, AUC, etc.) meet expectations, supporting its entry into the next stage of research. Based on the positive results of Phase I clinical data, Lizhu Pharmaceutical plans to launch Phase II clinical trials in June 2025 to further validate its safety and study the efficacy and dose optimization of SG1001 in patients.
As a rapidly rising emerging innovative pharmaceutical enterprise, Sungening Biotechnology relies on its efficient research and development system and core technological advantages to quickly build a product matrix in the fields of cardiovascular disease and antifungal therapy, and simultaneously break through the bottleneck of cyclic peptide drug technology. At present, the pipeline covers oral cyclic peptide lipid-lowering drug SG6001, antifungal drug SG1001, and long-acting antifungal drug SG5035. In the future, the company will continue to intensify its technological efforts, focusing on the development of oral/long-acting cyclic peptide drugs and "small molecule non drug targets" solutions, providing differentiated treatment options for patients worldwide.
Part of the information source: Lizhu Pharmaceutical official account
