Sungening and Livzon Pharmaceutical jointly announce that their Class 1 novel antifungal drug has successfully completed the Phase I clinical trial in April 2025.
The results demonstrate that SG1001 exhibits excellent performance in terms of human safety and pharmacokinetic properties, laying a solid foundation for subsequent clinical development.
As a Class 1 innovative drug with a novel mechanism of action, SG1001 pioneeringly targets fungal dihydroorotate dehydrogenase (DHODH). It is expected to address the challenges of drug resistance and suboptimal first-line treatment outcomes in invasive aspergillosis infections.
Currently, no drugs targeting the same target have been approved worldwide, making SG1001 a potential First-in-Class candidate for this target.
Invasive Aspergillosis: The clinical mortality rate ranges from 30% to 80%, and no innovative drugs have been launched in the past decade.
Global R&D of anti-infective drugs mainly focuses on three major areas: antiviral, antibacterial and antifungal therapies. Among them, the development of new antifungal drugs faces great challenges due to the complex variety of pathogenic fungi, as well as their unique cell wall structure that acts both as a physical barrier and an active drug efflux mechanism. In China, no innovative antifungal drugs have been launched for nearly a decade, leaving a pressing unmet clinical need.
Fungi are widely distributed in natural environments such as soil, air, water and food, as well as in extreme ecological conditions with high temperature, high salinity and high acidity, and some of them are pathogenic. Clinically, pathogenic fungal infections are divided into superficial and invasive types. The latter refers to systemic infections caused by pathogens invading the bloodstream or deep tissues.
Invasive aspergillosis stands out as a key focus of clinical prevention and treatment due to its high mortality rate. It mainly affects the lungs, eyes, sinuses and central nervous system, and is commonly encountered in departments of hematology, respiratory medicine, infectious diseases and Intensive Care Units (ICU). Among high-risk populations with weakened immune function, such as patients with leukemia, organ transplantation, chronic obstructive pulmonary disease and malignant tumors, the incidence of invasive aspergillosis ranges from 3% to 10%, with a clinical mortality rate as high as 30%–80%.
First-line treatment for invasive aspergillosis currently relies primarily on triazole agents, which are plagued by drug resistance and treatment breakthrough failure — a common challenge across the entire anti-infective therapeutic field. To address the evolving threat of drug resistance, two major strategies have been adopted in drug R&D: upgrading and iterating drugs with existing targets, and exploring novel agents with completely new mechanisms of action.
SG1001: Novel Target with Dual Mechanisms, Poised to Deliver a Breakthrough Treatment Regimen for Patients
SG1001 is jointly developed by Livzon Pharmaceutical and Sungening . As China’s first Class 1.1 innovative drug targeting DHODH, it is expected to address the unmet clinical challenges of drug resistance and suboptimal first-line treatment efficacy in invasive aspergillosis.
Different from existing triazoles (which interfere with cell membrane sterol synthesis) and amphotericin B (which binds to ergosterol in the cell membrane and disrupts membrane integrity), SG1001 primarily acts by selectively inhibiting DHODH enzyme activity. This blocks the pyrimidine nucleotide synthesis pathway in fungal cells, thereby hindering both cell wall construction and genetic material replication. This synergistic dual-hit effect enables potent inhibition of fungal growth and proliferation. Meanwhile, given that human cells lack a cell wall structure, SG1001 features superior target specificity and a lower off-target effect.
The Phase I clinical trial was designed to evaluate the safety, tolerability and pharmacokinetic profiles of SG1001 in healthy volunteers. The results showed that SG1001 demonstrated favorable safety and tolerability after single and multiple administrations, with no serious adverse events reported. Key pharmacokinetic parameters including Cmax and AUC were in line with expectations, supporting the progression to subsequent clinical studies. Based on the positive Phase I clinical data, Livzon Pharmaceutical plans to initiate the Phase II clinical trial in June 2025, to further validate its safety, as well as evaluate clinical efficacy and optimize dosage regimens in patients.
As a rapidly emerging innovative biotech enterprise, Sungening relies on its efficient R&D system and core technological strengths to rapidly build a product portfolio covering cardiovascular diseases and antifungal therapeutics, while breaking through technical bottlenecks in cyclic peptide drug development. Its current pipeline includes the oral cyclic peptide lipid-lowering candidate SG6001, the antifungal agent SG1001, and the ultra-long-acting antifungal drug SG5035. Moving forward, the company will continue to scale up technological research, focus on the development of oral/long-acting cyclic peptide drugs and solutions for undruggable small-molecule targets, and provide differentiated therapeutic options for patients worldwide.
Partial information source: Livzon Pharmaceutical Official WeChat Account
