On June 27, 2025, Sungening Biotechnology achieved a major milestone - its independently developed Class 1 antifungal innovative drug SG1001 officially obtained the Clinical Trial Approval (IND) from the US Food and Drug Administration (FDA) and was approved to conduct Phase I clinical trials in the United States. This breakthrough not only marks a crucial step in Sungening Biotech's internationalization strategy, but also brings new hope for global antifungal treatment.
SG1001: World's first target to solve the problem of drug resistance
SG1001 is an innovative antifungal drug with a novel mechanism of action, targeting fungal dihydroorotate dehydrogenase (DHODH). The target has not yet been approved for marketing globally, and SG1001 is expected to become the Best in class or even First in class drug in this field, providing a better treatment plan for patients with invasive aspergillosis.
SG1001 has completed Phase I clinical trials in China and is about to enter Phase II trials. SG1001 demonstrated excellent human safety and good pharmacokinetic properties in Phase I, laying a solid foundation for its global development.
Accelerate going global and open up global cooperation
Based on FDA's IND approval, Sungening Biotech will accelerate the global multicenter clinical trial of SG1001 and officially open up overseas equity cooperation, seeking to jointly develop with multinational pharmaceutical companies, biotechnology companies, and regional market partners, covering key markets such as Europe, America, and Asia Pacific.
The cooperation directions include:
●Jointly conducting international multicenter clinical trials (MRCT)
●Commercial equity cooperation in overseas markets
●Joint application for global regulatory approvals (such as EMA, FDA, etc.)
Huang Shenghong, founder and chairman of Sungening Biotechnology, said:
We are delighted that SG1001's IND has been approved by the US FDA, marking a milestone in Sungening Biotech's innovative antifungal drug development pipeline and an important step in the company's internationalization strategy. We look forward to working with global partners to accelerate the development of this innovative drug and benefit patients worldwide as soon as possible
