June 27, 2025– SG-1001, an antifungal developed by Sungening, has received IND clearance from the U.S. FDA to initiate Phase I clinical trials. It follows its earlier clinical approval in China, making a significant milestone, dual IND clearances in both countries. This milestone not only marks a critical step in Sungening’s global strategy but also brings renewed hope for the treatment of fungal infections worldwide.

As the preclinical CRO partner, Medicilon delivered the pharmacokinetic studies, a fully GLP compliant safety evaluation, and FDA IND submission documentation, paving the way to SG-1001’s dual approvals.

SG1001: A Novel Solution to Drug Resistant Fungal Infections

Antifungal drug R&D has been constrained by limited novel targets over the past two decades. In just four years, Sungening has transitioned from a follower to a leader with SG-1001:

• Innovative Target: SG-1001 target to fungal dihydroorotate dehydrogenase (DHODH), a novel mechanism never before brought to the market.
• Overcoming Drug Resistance: By selectively inhibiting DHODH, SG-1001 disrupts pyrimidine nucleotide synthesis, impeding both cell wall formation and genetic replication. Its target specificity and lower off-target effects, potentially addressing invasive aspergillosis resistance and suboptimal first-line treatments.
• Strong Clinical Potential: SG‑1001 has successfully completed a Phase 1 clinical trial in healthy subjects in China, Phase I data has showed excellent safety and favorable pharmacokinetic profile, laying a solid foundation for global R&D.

With worldwide pharmaceutical R&D accelerating, global submissions have become a core strategy for internationalization. As a pioneer CRO offering one stop services compliant with both Chinese and U.S. GLP standards, Medicilon has supported 520 INDs approved by NMPA, FDA, TGA, EMA, and KFDA, including 86 FDA approvals and 60 dual clearances. Medicilon operates with 29,000 m² laboratories certified by NMPA GLP, compliant with FDA/TGA/EMA GLP standards and ABSL-2; AAALAC accredited animal centers housing NHPs, canines, rodents, etc.

Medicilon congratulates Sungening on the SG-1001 breakthrough, SG-1001’s dual approvals has filled a gap in antifungal R&D. In the future, Sungening will accelerate global multicenter trials and open international partnerships, collaborating with multinational pharma, biotech firms, and regional players to expand into key markets like the U.S., Europe, and Asia-Pacific.