XtalPi × SigNature Bio: SIGX2649 Officially Submits IND to FDA

I. Key Events
• SigSci formally submitted the IND application for SIGX2649 to the U.S. FDA on April 23, marking the official transition of its second core pipeline from preclinical to clinical application stage;
• Highlights of Preclinical Data
1) Both in vitro (including organoid models) and in vivo experiments demonstrated potent anti-tumor activity and favorable pharmacokinetics;
2) Clear differentiated advantages: strong efficacy and better safety profile;
3) Core data was presented at the 2026 AACR Annual Meeting (Poster presentation), gaining international academic recognition.

II. Significance of Collaboration with Jingtai Holdings
• SIGX2649 is the second innovative drug pipeline resulting from the collaboration between Jingtai and SigSci (the first being SIGX1094);
• Jingtai is entitled to a substantial share of up to double-digit percentage of the pipeline's commercialization revenue, while also continuing to benefit from equity incubation;

III. Current Progress and Next Phase Expectations
• Today's milestone: Formal IND submission to the FDA (U.S.); China's NMPA submission is expected to follow concurrently or in the near future;
• Next steps: Await regulatory review in China and the U.S. (typically several months), followed by rapid initiation of Phase I clinical trials (primarily evaluating safety, tolerability, and preliminary efficacy) upon approval;
• Timeline estimate: IND approval is possible in Q3-Q4 2026, with Phase I initiation expected by late 2026 to early 2027.
• Parallel advancement with SIGX1094: Phase I for SIGX1094 continues, with Phase II expected to initiate in the second half of 2026.

Thoughts: Pipeline progress aligns with expectations (around the time of AACR). Next step is awaiting IND approval, which is expected to trigger the milestone payment. If realized as scheduled, this will become one of the certain revenue streams for Jingtai's drug discovery solutions business in 2026-2027.

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