Signet Therapeutics (Shenzhen) Co., Ltd. (“Signet Therapeutics”) today announced that its first-in-class drug pipeline SIGX1094, developed in collaboration with XtalPi Inc. (2228.HK), has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). This designation accelerates the review process for drugs addressing serious conditions or unmet medical needs, potentially shortening SIGX1094’s approval timeline and expediting its path to market to offer new treatment options for patients worldwide. This follows the FDA’s Orphan Drug Designation (ODD) for SIGX1094 in November 2024.
SIGX1094, Signet Therapeutics’ core product developed using its innovative “organoid + AI” drug discovery platform, targets diffuse gastric cancer and other advanced solid tumors. Based on a novel therapeutic target discovered by Signet Therapeutics and enhanced by XtalPi’s AI and robotics drug discovery platform, SIGX1094 represents the world’s first first-in-class innovative drug integrating organoid and AI technologies. It also holds promise as a breakthrough therapy to address the unmet need in targeted treatments for diffuse gastric cancer. The drug has completed dosing in its first solid tumor patient at Peking University Cancer Hospital, with the Phase I trial led by Professor Shen Lin, a leading expert in gastrointestinal oncology.
With Fast Track Designation, SIGX1094 gains increased opportunities for FDA communication during development and review, accelerating its commercialization. Eligible drugs may also benefit from accelerated approval, priority review, and rolling New Drug Application (NDA) reviews. In November 2024, SIGX1094 received FDA ODD for gastric cancer, granting priority review, exemption from NDA fees, and seven years of market exclusivity upon approval. The combined incentives from Fast Track and ODD will further hasten SIGX1094’s market entry, enabling faster access for patients in need.
In SIGX1094’s discovery and design phase, Signet Therapeutics and XtalPi collaborated deeply on the novel target, designing a preclinical candidate compound (PCC) with a novel molecular scaffold and superior drug-like properties in just over six months—greatly enhancing R&D efficiency. For efficacy evaluation, Signet Therapeutics’ patient genomics-based organoid platform better predicts real-world responses, increasing the potential for clinical success. From target discovery to IND approval, the project advanced in just over three years. Signet Therapeutics and XtalPi are also advancing multiple innovative cancer-targeted drug projects.
Signet Therapeutics pioneered the global “organoid + AI” model for cancer targeted drug R&D. Through deep collaboration with XtalPi, AI rapidly screens candidate molecules, while Signet’s proprietary organoid disease model platform evaluates efficacy and testing. This innovative approach not only boosts drug development speed and clinical success rates but also heralds a new era of efficient IT and BT integration in pharmaceuticals.
About Signet Therapeutics
Signet Therapeutics is a pioneer in the global “organoid + AI” drug discovery model, recognized as a Shenzhen Specialized, Refined, Distinctive, and Innovative (SRDI) enterprise and a national high-tech enterprise. Originating from Harvard University and established in Shenzhen in late 2020, the company has secured nearly RMB 220 million in funding and grants. With four drug pipelines, its lead program, SIGX1094—the world’s first targeted therapy for diffuse gastric cancer—has received IND approvals from the U.S. FDA and China’s NMPA, along with FDA ODD and Fast Track Designation, and is now in Phase I trials.
“Signet” echoes the company’s vision of “Hopeful Aspirations, Seeking Truth Through Inquiry.” It leverages organoid disease models mirroring patient genomics for efficacy evaluation and target discovery, combined with AI for screening, synthesizing, and optimizing small-molecule compounds to develop first-in-class targeted therapies. Signet operates a 1,200 m² R&D facility and a 500 m² animal lab. Its organoid platform supports not only internal pipelines but also empowers major pharma partners, including Shenzhen Second People’s Hospital, University of Hong Kong, Hong Kong University of Science and Technology, Shenzhen Bory Pharmaceutical, and RealBio, fostering more innovative drugs.
