Sig1094 Therapeutics Secures National Key R&D Program Grant to Advance Novel Small Molecule Inhibitors for Refractory Gastric Cancer

Recently, the project "Mechanism Analysis of Refractory Gastric Cancer and Research & Application of New Target Small Molecule Drugs," led by Peking University Cancer Hospital with SIGNET's FAK and TEAD small molecule inhibitors as core drugs, has been successfully approved.National Science and Technology Major Project for Innovative Drug Development 2025 Annual Project ApprovalDr. Haisheng Zhang, the founder and CEO of Signet Therapeutics, is the project leader for this initiative. The fact that Signet Therapeutics' two cutting-edge innovative drug pipelines, FAK and TEAD, have received national-level project funding indicates that the company's source innovation capabilities and research and development standards in the field of refractory gastric cancer have gained high recognition and substantial support at the national level in China.

In addition, Nanjing University Drum Tower Hospital, Fudan University, GenHouse Pharmaceuticals, and Xijing Hospital of Air Force Medical University are also participating units in this project. This project brings together top scientific research institutes and universities, including Beijing Cancer Hospital of Peking University, integrating their top clinical research platforms and clinical resources with Signet Therapeutics' globally leading "organoid + AI" drug discovery platform, to jointly tackle core key technologies such as the mechanism analysis of refractory gastric cancer, new target discovery, and innovative drug development.

SIGNET, incubated by XtalPi (XtalPi Holdings Limited, stock code: 2228.HK), the first company listed under Hong Kong Stock Exchange’s Chapter 18C, has developed SIGX1094R, the world's first targeted drug for diffuse gastric cancer based on an "organoid + AI" platform. It has successfully obtained IND approvals from both China and the US, Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the US FDA, and was nominated in 2025 for the Prix Galien USA Award, known as the "Nobel Prize of the pharmaceutical industry." Currently, its Phase I clinical trial is being led by Professor Lin Shen’s team at Peking University Cancer Hospital. In the future, SIGNET will strive to achieve breakthrough progress in new drug development and precision treatment strategies for refractory gastric cancer, contributing to the advancement of China’s innovative anti-cancer drugs and improving the treatment standards for major diseases.

The 2025 Open Competition Projects of the National Science and Technology Major Project for Innovative Drug Development will commence application in July 2025. The project closely aligns with the Healthy China strategy, aiming to achieve a leap from drug development to original innovation as its core objective. Leveraging the advantages of China's new national system, it strengthens source innovation and independent innovation, focusing on two major directions: the creation of significant new drug varieties and the construction of an innovation system.

Signet Therapeutics is a pioneer in the global "organoid + AI"-powered innovative targeted drug research and development model. It is a national high-tech enterprise and a specialized, refined, distinctive, and innovative enterprise. The company's founding team consists of outstanding talents from top institutions such as Harvard University, MIT, and the Chinese Academy of Sciences. As first/corresponding authors, they have published over 20 groundbreaking research papers in gastric cancer and esophageal cancer in journals with impact factors exceeding 20, including Nature, Nature Medicine, and Cancer Cell, making them a global leader in the field of gastric and esophageal cancer research. Since its establishment in Shenzhen at the end of 2020, the company has completed nearly 220 million yuan in financing and project funding, accumulating more than 40 core intellectual property rights.

The company currently has four first-in-class drug pipelines and one organoid platform in its portfolio. Its core pipeline, SIGX1094R, is the world’s first targeted drug for diffuse gastric cancer. It has received IND approvals from both the U.S. FDA and China's NMPA, and has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the U.S. FDA. In August 2025, this drug was nominated for the Galien Award, known as the "Nobel Prize of the pharmaceutical industry." It is currently undergoing Phase I clinical trials at the Peking University Cancer Hospital. This pipeline is also the world’s first drug to be advanced to the clinical stage through an "organoid + AI" technology platform and is expected to enter Phase II clinical trials by the end of 2025.

Since its establishment at the end of 2020, the company's forward-looking strategic layout of an "Organoid+AI"-powered technology system for innovative targeted cancer drug development has gained international authoritative recognition. It was featured on the homepage of the globally renowned biotech media Fierce Biotech and hailed as the "NEXT Generation paradigm for cancer drug development." In April 2025, the U.S. FDA officially issued a statement explicitly supporting the gradual replacement of traditional animal testing with organoid and AI technologies, fully validating the foresight and scientific rigor of the company’s technical layout from four years prior.