Signet Therapeutics Gains Spotlight at High-Tech Fair with Innovative Organoid+AI Platform and Lead Drug SIGX1094R
SIGNET
Innovative Targeted Cancer Drug Developer
At the 27th China International High-Tech Fair (hereinafter referred to as "CHTF") held in Shenzhen recently, SIGNET, a pioneer in the field of "organoid + AI" drug research and development, showcased two innovative products at the Futian Exhibition Hall: cardiac organoids and SIGX1094R, the world’s first targeted drug for diffuse gastric cancer. With its cutting-edge technological concepts and solid R&D achievements, SIGNET became one of the most notable highlights of the exhibition.
Cardiac Organoids: Redefining Drug Cardiac Safety Evaluation
SIGNET's Cardiac Organoids
At this year's CHTF, SIGNET vividly showcased a self-beating cardiac organoid with atrial and ventricular structures through holographic projection. The traditional gold standard for cardiac toxicity testing, "hERG," only reflects potassium ion channel function, with a predictive accuracy of approximately 45%. To address this issue, the SIGNET team systematically analyzed cardiac toxicity data from over 120 drugs, developed a 3D cardiac organoid model, and integrated AI technology to intelligently analyze the beating images of the organoids. This approach increased the blind test accuracy for cardiac toxicity to about 85%, offering a more reliable and physiologically relevant solution for preclinical drug safety evaluation.
Since its establishment at the end of 2020, SIGNET has strategically laid out a "organoid + AI" drug discovery platform. The company is actively participating in the formulation of organoid standards by the National Medical Products Administration (NMPA) and the National Institutes for Food and Drug Control (NIFDC). As the only pharmaceutical enterprise among the participating organizations, SIGNET is leading the methodology validation for cardiac organoids and tumor organoids. In October 2021, the company was featured on the homepage of Fierce Biotech, a globally renowned biotech media outlet, which described the drug discovery platform as the next-generation paradigm for cancer drug development (NEXT Generation). In April 2025, the U.S. FDA officially issued a statement expressing clear support for 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.
SIGX1094R: Expected to Address the Dilemma of No Available Treatment for Diffuse Gastric Cancer
The World's First Targeted Drug for Diffuse Gastric Cancer: SIGX1094R
As the world’s first targeted drug for diffuse gastric cancer, and the first candidate drug developed based on the "organoid+AI" platform to enter clinical trials globally, the debut of SIGNET's core drug pipeline, SIGX1094R, has also drawn significant attention. The drug has received IND approval from both China’s NMPA and the U.S. FDA, and was successively granted Orphan Drug Designation by the U.S. FDA in December 2024 and Fast Track Designation in February 2025. In August 2025, the drug was nominated for the Prix Galien USA, one of the highest honors in the international biopharmaceutical industry, often referred to as the "Nobel Prize of the pharmaceutical industry." Currently, SIGX1094R is undergoing Phase I clinical trials at Peking University Cancer Hospital, led by Professor Lin Shen, an authoritative expert in gastrointestinal cancer. In addition to showing remarkable therapeutic potential in preclinical models of diffuse gastric cancer and advanced ascites, SIGX1094R has also demonstrated excellent efficacy in preclinical studies for metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer.
SIGNET Receives Extensive Coverage from Mainstream Media
SIGNET's exhibition at the High-Tech Fair has garnered attention and in-depth coverage from several mainstream and local authoritative media, including Hong Kong Commercial Daily, Guangzhou Daily, Takungpao, First Scene App, Shenzhen Special Zone Daily, and Economic Daily.
SIGNET Chief Operating Officer Dr. Changgui Dai Accepts Media Interview
Shenzhen Media Group "First Scene"
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Hong Kong Mainstream Financial Newspaper "Hong Kong Commercial Daily"
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Shenzhen Press Group "Shenzhen Special Zone Daily"
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《Guangzhou Daily》
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Shenzhen Press Group's Read Special Client
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Takungpao
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About SIGNET
Signet Therapeutics is a global pioneer in the "organoid + AI"-powered innovative targeted drug R&D model, and is recognized as a national high-tech enterprise and a specialized and innovative enterprise. The company's founding team consists of top talents from prestigious institutions such as Harvard University, MIT, and the Chinese Academy of Sciences. As first/corresponding authors, they have published over 20 groundbreaking research papers on gastric cancer and esophageal cancer in high-impact journals such as Nature, Nature Medicine, and Cancer Cell, with impact factors exceeding 20, establishing themselves as global leaders in gastric and esophageal cancer research. Since its establishment in Shenzhen at the end of 2020, the company has raised nearly 220 million yuan in financing and project funding, and holds more than 40 core intellectual properties.
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 obtained IND approval from both the U.S. FDA and China's NMPA, and received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from 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, with Phase II clinical trials expected to commence by the end of 2025.
Since its establishment at the end of 2020, Signet Therapeutics' strategically forward-looking technology system, which integrates "organoids + AI" to empower innovative targeted cancer drug research and development, has gained international authoritative recognition. It was featured on the homepage of Fierce Biotech, a globally renowned biotech media outlet, 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 experiments with organoid and AI technologies, fully validating the foresight and scientific rigor of the company’s technical layout from four years prior.
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