Home SigOrganoid Biotech Honored as '2025 Deloitte Shenzhen Rising Star' and Advances Global First-in-Class Gastric Cancer Drug into Clinical Trials

SigOrganoid Biotech Honored as '2025 Deloitte Shenzhen Rising Star' and Advances Global First-in-Class Gastric Cancer Drug into Clinical Trials

Dec 05, 2025 09:28 CST Updated 09:28
SIGNET

Innovative Targeted Cancer Drug Developer

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YesterdayDeloitte High Tech High Growth Rising Star Awards Ceremony Grandly Held in Shenzhen. Signet Therapeutics, with its outstanding technological innovation capabilities and high growth potential, was honored with the "2025 Deloitte Shenzhen High Tech High Growth Rising Star" award.


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The 2025 Deloitte Shenzhen High Tech Growth 20 and Rising Stars Awards Ceremony, jointly organized by Deloitte China and the Shenzhen General Chamber of Commerce, aims to discover and honor outstanding local high-growth and continuously innovative enterprises, helping Shenzhen build a more globally competitive innovation and entrepreneurship ecosystem. The selection originated in Silicon Valley, USA, in 1995 and is known as the "benchmark for global high-growth enterprises." This year's selection, themed "Pursuing Innovation and Quality, Surpassing Growth," involved over five months of rigorous screening and comprehensive evaluation, with Signet Therapeutics ultimately standing out due to its exceptional capabilities.


Deloitte, as one of the Big Four accounting firms globally, its selection of the "Technology Fast 50 Program" has always been hailed as the "benchmark for high-growth companies worldwide." Many industry leaders have emerged from the annual rankings, such as Tencent, Alibaba, ByteDance, Microsoft, and Nvidia. Moreover, companies are typically in their early stages when selected for the list, which is also known as the "cradle of great technology enterprises."


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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 with 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 methodological validation of 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 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.


The core pipeline SIGX1094R developed by the company based on this platform is not only the world's first targeted drug for diffuse gastric cancer, but also the world’s first drug candidate molecule fully driven by an "organoid + AI" technology platform to enter the clinical stage. The drug has simultaneously received IND approval from China's NMPA and the U.S. FDA, and has been granted Orphan Drug Designation (December 2024) and Fast Track Designation (February 2025) by the U.S. FDA. 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, a leading expert in gastrointestinal cancer. In addition to showing significant therapeutic potential in preclinical models of diffuse gastric cancer and advanced ascites, SIGX1094R has also demonstrated excellent efficacy in preclinical studies of metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer.


This award is a high recognition of SIGNET's R&D innovation path and future development potential. The company will continue to deepen the construction of the "organoid + AI" platform, accelerate the source innovation of new drug R&D, and bring better treatment options to patients worldwide.


About SIGNET

SIGNET is a global pioneer in the "organoid + AI"-powered innovative targeted drug R&D model, and is a national high-tech enterprise as well as 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. They are global leaders 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, 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 received IND approval from both the U.S. FDA and China's NMPA, as well as 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 via 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' 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 Fierce Biotech, a globally renowned biotech media outlet, and hailed as the "NEXT Generation" paradigm in cancer drug research. 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.


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