Signet Therapeutics Announces NMPA IND Approval for SIGX1094, World’s First Targeted Therapy for Diffuse Gastric Cancer, Three Weeks Ahead of Schedule

Today, Signet Therapeutics (hereinafter referred to as "Signet") announced,SIGX1094, the world's first targeted drug independently developed by Signet Therapeutics for the treatment of diffuse gastric cancer and other advanced solid tumors, has been approved for clinical trials by the National Medical Products Administration (NMPA) three weeks ahead of schedule, demonstrating the NMPA's efforts to expedite the approval of innovative drugs that address unmet clinical needs., marking that SIGX1094 will initiate clinical trials in China and the United States, bringing new treatment hope to patients worldwide.

SIGX1094 Obtains IND Approval from China NMPA: A Significant Step for the First-in-Class Targeted Drug Developed Using Organoid Disease Models and AI

SIGNET Plans to Conduct Multi-Center, Open-Label, Dose-Escalation and Expansion Clinical Trials Simultaneously in China and the United States to Evaluate the Safety and Efficacy of SIGX1094 in Diffuse Gastric Cancer and Other Advanced Solid Tumors (Such as Ovarian Cancer, Breast Cancer, and Pancreatic Cancer). This Will Lay a Solid Foundation for the Global Commercialization of SIGX1094 and Promote Its Wide Application Worldwide.

SIGX1094 Receives Expedited Review from FDA and NMPA, Highlighting SIGNET's Superiority in Integrating Organoid Disease Models with AI Technology to Empower Innovative Drug Development.From the discovery of new targets to the approval of IND in both China and the US, SIGNET has taken just over three years, significantly improving the efficiency of new drug development compared to the traditional drug R&D cycle.SIGX1094 has demonstrated significant therapeutic potential in preclinical models of diffuse gastric cancer and advanced ascites, and has shown excellent efficacy in the treatment of malignant metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer. As clinical trials advance in both China and the United States, SIGX1094 is expected to become a major force in the market for anti-cancer drugs like gastric cancer, addressing the unmet need for effective treatments for diffuse gastric cancer and providing patients with safer and more effective treatment options.

SIGX1094 is a targeted drug independently developed by Signet Therapeutics against FAK (Focal Adhesion Kinase). This effective target for diffuse gastric cancer was discovered by the company's founder and CEO, Dr. Haisheng Zhang, in 2020 and published as the first author in Cancer Discovery. SIGX1094 has demonstrated significant efficacy against diffuse gastric cancer and other malignant tumors in preclinical, in vitro, and in vivo trials, with favorable pharmacokinetics and safety. The drug has received IND approval from the U.S. FDA and China's NMPA and will soon enter clinical trials in both countries.

Signet Therapeutics is the first biotech company in China to develop innovative targeted cancer drugs based on organoid disease models and AI. It was initially founded on the Harvard University campus, established in Shenzhen in 2020, and completed an angel round of financing worth nearly 150 million RMB within a year. SIGNET is not only a phonetic translation of Signet but also adheres to the vision of "full of hope, studying things to gain knowledge." The company leverages the critical role of organoid disease models that closely resemble patients' genomic characteristics in drug efficacy evaluation and new target discovery. Combined with AI-powered screening, synthesis, and optimization of small molecule compounds, it develops first-in-class innovative targeted drugs. Currently, the company has three drug pipelines, with the lead pipeline developing the world's first targeted drug for diffuse gastric cancer, which has now entered Phase I clinical trials. The company has a 1,200㎡ R&D facility and a 500㎡ animal laboratory. Signet Therapeutics' disease model platform not only serves its own drug pipelines but also actively empowers large pharmaceutical companies in new drug development, contributing to the birth of more innovative medicines.