Signet Therapeutics Announces SIGX1094 Granted FDA Orphan Drug Designation for Gastric Cancer, Accelerating Global Development of First-in-Class Diffuse Gastric Cancer Therapy

SIGNET announced today,SIGNET's independently developed first-in-class targeted drug SIGX1094 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer.。

As the world's first targeted therapeutic drug for diffuse gastric cancer, SIGX1094 has been granted orphan drug designation by the FDA.Will enjoy a series of policy preferences, such as enjoying includingClinical trial cost tax deduction, exemption from NDA application fees for new drugs (approximately USD 4.3 million in 2025), seven-year market exclusivity upon approval, special research funding support, priority review voucherA series of U.S. orphan drug incentive policies, including those in the review process, allow developers of orphan drugs to approach the FDA.Apply for Priority Review and Approval to Shorten the Review Cycle, accelerating product launch. These incentives will further expedite the launch process of SIGX1094, ensuring that patients in urgent need of effective treatment worldwide can benefit as soon as possible.

Currently, Signet Therapeutics is conducting a multi-center Phase I clinical trial of SIGX1094 to evaluate its safety and efficacy in diffuse gastric cancer and other advanced solid tumors. Previously, SIGX1094 has received IND approval from the U.S. FDA and China's National Medical Products Administration (NMPA). The FDA's ODD designation will further accelerate the global development of SIGX1094.

Signet Therapeutics is the first biotech company in China to develop innovative targeted cancer drugs based on organoid disease models and AI. Initially founded on the Harvard University campus, it was 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 “Hopeful Hearts, Investigating Truth through Science.” The company leverages the critical role of organoid disease models that closely resemble patient genomic characteristics in drug efficacy evaluation and new target discovery, combined with AI-powered screening, synthesis, and optimization of small molecule compounds, to develop first-in-class innovative targeted drugs. Currently, the company has four drug pipelines, with the lead pipeline developing SIGX1094, the world’s first targeted drug for diffuse gastric cancer, which has now entered Phase I clinical trials. The company has a 1,200-square-meter R&D facility and a 500-square-meter experimental animal housing area. Signet Therapeutics' disease model platform not only serves its own drug pipelines but also actively empowers large pharmaceutical companies in new drug development. Collaborative enterprises include Shenzhen Bori Medicine, Zhen Shi Biotechnology, and others, helping to bring more innovative drugs to life.