Signet Therapeutics Recognized as a KPMG China 'Top 50 Biotech Innovation Leader' and Advances Lead Candidate SIGX1094 into Clinical Development

In the third "Top 50 Biotech Pioneers" selection jointly organized by KPMG China, Hainan International Pharmaceutical Innovation Foundation, and Suzhou BioBay, Signet Therapeutics (Shenzhen) Co., Ltd. stood out from over 500 innovative companies across China with its globally leading "Organoid + AI" cancer drug R&D platform and the SIGX1094 pipeline achievements. After more than half a year of rigorous screening and expert on-site evaluations, the company successfully made it onto the list.

The "Top 50 Biotech Innovation Enterprises" selection of this session, with the aim of "professional evaluation, ecosystem empowerment, and leading the future," has formed a top-tier expert review panel covering the entire biomedical industry chain. At the closed-door review meeting held in January this year at the KPMG Beijing office, more than 30 authoritative experts from national pharmacological research institutes, leading investment institutions, multinational pharmaceutical companies, renowned universities, and regulatory agencies, including chief scientists of the Ministry of Science and Technology's Youth 973 Program and general managers of multinational pharmaceutical companies' China regions, conducted professional evaluations from multiple dimensions such as technological innovation capability, business prospects, and team strength.

As Chinese and U.S. regulatory agencies successively introduce policies to phase out animal testing and promote virtual alternative technologies, SIGNET's cancer drug innovation R&D system based on "organoids + AI" is ushering in vast development opportunities. Recently, SIGNET has garnered attention and recognition from authoritative media outlets such as the 21st Century Economic Report, Jian Shi Ju, Tong Xie Yi, Arterial Network, and Wall Street News. Being honored as one of KPMG's "Top 50 Biotech Innovators" not only reaffirms SIGNET’s technical strength and R&D achievements but also highlights its forward-looking strategy and leadership potential amid industry transformation.

Taking the innovative application of cardiac organoids as an example, the traditional gold standard for cardiotoxicity testing, "hERG," can only evaluate potassium channel function, with an accuracy rate of less than 40% in predicting real clinical cardiotoxicity. Through systematic analysis of the real cardiotoxicity data of more than 120 FDA-approved or Phase II clinical trial drugs, SIGNET discovered limitations in traditional 2D cell models and animal experiments.SIGNET's self-developed cardiac organoids, which possess atrial and ventricular structures and can beat regularly, combined with AI technology to establish a novel drug toxicity testing model for the analysis of cardiac organoid beating imaging data, have increased the blind prediction accuracy of cardiac toxicity to approximately 85%, providing a more reliable solution for drug safety evaluation.。

The effectiveness of SIGNET's "Organoid + AI" platform has also been fully validated through its own pipeline. The core pipeline developed based on this platformSIGX1094 is the world's first targeted drug for diffuse gastric cancer, and also the world's first FAK/SRC dual-target inhibitor to enter the clinical stage.SIGX1094 is currently undergoing Phase I clinical trials at the Peking University Cancer Hospital. It has demonstrated good safety and preliminary efficacy during the dose-escalation phase of the trial. SIGX1094 has also received Orphan Drug Designation and Fast Track Designation from the U.S. FDA.

In the future, SIGNET will continue to deepen the construction of the "organoid + AI" platform, actively promote the standardization of organoid technology, develop more innovative cancer drugs, and contribute Chinese solutions to the transformation of the global drug development paradigm.