One of the highest honors in the international biopharmaceutical industry – the 2025 Prix Galien USA Award – recently announced its list of nominees. Signet Therapeutics, with SIGX1094R, the world's first targeted drug for diffuse gastric cancer, has become the only Chinese biopharmaceutical company nominated for the "Best Biotechnology Product Award" this year. According to publicly available information, the last time a product from a Chinese biopharmaceutical company was nominated for the Prix Galien Award was BeiGene's BTK inhibitor Zanubrutinib.
The Galien Award has "The Nobel Prize of the Pharmaceutical Industry"which focuses on scientific innovation while emphasizing the actual value of drugs in improving human health. This year's Galien Award for Best Biotechnology Product has nominated a total of 16 pipelines from global top pharmaceutical companies such as Amgen, AstraZeneca, Johnson & Johnson, Pfizer, Merck, and Novartis. SIGNET’s nominated product, SIGX1094R, is the world's first first-in-class targeted drug developed based on the "organoid + AI" platform, and also the world's first targeted drug for diffuse gastric cancer. The drug has received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the US FDA and is currently undergoing Phase I clinical trials at the Peking University Cancer Hospital."
At the end of July this year, STAT, a globally authoritative pharmaceutical and health media outlet, featured SIGX1094R, the world's first targeted drug for diffuse gastric cancer developed by Signet Therapeutics, as a case study in its exclusive opinion column (First Opinion) to illustrate the trend of internationalization in China's biopharmaceutical innovation.
As the first innovative pharmaceutical company globally to deeply integrate organoids with AI technology for new drug development, SIGNET has built an "organoid + AI" drug discovery platform covering the entire process, including target discovery, drug screening, and preclinical evaluation. In addition to SIGX1094R, SIGNET is also advancing three other first-in-class pipelines rapidly toward clinical stages.
About the Galien Award
The Galien Award (Prix Galien USA), established in 1970 to honor the father of pharmacy, Galen, is acclaimed as the highest honor in the pharmaceutical industry. Since its inception, the Galien Award has been praised as the "Nobel Prize of the pharmaceutical industry" and has become the most prestigious award in the pharmaceutical and biomedicine sectors. The Galien Award comprises three categories: Best Pharmaceutical Product, Best Biotechnology Product, and Best Medical Technology. Its jury consists of Nobel laureates, former FDA officials, and others, with past winners including products such as the PD-1 inhibitor Keytruda and the gene therapy Zolgensma.
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, refined, distinctive, and innovative enterprise in China. 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 like *Nature*, *Nature Medicine*, and *Cancer Cell* (with impact factors exceeding 20), establishing themselves as global leaders in the field of 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 property rights.
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 successively received IND approvals from 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. Currently, it is undergoing Phase I clinical trials at 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 and is expected to enter Phase II clinical trials 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 the globally renowned biotech media Fierce Biotech 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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