Jingtai Technology's AI drug development platform helped Higer Biotech's first-class new drug pipeline obtain FDA fast track certification

Recently, Higer Biotech announced that it will cooperate with Jingtai Technology to complete the first innovative drug pipeline project for drug discovery SIGX1094 received US Food and Drug Administration (FDA) Fast Track Designation (Fast Track Designation).As the FDA's special accelerated review mechanism for serious diseases or new drugs that do not meet clinical needs, this certification is expected to significantly shorten the SIGX1094 approval cycle, accelerate its marketing process, and bring new treatment options to patients around the world. This is a new qualification following the FDA's Orphan Drug (ODD) certification for SIGX1094 in November 2024.

SIGX1094, a global drug pipeline targeting diffuse gastric cancer cooperated by Higer Biotech and Jingtai Technology, obtained US Drug Administration (FDA) fast track certification

SIGX1094 is a core product developed by Higer Biotech based on its innovative “organoid+AI” drug development platform. It is mainly used to treat diffuse gastric cancer and other advanced solid tumors. This drug is based on a new therapeutic target independently discovered by Higer Biotech.AI+ robotic drug discovery platform with Jingtai Technology, not onlyIt is the world's first innovative drug developed by integrating organoids and AI technology, and is also a breakthrough drug that is expected to fill the gap in targeted treatment of diffuse gastric cancer.Currently, SIGX1094 has been administered to the first solid tumor patient at Peking University Cancer Hospital. The first phase of clinical trials was led by Professor Shen Lin, an authoritative expert in the field of gastrointestinal tumors.

Once approved by the FDA Fast Track, SIGX1094 will enjoy more opportunities to communicate with the FDA during subsequent R&D and approval processes, which will greatly accelerate its marketing process. There is also an opportunity to enjoy drugs that have received this certificationAccelerated approval, priority review eligibility, rolling review of new drug marketing applications (NDA), etc.Preferential policies. In November 2024, SIGX1094 was granted by the FDA for gastric cancerOrphan Drug Qualification, eligible for the FDA Priority review and approval, exemption from NDA application fees for new drugs, and a seven-year market monopoly period after approvalOther policy support. The combination of FDA fast-track certification and a series of incentive policies for orphan drug qualification will further accelerate the SIGX1094 marketing process and benefit patients in urgent need of effective treatment as soon as possible.

In the drug discovery and design of SIGX1094, Higer Biotech and Jingtai Technology collaborated deeply to target innovative targets selected by Sieger Biotech,It only took more than 6 months to design a pre-clinical candidate compound (PCC) with a novel molecular framework and superior comprehensive drug propertiesResearch and development efficiency has been greatly improved; in pharmacodynamics evaluation, Higg Biotech can better screen out molecules close to the patient's real response using the organoid platform it has established based on the patient's genomic characteristics, thereby greatly improving the potential for successful clinical trials. From the discovery of the new target to the approval of the IND, Higg Biotech took just over three years.At the same time, Higer Biotech and Jingtai Technology have a number of innovative cancer-targeted drug research and development projects underway.

Higer Biotech is the first in the world to use the “organoid+AI” cancer innovative target drug development model. The company cooperated deeply with Jingtai Technology to quickly screen candidate compounds and molecules through AI technology, and relied on Higer Biotech's unique organoid disease model platform to evaluate and test pharmacodynamics. This innovative model has not only greatly improved the speed and clinical success rate of drug development, but also marked a new era of efficient integration of IT and BT in drug development.

● About Higer Biotech ●

Higer Biotech is a pioneer in the global “organoid+AI” drug development model. It is a specialized new enterprise in Shenzhen, and has been certified as a national high-tech enterprise. The company was first founded on the Harvard University campus and officially landed in Shenzhen at the end of 2020. So far, it has completed nearly 0.22 billion yuan in financing and project funding. Currently, the company has four drug pipelines. The first pipeline developed the world's first target drug for diffuse gastric cancer, SIGX1094, which has successively obtained IND approval from the US FDA and China NMPA, and has obtained US FDA orphan drug qualification and fast track certification, and has entered the first phase of clinical trials.

Higg is not only a transliteration of Signet, but also adhering to the vision of “hope is full of hope and knowledge”. The company uses the key role of organoid disease models close to patients' genomics characteristics in pharmacodynamic evaluation and new target discovery, and combines AI artificial intelligence to screen, synthesize, and optimize small molecule compounds to develop first-in-class innovative targeted drugs. The company has 1200 square meters of R&D site and 500 square meters of laboratory animal room. Higer Biotech's organoid platform not only serves its own drug pipeline, but also actively empowers major pharmaceutical companies to develop new drugs. Partners include Shenzhen Second People's Hospital, the University of Hong Kong, the Hong Kong University of Science and Technology, and Shenzhen Borui Pharmaceutical and Real Biology to help create more innovative drugs.

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