NIE 2023 | Fu Kang Pharmaceutical Shen Xiaokun: Right-6D Principle Combined with AI Technology Platform Accelerates New Drug R&D

According to Dr. Shen Xiaokun, there are approximately 500 AI pharmaceutical companies globally, divided into CRO, Pharma, andBiotechThe application of AI technology includes early-stage drug discovery, molecular screening, repurposing old drugs, preclinical prediction, clinical indication screening, as well as post-analysis and utilization of data.

AI pharmaceutical companies can be divided into two categories. One is those with a technical background who have shifted to drug design based on excellent AI algorithms. The other category is those that have expanded their advantages by leveraging AI technology based on past clinical needs and good pharmacological design. Fukang Pharmaceutical belongs to the latter group. The company uses AI technology for molecular structure simulation, prediction of metabolic sites, formulation prescription selection, indication selection, and more.CADDIt is used as a routine platform for drug discovery. In addition, the company has jointly built an AI drug discovery laboratory with Shenzhen MindTree Technology Co., Ltd., focusing on AI drug research and development. It is hoped that in the future, AI technology can be extended to the later stages of the drug lifecycle, such as product market sales strategy formulation.

Dr. Shen Xiaokun pointed out that oncology drugs are a major product research and development area for Fukang Pharmaceutical. In 2020, the company applied AI technology to assist in developing oncology drugs, attempting to leverage the AI technology platform for protein structure prediction, lead molecule optimization, comprehensive prediction of drug candidates, AI prediction of new indications, biomarkers, and resistance optimization.FICDevelop new drugs in aspects such as prediction and screening. The company has delved deep into mechanisms related to tumor resistance and summarized the 'Right-6D' principle, namelyDefine the right target, drive with the right safety measures, design the right combination, deliver the right tissue, document the right patient, and deploy with the right commercial potential.And we have been implementing the 'Right-6D' principle into the company's new drug research and development.

Dr. Shen Xiaokun stated that Fuke Pharmaceutical is based in China, aiming at the unmet clinical needs globally, and is committed to developing innovative drugs in areas such as oncology, virology, and aging diseases. The 'Right-6D' principle is a new drug development guideline proposed by Fuke Pharmaceutical based on clinical needs and years of biomedical research experience. The company has established a global innovative drug development platform combining bispecific antibody macromolecules and differentiated small molecules, and has introduced AI technology to accelerate the discovery of new drugs.

Fukang Pharmaceutical adheres to precise target selection and differentiated clinical development strategies to enhance the certainty of product approval for market launch; persists in the strategy of collaborative layout of product pipelines; and has formulated strategies for international R&D, FDA orphan drugs, and multiple indications. The company adheres to a dual-wheel drive strategy of 'success in clinical trials and success in sales', coordinating R&D and sales development, and collaborating with Fosun Pharma,Jiuzhou PassCooperating with powerful domestic and international sales networks such as Sinopharm, preparations are being made for the global commercialization of products.

The company has world-class scientific advisors and a research and development team with rich experience and a global perspective. After more than five years of development, it has completed multiple rounds of financing starting from scratch and is in a stage of rapid growth. It has obtained the qualification as a national specialized, refined, characteristic and innovative small giant enterprise and owns over a hundred global intellectual properties. Currently, Fukang Pharmaceutical is developing the product Hesaijia.^®The company is about to go public in China and overseas markets, and it is expected that the company will achieve profitability next year.

Dr. Shen Xiaokun listed examples of AI research and development for highly selective PI3K inhibitors (AI) at Fukan Pharmaceutical. Dr. Shen first elaborated on the importance of the phosphatidylinositol-3-kinase (PI3K) signaling pathway, the status of marketed drugs, the progress of drug pipelines under research, and research challenges. He further demonstrated Fukan Pharmaceutical's use of AI technology for the development of the PI3Kβ/δ inhibitor product CVL237 for advanced solid tumors with PTEN gene deletion. Fukan Pharmaceutical used AI technology for simulation, achieving highly selective inhibitory effects on both beta and delta groups. In vivo efficacy has proven that the drug can inhibit tumor resistance.IbrutinibThe drug has shown tumor growth suppression. Phase I clinical trials conducted in the United States for B-cell lymphoma have resulted in 4 out of 21 subjects achieving CR and 3 achieving PR, with the longest remission time exceeding 700 days; adverse reactions were not common to other drugs such as nausea, vomiting, elevated liver enzymes, etc., with rash, pneumonia, and other adverse reactions comparable to those of other drugs. Currently, the drug has entered Phase II clinical trials and will further expand its indications in the future.

Finally, Dr. Shen Xiaokun pointed out that AI technology can not only be used to detect and predict tumors, but also to guide tumor screening. More importantly, it can be used for tumor clustering, combination therapy plans, and drug resistance screening. These are all directions worth exploring in the future.