The inflammatory bowel disease (IBD) pipeline of Shanghai Lishan Biopharmaceutical Co., Ltd. has completed all the preparations for the preliminary FDA application and will undergo IND application in November this year, fully opening a new chapter of commercialization.

On the afternoon of September 25, 2024, the IBD pipeline commercialization progress report meeting of Lishan Biotech Zhangjiang Live Biopharmaceutical (LBP) R&D Center was held at Zhangjiang Pharmaceutical Valley. Professor Su Bing, Chief Scientist of Lishan Biotech and Director of Shanghai Institute of Immunology, and Professor Ma Jianpeng, Senior Advisor of Lishan Biotech and Dean of the Institute of Complex Systems Multiscale Research at Fudan University, accompanied by Mr. Long Kejin, Supervisor of Lishan Biotech, and Dr. Zhu Chaoyu, Director, listened to the progress report on the commercialization of IBD pipelines.

Lishan Biotech officially entered the Zhangjiang China Medicine Valley incubator in August 2023, embarking on a journey of LBP research and development. Zhangjiang Pharmaceutical Valley is a biopharmaceutical technology industry base in Shanghai, gathering more than 400 domestic and foreign research institutions in the field of life sciences. It has developed into one of the most prominent biopharmaceutical research and development bases in China. Lishan Biotechnology is based in the innovative land of Zhangjiang Medicinal Valley, deeply cultivating research on microbial community pipelines, committed to the transformation of cutting-edge scientific research theoretical achievements, and leading China's microbial community technology towards a new era of application and commercialization.

IBD Pipeline Commercialization Progress Report Meeting by LBP R&D Center DirectorChenWei JieLed by the doctor, he summarized the development process of the R&D center in the past year and provided insights forWang MengyaThe doctor awarded the appointment letter of "Deputy Director of LBP R&D Center".

Subsequently, Dr. Wang Mengya, Deputy Director, Ms. Wang Xuxia, R&D Manager, and Mr. Yang Weikang, Production Manager, reported on the progress of IBD pipeline commercialization work over the past year. The LBP R&D center has completed the construction of basic functions such as laboratory setup, microbial isolation and identification, and biochemical and physical property testing of bacteria; The laboratory library of bacteria has been established, with a cumulative collection of over 1000 live bacterial strains, including 13 types of probiotics, of which 9 are listed in the China Edible Probiotics List; The IBD pipeline is based on the innovative discovery of the swarm motion strain by the Lishan team, and its effectiveness as a drug has been verified through animal experiments. It is currently in the pre IND stage and has completed all preliminary preparations for filing with the FDA; The CMC of IBD pipeline has strictly screened CDMO companies, established a production strain library, confirmed the identification of production processes, and is synchronously optimizing project processes.

Wang Mengya

Wang Xuxia

Yang Weikang

Professor Su Bing, Chief Scientist of Lishan Biotech, fully affirmed the research and development progress and completion of indicators of the LBP R&D center over the past year, especially highly appreciated the world's first IBD pipeline based on swagming technology, which will undergo FDA IND application in November this year.

Professor Su Bing has put forward three new requirements for the future commercial development of Lishan Biotech: further strengthening global scientific research cooperation, actively participating in basic theoretical research at top universities around the world, and achieving the established goal of IBD pipeline entering clinical phase II by 2025 as soon as possible; We should further strengthen the cooperation of commercially valuable application technologies among domestic peers, adopt an open attitude towards the collision of core technologies, and drive the comprehensive development of the domestic microbial medicine industry; We should continue to maintain our continuous innovation capability and leverage global research forces such as Jiao Tong University School of Medicine, Fudan Shanghai Medical School, Stanford Medical School, and Einstein College of Medicine to lead the innovative development of China's microbial medicine industry, making basic theories the source of vitality and spreading scientific research results to every corner of the earth.

Finally, Professor Su Bing sent a heartfelt message to the researchers: "In the arena of the biopharmaceutical industry, research and development capabilities are regarded as the lifeline of enterprises. Lishan's true intangible wealth is your group of young scientists' persistence in exploring truth. Your ideas are precious seeds, and I believe Lishan will reap fruitful results from them. Today, I am delighted to see Lishan's team's insightful insights, drifting through the sea and finally seeing land. This is a mission driven undertaking that will awaken the spirit of struggle of the nation.

Today is the midst of autumn, and we hope that the LBP R&D center team, with the ambition to compete with the eternal heroes, will wholeheartedly plan the commercialization of Lishan ASD pipeline. The LBP R&D center has accumulated experience in the commercial operation of IBD pipelines and will continue to surpass itself in the future. Use the power of science to strengthen the soaring wings and continue to fly bravely with a broader perspective. Cheer and applaud for you. Fly towards the new era, towards poetry and distant places. Leave your own footprints in the world and realize your life value