Recently, Beijing Likang Life Science and Technology Co., Ltd. (hereinafter referred to as "Likang Life Science") independently developed a tumor neoantigen mRNA vaccine product, LK101 injection, which successfully obtained IND (clinical trial application) approval from the U.S. Food and Drug Administration (FDA). This is my country's first tumor neoantigen mRNA vaccine product approved by the FDA, marking that my country's innovative strength in the field of tumor immunotherapy has been internationally recognized.

Based on the patient's individual tumor-specific mutations, LK101 injection selects highly immunogenic neoantigens through high-throughput sequencing and artificial intelligence-driven antigen prediction platforms, and uses mRNA technology to encode target antigens, aiming to induce a directional immune response in the body. Compared with traditional treatments, this technology has higher accuracy and safety, and provides new ideas for the treatment of solid tumors.

Two years ago, LK101 injection was approved for clinical trials in China and conducted Phase I clinical trials in Beijing. At present, the Phase I clinical trial is nearing its end. Preliminary observations show that the vaccine has satisfactory performance in terms of safety and significant anti-tumor activity. Subsequent data will further verify its clinical potential.

According to reports, since 2018, Beijing has successively implemented three rounds of "Accelerating Collaborative Innovation in Medicine and Health" to promote the innovative development of Beijing's medicine and health industry. The FDA's IND approval this time marks that Likang Life Science's tumor neoantigen mRNA vaccine has officially entered the global competition arena for anti-cancer drugs. This is also a major breakthrough for my country's biopharmaceutical companies in the field of tumor immunotherapy.

Chen Li, founder of Likang Life Science, said: "The FDA's approval fully affirms our efforts and achievements in technological innovation and R&D compliance."

Wang Jie, director of the Department of Internal Medicine at the Cancer Hospital of the Chinese Academy of Medical Sciences, said that the current preliminary results show that LK101 has shown positive signals in terms of safety and potential efficacy, exploring new possibilities for personalized immunotherapy. Larger-scale clinical verification is needed in the future to confirm this trend.

At present, many well-known companies around the world are actively promoting the research and development of tumor neoantigen mRNA vaccines. The progress of LK101 has enabled my country to emerge in this field. The industry believes that as technology continues to mature, personalized tumor immunotherapy will usher in rapid development, providing more treatment options for patients.

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