Likang Life Sciences, an enterprise located in Beijing Economic-Technological Development Area (Beijing E-Town), has obtained approval for its tumor neoantigen mRNA vaccine product, LK101 Injection, from the US Food and Drug Administration (FDA).

The approval for the Investigational New Drug (IND) application, which will bring hope to cancer patients worldwide, is an international first for the product and demonstrates China's progress in the field of cancer immunotherapy.

LK101 Injection is an innovative vaccine based on individualized tumor neoantigen design. It utilizes high-throughput sequencing technology combined with AI-based tumor neoantigen analysis to accurately identify specific mutations in a patient's tumor cells.

Through this innovative technology, LK101 Injection can activate the patient's immune system to precisely target and attack tumor cells.

Compared to traditional therapies, neoantigen vaccines have highly individualized and precise characteristics. They can be designed to target each patient's unique tumor mutations, maximizing immune system activation while avoiding harm to normal cells.

LK101 Injection has become the first tumor neoantigen mRNA vaccine product from China to receive FDA approval, officially entering the global cancer drug market. The vaccine had previously obtained IND approval from the National Medical Products Administration in China and successfully conducted Phase I clinical trials.

With Phase I clinical trials nearing completion, preliminary data shows that LK101 Injection performans excellently in terms of safety and effectiveness, good patient tolerability and significant anti-tumor activity.

The FDA's approval of the LK101 Injection not only affirms the research and development capabilities of Likang Life Sciences but also signifies international recognition of China's innovative achievements in the field of cancer immunotherapy.