GeneQiming Announces IND Acceptance of China's First Allogeneic Off-the-Shelf iNKT Cell Therapy GKL-006Allo for Solid Tumors

Beijing Gene Key Life Technology Co., Ltd. was established in 2015 and is located in Building 11 of the Zhongguancun (Daxing) Cell and Gene Therapy Industrial Park, Daxing District, Beijing. It is the world's first leading company to develop a series of iNKT cell pipeline products; it has a biomedical and immunology basic research team, an iNKT cell basic research platform, a clinical research platform, and a large-scale cell culture system for expansion.National High-tech Enterprise, a high-tech enterprise in Zhongguan Village, a "specialized, refined, novel" enterprise, a technology-based small and medium-sized enterprise, an intellectual property pilot unit, a leading cell industry enterprise in the Zhongguan Village Biomedical Base, and a vice-chairman unit of the Daxing District Science and Technology Association in Beijing,Vice Chairman Unit of Beijing Specialized, Fine, Unique and New Enterprises Chamber of Commerce,Level III Enterprise for Standardization of Safe Production, 2024 Credit Leading Enterprise,The first group standard drafting unit in the iNKT cell therapy industry,Awarded multiple national and international invention patents, the iNKT cell hyperexpansion platform and unique subpopulation distribution technologies represent groundbreaking innovations with fully independent intellectual property rights.

Important Breakthrough:

(1) Completed the world's first safety and efficacy validation of iNKT cell therapy for primary liver cancer;

（2）GKL-006 InjectionFor the treatment of unresectable primary hepatocellular carcinomaObtained the registration clinical trial approval from the National Medical Products Administration (NMPA) (Clinical Trial Notification No.: 2023LP02333);

（3）GKL-006 InjectionFor the prevention of high-risk primary hepatocellular carcinoma patients after radical resectionObtained the registration clinical trial approval from the National Medical Products Administration (NMPA) (Clinical Trial Notice No.: 2024LP01859).

（4）GKL-006 InjectionUsed for treatmentAdvanced Pancreatic CancerObtained the registration clinical trial approval from the National Medical Products Administration (NMPA) (Clinical Trial Notification No.:2024LP02731）。

（5）GKL-006Allo InjectionFor the treatment of solid tumorsAccepted for IND review by the National Medical Products Administration (NMPA).

China has initially completed the core technology breakthrough and industrial upgrading in the field of iNKT cell therapy, achieving a "leading" position in this area.Bringing Innovative Treatments to New Heights for Patients Worldwide。