GeneQiming's iNKT Cell Therapy GKL-006 Receives CDE IND Acceptance for Advanced Pancreatic Cancer

1) GKL-006 Injection for Unresectable Primary Hepatocellular CarcinomaThe registrational clinical trial for bladder cancer has made significant progress.

2) A registrational clinical trial of GKL-006 injection for the prevention of high-risk recurrence in patients with primary hepatocellular carcinoma after radical resection is currently being initiated.

Beijing Gene Key Life Technology Co., Ltd was established in 2015. 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 expanded cell culture system.National High-tech Enterprise, a high-tech enterprise in Zhongguan Village, a "Specialized, Precise, Unique, and Innovative" enterprise in Beijing, 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 President Unit of Beijing Specialized, Fine, Distinctive and Innovative Enterprises Chamber of Commerce, awarded multiple national and international invention patents, owns fully independent intellectual property rights for the iNKT cell hyperexpansion platform and unique breakthrough technologies such as exclusive subpopulation distribution.

Major 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 Notice No.: 2023LP02333);

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

（4）GKL-006 InjectionUsed forUnresectable locally advanced or metastatic pancreatic ductal adenocarcinomaAccepted by the IND of the National Medical Products Administration (NMPA).

We have initially completed the core technology breakthrough and industrial upgrade in the field of iNKT cell therapy in China, achieving a "leading" position in this field and contributing to the accelerated development of new quality productive forces.