GeneQiming Breaks Ground on China's First iNKT Cell Therapy GMP Manufacturing Facility

Apr 09, 2025 08:15 CST Updated 08:15

Gene Key

Developer of Immune Cell Product Technologies and Provider of Clinical Application Services

Recently, the GMP factory construction project of Beijing Gene Key Life Technology Co., Ltd. has officially started! The groundbreaking ceremony for Gene Key's GMP factory construction project was grandly held at Building 11 of Zhongguancun (Daxing) Cell and Gene Therapy Industrial Park. Li Haitao, Deputy General Manager of Daxing Biomedical Industry Base Management Committee, attended the event.Representative of COFCO Group, Zhongguancun (Daxing) Cell and Gene Therapy Industrial ParkAssistantGeneral Manager Luo Zhen, Chairman of the Board Feng Jikai from Beijing Gene Key Life Technology Co., Ltd., shareholder representatives General Manager Zhang and General Manager Zhao attended the event in person. Founding shareholder Xie Hang sent a congratulatory message to jointly witness this milestone moment for Gene Key Life Technology.

AsZhongguancun (Daxing) Cell Gene Therapy Industrial ParkKey benchmark project for introduction, GMP production workshop for iNKT cells by Gene Key Life TechnologyWillBuilt according to the highest international standards, achieving from "iNKTCell R&D Laboratory—iNKT Cell Pilot Platform—iNKTCell Drug Production"A Brilliant Transformation,Accelerate the iNKT cell therapy product from the laboratory to the market, benefiting patients with solid tumors such as liver cancer and pancreatic cancer.

Zhongguan Village (Daxing) Cell and Gene Therapy Industrial Park, as the first characteristic industrial park in Beijing focusing on cell and gene therapy, opened in September 2024. It is committed to building an internationally influential CGT innovation hub, having introduced one Nobel laureate, seven academicians, and multiple core platform technologies in the field of cell and gene therapy. It continuously constructs a full industrial chain ecosystem for cell and gene therapy and new vaccines, explores an integrated development model of education, technology, and talent, and aims to create a globally influentialScience and Technology Innovation High Ground, Talent Highlands andIndustrial High Ground。

Vice General Manager Li Haitao stated: "Daxing Biomedical Base will leverage the cluster advantages of Zhongguan Village (Daxing) Cell and Gene Therapy Industrial Park to provide projects with policy fast-track, priority resource allocation, and full-cycle service support, helping projects become industry benchmarks."

COFCO GroupTable,Zhongguancun (Daxing)Cell and Gene Therapy Industrial ParkAssistantTotalManagerLuo Zhen emphasized: "COFCO Group will fully leverage its strategic investment advantages to accelerate the rapid development of Gene Key Life Technology through capital empowerment, industrial synergy, and the introduction of international resources, thereby enhancing industrial competitiveness."

Chairman of Beijing Gene Key Life Technology Co., Ltd, Feng Jikai, thanked all parties for their support and stated: "The project will adopt an intelligent production system and international advanced quality control standards, relying on...Zhongguancun (Daxing) Cell Gene Therapy Industrial ParkPlatform Advantages, accelerate the marketing and industrialization process of innovative drugs."

Zhang Hailong, representative of the construction party, promised: "We will allocate an 'elite team + cutting-edge equipment' to ensure project quality with 'precision engineering and intelligent manufacturing,' and guarantee construction progress through 'node control,' helping the project commence operations and achieve effectiveness as soon as possible."

Gene Key Life as a cellGeneAs a pioneer in innovative therapies, the construction of the GMP facility will significantly enhance the company's R&D transformation capabilities and industrialization process. The "ecological empowerment" from Zhongguancun (Daxing) Cell and Gene Therapy Industrial Park, the "policy support" from Daxing Biomedical Base, the "industrial synergy" from COFCO Group, and the "precision engineering guarantee" from the construction team will lay a solid foundation for the project’s development.

With the successful conclusion of the groundbreaking ceremony, the GMP facility construction project of Beijing Gene Key Life Technology Co., Ltd. has officially entered the construction phase. In the future, with the full collaboration of the government, COFCO, and Gene Key, Gene Key will become a shining star in China's Medical Valley, injecting strong momentum into the development of China's cell therapy industry and bringing innovative treatments to new heights for patients worldwide.

Beijing Gene Key Life Technology Co., Ltd

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; the company 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 extensive 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, Refined, Distinctive and Innovative Enterprises Chamber of Commerce,Third-level Enterprise of Safety Production Standardization, 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 breakthroughs with full independent intellectual property rights.

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 Notification 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 for treatmentAdvanced Pancreatic CancerObtained the registration clinical trial approval from the National Medical Products Administration (NMPA) (Clinical Trial Notification Number:2024LP02731）。

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。

E.N.D

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Statement: ContentComeSourceOfficially from Beijing Gene Key Life Technology Co., Ltd., ThisWenPurposeInKnowFor informational purposes only, all content is for reference and does not constitute any advice.