Zhiling Bio Submits IND Application for ZLT-001, the First TIL Therapy in South China, Accepted by CDE

CDE Acceptance Publicity Chart

On April 12, 2022, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that the first tumor-infiltrating lymphocyte (TIL) new drug, ZLT-001 injection, independently developed by Guangzhou Zhiling Biomedical Co., Ltd., has been accepted. This is also the first IND application for a TIL cell new drug in South China.

About ZLT-001 Injection

ZLT-001 is an immunocyte drug targeting solid tumors. This therapy involves isolating Tumor-Infiltrating Lymphocytes (TILs) from the patient's tumor tissue, which are then processed through Guangzhou Zhiling Biomedical Co., Ltd.'s proprietary YoungTIL-Exp™ technology platform. Unique techniques such as time-axis activation, targeted coupling, and TME anti-interference are applied to purify and enhance the activity and tumor-killing ability of the TILs. The number of TILs is expanded to billions or even tens of billions before being reinfused into the patient’s body to achieve rapid and effective elimination of tumor cells and control tumor growth.

Zhiling Biomedical

Guangzhou Zhiling Biomedical Co., Ltd. was established in 2016. Guided by clinical value and relying on self-developed technologies, the company focuses on the R&D of innovative drugs using engineered tumor-infiltrating lymphocytes (TILs) for solid tumors. It has been honored as a National High-tech Enterprise, a "High-precision and Advanced" enterprise in Guangzhou, an "Emerging Unicorn" innovative enterprise in Guangzhou, and one of the top 50 biopharmaceutical enterprises in the Guangdong-Hong Kong-Macao Greater Bay Area.

ZLT-001 Injection, the first drug in Guangzhou Zhiling Biomedical Co., Ltd.'s GTIL® pipeline system for prototype cell therapy, has successfully completed its IND application. Multiple clinical pipelines for solid tumors are also under parallel development. Zhiling Biomedical has independently designed a GMP cell preparation center, quality control center, and research and development center tailored to the TIL cell preparation process, equipped with internationally top-tier instruments and devices to meet the clinical trial needs for various solid tumors.

The core team of Zhiling is composed of academicians, doctoral supervisors, professors, and PhD teams from well-known research institutes at home and abroad, including Tsinghua University, the University of Queensland, Harvard University, and Baylor College of Medicine in the United States (listed in no particular order). Integrating immunology, nanomedicine, and clinical medicine, and guided by medical sensitivity, they jointly build a cutting-edge interdisciplinary engineering platform to promote constructive treatment models for tumors.

Clinical Advantages

The Zhiling team has completed clinical trials for multiple solid tumors, including nasopharyngeal cancer, liver cancer, and cervical cancer, fully verifying the safety and efficacy of the company's TIL product in clinical settings. They have accumulated a significant amount of valid clinical data and numerous core patents.

Technology Layout

Relying on its independently innovative YoungTIL-Exp™ and NanoE technology platforms, Zhiling Biomedical has adopted a clinical value-oriented technical pathway, rather than fast-following foreign technologies. This approach not only avoids the "bottleneck" risks posed by imported non-standard consumables but also significantly reduces production costs. The company has collaborated with teams from renowned institutions such as Tsinghua University, the Chinese Academy of Sciences, and the University of Science and Technology of China (listed in no particular order) to develop next-generation TIL products based on the intelligent TIL platform TILBOT™, achieving agile, efficient, and secure production deployment.

Zhiling Biomedical will continue to increase investment in its R&D platform, gradually building world-class AI high-throughput drug screening and discovery platforms, TME organoid digital twin laboratories, and biochip matrix centers—all independent R&D platforms with proprietary intellectual property rights led by world-class scientists. The company will also collaborate with well-known CDMO enterprises both in China and internationally, actively advancing clinical trials domestically and globally, expanding the range of indications, and improving the objective cure rate for solid tumors.

Popular Science

Cancer Immunotherapy:

Cancer immunotherapy refers to a treatment method that controls and eliminates tumors by restoring or enhancing the body's anti-tumor immune response. These methods include immune checkpoint inhibitors, cancer vaccines, cellular immunotherapy, and small molecule inhibitors.

Cellular Immunotherapy:

Cellular immunotherapy refers to the collection of autologous or allogeneic immune cells from the human body, which are then activated, expanded, or genetically modified in vitro before being reinfused into the body to suppress or kill tumor cells, thereby achieving treatment or preventing the recurrence and metastasis of tumors. These methods include CAR-T, TCR-T, CAR-M, CAR-NK, TIL, etc.