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Industrial News | Congratulations to HankeMab for receiving NMPA IND Approval for 4-1BB Antibody

2021-12-01 Zencore News

Zencore Biologics congratulates Hefei HankeMab Biotech Co., Ltd. (HankeMab), the partner of Zencore Biologics on receiving National Medical Products Administration (NMPA) IND approval (Approval No. CXSL2101328).

ZG033 injection is a Class 1 innovative drug, which is a humanized monoclonal antibody tumor immunotherapy drug targeting 4-1BB molecule self-developed by HankeMab. The sequence and antigen-binding epitopes of this molecule are different from other reported anti-human 4-1BB antibodies. It is an Fc cross-linking dependent excitatory antibody, which can conditionally activate the human immune system, promote the proliferation and activation of T cells and NK cells and the production of cytokines, thus inhibiting the occurrence and development of tumors.

At present, the most advanced monoclonal antibody or dual antibody related to this target is still in the stage of clinical trial, and there is no relevant target drug on the market at home and abroad. The clinical trial of ZG033 injection is planned to test its initial efficacy in patients with advanced malignant tumor, and it is expected that it can be used not only for patients with immune tolerance after existing clinical treatments such as PD-1/PD-L1, but also for patients with low response rate, so as to expand new indications and market.

With high-quality CDMO technology services, seasoned in teamwork and strong equipment strength, Zencore Biologics provides CMC development and IND application services for global biomedical enterprises, accelerating the development process of biological drugs.

Zencore Biologics once again congratulates HankeMab and wishes ZG033 injection project to be approved for marketing as soon as possible to serve patients, alleviate their pain and improve their lives. We embrace technology with heart and mind, make quality medicines with unyielding focus, strive for a better world where no one is suffering from any disease, contribute to a healthier world with conviction, and become a global force - to make the world a healthier place with quality and innovation!

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