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Within 10 days, three Bispecific Antibody Drugs Assisted by Medicilon were Approved!

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On October 19, Bio-Thera’s new double-antibody drug BAT7104 was granted implicit approval for clinical trials.

On October 21, the PD-L1/TGF-β dual-target antibody (GT90008) of Kintor was approved for clinical trials.

On October 28, HCW Biologics Inc. (hereinafter referred to as "HCW") fusion protein complex HCW9218 was approved by the FDA for cancer treatment trials.

In just 10 days, Medicilon assisted in the approval of 3 bispecific antibody drugs! This is another achievement of Medicilon's one-stop preclinical drug R&D service platform. Behind these remarkable achievements, it is inseparable from the silent efforts and dedication of every Medicilon's researcher.

Medicilon provides antibody drugs discovery, CMC research (API + formulation), pharmacodynamics research, PK study, safety evaluation and other services. As of the end of June 2023, Medicilon has successfully assisted in the clinical approval of 31 antibody drugs (8 approved by FDA and NMPA, 1 approved by NMPA and TGA, 1 approved by FDA, NMPA, and TGA) and has multiple antibody projects under development.


Medicilon assisted Bio-Thera's bispecific neutralizing antibody drug for injection BAT2022 for the treatment of new coronary pneumonia was approved for clinical use

[Medicilon Assist] Bio-Thera's Bispecific Antibody BAT7104 has been Approved for Clinical Trials

The Biological Analysis of Bispecific Atibody

This is a technology-driven "tough battle"

"HCW9218 is a special preparation with many targets and many interfering factors, making it much more difficult to develop than ordinary innovative drugs. This is a challenge for researchers and an experience to surpass themselves." Dr. Dengji Zhang, Director of Biological Analysis said.

As a heterodimeric, bifunctional fusion protein complex, HCW9218 contains the extracellular domain of TGF-β receptor II and IL-15/IL-15 receptor α complex, which can effectively activate and proliferate NK cells and CD8+ T cells, enhance the cytotoxicity of cells against tumor targets, optimize the efficacy of chemotherapy and reduce the side effects of chemotherapy.

As a partner of HCW, Medicilon has set up a team of research experts in accordance with the principle of "case by case" in view of the HCW9218 project's key technical points. Analysis and exploration, and finally Medicilon established an analysis method suitable for HCW9218 under the GLP laboratory environment and operating specifications, provided preclinical pharmacokinetics and safety evaluation studies, and fully contributed to the high-quality and efficient completion of the project. In addition, Medicilon's preclinical pharmacology and toxicology research team relied on the comprehensive and mature SEND data conversion platform in software, technology, specifications, quality and other aspects to help HCW9218 successfully apply for FDA and promote it to enter the clinical trial stage.

Medicilon's preclinical pharmacology and toxicology research team is equipped with a professional send format conversion team, and has established a send data conversion platform that is fully mature in terms of software, technology, specification and quality, so as to realize accurate data conversion and provide a good environment for electronic data submission. In 2020 alone, it has helped customers complete 14 send data conversion projects, of which 3 new drug projects have obtained clinical licenses from FDA.

If the research and development of HCW9218 is a "tough battle" related to technology, then the research and development of GT90008 is a "competition" against time.

It's a race against time

GT90008 is a PD-L1/TGF-β dual-target antibody, which can simultaneously inhibit the high activity of PD-L1 and TGF-βR2, and has the potential to become the best drug in its class. The product is currently being developed for the treatment of various types of solid tumors. In the research and development of GT90008, relying on the protein/antibody pharmacokinetic research platform and the non-human primate safety evaluation technology service platform for biotech drugs, Medicilon beat the time with innovative R&D technology and provided GLP-compliant (including pharmacokinetics and safety evaluation) and comprehensive preclinical research services of pharmacokinetics, the research and development of the entire project is progressing smoothly and efficiently.

Within 10 days, 3 bispecific antibody therapeutic drugs assisted by Medicilon were approved. In addition to Medicilon’s strong R&D team, this also benefited from the excellent academic atmosphere of Medicilon’s R&D laboratory and the team’s 17 years of accumulation. In the future, Medicilon will help more new drugs to be approved and launched one day earlier.

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