- source： CentryMed
- author： CentryMed
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2025.06.26
February 21, 2025—Zhejiang Shimabio Co., Ltd. announced that its self-developed Class I therapeutic biologic, CMD011 Injection, has received FDA Investigational New Drug (IND) clearance. CMD011 is a fully human bispecific antibody targeting GPC3 and CD3, intended for the treatment of advanced hepatocellular carcinoma (HCC). It is the third GPC3×CD3 bispecific antibody globally to secure FDA clinical trial approval.
About CMD011
CMD011 is a fully human bispecific antibody developed using Shimabio’s proprietary antibody screening library and bispecific antibody platform. It combines a tumor cell target (GPC3) with an immune cell target (CD3).
Current HCC therapies face unmet clinical needs, such as rapid drug resistance with small-molecule targeted agents and suboptimal efficacy of PD-1 inhibitors. GPC3 is specifically expressed in HCC tumor cells with negligible presence in normal tissues, making it an ideal target for GPC3×CD3 bispecific antibody development. CMD011 exhibits a well-defined antitumor mechanism: by simultaneously binding GPC3-positive tumor cells and CD3-positive T cells, it activates T cells to eliminate tumors. Leveraging Shimabio’s proprietary HBiTE platform, CMD011’s affinity for GPC3 and CD3 has been optimized to enhance tumor selectivity while minimizing toxicity.
Potential Advantages and Features of CMD011
Current GPC3-targeting approaches include CD3 bispecific antibodies, CAR-T therapies, monoclonal antibodies, and novel immunotherapies. Among these, CMD011 demonstrates the following unique advantages:
Reduced Toxicity: The innovative design of Shimabio’s HBiTE platform prevents T-cell overactivation caused by homodimerization, maintaining potent antitumor activity while lowering nonspecific toxicity.
Enhanced Therapeutic Potential: The HBiTE platform’s structural engineering improves tumor targeting, broadens the therapeutic window, and simplifies manufacturing. CMD011’s stability and scalability enable cost-effective large-scale production, positioning it as a more accessible treatment option.
Superior Compatibility: Compared to CAR-T therapies, CMD011 offers milder activity and greater potential for combination therapies, paving the way for personalized HCC treatment strategies.
Convenient Administration: CMD011 can be administered via intravenous injection, making it suitable for outpatient or long-term care settings.
Conclusion
GPC3-targeted bispecific antibody development remains in its early stages. As bispecific technologies advance, more companies are expected to enter this field, bringing expanded therapeutic options and clinical benefits to HCC patients.
Shimabio’s FDA clearance for CMD011, alongside the completion of IND submissions in both China and the U.S., validates the company’s technological capabilities and reinforces global recognition of its platform. This milestone accelerates international multicenter clinical trials, streamlines global drug development, and enhances the clinical and commercial value of CMD011 through strategic resource integration, risk mitigation, and capital optimization. Shimabio is poised to solidify CMD011’s leadership in the global oncology landscape.