Remegen Co., Ltd. (688331.SH) announced that it has received a clinical trial approval notice from the National Medical Products Administration. The approval permits the company to proceed with a Phase I/IIa clinical trial of its self-developed bispecific antibody-drug conjugate (ADC) RC288 as a monotherapy for locally advanced unresectable or metastatic malignant solid tumors. RC288 is a bispecific ADC that targets both PSMA and B7H3. It is an innovative drug molecule developed by Remegen using next-generation conjugation and toxin technology. PSMA, or prostate-specific membrane antigen, is a type II transmembrane glycoprotein that supports tumor growth and angiogenesis. B7H3 is an immune checkpoint molecule that, when overexpressed in tumors, promotes immune evasion and tumor progression. Both PSMA and B7H3 are considered promising therapeutic targets, as they are highly expressed in various malignant tumor tissues and tumor neovascularure and are involved in signaling pathways related to tumor proliferation, invasion, and drug resistance.
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