REMEGEN (09995): The National Medical Products Administration approved the clinical trial of the injection drug RC288, a bispecific antibody-drug conjugate (bispecific ADC).

REMEGEN (09995) announced that the company has received the Drug Clinical Trial Approval Notice issued by the China National Medical Products Administration. The company's independently developed bispecific antibody-drug conjugate (bispecific ADC) RC288 (drug name: RC288 for injection, acceptance number: CXSL2600288) has been approved for phase I/IIa clinical trials for the treatment of locally advanced unresectable or metastatic malignant solid tumors. According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, the injection of RC288 meets the requirements for drug registration, and the National Medical Products Administration has approved this drug for clinical trials as monotherapy in patients with advanced malignant solid tumors. RC288 is a bispecific ADC targeting PSMA and B7H3, an innovative drug molecule developed by the company using a new generation of conjugation and toxin technologies. PSMA, also known as prostate-specific membrane antigen, is a type II transmembrane glycoprotein that can support tumor growth and angiogenesis; B7H3 is an immune checkpoint molecule that, when overexpressed in tumor tissue, can promote immune escape and tumor progression. PSMA and B7H3 are both potential therapeutic targets, with high expression in a variety of malignant tumor tissues and tumor neovasculature, and involvement in signaling pathways related to tumor proliferation, invasion, and drug resistance.