RemeGen secures NMPA green light for Phase I/IIa trial of bispecific ADC RC288 targeting PSMA/B7H3

Bulletin Express04-01 22:44

RemeGen has obtained approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa clinical study of RC288 for injection, a bispecific antibody–drug conjugate (ADC) designed to treat locally advanced unresectable or metastatic malignant solid tumours.

RC288 is engineered to simultaneously target prostate-specific membrane antigen (PSMA) and the immune checkpoint molecule B7H3. Both proteins are highly expressed in a range of solid tumours and tumour neovasculature, where they contribute to proliferation, invasion, angiogenesis and immune escape. Leveraging next-generation conjugation and toxin technologies, the candidate aims to enhance antitumour efficacy by combining dual-target specificity with the cell-killing capacity of an ADC.

In accordance with Chinese drug-registration regulations, the product must complete the full clinical-trial pathway and secure marketing authorisation before commercial launch. Management indicated that the trial approval is not expected to have a material impact on the company’s near-term financial performance and highlighted the inherent uncertainties associated with early-stage drug development.

The approval notice (acceptance number CXSL2600288) was issued on 1 April 2026. RemeGen’s board is chaired by Mr Wang Weidong.

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