RemeGen Ltd (HKG: 9995) has announced the receipt of two clinical trial approvals for its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin). The Chinese firm is set to assess the drug as a neo-adjuvant therapy for HR-positive, HER2 low-expression breast cancer, either in combination with Junshi Bio’s (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) or letrozole. Additionally, RC48 will be evaluated as a neo-adjuvant therapy in HER2 positive breast cancer, combined with pertuzumab, with or without toripalimab.
RC48: A Pioneering ADC from China
RC48 is the first home-grown ADC to emerge from China, having obtained conditional market approval in June 2021 as a third-line treatment for HER2-positive gastric cancer (GC). The National Medical Products Administration (NMPA) issued a second approval to treat urothelial cancer (UC) on December 31, 2021. The drug is currently listed as a Category B National Reimbursement Drug List (NRDL) product.
Toripalimab and Pertuzumab: Key Partners in Clinical Trials
Toripalimab was China’s first domestic PD-1 inhibitor to be approved in December 2018 as a second-line treatment for melanoma. It has since received additional approvals for various indications, including nasopharyngeal carcinoma (NPC) and urothelial cancer. Pertuzumab, developed by Swiss major Roche, obtained market approval in China in December 2018 for use as an adjuvant treatment for HER2-positive early breast cancer patients at high risk of recurrence, combined with trastuzumab plus chemotherapy. It was also approved for neoadjuvant therapy and as a first-line treatment for HER2-positive metastatic breast cancer.-Fineline Info & Tech
