China – based biopharmaceutical company RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II study of its antibody – drug conjugate (ADC) candidate RC48 (disitamab vedotin). The study will assess the efficacy and safety of RC48 in combination with gemcitabine for the treatment of high – risk non – muscle invasive bladder cancer (NMIBC) patients who are either untreated with or unresponsive to BCG intravesical instillation therapy.
Background on RC48
RC48 is a groundbreaking ADC that has demonstrated world – leading data in clinical studies involving HER2 – expressing advanced gastric cancer, urothelial carcinoma (UC), and breast cancer. It became the first home – grown ADC from China to achieve conditional market approval in June 2021 as a third – line treatment for HER2 – positive gastric cancer (GC). RC48 has also received breakthrough therapy designations (BTDs) in both the US and China due to its superior performance in treating UC.
Regulatory Milestones and Future Prospects
In 2021, RC48 was included in the Chinese Society of Clinical Oncology’s (CSCO) guidelines for UC and was added to the National Reimbursement Drug List (NRDL). The NMPA further granted a second approval for RC48 to treat UC on December 31, 2021. The latest approval for the Phase II study in NMIBC marks another significant step forward in expanding the therapeutic applications of RC48, highlighting RemeGen’s commitment to advancing innovative cancer treatments.-Fineline Info & Tech
