RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression, in combination with the programmed death-1 (PD-1) inhibitor Loqtorzi (toripalimab).
Disitamab vedotin marked a significant milestone as the first domestically developed ADC in China, receiving conditional market approval in June 2021 for use as a third-line treatment for HER2-positive gastric cancer (GC). The National Medical Products Administration (NMPA) granted a second approval for the molecule to treat urothelial cancer (UC) on December 31, 2021. This indication has earned the drug BTD statuses both in the US and China.
RemeGen anticipates presenting the results of a Phase II study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study will focus on the combo’s efficacy as adjuvant therapy for MIBC with HER2 expression, as well as its role in selective bladder conserving or radical cystectomy after neoadjuvant treatment in patients with MIBC.- Flcube.com
