China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer.
First Home-Grown ADC with Conditional Approvals
Disitamab vedotin stands out as the first domestically developed ADC in China, having secured a conditional market approval in June 2021 as a third-line treatment for HER2-positive gastric cancer (GC). The NMPA later granted a second approval for disitamab vedotin to treat urothelial cancer (UC) on December 31, 2021. The drug is already listed as a Category B product on the National Reimbursement Drug List (NRDL), enhancing its accessibility to patients.
International Prospects and Strategic Partnerships
In addition to its domestic approvals, disitamab vedotin has received breakthrough therapy designation and fast-track status in the U.S. for the treatment of UC. RemeGen is conducting multiple trials in international markets targeting tumors with HER2 expression, including gastric GC, UC, breast cancer, bladder cancer, and non-small cell lung cancer (NSCLC). Notably, U.S.-based Seagen Inc. (Nasdaq: SGEN) acquired international rights to disitamab vedotin through a substantial $2.6 billion licensing agreement with RemeGen in August 2021.-Fineline Info & Tech
