RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48). This single-arm, open, single-center study aims to evaluate the safety and maximum tolerable dosage of the drug in combination with radiotherapy for HER2-positive locally advanced solid tumors.
Study Design and Objectives
The study is designed to confirm the dosage for the expansion phase, assess safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced solid tumors. This trial marks another step forward for disitamab vedotin as RemeGen seeks to establish its potential in treating a range of HER2-positive cancers.
Disitamab Vedotin’s Market Approvals and Reimbursement
Disitamab vedotin made history as the first home-grown ADC from China, obtaining conditional market approval in June 2021 for use as a third-line treatment for HER2-positive gastric cancer (GC). The NMPA granted a second approval for the molecule to treat urothelial cancer (UC) on December 31, 2021. The drug is listed as a Category B product on the National Reimbursement Drug List (NRDL), making it accessible to a broader patient population.
Overseas Trials and Designations
RemeGen’s drug has also received breakthrough therapy designation and fast-track statuses in the US for the treatment of UC. The company is conducting multiple trials in overseas markets, targeting tumors with HER2 expression. These trials cover a variety of cancers, including gastric GC, UC, breast cancer, bladder cancer, and non-small cell lung cancer, highlighting the potential versatility and impact of disitamab vedotin in the global oncology space.
Conclusion
The NMPA’s approval for RemeGen’s Phase I study of disitamab vedotin (RC48) is a significant milestone, reflecting the drug’s progress in clinical development and its potential to offer new treatment options for patients with HER2-positive tumors. With a robust pipeline of international trials and existing market approvals, RemeGen is well-positioned to expand the reach and impact of its innovative ADC therapy.-Fineline Info & Tech
