China-based RemeGen Ltd (HKG: 9995) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate an open, single-center Phase Ib/II clinical study. The study will assess the safety, efficacy, and pharmacokinetics of its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin) combined with Hengrui pharmamceuticals’ pyrotinib, a tyrosine kinase inhibitor (TKI). The targeted indication for this combination therapy is locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 gene mutation.
RC48: First Home-Grown ADC from China
RC48, the first home-grown ADC to emerge from China, obtained conditional market approval in the country in June 2021 as a third-line treatment for HER2-positive gastric cancer (GC). It also obtained breakthrough therapy designations (BTDs) both in the US and China due to its leading data in urothelial carcinoma (UC). The NMPA issued a second approval to treat UC on December 31, 2021. The drug is already listed as a Category B National Reimbursement Drug List (NRDL) product.
Pyrotinib: EGFR/HER2 Inhibitor
Pyrotinib is an in-house developed Category 1.1 EGFR/HER2 inhibitor. The drug was included on the NRDL in 2019 and won conditional market approval in China in August 2018. It received full market approval for use in HER2-positive advanced or metastatic previously treated breast cancer in combination with capecitabine in July 2020. In October 2022, another market filing for the drug in HER2-positive recurrent or metastatic breast cancer in combination with trastuzumab plus docetaxel was accepted for review by the NMPA.-Fineline Info & Tech
