China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric cancer, including adenocarcinoma of the gastroesophageal junction.
Disitamab Vedotin: A Pioneering ADC from China
Disitamab vedotin marked a significant milestone 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 National Medical Products Administration (NMPA) granted a second approval for the molecule to treat urothelial cancer (UC) on December 31, 2021. The drug is already recognized as a Category B National Reimbursement Drug List (NRDL) product, enhancing its accessibility for patients. RemeGen expanded its global reach by entering into a licensing agreement with Seagen Inc., (Nasdaq: SGEN) in August 2021, which granted the US firm global development and commercialization rights to disitamab vedotin outside of RemeGen’s territory.
Cadonilimab: A Promising BsAb for Multiple Cancers
Cadonilimab, an in-house developed first-in-class PD-1/CTLA-4 bispecific antibody, has shown excellent efficacy and safety in treating various malignant tumors, including cervical cancer, lung cancer, liver cancer, gastric cancer, kidney cancer, and esophageal squamous cell carcinoma. Clinical research data indicates that cadonilimab has significantly reduced toxicity compared to the combination therapy of PD-1 and CTLA-4 monoclonal antibodies, offering substantial safety and efficacy benefits.-Fineline Info & Tech
