Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review its Category 1 new drug application (NDA) for A166, an anti-HER2 antibody drug conjugate (ADC). The drug is intended for the treatment of HER2 positive locally advanced, recurrent, or metastatic breast cancer patients who have experienced failure after second-line or above anti-HER2 treatment.
A166: A Third-Generation Anti-HER2 ADC with Innovative Features
A166 stands out as the world’s first third-generation anti-HER2 ADC, characterized by its lysine fixed-point quantitative coupling, innovative linkers, and a highly active toxin. These features position A166 as a cutting-edge therapeutic option in the treatment of HER2 positive breast cancer. The drug obtained clinical trial approvals in both the United States and China in May 2018, demonstrating superior results in clinical studies.
Implications for Breast Cancer Treatment
The acceptance of A166’s NDA for review by the NMPA signifies a significant step forward in the potential approval and commercialization of this promising drug. If approved, A166 could offer a new treatment option for patients with HER2 positive breast cancer who have not responded to prior anti-HER2 therapies, potentially improving outcomes and survival rates in this patient population.-Fineline Info & Tech
