Gelonghui, March 13 | Colon Pharmaceutical (002422.SZ) announced that the company recently learned that the core product SKB264 (also known as MK-2870) of the company's holding subsidiary, Sichuan Colunbotai Biomedical Co., Ltd. (hereinafter referred to as “Columbite”), was recently recognized as a breakthrough therapy by the National Drug Administration (hereinafter referred to as “NMPA”) Drug Evaluation Center (TNBC) for first-line treatment of locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer (TNBC) that cannot be surgically removed. This is the fourth breakthrough therapy for SKB264 after treatment of locally advanced or metastatic TNBC, locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC) with disease progression after treatment with EGFR tyrosine kinase inhibitors (TKI), and locally advanced or metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients who have previously received at least second-line systemic chemotherapy.

In order to encourage research and development of drugs with obvious clinical advantages, CDE issued the “National Drug Administration's Working Procedure for Issuing Breakthrough Therapeutics Evaluation (Trial)” (No. 82 of 2020). For drugs included in the breakthrough therapeutic drug program, CDE will prioritize the allocation of resources to communicate, strengthen guidance, and promote drug research and development; furthermore, those that meet the relevant conditions after evaluation can also submit conditional approval applications and priority review and approval applications when applying for drug marketing licenses. The relevant procedures will help accelerate SKB264 development and product launch.