The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer (TNBC).
Drug Profile
SKB264 directly targets tumor cells by connecting novel toxin molecules through the TROP2 monoclonal antibody, effectively reducing off – target toxicity while maintaining efficacy and safety. The drug has obtained three clinical trial approvals in China: as a monotherapy for advanced solid tumors, in combination with Kelun’s anti – PD – L1 drug KL – A167 for advanced or metastatic non – small cell lung cancer and TNBC, and as a monotherapy in the second – line setting for advanced or metastatic TNBC (Phase III study).
Licensing Agreement
On May 16, 2022, Kelun Pharma entered into a USD 1.36 billion licensing agreement with Merck Sharp & Dohme Corp., (MSD) granting the US company development and commercial rights to an undisclosed biologic drug candidate from Kelun’s pipeline. Local media speculated that the TROP2 – targeted SKB264 was the subject of the deal. Kelun Pharma announced earlier this week that it had received USD 30 million from MSD, indicating the full initiation of the partnership.
Competitive Landscape
Other companies such as DAC Biotech / Junshi Bio, Fudan – Zhangjiang, Escugen Bio / Tot Bio, and others are also developing TROP2 – ADC products, though these are currently at the Phase I or II stage.-Fineline Info & Tech
