Kelun-Biotech's TROP2-ADC SKB264 Receives Second Breakthrough Therapy Designation in China for EGFR-TKI–Resistant NSCLC

China Finance and Economics News, January 29 (Reporter Du Ding) — Today, Kelun-Biotech, a holding subsidiary of Kelun Pharmaceutical, announced that the innovative TROP2-ADC (SKB264, MK2870) jointly developed with MSD has officially received the Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It is intended for locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) that has failed EGFR-TKI treatment. This designation is based on the Phase II expansion study data of SKB264.

Previously, SKB264 was included in the list of breakthrough therapies by the CDE for the treatment of locally advanced or metastatic triple-negative breast cancer. In less than a year, SKB264 received two Breakthrough Therapy Designations (BTDs).
Breakthrough Therapy Designation is designed to expedite the development of new drugs that target serious diseases and have demonstrated significant improvements in efficacy or safety over existing treatments in preliminary clinical trials. For drugs included in the breakthrough therapy list, the Center for Drug Evaluation (CDE) will prioritize resource allocation for communication and guidance, enhancing drug development. If assessed to meet relevant criteria, conditional approval and priority review may also be requested during the application for marketing authorization. This will help SKB264 accelerate drug development and market entry, addressing unmet clinical needs for patients in China sooner.

According to the latest data from the International Agency for Research on Cancer (IARC), in 2020, there were 2.2 million new cases of lung cancer globally and 1.79 million deaths, making it the malignant tumor with the highest number of deaths worldwide. In China, there were 810,000 new cases of lung cancer and 710,000 deaths, ranking it as the malignant tumor with the highest number of both new cases and deaths.

Non-small cell lung cancer (NSCLC) accounts for approximately 80%-85% of lung cancer cases. EGFR mutations are the most common driver gene mutations in NSCLC adenocarcinoma, occurring in 40%-50% of East Asian populations and 10%-17% of Caucasian populations. Tyrosine kinase inhibitors (TKIs) targeting EGFR significantly prolong patient survival and are the first-line standard treatment for advanced NSCLC with EGFR mutations. EGFR-TKIs have evolved through first-, second-, and third-generation drugs (such as osimertinib), with third-generation EGFR-TKIs becoming the preferred treatment due to better efficacy. However, resistance to targeted TKI therapy in EGFR-mutated NSCLC is inevitable, and treatment options post-resistance are very limited, representing a significant unmet clinical need.