China’s 4th‑Generation BTK Inhibitor Lobrutinib Approved to Overcome Lymphoma Resistance

In early June 2026, the China NMPA granted conditional approval for lobrutinib tablets (LuKeda®) in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies, including a BTK inhibitor.

As the world’s first 4th‑generation covalent/non‑covalent BTK inhibitor, lobrutinib overcomes resistance to traditional BTK inhibitors via a dual mechanism, potently inhibiting both wild‑type and mutant BTK and offering a new option for resistant patients.

Approval was based on pivotal Phase II data: objective response rate (ORR) 78%, complete response rate (CR) 32%, with a favorable safety profile. Developed by Guangzhou Lupeng Pharma, it is the first innovative drug approved in Guangzhou in 2026, marking China’s global leadership in precision hematologic oncology.