UK approves CStone’s Sugemalimab for non-small cell lung cancer treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has awarded marketing authorisation to CStone Pharmaceuticals for sugemalimab (Eqjubi) as a
first-line treatment for non-small cell lung cancer (NSCLC) in the UK.

NSCLC is the most common form of lung cancer, accounting for around 80 to 85 out of 100 cases.

Sugemalimab is now approved as a first-line treatment, in combination with platinum-based chemotherapy, for adult patients with metastatic NSCLC who do not have
EGFR-sensitive mutations or ALK, ROS1, or RET genomic alterations.

This UK approval follows its recent authorisation by the European Commission, marking the second international approval for sugemalimab.

CStone’s CEO Dr. Jason Yang described the UK’s approval as a significant milestone in their global expansion strategy.

“Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world’s second-largest pharmaceutical
market, the EU.

“Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year’s
ESMO Congress, further confirmed sugemalimab’s value in the frontline treatment landscape for metastatic NSCLC,” he said.