CStone Pharmaceuticals-B (02616) rose more than 5% in Hong Kong trading. At the time of writing, the stock was up 5.12% to HK$6.36, with a turnover of HK$23.93 million.
The increase follows the company's announcement that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for sugemalimab. The therapy is now authorized as a monotherapy for adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 ≥1%, who do not have EGFR sensitizing mutations or ALK or ROS1 genomic alterations, and who have not experienced disease progression after platinum-based chemoradiotherapy (CRT).
This marks the second indication approval for sugemalimab in the UK, coming after a similar approval from the European Commission (EC) for Stage III NSCLC. To date, CStone has entered into four commercialization partnerships for sugemalimab across Europe, the Middle East, Africa, and Latin America, covering more than 60 countries and regions. Commercialization efforts overseas are currently underway.