CStone Pharmaceuticals has recently received the National Medical Products Administration (NMPA) of China approval for Cejemly (sugemalimab). Against this backdrop, Cejemly is expected to drive the CStone’s overall growth, says GlobalData, a leading data and analytics company.

Cejemly is an OmniAb-derived anti-PD-L1 monoclonal antibody for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) in combination with chemotherapy and is the first PD-L1 therapy approved globally for the first-line treatment of metastatic non-squamous and squamous NSCLC. In addition, Cejemly is CStone’s third new drug approval in China in 2021, following two first-in-class precision medicines Gavreto and Ayvakit.

According to GlobalData’s Pharma Intelligence Center, CStone generated sales of US$151m in 2020. Sales are expected to grow at a compound annual growth rate of 33.7% to reach US$1.1bn in 2027.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Cejemly is expected to be the key driver in CStone’s growth with a contribution of over 60% in total company’s sales by 2027.”

Earlier in September 2020, Pfizer invested US$200m for 9.9% stake in CStone to collaborate on the development and commercialization of CStone’s second-generation PD-L1 inhibitor, sugemalimab.

Sugemamilab is also under review by China’s NMPA as consolidation therapy in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy.

Sugemalimab is the world’s first PD-L1 therapy to have shown efficacy in both concurrently and sequentially treated Stage III NSCLC patients. However, AstraZeneca’s PD-L1 therapy Imfinzi (durvalumab) is the first approved therapy globally for maintenance Stage III NSCLC treatment after concurrent chemoradiotherapy only.

Khadayate concludes: “Considering the competition within PD-L1, Cejemly is the fourth PD-L1 approved in China and the second domestic PD-L1. Against this backdrop, partnership with Pfizer for Cejemly will provide solid commercial strength in promoting it to the target patient population in China. Furthermore, with approval for stage IV NSCLC and expected approval for stage III, CStone will cover broader patient population with late-stage NSCLC.”