The National Medical Products Administration (NMPA) of China has recently approved CStone Pharmaceuticals’ sugemalimumab (Cejemly) to treat patients with stage III non-small cell lung cancer (NSCLC), whose disease has not progressed following concurrent or sequential or platinum-based chemoradiotherapy. Against this backdrop, sugemalimumab will still face stiff competition in China, observes GlobalData, a leading data and analytics company.

Notably, the Chinese Society of Clinical Oncology 2022 guideline has already recommended sugemalimumab: level 1 for stage IV NSCLC and level 3 for stage III NSCLC.

According to GlobalData’s Pharma Intelligence Center, the  total incident cases of NSCLC in China were 345,614 this year, of which about 60-65% fall in stages III and IV.

Earlier in September 2020, Pfizer invested US$200m for a 9.9% stake in CStone to collaborate on the development and commercialization of CStone’s second-generation PD-L1 inhibitor, sugemalimumab. It is the world’s first anti-PD-1/PD-L1 monoclonal antibody covering stage III and stage IV NSCLC patients.

Dr. Sarada Anepu, Pharma Analyst at GlobalData, comments: “A large subset of NSCLC patients will benefit from the commercialization experience of Pfizer in targeting the relevant patient segments in China. Pfizer, with more than 1,000 sales representatives and coverage of more than 4,600 hospitals with a focus on KOL and HCP perception, will make it a well-recognized treatment within China.”

According to GlobalData’s Non-Small Cell Lung Cancer: Global Drug Forecast and Market Analysis to 2029, among the eight major markets* (8MM), diagnostic testing for biomarkers, access to targeted therapies and immune-oncology agents are the lowest in China due to lack of national reimbursement for the majority of agents or the infrastructure for testing.

Stiff competition exists between domestic PD-(L)1 drugs like camrelizumab, tislelizumab, sintilimab and the globally accepted nivolumab, pembrolizumab, atezolizumab, and durvalumab which is already approved in China for certain NSCLC patient segments.

Anepu concludes: “Chinese reimbursement policies play a key role in the market penetration. The inclusion of approved drugs in the National Reimbursement Drug List (NRDL) plays a crucial role in the uptake and improving patient affordability. In the NRDL, domestic company’s drugs are preferred over multinational companies drugs. Within NSCLC, none of the multinational companies drugs are included in NRDL. However, competition among domestic players will increase with the expected approval of toripalimab, penpulimab, and serplulimab in NSCLC segments.

*8MM: The US, the UK, Germany, France, Spain and Italy (EU-5), Japan and China