On sale with the unit price of CNY 12,375/bottle, Sugemalimab is planning to file for a third indication

Recently, Sugemalimab (trade name: Cejemly®), Stone Pharma PD-L1 monoclonal antibody, is on sale in China. It is reported that its public retail price is CNY 12,375/bottle (600mg/20ml) (tax included). 

Sugemalimab (CS1001) is a PD-L1-targeted, all-human IgG4 monoclonal antibody developed by Stone Pharma based on the OmniRat® transgenic animal platform imported from Ligand, U.S. Sugemalimab is known to be the closest natural G-type immunoglobulin 4 (IgG4) monoclonal antibody to the human body, with a much lower risk of immunogenicity and associated toxicity in patients. 

In December 2021, Sugemalimab was officially approved by NMPA for the following indications: combination of pemetrexed and carboplatin in the first line for metastatic non-squamous non-small cell lung cancer (NSCLC) negative for epidermal growth factor receptor (EGFR) mutation and negative for anaplastic lymphoma kinase (ALK), and combination of paclitaxel and carboplatin in the first line for metastatic squamous non-small cell lung cancer (NSCLC). 

Currently, there is another listing application for Sugemalimab under review, with the relevant acceptance No. CXSS2101026. According to the company's official website, the indication declared for the acceptance No. is the consolidation of unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after synchronous or sequential radiotherapy. 

On January 13, another good news on Sugemalimab was delivered. Stone Pharma announced that its registrational clinical research (GEMSTONE-201) for the treatment of relapsed or refractory extranodal natural killer cell/T-cell lymphoma (R/R ENKTL) met the primary study endpoint. The company plans to submit a listing application to the NMPA for a new indication of Sugemalimab for R/R ENKTL in the near future. The study is a single-arm, multicenter Phase 2 registration one, designed to evaluate the efficacy and safety of Sugemalimab monotherapy in adults with R/R ENKTL. The results are as follows. Assessment by Independent Radiology Review Committee (IRRC) showed that Sugemalimab significantly increased the objective remission rate (ORR) compared to historical controls, and the investigator-assessed ORR was consistent with the IRRC assessment. Furthermore, Sugemalimab has a favorable safety profile in patients with R/R ENKTL, and no new safety signals were identified. 

Notably, based on the preliminary efficacy results of this study, the FDA granted breakthrough therapy designation to Sugemalimab for the treatment of adults with relapsed or refractory extranodal natural killer cell/T-cell lymphoma in October 2020. In January of this year, Sugemalimab has been included by China CDE as a breakthrough therapy variety. Want to know more about Sugemalimab, access to Pharmasources, a vertical e-commerce online platform serving the pharmaceutical industry.

Extranodal natural killer cell/T-cell lymphoma (ENKTL), closely related to Epstein-Barr (EB) virus infection, is an aggressive group of lymphomas, which primarily involves the nasal cavity and nasopharynx, but with less common involvement of the central nervous system. A multicenter analysis of the pathological type of 10,002 lymphoma patients conducted in 2012 in China showed that: ENKTL accounts for approximately 6% of all lymphomas, and 28% of mature T-cell and NK-cell lymphomas. There is a lack of effective salvage therapy for ENKTL patients whose disease progresses after receiving standard regimens based on Asparaginase, and the 1-year survival rate for patients with R/R ENKTL is typically less than 20%. At present, we pin our hopes on new drugs for the treatment of R/R ENKTL, among which PD-1 monoclonal antibody, CD30 monoclonal antibody, mitoxantrone hydrochloride liposome and chidamide have achieved good efficacy in clinical research. According to the published data, in patients with R/R ENKTL, the ORR of PD-1 monoclonal antibody in combination with chidamide was 58.3% and the CR rate was 44.4%. There is a long effective maintenance time and a high safety profile. The ORR of mitoxantrone liposome monotherapy for R/R ENKTL was 52.4% and the CR rate was 28.6%. We look forward to the future approval of Sugemalimab for this indication, providing a new option for patients with R/R ENKTL.