China-based CStone Pharmaceuticals (HKG: 2616) released its 2022 financial report, recording total revenues of RMB 481.4 million (USD 69.78 million), marking a 97.54% year-on-year (YOY) increase. This growth was primarily driven by drug sales and licensing fees for Cejemly (sugemalimab). Commercial revenues reached RMB 394.1 million (USD 57.1 million), up 142% YOY, with drug sales contributing RMB 364.3 million (USD 52.7 million).
Drug Sales and Approvals
The company’s drug sales were bolstered by Gavreto (pralsetinib), Ayvakit (avapritinib), and Tibsovo (ivosidenib). During 2022, sugemalimab and ivosidenib obtained market approvals for treating Stage III non-small cell lung cancer (NSCLC) and recurrent or refractory acute myeloid leukemia (R/R AML) with isocitrate dehydrogenase 1 (IDH1) mutation, respectively. Avapritinib also gained market nods for advanced or metastatic RET mutant medullary thyroid carcinoma (MTC) and RET fusion-positive thyroid carcinoma (TC) in mainland China, RET fusion-positive NSCLC in Hong Kong, and RET fusion-positive NSCLC, RET mutant MTC, and RET fusion-positive TC in Taiwan.
R&D Expenditure and Partnerships
Research and development (R&D) expenditures totaled RMB 614.2 million (USD 89 million), a significant decrease from RMB 1.305 billion (USD 189 million) in 2021, due to reduced milestone payments and lower third-party compliance and employee costs. CStone struck a partnership with Blueprint Medicines in 2018, securing exclusive development and commercialization rights to Gavreto and avapritinib in Greater China. The company filed a technology transfer filing for avapritinib in 2022, with the technology transfer of pralsetinib proceeding smoothly. Roche is responsible for the manufacturing and supply of pralsetinib before completing the technology transfer.
Focus on Precision Medicine
CStone is doubling down on the precision medicine field, with its sales team covering 800 hospitals in 180 cities, accounting for 75%-80% of the precision medicine market. The company has also partnered with gene sequencing firms and the national pathology quality control center (PQCC) to further strengthen its position in this sector.-Fineline Info & Tech
