The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG: 9969) orelabrutinib (a Bruton’s tyrosine kinase, BTK inhibitor) and CStone Pharmaceuticals’ (HKG: 2616) sugemalimab (a PD-L1 inhibitor, Cejemly). Orelabrutinib is filed for marginal zone lymphoma (MZL), while sugemalimab seeks approval for relapsed/refractory extranodal NK/T-cell lymphoma (R/R ENKTL).
InnoCare’s Orelabrutinib
- Indications: Approved in 2020 for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL). Added to China’s National Reimbursement Drug List (NRDL) in 2021.
- Pipeline: Filed for Waldenström’s macroglobulinemia (WM) in March 2022 and MZL in August. Holds US breakthrough therapy designation (BTD) for MCL. Global Phase II trials ongoing in multiple sclerosis (MS), systemic lupus erythematosus (SLE), and other autoimmune diseases.
CStone’s Sugemalimab (Cejemly)
- Approvals: China’s only tumor immunotherapy for Stage III/IV non-small cell lung cancer (NSCLC), approved in December 2021. Expanded to first-line NSCLC (non-squamous and squamous) and unresectable Stage III NSCLC.
- Partnership: Co-developed with Pfizer for mainland China commercialization.
Strategic Outlook
Both companies aim to leverage prioritized review to accelerate approvals, with InnoCare focusing on hematologic malignancies and autoimmune diseases, and CStone expanding sugemalimab’s reach via partnerships.-Fineline Info & Tech
