The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to obtain priority review status, with the drug in line for conditional approval. HL-085 is being developed to treat advanced melanoma with NRAS mutations in patients previously treated with immunotherapy. The investigational MEK inhibitor is undergoing multiple clinical studies, either alone or in combination with other therapies, targeting melanoma, non-small cell lung cancer (NSCLC), and other solid tumors.
Clinical Results for HL-085
Phase I/II single-arm study results for HL-085 showed an objective response rate (ORR) of 33.3%, a disease control rate (DCR) of 83.3%, and a median progression-free survival time (PFS) of 17.4 weeks. As a monotherapy, HL-085 demonstrated controllable side effects, good tolerability, and safety, with no dose-limiting toxicity observed.
Huiyu Pharma’s Methotrexate Injection
Separately, Huiyu Pharma’s injectable generic version of Strides Pharma’s methotrexate is also on course to obtain priority review status as a “clinically urgently needed in-shortage drug.” The folate reductase inhibitor is approved for treating tumors and psoriasis, either alone or in combination with other products. Currently, 18 similar products have been approved for marketing in China, all in tablet, API, or powder injection forms. Pfizer’s version was approved in 1999.-Fineline Info & Tech
