The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs, including Jiedi Pharma’s mitotane, Pfizer’s ritlecitinib, Northrop Grumman’s trientine, and Ark Bio’s ziresovir, have been prioritized for review. This move highlights the CDE’s efforts to expedite the approval process for drugs with significant therapeutic potential.<\/p>\n\n\n\n
Mitotane for Adrenal Cortical Carcinoma<\/strong> Ritlecitinib for Alopecia Areata and Ulcerative Colitis<\/strong>
Mitotane, a steroid hormone synthesis inhibitor and an anti-tumor drug, is used to treat adrenal cortical carcinoma (ACC) and Cushing’s syndrome. Originally developed by Bristol-Myers Squibb, mitotane was first approved in the US in 1970 and initially marketed as an orphan drug for ACC due to limited market demand. HRA took over manufacturing and marketing from BMS in 2019. The drug entered the second list of clinically urgent overseas drugs in mainland China in May 2019, where it is still not yet approved. The priority review indication is for advanced (unresectable, metastatic, or recurrent) ACC.<\/p>\n\n\n\n
Ritlecitinib, an oral Janus kinase 3 (JAK3) inhibitor, achieves selective inhibition of JAK isozymes through covalent interaction with the JAK3-specific residue CYS-909. The drug, under development for alopecia areata, has entered Phase III clinical trials and received breakthrough therapy designations (BTDs) in the US and China in September 2018 and December 2020, respectively. In June 2022, it received another BTD for the treatment of moderate to severe active ulcerative colitis (UC). The prioritized indication this time is for adolescents and adults aged 12 years and above suitable for systemic treatment of alopecia areata, due to its classification as a breakthrough therapy.<\/p>\n\n\n\n