The Center for Drug Evaluation (CDE) website has indicated that three home-grown drugs are on track to obtain priority review statuses. These include Shenyang Sinqi Pharmaceutical Co. Ltd.’s atropine for arresting the progression of myopia in children, Zhuhai Jinzhidun Pharmaceutical Technology Co., Ltd.’s trientine for hepatolenticular degeneration that cannot tolerate penicillamine, and Jiddi Pharmaceutical Technology (Shanghai) Co.,Ltd.’s carglumic acid for hyperammoniaemia caused by primary deficiency of N-acetylglutamate synthase (NAGS), isovaleralemia (IVA), methylmalonic acid (MMA), or propionic acidemia (PA).
Atropine for Myopia Control
Low concentration atropine is believed to delay the deepening of myopia in children and achieve the effect of preventing myopia. The concluded Phase III clinical study results showed a statistically significant difference in the main efficacy indicators between the atropine sulfate eye drops group and the placebo group, with good safety. There is no similar product approved for marketing in China, where Ocumension Therapeutics’ OT-101, Arctic Vision’s ARVN002, and Zhaoke Ophthalmology’s NVK002 are under development.
Trientine for Wilson’s Disease
Trientine, a copper ion complexing agent originated by Germany’s Merck KGaA, was first approved in the US for the treatment of hepatolenticular degeneration (Wilson’s disease) that cannot tolerate penicillamine. The drug, included in the third list of pediatric drugs encouraged for development in China in June 2019, sees generic versions by Deruike Pharma, Orphalan/ Northrop, and Jiddi Pharma filed for marketing in China, with priority review statuses.
Carglumic Acid for Hyperammonemia
Carglumic acid, a functional analogue of N-acetylglutamate (NAG) and an activator of carbamoyl phosphate synthase 1 (CPS1) originated by Italy-based Recordati, is used to treat acute and chronic hyperammonemia. The drug, first approved in Europe in January 2003, was filed for marketing in China in March 2022 with priority review status. Meanwhile, China Grand Pharmaceutical and Healthcare Holdings Ltd’s generic version obtained priority review status in August 2022.-Fineline Info & Tech
