Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its generic versions of Incyte Corporation’s Jakavi(ruxolitinib) and Missionpharma’s Urocit-K(potassium citrate), marking a significant milestone for the company.
Approval of Generic Jakavi
Jakavi, a JAK inhibitor, is utilized in the treatment of myelofibrosis and graft-versus-host disease (GVHD). Easton Pharmaceutical’s generic version of Jakavi is the first of its kind to be approved in China, signifying that it has successfully passed the generic quality consistency evaluation (GQCE). This approval positions Easton Pharmaceutical as a frontrunner in the generic market for this crucial medication.
Approval of Generic Urocit-K
Urocit-K is a potassium supplement indicated for renal tubular acidosis with calcium stones, calcium oxalate kidney stones resulting from low citrate urine, and uric acid stones, with or without calcium stones. As the originator product is not yet registered in China, Easton Pharmaceutical’s generic Urocit-K is the first generic version to be approved under the new Category and is deemed to have passed GQCE.
Implications for Easton Pharmaceutical and the Generic Market
These approvals from the NMPA not only bolster Easton Pharmaceutical’s product portfolio but also contribute to the broader generic drug market in China. The company’s ability to develop and secure approval for high-quality generic alternatives has the potential to increase patient access to essential medications and enhance healthcare outcomes.
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