京新藥業(002020.SZ):鹽酸美金剛緩釋膠囊獲藥品註冊批件
格隆匯6月15日丨京新藥業(002020.SZ)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的化學藥品“鹽酸美金剛緩釋膠囊”【規格28mg】的《藥品註冊證書》,批准文號為國藥準字H20213467,批准文號有效期至2026年06月07日。
據流行病學調查顯示,中國65歲以上人羣痴呆的發病率為5.6%(2019年)。鹽酸美金剛是一種低到中等親和力的非競爭性N-甲酰-D-天冬氨酸(NMDA)受體拮抗劑,適用於中重度至重度阿爾茨海默型痴呆。鹽酸美金剛緩釋膠囊是由德國梅爾茲公司(Merz)和Forest Laboratories LLC公司開發,丹麥靈北製藥公司(Lundbeck)獲得了產品授權,並於2010年6月在美國獲准上市。米內網數據顯示,2020年鹽酸美金剛口服制劑在中國城市公立醫院銷售約5.6億元。
經查詢,截止公吿日,國內已獲批上市鹽酸美金剛緩釋膠囊的企業有成都宛東生物製藥股份有限公司、海南合瑞製藥股份有限公司、江蘇長泰藥業有限公司,公司為第4家獲批企業。
公司鹽酸美金剛緩釋膠囊,為按照與原研藥品質量和療效一致性評價的原則受理、審評的品種,因此批准後視為通過仿製藥質量和療效一致性評價。公司聚焦精神神經領域積極打造核心競爭力,在阿爾茨海默老年痴呆藥物上,除已首仿上市的重酒石酸卡巴拉汀膠囊外,此次再添鹽酸美金剛緩釋膠囊,將進一步豐富公司精神神經管線產品,提升市場競爭力,對公司藥品業務產生積極影響。
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