綠葉製藥(02186.HK):地舒單抗注射液中國上市許可申請獲受理
格隆匯10月13日丨綠葉製藥(02186.HK)公吿,公司附屬公司山東博安生物技術股份有限公司開發的地舒單抗注射液(LY06006/BA6101)的上市許可申請已獲中國國家藥品監督管理局(NMPA)藥品審評中心受理。
LY06006/BA6101為Prolia(通用名地舒單抗注射液)的生物類似藥。地舒單抗是IgG2全人源單克隆抗體,能夠抑制RANKL與其受體RANK的結合,減少破骨細胞形成、功能和存活,從而降低骨吸收、增加骨量、改善皮質骨或松質骨強度。
2010年,Prolia首先在美國上市,隨後已在全球80多個其他國家或地區上市。Prolia在全球範圍內獲批准的適應症有:(1)治療具有骨折高危風險的絕經後婦女骨質疏鬆症;(2)增加具有骨折高危風險的男性骨質疏鬆症患者的骨量;(3)治療骨折高危風險的糖皮質激素誘導的男性和女性骨質疏鬆症;(4)增加因非轉移性前列腺癌接受雄激素剝奪治療所致的具有骨折高危風險的男性的骨量;及(5)增加因乳腺癌接受芳香化酶抑制劑治療所致的具有骨折高危風險的女性的骨量。
根據公開的財務報吿,Prolia於2020年的全球銷售額為27.6億美元。2020年6月,Prolia經NMPA批准在中國上市。除中國市場外,博安生物同時擬在全球其他國家和地區開展LY06006/BA6101的註冊工作。
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