昆藥集團(600422.SH):阿法骨化醇軟膠囊通過一致性評價
格隆匯 2 月 22日丨昆藥集團(600422.SH)公佈,近日,公司全資子公司昆明貝克諾頓製藥有限公司(“貝克諾頓”)收到國家藥品監督管理局(“藥監局”)頒發的關於阿法骨化醇軟膠囊的《藥品補充申請批准通知書》(通知書編號:2021B00288),該藥品通過仿製藥質量和療效一致性評價。
阿法骨化醇用於治療內源性1,25-二羥基維生素D3產生不足所致的鈣代謝紊亂性疾病,例如腎性骨營養不良、術後性或特發性甲狀旁腺功能低下症、假性甲狀旁腺功能低下症、作為第三性甲狀旁腺功能亢進的輔助治療、抗維生素D性佝僂病或骨軟化症、維生素D依賴型佝僂病、新生兒低鈣血癥或佝僂病、鈣吸收不良症、骨質疏鬆症、吸收不良性及營養性佝僂病及骨軟化症等。阿法骨化醇被《維生素D及其類似物臨牀應用共識》(2018年版)、《骨質疏鬆性骨折圍手術期干預指南》(2018年版)、《甲狀旁腺功能減退症臨牀診療指南》(2018年版)、《中國骨質疏鬆性骨折圍手術期處理專家共識》(2018年版)等權威指南和共識廣泛推薦。2019年,貝克諾頓就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。
截至公吿日,中國境內已上市的阿法骨化醇製劑包括以色列梯瓦製藥工業有限公司的阿法迪三®、正大製藥(青島)有限公司的海德威、上海信誼延安藥業有限公司的延迪諾等。根據IQVIA數據統計(IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商),2019年度,阿法骨化醇製劑在中國境內銷售額約為人民幣4.14億元。除貝克諾頓外,阿法骨化醇軟膠囊現僅有一家國內藥企通過一致性評價。
截至公吿日,公司現階段針對該藥品一致性評價累計研發投入人民幣約1370萬元(未經審計)。
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