中國醫藥(600056.SH)：瑞舒伐他汀鈣膠囊通過仿製藥一致性評價
格隆匯3月20日丨中國醫藥(600056.SH)公佈，近日，公司下屬全資子公司海南通用三洋藥業有限公司(“通用三洋”)獲得國家藥品監督管理局(“國家藥監局”)核准簽發的化學藥品“瑞舒伐他汀鈣膠囊”的兩份《藥品補充申請批件》，該藥品通過仿製藥質量和療效一致性評價。
1.藥品名稱：瑞舒伐他汀鈣膠囊；受理號：CYHB1950228；批件號：2020B02552；劑型：膠囊劑；規格：5mg(按C22H28FN3O6S計)；註冊分類：化學藥品；申請人：海南通用三洋藥業有限公司；審批結論：根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。
2.藥品名稱：瑞舒伐他汀鈣膠囊；受理號：CYHB1950229；批件號：2020B02553；劑型：膠囊劑；規格：10mg(按C22H28FN3O6S計)；註冊分類：化學藥品；申請人：海南通用三洋藥業有限公司；審批結論：根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。
瑞舒伐他汀是一種選擇性3-羥基-3-甲基戊二酰輔酶A(HMG-CoA)還原酶抑制劑，通過抑制HMG-CoA還原酶，減少肝細胞合成及儲存膽固醇，從而降低血中總膽固醇(TC)和低密度脂蛋白膽固醇(LDL-C)水平。適用於原發性高膽固醇血癥(Ⅱa型，包括雜合子家族性高膽固醇血癥)或混合性脂血障礙(Ⅱb型)患者在節食或鍛鍊療法不理想時的輔助治療。也可降低升高的LDL-膽固醇、總膽固醇、甘油三酸酯和ApoB，增加HDL-膽固醇。
根據國家相關政策，通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。通用三洋的瑞舒伐他汀鈣膠囊通過仿製藥質量和療效一致性評價，有利於擴大該藥品的市場份額，提升市場競爭力。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
