復宏漢霖-Ｂ(02696.HK)：重組抗RANKL全人單克隆抗體注射液(HLX14)臨牀試驗獲國家藥監局受理
格隆匯3月9日丨復宏漢霖-Ｂ(02696.HK)公告，近日，公司研製的用於高危骨折風險的女性絕經後骨質疏鬆症治療的重組抗RANKL全人單克隆抗體注射液(HLX14)的臨牀試驗申請獲國家藥品監督管理局(NMPA)受理。
公司自主研發的HLX14是Denosumab(英文商品名：Prolia ®)的生物類似藥，擬用於高危骨折風險的女性絕經後骨質疏鬆症的治療。Prolia ®是由安進公司(AmgenInc.)研發的全球首個獲批的特異性靶向RANK(Receptor Activatorof Nuclearfactor-кB,RANK)配體(RANKL)的IgG2單克隆抗體，其可阻止RANKL活化破骨細胞表面的RANK，從而抑制破骨細胞活化和發展，減少骨吸收，增加皮質骨和骨小樑兩者的骨密度和骨強度，促進骨重建，降低絕經後骨質疏鬆症婦女椎骨、非椎骨和髖骨骨折的發生率。
Prolia ®已於2010年5月和6月分別獲歐洲藥品管理局(EMA)和美國食品藥品監督管理局(FDA)批准上市，用於絕經後婦女骨質疏鬆症和前列腺癌患者激素抑制相關骨丟失的治療，以及目前其他治療方法無效或不能耐受的患者，以降低患者骨折的風險。
根據《生物類似藥研發與評價技術指導原則(試行)》，公司對HLX14與原研藥Denosumab從臨牀前藥理學、藥代動力學及毒理等方面進行了頭對頭比較。臨牀前比較結果顯示，HLX14和Denosumab的體外體內藥效學特徵、藥代動力學和毒代動力學特徵、免疫原性和毒性特徵均相似或未見明顯差異。
截至本公告日，於全球範圍內上市的RANKL靶點的單克隆抗體藥品有AmgenInc.的Prolia®(Denosumab)、Xgeva®(Denosumab)等。根據IQVIAMIDAS資料(由IQVIA提供，IQVIA是全球領先的醫藥健康產業專業資訊和戰略諮詢服務提供者)，2019年度，RANKL靶點的單克隆抗體藥品於全球範圍內的銷售額約為50.29億美元。
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.
