科倫藥業(002422.SZ)：創新藥物SKB336注射液獲批臨牀試驗
格隆匯7月2日丨科倫藥業(002422.SZ)公佈，公司近日獲悉，公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的創新藥物SKB336注射液獲得國家藥品監督管理局(NMPA)臨牀試驗通知書。
審評結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2021年4月9日受理的SKB336注射液符合藥品註冊的有關要求，同意開展臨牀試驗，擬研究適應症：預防和治療血栓栓塞性疾病。
SKB336注射液是公司開發的全新的具有自主知識產權的靶向FXIa/FXI 因子的人源化創新單克隆抗體，擬用於預防和治療血栓栓塞性疾病。
截至公吿披露日，全球尚未有獲批上市的同靶點藥物，目前同靶點單克隆抗體研發進度最領先的為Bayer Inc.開發的Osocimab (BAY-1213790)和Novartis Inc.開發的MAA868 (Abelacimab)，二者均處於II期臨牀研究階段。所開展研究的適應症為TKA/THA(全髖/全膝關節置換術)後的VTE(靜脈血栓栓塞症)預防和房顫卒中的預防。
中國有TKA手術需求的人羣約9700萬，2018年，國內TKA手術量約24.9萬台；我國有THA(全膝關節置換術)手術需求人數約500~750萬，2018年，國內THA(全膝關節置換術)手術量約43.9萬台。據ACCP(美國胸科醫師協會)報道，骨科大手術後DVT(深靜脈血栓)總髮生率為20.6％～58.2%，因此TKA手術人羣具有廣泛的抗凝需求。中國心血管健康與疾病報吿2019中推算心血管病現患人數3.3億，其中房顫患病率0.71%(預計1000萬)，房顫發生腦卒中總體比例17.5%，非瓣膜性房顫卒中比例24.2%，房顫抗凝比例30%。
雖然目前已上市的抗凝藥物眾多，且作用機制不同，但目前已上市的抗凝治療藥物均作用於凝血級聯反應中的共同凝血通路因子，在達到抗凝治療的同時，患者存在出血的風險，甚至部分患者存在的大出血風險可能危及生命。研發更加安全有效的新一代抗凝治療藥物，滿足抗凝治療效果的同時，減低和避免出血風險是當前未被滿足的臨牀需求。
非臨牀研究數據證實，SKB336注射液對內源性凝血因子FXI和FXIa具有高親和性和高選擇性，而對其他外源性凝血因子和共同通路的下游凝血因子無作用；體內外試驗研究結果顯示，SKB336注射液能夠顯著延長aPTT，阻止血液的凝聚並防止血栓的生成，具有明顯的抗凝血療效；同時SKB336注射液體內外試驗結果顯示，其不影響PT的變化，食蟹猴毒理學試驗在較高劑量和體內暴露量下，未觀察到出血不良反應，具有良好的安全性。
截至目前，公司在SKB336注射液整體項目已投入研發費用約3295萬人民幣。
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.
