科倫藥業(002422.SZ)：KL280006注射液獲批開展尿毒症瘙癢的臨牀試驗
格隆匯6月24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KL280006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KL280006注射液符合藥品註冊的有關要求，同意開展尿毒症瘙癢的臨牀試驗。
KL280006注射液是我公司開發的全新的具有自主知識產權的外周κ阿片受體(KOR)激動劑，具有新穎的短肽結構，其作用機制和化學結構明確，擬用於尿毒症瘙癢的治療。
截至公吿披露日，全球尚未有獲批上市的同類化合物，目前同類化合物研發進度最領先的同靶點藥物為Cara Therapeutics Inc.開發的KORSUVA(CR845/difelikefalin)。近日美國食品和藥物管理局(FDA)已受理CR845用於治療血液透析患者的中度至重度瘙癢的新藥申請(NDA)並授予了優先審查，前期FDA已授予CR845治療該適應症的突破性藥物資格(BTD)。
截止2019年，預計我國終末期腎病(ESRD)患者超過300萬人(每年新增10萬-15萬患者)，據醫械研究院發佈數據顯示，當前中國血液透析治療的ESRD患者71萬人。
在接受透析的慢性腎臟疾病患者中，60%-70%的患者報吿瘙癢，中至重度瘙癢發生率達41.7%，推算我國ESRD血液透析伴中至重度瘙癢患者約29.6萬人。尿毒症瘙癢主要藥物治療方式為局部外用治療和系統性治療，國內無批准的治療方案，現有藥物多為超適應症使用，例如抗組胺藥和皮質類固醇等，無法提供一致的、充分的緩解，臨牀未滿足的需求較大。
非臨牀研究數據證實，KL280006 注射液對外周KOR具有高親和性和高選擇性，具有顯著的抗瘙癢效果，且不易透過血腦屏障，故可避免傳統中樞阿片類藥物的常見不良反應，如呼吸抑制、藥物成癮、便祕等，兼具良好的有效性和安全性。
尿毒症瘙癢是KL280006注射液獲得臨牀研究許可的第二個適應症，首個適應症“急性疼痛”於2018年7月獲得國家藥品監督管理局下發的臨牀試驗批件，已完成I期健康人SAD研究，臨牀研究顯示可接受的安全性。
截至目前，公司在KL280006注射液整體項目已投入約3885萬人民幣研發費用。
公司將按照國家藥品監督管理局簽發的臨牀試驗通知書的要求，組織實施KL280006注射液的臨牀試驗。
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.
