康哲藥業(00867.HK):獲得抗缺血性腦卒中1類新藥獨家許可權利
格隆匯8月24日丨康哲藥業(00867.HK)公吿,於2023年8月24日,集團通過公司全資附屬公司與一家創新與研發驅動的新藥企業南京寧丹新藥技術有限公司就抗缺血性腦卒中腦細胞保護劑1類新藥Y-3注射液簽署合作協議。根據協議,集團獲得產品在中國大陸、香港特別行政區、澳門特別行政區的獨家推廣權。協議期限為永久。
Y-3注射液是1類新藥小分子化合物,用於改善急性缺血性腦卒中所致的神經症狀、日常生活活動能力和功能障礙。產品作用機制為解離PSD-95和nNOS偶聯和激動α2-GABAA受體,同時干預雙重靶點,作用機制清晰,有利於發揮腦細胞保護作用。同時,產品具有快速抗抑鬱焦慮功能,有望成為首個卒中和卒中後抑鬱兼顧同治的新型腦細胞保護劑。產品在中國擁有化合物和製劑專利,2023年一月完成中國I期臨牀研究,結果顯示整體安全性良好,目前處於中國臨牀II期階段。
腦卒中是嚴重危害中國國民健康的重大非傳染性疾病,中國總體卒中終生髮病風險為39.9%,位居全球首位。2019年,中國缺血性腦卒中新發人數約287萬,1990年到2019年發病率大幅增長226.5%,患者人羣規模大。腦卒中具有高致殘率和高經濟負擔等特點,臨牀急需循證依據充分的藥物減輕家庭和社會負擔。Y-3注射液對廣大卒中患者長期神經功能改善和總體預後具有重大潛在價值,市場前景廣闊。
集團深耕心腦血管/中樞神經系統治療領域,持續鞏固在該優勢專科領域的競爭力及影響力。Y-3注射液將豐富及優化集團心腦血管/中樞神經系統領域產品管線,並與集團現有產品新活素(注射用重組人腦利鈉肽)、維圖可(地西泮鼻噴霧劑)、黛力新(氟哌噻噸美利曲辛片)等產生協同效應。憑藉集團在心腦血管線(含中樞神經系統)成功的商業化經驗、合規高效的商業化運營體系,中樞神經系統治療領域1類新藥Y-3注射液如獲批上市,將為中國缺血性腦卒中患者帶來新的治療選擇,滿足兼具安全性與療效藥物的臨牀需求,提升疾病診療和操作實踐,從而使患者受益,並預期對集團業績產生積極正面影響。
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.