京新藥業(002020.SZ):普拉克索雷沙吉蘭緩釋膠囊獲批開展I臨牀試驗
格隆匯8月31日丨京新藥業(002020.SZ)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的普拉克索雷沙吉蘭緩釋膠囊的《藥物臨牀試驗批准通知書》。
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年6月15日受理的普拉克索雷沙吉蘭緩釋膠囊符合藥品註冊的有關要求,同意開展I臨牀試驗。
帕金森病(Parkinson Disease,PD),又稱震顫麻痺,是一種不明的腦部萎縮退化性疾病,主要因大腦分泌多巴胺的神經細胞變形死亡,多巴胺的產生明顯減小而發病。目前治療藥物包括多巴胺受體激動劑、單胺氧化酶B 抑制劑、兒茶酚-O-甲基轉移酶(COMT)抑制劑等。普拉克索雷沙吉蘭緩釋膠囊(“該藥品”)是由已上市藥物普拉克索和雷沙吉蘭組成的複方製劑,用於治療早期帕金森病;治療策略是將不同作用機制的兩種藥物相組合,採用緩控釋製劑技術,實現平穩釋放,與目前使用較高劑量的任何一種單用藥物療效相比,這種組合能提高抗帕金森病的療效且達到更好的安全性。該藥品屬於2 類改良,主要作為早期患者的添加治療,少部分患者中可衝擊一線治療,為早期患者提供耐受性更好、副作用更小的治療方案。
該藥品由以色列Pharma Two B Ltd (“P2B”)公司研發,目前在美國已完成III期臨牀入組,預期2022年上半年申報NDA。公司於2017年與P2B簽署合作協議,以自有資金500萬美元投資P2B取得P2B不超過5%的股權及擁有該藥品在中國市場的權益。2021年6月,公司向國家藥監局提交該藥品臨牀註冊申請獲得藥品審評中心正式受理。後續公司將按照上述《藥物臨牀試驗批准通知書》要求進行本品臨牀試驗研究。
截至目前,公司在該藥品研發項目上已投入約1420萬元人民幣。
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