康哲藥業(00867.HK)與Zydus就創新產品Desidustat簽訂許可協議
格隆匯1月20日丨康哲藥業(00867.HK)公佈,該集團通過其全資附屬公司於2020年1月20日與Cadila Healthcare Limited就其產品Desidustat(ZYAN1)簽訂了許可協議。根據協議的約定,集團通過其全資附屬公司獲得了根據許可技術和Zydus數據在大中華地區(包括中國大陸、香港特別行政區、澳門特別行政區和台灣)開發、註冊、生產、使用與商業化產品的付特許權使用費的、獨家的、可分許可的許可權利,該集團將通過Zydus的技術轉移以實現製劑產品生產在中國的本地化。通過此次合作,該集團現有的產品組合將在產品於區域上市後得以豐富及擴張。
Desidustat是一種創新型口服低氧誘導因子脯氨醯羥化酶抑制劑(HIF-PHI),擬用於治療慢性腎病(CKD)患者的貧血。據報告,中國預估有超過1.2億CKD患者。與現有療法相比,Desidustat採用口服給藥,有望提高患者的治療順應性。Zydus已啟動了兩項DesidustatIII期臨牀試驗。經過6周的治療,與安慰劑相比,在三個Desidustat劑量水平組,主要有效性終點Hb水平的升高均實現了有統計學意義的顯着差異。此外,次要終點Hb反應率在三個Desidustat劑量水平均超過60%。安全性方面,沒有觀察到嚴重不良事件,生命體徵、心電圖參數或安全化驗值均無明顯變化。Desidustat作為新分子實體,已在中國大陸、香港特別行政區、澳門特別行政區和台灣授予物質專利,保護期至2033年12月。
此外,Zydus是一家全球創新制藥公司,從事發現、開發、生產和銷售廣泛的醫療保健療法,這些療法包括小分子藥物、生物製劑和疫苗。Zydus致力於在全球建立更健康的社區,其在全球僱傭了近25,000名員工,其中包括1,400名從事研發的科學家。
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