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亞盛醫藥(06855.HK):APG-2575在中國獲批一項Ib/II期臨牀試驗
格隆匯 04-07 17:15

格隆匯4月7日丨亞盛醫藥-B(06855.HK)發佈公告,公司在研原創新藥Bcl-2選擇性抑制劑APG-2575日前獲國家藥品監督管理局(NMPA)藥物審評中心(CDE)批准,將在中國開展一項Ib/II期臨牀研究。

該項研究為開放性Ib/II期劑量療效探索研究,旨在評估APG-2575單藥及聯合治療復發╱難治性慢性淋巴細胞白血病╱小淋巴細胞淋巴瘤(r/rCLL/SLL)患者的安全性、耐受性,並初步評估有效性。

APG-2575是公司開發的新型口服Bcl-2選擇性小分子抑制劑,目前在中國、美國和澳大利亞進行多項臨牀研究,同時也是中國首個進入臨牀研究的國產Bcl-2選擇性抑制劑。

公司深信,APG2575近期在中國和美國接連獲批多項Ib/II期臨牀試驗批准,乃是基於該藥物良好的臨牀前數據及早期臨牀數據。公司將積極推進該產品在全球範圍的臨牀試驗,爭取早日上市造福患者。

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