亞盛醫藥-B(06855.HK)訂立HQP1351合作授權協議及APG-2575聯合治療戰略合作協議
格隆匯7月14日丨亞盛醫藥-B(06855.HK)發佈公吿,於2021年7月14日,公司全資附屬香港亞盛、廣州亞盛及蘇州信達訂立HQP1351合作及授權協議。據此,亞盛同意授予蘇州信達在該領域及合作區域內開發HQP1351的權利,以及在合作區域內分配至蘇州信達的城市內進行HQP1351商業化的權利。
HQP1351是公司開發的新型口服活性第三代BCR-ABL酪氨酸激酶抑制劑(TKI),旨在有效靶向包括T315I在內的多種BCR-ABL突變體,以及中國首個開發的針對耐藥慢性髓性白血病(CML)的第三代BCR-ABLTKI。自2018年起,HQP1351的臨牀結果已連續三年入選美國臨牀腫瘤學會(ASCO)年會口頭報吿。目前,HQP1351已在中國提交新藥上市申請(NDA),該申請隨後獲得優先審評資格。此外,HQP1351獲FDA批准進入第Ib期臨牀研究,並隨後獲FDA授予孤兒藥資格認定及快速通道資格認定。
同日,公司全資附屬蘇州亞盛及蘇州信達訂立APG-2575聯合治療戰略合作及臨牀試驗協議。據此,蘇州亞盛及蘇州信達同意抗CD20單抗、抗CD47單抗與APG-2575聯合治療某些適應症的聯合療法進行共同開發和共同開展臨牀試驗。
APG-2575是公司正在開發的新型口服小分子Bcl-2選擇性抑制劑。APG-2575旨在通過選擇性阻斷抗鉑蛋白Bcl-2以恢復癌細胞的正常細胞凋亡過程,從而治療血液惡性腫瘤及實體瘤。APG-2575是中國第一款進入臨牀開發的Bcl-2抑制劑。APG-2575迄今已在中國、美國、澳洲及歐洲獲得多項第Ib/II期臨牀研究的授權及批准,全球正在開發APG-2575以治療多種血液惡性腫瘤。作為單一藥物,APG-2575在Bcl-2依賴性腫瘤細胞系中具有有效的抗腫瘤活性,與其他抗腫瘤療法一起使用時顯示出廣泛的抗腫瘤效果。
此外,於2021年7月14日,公司及信達訂立認股權證認購契據,據此,公司同意向信達發行678.76萬份認股權證。信達毋須就認股權證支付任何代價。認股權證股份每股的初步認購價為57.20港元,較股份於2021年7月14日收市價每股52.95港元溢價約8.03%。
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