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復宏漢霖-B(02696.HK)公佈幾款研發新藥的最新臨牀研究數據
格隆匯 11-26 22:42

格隆匯11月26日丨復宏漢霖-B(02696.HK)公佈,近日,公司在2019年歐洲腫瘤內科學會亞洲年會(ESMO-Asia 2019)上,以口頭報告或海報展示形式公佈了注射用曲妥珠單抗(HLX02)、漢利康®(HLX01,利妥昔單抗注射液)、重組抗PD-1人源化單克隆抗體注射液(HLX10)及重組抗EGFR人源化單克隆抗體注射液(HLX07)的最新臨牀研究數據。

1. 首個開展國際臨牀試驗的中國製造曲妥珠單抗生物類似藥HLX02的3期臨牀試驗達到主要終點

HLX02和原研曲妥珠單抗(歐洲市售)24周的最佳總緩解率組間差異95%置信區間在預設的等效區間內,兩治療組療效等效性成立。截止到資料截止日,所有HLX02的次要療效和安全性分析結果均支持HLX02與原研曲妥珠單抗(歐洲市售)在既往未經治療的複發性或轉移性HER2陽性乳腺癌患者中生物相似性成立。

2. 羣體藥代動力學模型:HLX01和原研利妥昔單抗藥代動力學相似性評估

該項基於RA患者建立的羣體藥代學模型可以預測HLX01和原研利妥昔單抗(中國市售)在DLBCL患者中的藥代學特徵。歐洲市售與中國市售的原研利妥昔單抗在模型中呈現出相似的藥代動力學參數和協變數。該研究與已有文獻的模型預測結果顯示,利妥昔單抗在中國人羣與高加索人羣中的藥代動力學特徵相似。上述結果進一步論證了HLX01和原研利妥昔單抗在RA和DLBCL適應症中都達到了藥代動力學相似性。

3. 新型抗EGFR抗體HLX07的1期臨牀試驗結果

HLX07顯示出良好的安全耐受性:直至最高劑量組(800mg劑量組),試驗中均未出現劑量限制性毒性(DLT),也未達到最大耐受劑量(MTD)。 HLX07顯示良好的腫瘤抑制效:17例可評價的患者中有1例部分緩解(PR),5例疾病穩定(SD)。 此結果支持了HLX07開展其1b/2期臨牀試驗(NCT03577704),進一步驗證HLX07聯合不同化療方案在晚期實體瘤患者中的安全性和有效性。

4. HLX10-新PD-1抗體領航聯合免疫療法

 HLX10在復發或轉移性實體瘤患者中的耐受性良好,單藥治療在多種實體瘤患者中表現出令人期待的抗腫瘤活性。

此外,HLX10的臨牀效果及安全性結果為正在進行的HLX10聯合HLX04治療試驗提供了有力依據,進一步的試驗將評估HLX10聯合HLX04治療標準療法耐受的實體瘤患者。

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