复宏汉霖-B(02696.HK)公布几款研发新药的最新临床研究数据
格隆汇11月26日丨复宏汉霖-B(02696.HK)公布，近日，公司在2019年欧洲肿瘤内科学会亚洲年会(ESMO-Asia 2019)上，以口头报告或海报展示形式公布了注射用曲妥珠单抗(HLX02)、汉利康®(HLX01，利妥昔单抗注射液)、重组抗PD-1人源化单克隆抗体注射液(HLX10)及重组抗EGFR人源化单克隆抗体注射液(HLX07)的最新临床研究数据。
1. 首个开展国际临床试验的中国制造曲妥珠单抗生物类似药HLX02的3期临床试验达到主要终点
HLX02和原研曲妥珠单抗(欧洲市售)24周的最佳总缓解率组间差异95%置信区间在预设的等效区间内，两治疗组疗效等效性成立。截止到资料截止日，所有HLX02的次要疗效和安全性分析结果均支持HLX02与原研曲妥珠单抗(欧洲市售)在既往未经治疗的复发性或转移性HER2阳性乳腺癌患者中生物相似性成立。
2. 群体药代动力学模型：HLX01和原研利妥昔单抗药代动力学相似性评估
该项基于RA患者建立的群体药代学模型可以预测HLX01和原研利妥昔单抗(中国市售)在DLBCL患者中的药代学特徵。欧洲市售与中国市售的原研利妥昔单抗在模型中呈现出相似的药代动力学参数和协变数。该研究与已有文献的模型预测结果显示，利妥昔单抗在中国人群与高加索人群中的药代动力学特征相似。上述结果进一步论证了HLX01和原研利妥昔单抗在RA和DLBCL适应症中都达到了药代动力学相似性。
3. 新型抗EGFR抗体HLX07的1期临床试验结果
HLX07显示出良好的安全耐受性：直至最高剂量组(800mg剂量组)，试验中均未出现剂量限制性毒性(DLT)，也未达到最大耐受剂量(MTD)。 HLX07显示良好的肿瘤抑制效：17例可评价的患者中有1例部分缓解(PR)，5例疾病稳定(SD)。 此结果支持了HLX07开展其1b/2期临床试验(NCT03577704)，进一步验证HLX07联合不同化疗方案在晚期实体瘤患者中的安全性和有效性。
4. HLX10－新PD-1抗体领航联合免疫疗法
HLX10在复发或转移性实体瘤患者中的耐受性良好，单药治疗在多种实体瘤患者中表现出令人期待的抗肿瘤活性。
此外，HLX10的临床效果及安全性结果为正在进行的HLX10联合HLX04治疗试验提供了有力依据，进一步的试验将评估HLX10联合HLX04治疗标准疗法耐受的实体瘤患者。
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