欧洲机构对HLX11进行鉴定,HLX11对于乳腺癌来说是相似的生物,因此有可能进入市场。 European agency validates HLX11, a biosimilar for breast cancer, for potential market entry.

欧洲医药局验证了HLX11的营销申请,这是上海Henlius生物技术公司和Organ公司开发的Perjeta(pertuzumab)生物类同的Perjeta(pertuzumab)的营销申请。 The European Medicines Agency has validated the marketing application for HLX11, a biosimilar of Perjeta (pertuzumab), developed by Shanghai Henlius Biotech and Organon. HLX11在治疗HER2-呈阳性、HR-阴性乳腺癌的第三阶段研究中接受了HLX11的测试,并达到其主要终点。 HLX11 was tested in a phase 3 study for treating HER2-positive, HR-negative breast cancer and met its primary endpoint. 公司协议允许Organon在美国、欧盟和加拿大将HLX11商业化。 The companies' agreement allows Organon to commercialize HLX11 in the U.S., EU, and Canada.