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中国上海,
2023年3月9日
全球领先的生物偶联药CRDMO服务公司药明合联(WuXi XDC)祝贺新加坡科技研究局(A*STAR)下属国家药物发现和开发平台——实验药物研发中心 (EDDC)及其合作伙伴研发的创新抗体偶联药物 (ADC)EBC-129获得美国FDA批准在实体瘤患者中展开人体临床试验。EBC-129 也是首个在新加坡研发的ADC。
借助药明合联领先的一体化技术平台,EBC-129用于新药临床试验申请(IND)的所有CMC研究均以高质量、高标准,高效完成。EDDC与药明合联之间的强强联合也为生物偶联药生态圈合作共赢树立了标杆——在CRDMO公司的赋能下,科技合作成功将前沿研究转化为具有治疗前景的候选药物。
李锦才
博士
药明合联首席执行官
祝贺EDDC及其合作伙伴取得这一令人兴奋的里程碑!我们很荣幸通过药明合联开放式、一体化偶联制药技术平台,赋能以EDDC为代表的科研机构将ADC从研究阶段推进至临床试验阶段。衷心祝愿该项目早日取得成功,造福广大病患。
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关于药明合联
药明合联(WuXi XDC)是药明生物和合全药业成立的合资公司,专注于提供抗体偶联药物(ADC)等生物偶联药物端到端CRDMO服务,服务涵盖抗体和其他偶联生物药、连接子/化学有效载荷、偶联原液及制剂等研发和生产领域。药明合联已成功赋能多个ADC药物在15个月以内完成从DNA到新药临床试验申请(IND),相比传统开发时间几乎缩短了一半。
如需更多信息,请浏览:https://www.wuxibiologics.com/services-solutions/#XDC
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WuXi XDC Congratulates EDDC on FDA Clearance of IND Application for First Made-in-Singapore Antibody-Drug Conjugate
SHANGHAI, China
March 9, 2023
WuXi XDC ("XDC"), a leading global CRDMO company dedicated to end-to-end bioconjugate services, congratulates its partner, the Experimental Drug Development Centre (EDDC), Singapore's national drug discovery and development platform hosted by the Agency for Science, Technology and Research (A*STAR), and its collaborators on clearance by the U.S. FDA for EBC-129 to begin its first-in-human trial in patients with solid tumors. EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC).
With the employment of WuXi XDC's proprietary integrated technology platforms, all of the CMC studies for EBC-129's Investigational New Drug (IND) application were completed effectively and at the highest level of quality. The partnership between EDDC and WuXi XDC demonstrates how collaborative science can translate research into promising therapeutic candidates when enabled by CRDMOs.
Dr. Jimmy Li
CEO of WuXi XDC
Congratulations to EDDC and its collaborators on reaching this exciting milestone. We are honored to enable innovative partners such as EDDC in advancing ADCs from research to clinical trials through WuXi XDC's integrated and open-access bioconjugate technology platform. We wish the program great success for the future benefit of patients worldwide.
About WuXi XDC
WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing services for bioconjugates, including antibody drug conjugates (ADCs). The company’s services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline.
For more information about WuXi XDC, please visit: https://www.wuxibiologics.com/services-solutions/#XDC
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注:本信息不构成药明生物的信息披露或投资建议

