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协和发酵麒麟与Ultragenyx达成单抗药KRN23合作协议

来源:生物谷 2013-09-05 13:20

2013年9月5日讯 /生物谷BIOON/ --9月3日,日本协和发酵麒麟株式会社(KHK)与Ultragenyx制药达成合作和许可协议,开发和商业化一种重组全人源化单克隆IgG1抗体KRN23,用于治疗罕见的骨代谢紊乱疾病—X连锁低磷血症(XLH)。

目前,KHK即将完成在美国和加拿大开展的一项成人XLH I/II期临床试验,双方计划在2014年启动一项儿科XLH患者项目。

按照协议,KHK和Ultragenyx将共同合作KRN23在美国、加拿大、欧盟的开发。如果KRN23获批,KHK和Ultragenyx将分享在美国和加拿大的商业责任和利润,KHK将负责KRN23在欧盟的商业化,Ultragenyx将负责KRN23在墨西哥、中美洲、南美洲的开发和商业化。KHK将负责生产和供应KRN23,用于全球的临床和商业用途。

根据KHK,XLH患者的低血磷水平,是由高水平的FGF23所致。FGF23是一种激素,能够抑制从尿液中的磷酸盐重吸收。KRN23旨在结合FGF23并使之失活,从而增加肾小管对尿液磷酸盐的吸收,来提高血磷水平。

KRN23有望成为首个特异性疗法,解决XLH患者中FGF23的过度生产问题。(生物谷Bioon.com) 

英文原文:Ultragenyx, Kyowa Hakko Kirin to Develop Rare Bone Disease-Fighting mAb
Ultragenyx Pharmaceutical entered a collaboration and license agreement with Kyowa Hakko Kirin (KHK) to develop and commercialize KRN23, a recombinant fully human monoclonal IgG1 antibody intended to treat the rare metabolic bone disorder X-linked hypophosphatemia (XLH). KHK is currently completing a Phase I/II study in adults with XLH in the United States and Canada, and the two companies are planning to initiate a pediatric XLH program in 2014.

Per the agreement, Ultragenyx and KHK will work together to develop KRN23 for the United States, Canada, and the European Union, with Ultragenyx leading development efforts in the XLH indication. If KRN23 is approved, Ultragenyx and KHK will share commercial responsibilities and profits in the United States and Canada, KHK will commercialize KRN23 in the European Union, and Ultragenyx will develop and commercialize KRN23 in Mexico as well as Central and South America. KHK will manufacture and supply KRN23 for clinical and commercial use globally.

According to KHK, XLH patients have low serum phosphate levels due to high levels of FGF23, a hormone that represses the reabsorption of phosphate from the urine. KRN23 is intended to bind to FGF23 and render it inactive, leading to an increase in kidney tubular absorption of phosphate and increased serum phosphate levels. KHK says that KRN23 is potentially the first specific treatment that addresses the problem of excess FGF23 production in XLH.

“We believe that the collaboration with Ultragenyx will accelerate the development and commercialization of KRN23 and maximize its value in global markets,” said Yoichi Sato, executive managing officer, vp, and head of the development division at KHK, in a statement.

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