联拓生物宣布获得Infigratinib在中国大陆3期临床试验批件

联拓生物宣布获得Infigratinib在中国大陆开展治疗针对具有FGFR2基因融合的局部晚期或转移性不可切除胆管癌患者的3期PROOF临床试验批件

上海和普林斯顿(新泽西州)-2020年11月4日-联拓生物,一家专注于为中国和亚洲主要市场的患者带来颠覆性药物的生物制药公司,今日宣布已获得中国国家药品监督管理局(NMPA)药品审评中心(CDE)关于Infigratinib的3期PROOF临床试验批件。Infigratinib是一种潜在的用于治疗伴有FGFR2基因融合的局部晚期或转移性不可切除胆管癌患者的一线治疗方式。 联拓生物已获得BridgeBio Pharma, Inc.关于Infigratinib的授权许可,并负责该候选药物在中国大陆、香港和澳门地区的注册申请、临床开发和未来的商业运营。

Infigratinib是一种在研的创新型、口服、成纤维细胞生长因子受体(FGFR)1-3选择性强效抑制剂,具有明确的新型化学结构及药理作用,目前BridgeBio正在进行全球3期临床开发。在另一项针对伴有FGFR2基因融合且经吉西他滨治疗进展的胆管癌患者中,Infigratinib显示出27%的总体有效率[1]。本次拟开展的PROOF临床试验是一项3期国际多中心,随机,对照临床研究,旨在评价Infigratinib在治疗伴有FGFR2基因融合的局部晚期或转移性不可切除的胆管癌患者中的药代动力学特征、疗效和安全性。

“中国国家药品监督管理局(NMPA)本次批准彰显了联拓生物将前沿技术引入中国的运营模式的高效性。” 联拓生物首席执行官黎兵博士表示,“未经治疗的胆管癌通常是致命的,只有50%的患者能存活一年。鉴于该疾病的严重性和中国日益上升的患病率,迫切需要为这一患者群体提供创新的治疗方法。在我们的合作伙伴BridgeBio的支持下,联拓生物做好了充分准备推进该候选药物的临床开发。”

参考资料

Javle M. et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions; ESMO 2018 Annual Meeting. Poster #LBA28.

关于联拓生物

联拓生物(LianBio)的使命是通过与全球领先的生物制药公司达成战略合作关系,以高效的产品开发为中国和亚洲其他主要市场的患者提供优质的颠覆性治疗药物及科学疗法。通过与世界级合作伙伴在不同的治疗领域和地域进行合作,联拓生物建立了基于疾病相关性的产品管线,并通过转化机制和精准疗法来改善患者病情。如需了解详细信息,请访问。

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SHANGHAI & PRINCETON, N.J. – November 4, 2020 – LianBio, a biotechnology company focused on bringing paradigm-shifting medicines to patients in China and major Asian markets, today announced that it has received clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the Phase 3 PROOF trial of infigratinib, a potential first-line treatment for patients with locally advanced or metastatic unresectable cholangiocarcinoma with FGFR2 gene fusions. LianBio has in-licensed infigratinib from BridgeBio Pharma, Inc. and is responsible for the registration application, clinical development and future commercial operations of the product candidate in Mainland China, Hong Kong and Macau.

Infigratinib is an investigational innovative, oral, selective and potent inhibitor of fibroblast growth factor receptor (FGFR) 1-3 with well-defined novel chemical structures and pharmacological effects, currently under Phase 3 global development by BridgeBio. In a separate clinical trial investigating infigratinib for patients with FGFR2-fusion positive cholangiocarcinoma who had progressed on gemcitabine-based therapy, infigratinib demonstrated an overall response rate of 27% [1]. The Phase 3 PROOF trial is a multicenter, randomized and controlled study designed to evaluate the pharmacokinetic profile, efficacy, and safety of infigratinib in patients with locally advanced or metastatic unresectable cholangiocarcinoma with FGFR2 gene fusions.

“This clearance by the China NMPA highlights the efficiency of LianBio’s operational model to bring cutting-edge technology to China,” said Dr. Bing Li, Chief Executive Officer of LianBio. “Untreated cholangiocarcinoma is usually fatal, with only 50% of patients surviving for one year. Given the severity of the disease and increasing prevalence in China, there is a high urgency to bring innovative treatments to this patient population. Supported by our partner BridgeBio, LianBio is well-positioned to advance the clinical development of this product candidate.”

Reference

Javle M. et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions; ESMO 2018 Annual Meeting. Poster #LBA28.

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