GSK plc (LSE/NYSE: GSK) today announced that it has completed the acquisition of IDRx, Inc. (IDRx), a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of gastrointestinal stromal tumours (GIST).

GSK plc（LSE/NYSE：GSK）今天宣布已完成对IDRx公司的收购。IDRx是一家位于波士顿的临床阶段生物制药公司，致力于开发用于治疗胃肠道间质瘤（GIST）的精准疗法。

As announced previously

正如之前宣布的那样

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, the acquisition includes lead molecule IDRX-42, an investigational, highly selective tyrosine kinase inhibitor (TKI) that is designed to improve outcomes for patients with GIST. IDRX-42 has demonstrated activity against all clinically relevant primary and secondary KIT mutations, a key medical need in current GIST treatment.

，此次收购包括先导分子IDRX-42，这是一种研究性的、高度选择性的酪氨酸激酶抑制剂（TKI），旨在改善GIST患者的治疗效果。IDRX-42已显示出对所有临床上相关的主要和次要KIT突变的活性，这是当前GIST治疗中的一个关键医疗需求。

GIST typically presents in the gastrointestinal (GI) tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations)..

胃肠道间质瘤 (GIST) 通常发生在胃肠道 (GI)，其中 80% 的病例由 KIT 基因突变驱动，这些突变导致肿瘤细胞的生长、增殖和存活（原发性或激活突变）。

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90% of patients treated in the first line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options.

一线治疗的患者中有90%会发展出新的KIT突变（继发性或耐药性突变），这通常会导致复发且治疗选择有限。

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Hesham Abdullah, Senior Vice President, Global Head Oncology R&D, GSK, said:

葛兰素史克（GSK）全球肿瘤研发高级副总裁兼全球负责人赫沙姆·阿卜杜拉表示：

“This acquisition adds to GSK’s growing pipeline of targeted therapeutics for cancers originating in the gastrointestinal tract. We plan to advance IDRX-42 for second line treatment of gastrointestinal stromal tumours, where there are no approved treatments to effectively address all resistance mutations, and accelerate development in an earlier setting.”.

“此次收购增加了GSK在胃肠道癌症领域不断增长的靶向治疗药物管线。我们计划推进IDRX-42用于胃肠道间质瘤的二线治疗，目前尚无获批疗法能够有效应对所有耐药突变，并加速其在更早期治疗中的开发。”

Financial Considerations

财务考量

The total cash consideration for this acquisition amounts to up to $1.15 billion. This includes an upfront payment of $1 billion, with the possibility of an additional $150 million milestone payment contingent upon success-based regulatory approval. GSK will also be responsible for success-based milestone payments as well as tiered royalties for IDRX-42 owed to Merck KGaA, Darmstadt, Germany..

此次收购的总现金对价高达 11.5 亿美元。其中包括 10 亿美元的首付款，以及在基于成功的监管批准的前提下，额外支付 1.5 亿美元的里程碑付款。GSK 还将负责基于成功的里程碑付款以及向德国达姆施塔特默克集团支付 IDRX-42 的阶梯式专利使用费。

About GIST

关于GIST

GIST represent the most prevalent form of soft tissue sarcoma, with an estimated annual global diagnosis of 80,000 to 120,000 patients.

胃肠道间质瘤（GIST）是最常见的软组织肉瘤类型，据估计，全球每年新增患者约80,000至120,000例。

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GIST commonly manifests in the GI tract, with approximately 80% of cases being attributed to mutations in the KIT gene.

胃肠道间质瘤通常在胃肠道中表现出来，大约80%的病例是由KIT基因突变引起的。

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These mutations, known as primary or activating mutations in exons 9 and 11, drive the growth, proliferation, and survival of tumour cells. In the first line of treatment, around 90% of patients develop secondary or resistance mutations in exons 13 and 17 of the KIT gene, leading to relapse with limited therapeutic alternatives..

这些突变被称为外显子9和11中的初级或激活突变，驱动肿瘤细胞的生长、增殖和存活。在一线治疗中，大约90%的患者会在KIT基因的外显子13和17中出现继发性或耐药性突变，导致复发且治疗选择有限。

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Notably, there are currently no approved TKIs capable of effectively targeting the full range of clinically significant primary and secondary mutations in KIT.

值得注意的是，目前尚无获批的TKI能够有效靶向KIT中所有临床上重要的原发和继发突变。

About IDRX-42

关于IDRX-42

IDRX-42 is a highly selective, investigational small molecule TKI designed to target all key KIT mutations in GIST. The U.S. Food and Drug Administration (FDA) has granted IDRX-42 Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST..

IDRX-42 是一种高度选择性的研究性小分子 TKI，旨在靶向 GIST 中的所有关键 KIT 突变。美国食品药品监督管理局 (FDA) 已授予 IDRX-42 快速通道资格，用于治疗伊马替尼治疗后疾病进展或不耐受的 GIST 患者，并授予其治疗 GIST 的孤儿药资格。

About IDRx

关于IDRx

IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumour escape mechanisms and prolong response to therapy. .

IDRx是一家临床阶段的生物制药公司，致力于通过智能设计的精准疗法改变癌症治疗。IDRx旨在通过高效和选择性靶向疗法解决当前精准抗癌药物的局限性，阻止关键的肿瘤逃逸机制并延长对治疗的反应。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性陈述的谨慎声明

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q4 Results for 2024..

GSK提醒投资者，GSK所做的任何前瞻性声明或预测，包括本公告中所包含的内容，均受可能导致实际结果与预测结果存在重大差异的风险和不确定性影响。这些因素包括但不限于GSK 2023年Form 20-F年度报告第3.D项“风险因素”中描述的内容，以及GSK 2024年第四季度财报中提及的信息。

References

参考文献

GSK enters agreement to acquire IDRx, Inc. - https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-idrx-inc/

GSK达成协议收购IDRx公司 - https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-idrx-inc/

Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500.

鲍尔 S，乔治 S，冯·梅伦 M，海因里希 MC。早期和下一代 KIT/PDGFRA 激酶抑制剂以及晚期胃肠道间质瘤治疗的未来。《肿瘤学前沿》。2021年7月12日；11:672500。

Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153

周 S，阿卜迪哈米德 O，谭 F，周 H，刘 H，李 Z，肖 S，李 B。KIT突变与表达：克服胃肠道间质瘤中伊马替尼耐药性的现有知识与新见解。细胞通讯与信号。2024年2月27日；22（1）：153

Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46.

Søreide K、Sandvik OM、Søreide JA、Giljaca V、Jureckova A、Bulusu VR。胃肠道间质瘤（GIST）的全球流行病学：基于人群的队列研究的系统综述。《癌症流行病学》。2016年2月；40卷：39-46页。

Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500.

鲍尔 S，乔治 S，冯·梅伦 M，海因里希 MC。早期和下一代 KIT/PDGFRA 激酶抑制剂以及晚期胃肠道间质瘤治疗的未来。《肿瘤学前沿》。2021年7月12日；11:672500。

Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153

周S，阿卜迪哈米德O，谭F，周H，刘H，李Z，肖S，李B。KIT突变与表达：克服胃肠道间质瘤中伊马替尼耐药性的现有知识与新见解。细胞通讯与信号。2024年2月27日；22（1）：153