Roche on Monday agreed to pay $850 million to acquire two experimental breast cancer drugs being developed by China-based biotechnology startup Regor Therapeutics.

罗氏周一同意斥资8.5亿美元收购两家由中国生物技术初创公司Regor Therapeutics开发的实验性乳腺癌药物。

The deal hands Roche two medicines that Regor, in a statement, described as “next-generation” versions of the CDK inhibitors widely used to treat certain breast cancers. One prospect is in early-stage testing already, while the other is ready to begin its first human trials. In a presentation to investors, Roche executives revealed early data showing one of the drugs, RGT-419B, has “durable single agent activity” in people whose cancers have progressed after treatment with CDK drugs like Pfizer’s Ibrance and Eli Lilly’s Verzenio..

这笔交易将罗氏公司的两种药物交给了雷格，雷格在一份声明中称这两种药物是广泛用于治疗某些乳腺癌的CDK抑制剂的“下一代”版本。一种前景已经处于早期测试阶段，而另一种前景则准备开始其首次人体试验。在向投资者介绍的情况下，罗氏高管透露，早期数据显示，其中一种药物RGT-419B在接受辉瑞（Pfizer）的Ibrance和礼来（Eli Lilly）的Verzenio等CDK药物治疗后癌症进展的患者中具有“持久的单药活性”。

Roche is building on a pipeline of breast cancer therapies focused on people whose tumors respond to hormone therapy, but not HER2-targeting medicines like its popular drug Herceptin. One, called inavolisib, could be approved in the U.S. by Nov. 27 for use in a regimen involving Ibrance.

罗氏正在建立一个乳腺癌治疗管道，该管道主要针对肿瘤对激素治疗有反应的人群，但不针对HER2靶向药物，如其流行药物赫赛汀。其中一种名为inavolisib的药物可能于11月27日在美国获得批准，用于涉及Ibrance的治疗方案。

Dive Insight:

潜水洞察：

Almost three decades ago, Roche’s now-subsidiary Genentech revolutionized breast cancer care. A drug it developed, Herceptin, in 1998 became the first targeted treatment for people with so-called HER2-positive disease, an aggressive tumor associated with poor health outcomes. The outlook for people with HER2 breast cancers has substantially improved since, with the advent of follow-on drugs like Perjeta and Kadcyla, as well as newer medicines..

大约三十年前，罗氏现在的子公司Genentech彻底改变了乳腺癌护理。它于1998年开发的一种药物赫赛汀成为第一种针对所谓HER2阳性疾病患者的靶向治疗药物，HER2阳性疾病是一种侵袭性肿瘤，与健康状况不佳有关。自那以后，随着Perjeta和Kadcyla等后续药物以及新药的出现，HER2乳腺癌患者的前景大大改善。

Roche is now trying to make inroads elsewhere in breast cancer. In addition to inavolisib, the company also has in late-stage trials a type of treatment it hopes to prove superior to a decades-old hormone therapy. And with the Regor deal, it’s added two prospects it’s positioning as successors to so-called CDK 4/6 inhibitors like Ibrance, Verzenio and Novartis’ Kisqali, which are used in multiple breast cancer settings..

罗氏目前正试图在乳腺癌的其他领域取得进展。除了inavolisib之外，该公司还在后期试验中使用了一种治疗方法，希望证明其优于几十年前的激素疗法。通过Regor协议，它增加了两个前景，它将其定位为所谓的CDK4/6抑制剂的继任者，如Ibrance，Verzenio和Novartis的Kisqali，它们用于多种乳腺癌环境。

Roche sees the drugs as potentially able to sidestep some of the immune, gastrointestinal and cardiovascular side effects associated with CDK blockers. In its presentation Monday, it also noted how RGT-419B acts on a target, CDK2, that tumors use to develop resistance to other therapies. The drug has “best-in-class” potential, Roche claimed..

罗氏认为这些药物有可能避免与CDK阻滞剂相关的一些免疫，胃肠道和心血管副作用。在周一的演讲中，它还注意到RGT-419B如何作用于肿瘤用于产生对其他疗法的耐药性的靶点CDK2。罗氏声称，这种药物具有“同类最佳”的潜力。

So far in its Phase 1 trial, Regor has evaluated four dose levels of RGT-419B in people who’ve already progressed on a CDK therapy. According to Roche, the drug shrank tumors in four of 12 patients, two of whom had responses lasting through 35 months. The company intends to start a Phase 2 trial next year testing it alongside hormone therapy..

到目前为止，在其第一阶段试验中，Regor评估了已经在CDK治疗中取得进展的人中RGT-419B的四个剂量水平。据罗氏公司称，该药物使12名患者中的4名肿瘤缩小，其中2名患者的反应持续了35个月。该公司计划明年开始第二阶段试验，与激素疗法一起进行测试。

In addition to the $850 million upfront payment, Regor stands to receive future payouts if the drugs hit certain clinical, regulatory and commercial milestones. Regor will continue to manage ongoing Phase 1 clinical trials, while Roche will take over clinical development, manufacturing and commercialization responsibilities..

除了8.5亿美元的预付款外，如果药物达到某些临床，监管和商业里程碑，Regor还将获得未来的付款。Regor将继续管理正在进行的1期临床试验，而Roche将接管临床开发、制造和商业化职责。