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September 2, 2015

Incyte to Co-Develop Hengrui's SHR-1210 in Up-to-$795M+ Deal

  • Incyte said today it gained exclusive development and commercialization rights to Jiangsu Hengrui Medicine’s SHR-1210, an anti-PD-1 monoclonal antibody heading into proof-of-concept studies on patients with advanced solid tumors.

    The deal—which could generate up to $795 million-plus for Hengrui—also includes several unspecified “back-up compounds,” Incyte stated in a Form 8-K filing.

    SHR-1210 is an immune checkpoint blockade designed to work by inhibiting the interaction between PD-1 and PD-L1. SHR-1210 will be assessed in an upcoming open-label, multicenter, nonrandomized, dose-escalation Phase I trial (NCT02492789) that was not yet open for patient recruitment as of July 6, according to the study’s page on ClinicalTrials.gov.

    The upcoming trial will enroll patients with advanced solid tumor who have failed current standard anti-tumor therapies. The study’s estimated completion date is July 2016.

    “The addition of this anti-PD-1 candidate to our early stage portfolio reinforces our commitment to cancer patients and further diversifies our clinical development programs,” Incyte president and CEO Hervé Hoppenot said in a statement.

    Incyte secured SHR-1210 rights for most of the world—except for China, Hong Kong, Macau, and Taiwan—in return for paying Hengrui $25 million upfront. Incyte also agreed to pay Hengrui up to $770 million in payments tied to achieving milestones.

    Incyte said its potential milestone payments consist of $90 million for regulatory approval milestones, $530 million for commercial performance milestones, and $150 million for clinical superiority. Hengrui will also receive tiered royalties “in the high single digits to mid-double digits” on net sales of SHR-1210 in Incyte territories, Incyte said in the filing.

    Hengrui and Incyte will assume all financial obligations associated with the development and commercialization of SHR-1210 in their respective territories, Incyte said.

    “We are pleased to see Incyte’s commitment to this PD-1 program. Combining the expertise and resources of both companies can accelerate the development of SHR-1210,” Hengrui chairman Piaoyang Sun added.

    Established in 1970, Hengrui is a fully integrated pharmaceutical company headquartered in Lianyungang, Jiangsu Province, China. According to its website, Hengrui’s annual net sales exceed $1.2 billion. In addition to oncology, Hengrui's therapeutic areas include hematology, anesthesiology and pain management, cardiovascular and metabolic diseases, contrast media, and inflammation.

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