Three leading Chinese diagnostic kit manufacturers have initiated clinical trials using Horizon HDx Reference Standards. Agreements provide upfront revenue with potential for strong recurring revenue streams post regulatory approvals.
Horizon Discovery Group plc, the world leader in the application of gene editing technologies, today announces that it has entered into partnerships with three leading Chinese diagnostic kit developers. Under the terms of the agreements, Horizon will provide HDx Reference Standards for novel Next Generation Sequencing (NGS) assay development, clinical trials, and ultimately for inclusion as in-kit controls under Original Equipment Manufacturer agreements.
Under these agreements, Horizon will support the development of new NGS diagnostic assays that, upon approval by the Chinese FDA, will be used to identify which patients would benefit from receiving novel targeted therapies to treat solid and liquid tumours.
The developers will initially pay Horizon for Reference Standards for use as quality controls in their assay development and clinical trial programmes, with typical revenues expected from each programme in the mid- to high five figure (sterling) range.
Assays in China are under obligation by the Chinese FDA not to make any changes in the format of the test for a period of five years from approval, and so Horizon is in discussions with each developer to provide Reference Standards as in-kit controls for a minimum of five years post-clearance. Cleared assays under such agreements would provide Horizon with expected revenues in the six figure (sterling) range per annum. Each developer is anticipated to develop three to four assays per year over the next several years with Horizon providing Reference Standards for each. The first assays are anticipated by partners to be approved in 2018.
Based on this initial work, Horizon is now being approached for additional partnerships with the estimated 20-30 other players in a market which is among the fastest growing in the world, with strong double digit growth rates expected to reach US$ 10 Billion by 2021.
Dr. Darrin Disley, CEO, Horizon Discovery Group, commented: “Our leadership and brand reputation has allowed us to enter the important Chinese market, leading with our HDx reference standards and bioproduction cell lines. Our dedicated emerging markets team, under the leadership of Dr. Liangshen Wei, is establishing the relationships and status necessary to succeed in this large, growing, but complex market. Today’s announcement is a validation of this effort as we establish Horizon as the preeminent provider of Reference Standards to China, initially for NGS applications and soon expanding to other genomic assays and immunohistochemistry.”