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Horizon Discovery Group plc. (11/16/16). "Press Release: Horizon Discovery Enters Chinese Clinical Diagnostics Market". Cambridge.

Region Region China
Organisations Organisation Horizon Discovery Group plc (LSE: HZD)
  Group Horizon Discovery (Group)
  Organisation 2 CFDA (Chinese Food and Drug Administration)
  Today National Medical Products Administration of China (NMPA, formerly CFDA)
  Group China (govt)
Products Product cell free DNA HDx™ Reference Standards (cfDNA Reference Standards)
  Product 2 Next Generation Sequencing (NGS) technology [about 2007/8]
Persons Person Disley, Darrin M. (Mogrify 201902– CEO of Cell Mogrify Ltd before 11 years at Horizon Discovery)
  Person 2 Wei, Liangshen (Horizon Discovery 201611 Head of Emerging Markets Team)
     


· 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 (LSE: HZD) ("Horizon"), 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 (OEM) 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 20211.

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.”


- ENDS -


1. China In Vitro Diagnostics (IVD) – Opportunity Assessment, Competitive Landscape and Market Forecasts to 2021, DPI Research, 2016


For further information about Horizon Discovery Group plc, please contact:


Horizon Discovery Group plc
Chris Claxton, VP Investor Relations and Corporate Communications
Tel +44 (0) 1223 655 580

Zyme Communications (Trade and Regional Media)
Katie Odgaard
Tel: +44 (0)7787 502 947
Email: katie.odgaard@zymecommunications.com

Consilium Strategic Communications (Financial Media and Investor Relations)
Mary-Jane Elliott, Susan Stuart, Matthew Neal, Melissa Gardiner
Tel: +44 (0) 20 3709 5701
Email: horizon@consilium-comms.com

Numis Securities Limited (Joint Broker and NOMAD)
Michael Meade / Freddie Barnfield
Tel: +44 (0) 207 260 1000

RBC Capital Markets (Joint Broker)
Paul Tomasic / Marcus Jackson
Tel: +44 (0) 20 7653 4000


Notes for Editors:


About Horizon Discovery Group plc www.horizondiscovery.com/

Horizon Discovery Group plc (LSE: HZD) ("Horizon"), is a world-leading gene editing company that designs and engineers genetically-modified cells and then applies them in research and clinical applications that advance human health.

Horizon’s core capabilities are built around its proprietary translational genomics platform, a highly precise and flexible suite of gene editing tools (rAAV, ZFN and CRISPR) able to alter almost any gene sequence in human or mammalian cell-lines.

Horizon offers over 23,000 catalogue products and related research services, almost all of which are based on the generation and application of cell and in vivo models that accurately recapitulate the disease-causing genetic anomalies found in diseases like cancer. Horizon’s commercial offering has been adopted by c1,600 unique research organisations in over 50 countries as well as in the Company’s own R&D pipeline to support a greater understanding of the genetic drivers of disease and the development of molecular, cell and gene therapies that can be prescribed on a personalised basis.

Horizon is headquartered in Cambridge, UK, and is listed on the London Stock Exchange’s AIM market under the ticker “HZD”.

   
Record changed: 2019-06-09

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