Biocartis : and Wondfo Announce Joint Venture for Commercialization of Idylla™ Platform in China

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3 September 2018, 07:00 CST/ 01:00 CEST

Biocartis and Wondfo Announce Joint Venture for Commercialization of Idylla™ Platform in China

Mechelen, Belgium, and Guangzhou, China, 3 September 2018 - Biocartis Group NV, an innovative molecular diagnostics company ('Biocartis', Euronext Brussels: BCART), and Guangzhou Wondfo Biotech Co., Ltd. ('Wondfo', SHE: 300482), a fast growing diagnostics leader in China, announce entering into a joint venture aimed at the commercialization of the fully automated molecular diagnostics (MDx) Idylla™ platform in mainland China, within the field of oncology.

The Chinese MDx market is one of the fastest growing in the world and expected to reach a total value of USD 1.5bn by the end of 20221. This market growth is driven by, amongst others, a rising cancer incidence in China, with over 4 million diagnosed cancer cases in 20152, of which lung cancer is the most frequent cancer type in China with close to 800,000 patients being diagnosed every year3. Due to the rising cancer incidence, the number of targeted and immuno-oncology therapies that are prescribed based on molecular diagnostic test results is growing, with already over 500 immuno-oncology clinical trials that were ongoing in China in 20164.

Giving the increasing market demand for fast, high performing and cost effective MDx testing, the fully automated, real-time PCR5-based MDx Idylla™ platform is expected to provide Chinese laboratories and hospitals with a unique solution allowing for fast and easy access to molecular biomarker information, covering the entire process from sample to result within 150 minutes6. Moreover, the Idylla™ platform can analyse both RNA and DNA and can directly process, with less than two minutes hands-on time, both solid and liquid biopsy sample types, including FFPE (formalin-fixed paraffin embedded) tumor samples.

The initial activities of the joint venture are focused on the local manufacturing, commercialization and registration with the Chinese Regulatory Authorities (CFDA) of the existing products in the Idylla™ MDx oncology test menu for amongst others colorectal and lung cancer. Furthermore, in a next phase, the joint venture is expected to develop new Idylla™ assays tailored to meet specific needs for the Chinese market.

The joint venture will be 50% owned by Biocartis and 50% owned by Wondfo. In order to fund amongst others the initial product registration, manufacturing and commercialization efforts of the joint venture, both parties will, over several tranches, provide a total of EUR 14m of equity funding. The joint venture will acquire from Biocartis a license to the Idylla™ platform.

Herman Verrelst, Chief Executive Officer at Biocartis, commented: "We are proud and honored to announce our strategic collaboration with Wondfo for the Chinese market. With Wondfo, we team up with a partner that has deep knowledge and experience of the Chinese diagnostics market. The current size and expected growth of this market provide significant opportunities for Idylla™, whose features are an excellent fit with local market needs. Furthermore, we see great interest from pharma and test content partners to extend existing collaborations into China. The announcement today is as such a first important step in unlocking Idylla™'s commercial potential in China that will provide a broader cancer patient population with access to personalized medicines."

• 1 Source: DataMintelligence, "Global Molecular Diagnostics Market 2018-2025".

• 2 Oncology (14.3%) is the second largest market share after infectious diseases (72%). Source:https://www.ncbi.nlm.nih.gov/pubmed/26808342,last consulted on 30

August 2018.

• 3 Source: GB Times,https://gbtimes.com/lung-cancer-tops-chinas-malignant-tumour-incidence-rate,last consulted on 30 August 2018.

• 4 Source: Informa Pharma Intelligence,https://pharmaintelligence.informa.com/~/media/Informa-Shop-Window/Pharma/Whitepapers/IsChinathe_DarkHorse.pdf,last

consulted on 30 August 2018.

• 5 Polymerase Chain Reaction.

• 6 Actual turnaround time is assay-type dependent and ranges from 35 to 150 minutes.

Mrs. Jihua Wang, chairman of the board at Wondfo, added: "We are honored to announce our strategic collaboration with Biocartis. The Idylla™ technology and how it enables access to revolutionary personalized medicine already improved so many lives of cancer patients. We believe that thanks to the use of molecular diagnostics enabling innovative targeted therapies, one day, cancer might be treatable like a chronic disease. Through our collaboration with Biocartis, Wondfo will be the first to introduce the rapid, high precision MDx testing concept into the precision medicine field in China. Additionally, with a focus on developing companion diagnostic tests7, Wondfo will be able to expand its footprint to the therapeutic area and as such, close the loop. We sincerely hope that thanks to this collaboration and our joint efforts as leading diagnostic companies, patients and patient communities in China will soon be able to benefit from the advanced Idylla™ technology."

The closing of the collaboration between Biocartis and Wondfo is subject to certain customary closing conditions. The joint venture is expected to launch its operational activities towards the end of 2018.

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More information:

Wondfo 胡洪 Sabrina Hu, CFA 证券部总监 Director of Securities Dept.

直线(Direct): 020 3229 9999 手机(Mobile): 13751768436 邮箱(Email): 广州万孚生物技术股份有限公司 Guangzhou Wondfo Biotech Co., Ltd. 地址：广州市黄埔区科学城荔枝山路 8号 Address: No.8 Lizhishan Road, Scientific City, Huangpu District,Guangzhou, Guangdong, China

Biocartis

Renate Degrave

Manager Corporate Communications & Investor Relations [e-mail] tel [phone] mobile [phone]

@Biocartis_

www.linkedin.com/Biocartis

About Wondfo

Founded in 1992, Wondfo is a leading biotech company focusing on point of care testing (POCT) in China. Wondfo has strong technological basis, who has already built several biotech platforms. Wondfo consistently provides POCT products to our customers, helping them to quickly implement infectious diseases tests, drug use tests, pregnancy tests, tumor markers tests, cardiac marker tests, etc. With its headquarters in Guangzhou, as well as overseas laboratories in the US (San Diego, Chicago) and five other overseas offices, Wondfo has business activities in more than 110 countries worldwide, serving customers around the world. Wondfo is listed on the Shenzhen Exchange in China and currently has a market capitalization of USD 1.7bn and revenues of USD 160m in 20178.

About Biocartis

Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla™ platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market

• 7 A CDx test is a test used as a companion to a therapeutic drug that helps predict if a patient is likely to respond to a treatment or not.

• 8 Source:http://www.pharmexec.com/chinas-vitro-diagnostics-market-2018,last consulted on 30 August 2018.

worldwide. Today, Biocartis offers fifteen oncology tests and two infectious disease tests in Europe. More information:www.biocartis.com. Press Photo Library availablehere.Follow us onTwitter:@Biocartis_.

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