SOURCE: oncgnostics GmbH

oncgnostics GmbH

April 05, 2017 11:02 ET

GynTect soon available in China

oncgnostics grants exclusive license for GynTect to the Chinese SINOPHARM subsidiary CJMT; Approval for the Chinese market planned

JENA, GERMANY--(Marketwired - Apr 5, 2017) - The Chinese pharma company Changchun Jienuo Medical Technology (CJMT), a subsidiary of the Chinese state-owned SINOPHARM Group (www.sinopharm.com/en), has purchased an exclusive license from oncgnostics (www.oncgnostics.com) for marketing GynTect® in China, Hongkong and Macao. The contract comprising four milestones rules the approval of GynTect® at the Chinese Food and Drug Agency (CFDA) within the coming three years. Oncgnostics will receive upfront and milestone payments as well as royalties on future revenues.

During a visit of the Chinese partner in the science city Jena the contracts were signed in the presence of the Chairman of the Sinopharm Group, Mr. Jianxin Guo, and of Thuringia's Minister for Economics, Science and Digital Society, Mr. Wolfgang Tiefensee. "oncgnostics constitutes an exciting example how research in Jena is the basis of a promising business model. The cooperation with the Chinese partner which includes the distribution of the triage test GynTect, is the right and important step for the internationalization of the enterprise and the exploration of the by far largest patient market. This case shows that it is worth to support substantial innovative foundings, which are a main focus of our economic policy," Wolfgang Tiefensee explained during the signing ceremony.

The molecular diagnostic test GynTect (http://www.oncgnostics.com/gyntect-cervical-cancer/?lang=en) clarifies timely if a patient with abnormal Pap smear and/or positive HPV test result develops or already has a cervical cancer requiring treatment. GynTect provides fast and reliable results and thus certainty for women affected. Therefore, risk assessment in cervical cancer screening is significantly improved: on the one hand hasty and unnecessary surgeries can be avoided, on the other hand the chances for obtaining a successful treatment can be improved.

GynTect has received CE IVD mark for the EU market already in 2015. Together with its clinical partner at the University women's hospital in Jena, oncgnostics has driven forward validation of the markers, development of the test format and CE IVD mark of GynTect, using more than 2,000 clinically well-characterized samples. Together with its new partner CJMT oncgnostics intends to enter the enormous market in China. Cervical cancer diagnostics based on HPV screening yields a market potential of > 1 bn EUR .

In China, more than 550 million women aged > 15 years are at risk of developing cervical cancer. "China has a very high demand for screening and triage tests. GynTect will help us to diagnose cervical cancer and its precancerous stages reliably, in order to prevent unnecessary surgeries and to detect malignant tissue alterations early," Dr. Xiaokai Xia, director of the Chinese partner CJMT, stated.

CJMT, a subsidiary of the China National Biotech Group (CNBG; http://en.cnbg.com.cn/html/about/show_1.html), is specialized on clinical diagnostics. Both companies belong to the governmentally held SINOPHARM group (www.sinopharm.com/en), which with more than 100,000 employees and more than $40 bn annual turnover constitutes one of the largest pharma companies world-wide.

The exclusive license contract was signed on 5th of April 2017 at the BioInstrumentation center in a top-class event. Wolfgang Tiefensee, Thuringia's Minister for Economics, Science and Digital Society, welcomed the Chinese delegation comprising of 13 representatives. With Jianxin Guo, Chairman of the Sinopharm Group, Shengyi Shi, Vice President of Sinopharm Group and Xiaoming Yang, Chairman of CNBG, the top-level management of Sinopharm visited Jena. Besides the founders and the management of oncgnostics GmbH, the lead investors of the first two financing rounds High-Tech Gruenderfonds and beteiligungsmanagement thueringen GmbH, represented by their CEOs, Dr. Michael Brandkamp and Udo Werner, respectively, joined the signing ceremony.

About GynTect
In Germany 5000 new cases of cervical cancer are diagnosed, and approx.1600 women die from the disease annually. On the other hand, more than 200,000 women receive an abnormal result in the Pap smear diagnosis, the current cervical cancer screening method. Only a minority of these women, however, have a disease requiring treatment, as most of the diagnosed cervical dysplasias (cellular changes) will heal spontaneously. The early detection test GynTect yields fast and reliable results and thus certainty after an abnormal Pap smear and/or a positive HPV test result. GynTect may be performed on residual material from a cervical smear taken for liquid-based cytology. GynTect detects cancer cases with a sensitivity of 100% - all cancer cases included in studies so far yielded a positive GynTect result. The test is based on biomarkers that are present in cervical carcinomas as well as cervical dysplasias that develop into cancer.

About oncgnostics
oncgnostics GmbH is a spin-off from the university women's hospital Jena and was founded early in 2012. As a molecular diagnostic company oncgnostics is specialized on cancer diagnostics. Oncgnostics tests target epigenetic changes, so-called DNA methylations, that typically occur in cancer cells. The patented biomarkers which are evaluated using a specific algorithm are the core of the products and provide thus the basis for the company's activities.

About Sinopharm Inc. and CJMT
China National Pharmaceutical Group Corp. (CNPGC) known as Sinopharm is a Chinese state-owned enterprise. In 2015, Sinopharm Group had 104.464 employees, annual sales of more than $44bn and was ranked 205 in the global Fortune500 list (http://beta.fortune.com/global500/sinopharm-205).

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