The Chinese pharmaceutical company Changchun Jienuo Medical Technology (CJMT), a subsidiary of the Chinese state-owned Sinopharm Group (www.sinopharm.com/en), has acquired an exclusive licence for the cervical cancer screening test GynTect for China, Hong Kong and Macao from the Jena-based company oncgnostics (www.oncgnostics.com). A four-milestone agreement outlines how to obtain China Food and Drug Administration (CFDA) approval for GynTect within three years. oncgnostics will receive upfront and milestone payments as well as a share of future sales.
The official signing of the contract took place during a visit of the Chinese partner in the science city of Jena in the presence of the managing director of the Sinopharm Group Jianxin Guo and the Thuringian Minister of Economics and Science Wolfgang Tiefensee. “oncgnostics GmbH is an excellent example of how research in Jena can form the basis for a promising business model. The cooperation with the Chinese partner on the distribution of the clarification test GynTect® is the right and important step towards internationalising the company and opening up the world’s largest market of female patients. This shows that the promotion of substantial innovative start-ups, which is a special focus of our economic policy, pays off,” explained Wolfgang Tiefensee on the occasion of the signing of the contract.
The molecular biological test GynTect developed by oncgnostics determines at an early stage whether a patient with a conspicuous Pap test result or a human papillomavirus infection (HPV) has a cervical carcinoma (cervical cancer) that needs to be treated. GynTect provides fast and reliable examination results and thus gives affected women just as much certainty as to how best to proceed with a conspicuous preliminary examination. This greatly facilitates risk assessment in early cervical cancer detection: on the one hand, unnecessary, premature operations can be avoided, and on the other hand, the chances of successful treatment measures can be increased.
GynTect is already approved for use in laboratories throughout Europe via the CE-IVD approval obtained in 2015. The validation of the markers, the development of the test format and the CE-IVD approval of GynTect was driven forward by oncgnostics in close cooperation with the University Women’s Hospital Jena on the basis of more than 2000 clinically validated samples. With its partner CJMT, oncgnostics aims to tap into the huge market in China with an annual market potential of >€1 billion.
There are over 550 million women aged 15 and over living in the People’s Republic of China, all of whom are at risk of developing cervical cancer. “There is a very high demand for reliable screening and detection tests in China. GynTect will help us to reliably diagnose cervical cancer and its precursors, avoid unnecessary surgery and, most importantly, detect malignant tissue changes in time,” said Dr Xiaokai Xia, Managing Director of Chinese partner CJMT at the signing ceremony.
CJMT is the subsidiary of the China National Biotech Group (CNBG) specialising in clinical diagnostics. Both belong to the state-owned pharmaceutical group SINOPHARM (www.sinopharm.com/en). The Sinopharm Group is one of the world’s largest pharmaceutical companies with over 100,000 employees and more than US$40 billion in sales (2015).
The signing of the exclusive licence agreement took place on 5 April 2017 at the Bioinstrument Centre in Jena in a high-profile gathering. Economics Minister Wolfgang Tiefensee welcomed the 11-member Chinese delegation. With Jianxin Guo, Managing Director of Sinopharm Group, Shengyi Shi, Vice President of Sinopharm Group and Xiaoming Yang, Managing Director of CNBG, the top management of Sinopharm was in Jena. In addition to the founding and management team of oncgnostics GmbH, Dr. Michael Brandkamp (High Tech Gründer Fonds, HTGF) and Udo Werner (Beteiligungsmanagement Thüringen GmbH, bm‑t), the managing directors of the lead investors of oncgnostics’ first two financing rounds were also present.
In Germany, almost 5,000 new cases of cervical cancer are diagnosed every year and more than 1,600 women die from this disease every year. On the other hand, about 200,000 women in Germany receive an abnormal diagnosis in the Pap test every year. Only very few of these women have a disease that needs to be treated, because most dysplasias (cell changes) regress on their own. The early detection test GynTect quickly and reliably provides certainty in the case of a positive Pap or HPV test result. GynTect can be performed on a sample that has already been taken for thin-layer cytology. The sensitivity of GynTect for detecting cancer is 100%. This means that all patients with cervical cancer also received a positive result. The test works with biomarkers that only occur in cervical cancer or those dysplasias that also lead to it.
About oncgnostics GmbH:
oncgnostics GmbH was founded in 2012 as a spin-off from a university research group at the University Women’s Hospital in Jena. As a molecular diagnostics company, the Jena-based start-up specialises in the diagnosis of cancer. The tests detect characteristic epigenetic changes, so-called DNA methylations, in cancer cells. The biomarkers identified and patented with a special algorithm form the core of the products and are the basis of the company.
About SINOPHARM Group and CJMT:
China National Pharmaceutical Group Corp. (CNPGC), known as Sinopharm, is a state-owned Chinese company. In 2015, Sinopharm had 104,464 employees and annual sales of over $44 billion. It is also ranked 205th on the Global Fortune 500 list.