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.

About GynTect

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 205^th on the Global For­tune 500 list.