Shenogen enters into an exclusive license with BioArdis to develop and commercialise FGFR4 kinase inhibitor for Asian market

Shenogen has entered into an exclusive collaboration and licensing agreement with Shanghai BioArdis and BioArdis for the development and commercialization of BioArdis' novel FGFR4 (fibroblast growth factor receptor 4) kinase inhibitor, BIO-1262/SNG-203, either as monotherapy or combination therapy in Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.

BioArdis will retain all rights to the licensed product in the rest of the world.

BIO-1262 is being evaluated as a potential new treatment for hepatocellular carcinoma (HCC) and other solid tumors positive for FGFR4 and KLB (klotho beta) expression. HCC is the most common form of liver cancer. Fibroblast growth factor receptors (FGFRs) play a key role in regulating cell survival and proliferation, and a growing body of evidence suggests they also play a role in cancer progression.

Pursuant to the terms of the agreement, Shenogen will be responsible for conducting all development and commercialization activities in the territory related to the licensed product.

"Founded by seasoned executives with deep global and regional development experience and with a growing portfolio of potentially complementary cancer therapies, Shenogen is an ideal partner in China," said Ian Wisenberg, Chief Business Officer of BioArdis. "With recent regulatory reforms in China and the emergence of innovative companies like Shenogen, we believe this forward-looking collaboration has the potential to expand our ability to address significant patient needs in Greater China while supporting global development of BIO-1262/SNG-203."

"We are very excited about the exclusive co-development opportunity for BioArdis’ selective FGFR4 inhibitor BIO-1262/SNG-203," commented Dr. Meng Kun, chairman of Beijing Shenogen Pharmaceutical Group. "Icaritin from Shenogen is currently in late stage of phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC) as a single agent and in combination therapies. The addition of clinical development of BIO-1262/SNG-203 will strategically solidify our company’s leading position in the field of hepatocellular carcinoma treatments. We believe that BIO-1262/SNG-203 as a potentially best-in-class FGFR4 selective inhibitors can provide superior efficacy and better meet the needs of Chinese patients."

According to the Centers for Disease Control and Prevention, liver cancer is the fifth most common form of cancer worldwide, with disease rates in Asia approximately 30 percent higher than in the U.S. due in part to untreated hepatitis B infections.

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