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[其他] Shenogen与BioArdis签订了独家许可,以开发和商业化面向亚洲市 [复制链接]

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发表于 2020-4-4 17:23 |只看该作者 |倒序浏览 |打印
Shenogen enters into an Exclusive License with BioArdis to Develop and Commercialize Novel FGFR4 Kinase Inhibitor for Asian Market

    By BioArdis LLC;Shenogen Pharma Group; Apr 3, 2020 Updated 7 hrs ago

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BEIJING and SHANGHAI and SAN DIEGO, April 3, 2020 /PRNewswire/ -- Shenogen, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in China and beyond, today announced that it has entered into an exclusive collaboration and licensing agreement with Shanghai BioArdis Co., Ltd. and BioArdis LLC 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, Macau and Taiwan. 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.

About Shenogen
Shenogen Pharma Group is a drug discovery and development company founded in 2006 at Beijing, China. Shenogen aims to develop and commercialize first-in-class therapeutics for cancer and autoimmune diseases. With the mission of "Better Medicine, Better Life", we aim is to be a leading Chinese biopharmaceutical company with a growing worldwide footprint.

We have a seasoned management team leading a dynamic, creative and engaging workforce to strive hard towards our goals. A scientific advisory board composed of world-renowned scientists helps us to develop long-term strategies. Meanwhile, we are collaborating extensively with key research institutions and business partners to advance our pipeline.

For more information, please visit the website at www.shenogen.com

About BioArdis
BioArdis LLC, founded in 2017 with operations in San Diego and Shanghai, is a biopharmaceutical company that strives to discover and develop life-changing medicines for patients while also bringing value to the healthcare ecosystem.

We strive to advance the discovery and development of first-in-class and best-in-class therapeutics to validated targets for markets with significant medical need.

We are developing promising therapies and accelerating their development to pre-clinical development candidate (pre-IND enabling studies) leveraging our deep relationships with world-class scientists and business professionals with access to state-of-the-art facilities and capabilities.

For more information, please visit the website at www.bioardis.com  

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发表于 2020-4-4 17:24 |只看该作者
Shenogen与BioArdis签订了独家许可,以开发和商业化面向亚洲市场的新型FGFR4激酶抑制剂

由BioArdis LLC;申根制药集团; 2020年4月3日,更新7小时前

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北京,上海和圣地亚哥,2020年4月3日,美国生物技术公司PRNewswire / -Shenogen,致力于开发和商业化可满足中国及其他地区患者未满足的关键医疗需求的转化药物,今天宣布已独家与上海BioArdis有限公司和BioArdis LLC达成合作和许可协议,以开发BioArdis新型FGFR4(成纤维细胞生长因子受体4)激酶抑制剂BIO-1262 / SNG-203,并将其作为单一疗法或联合疗法中国大陆,香港,澳门和台湾。 BioArdis将在世界其他地区保留许可产品的所有权利。

BIO-1262被评估为对肝细胞癌(HCC)和其他对FGFR4和KLB(klotho beta)表达呈阳性的实体瘤的潜在新疗法。肝癌是最常见的肝癌形式。成纤维细胞生长因子受体(FGFRs)在调节细胞存活和增殖中起关键作用,越来越多的证据表明它们在癌症进展中也起作用。

根据该协议的条款,Shenogen将负责在与许可产品相关的领域内进行所有开发和商业化活动。

BioArdis首席商务官Ian Wisenberg表示:“由经验丰富的高级管理人员创立,他们具有丰富的全球和区域开发经验,并且潜在的互补性癌症疗法产品组合不断增长,是中国的理想合作伙伴。” “随着中国最近的监管改革以及像Shenogen这样的创新公司的出现,我们相信这种前瞻性的合作有可能扩大我们满足大中华地区重要患者需求的能力,同时支持BIO-1262 / SNG-203的全球发展“

北京申根制药集团董事长孟坤博士说:“我们对BioArdis选择性FGFR4抑制剂BIO-1262 / SNG-203的独家共同开发机会感到非常兴奋。” “来自Shenogen的伊利替林目前处于III期临床试验的晚期,该阶段以单药和联合疗法的方式治疗晚期肝细胞癌(HCC)。BIO-1262/ SNG-203的临床开发将有力地巩固我们的该公司在肝细胞癌治疗领域的领先地位。我们相信BIO-1262 / SNG-203作为潜在的最佳FGFR4选择抑制剂可以提供卓越的疗效并更好地满足中国患者的需求。”

根据疾病控制与预防中心的数据,肝癌是全球第五大最常见的癌症形式,亚洲的疾病发生率比美国高约30%,部分原因是未经治疗的乙型肝炎感染。

关于申根
Shenogen Pharma Group是一家药物发现与开发公司,于2006年在中国北京成立。 Shenogen致力于开发和商业化用于癌症和自身免疫性疾病的一流疗法。以“更好的医学,让生活更美好”为使命,我们的目标是成为全球领先的中国生物制药公司。

我们拥有一支经验丰富的管理团队,领导着一支充满活力,富有创造力和敬业精神的员工队伍,以朝着我们的目标努力。由世界知名科学家组成的科学顾问委员会可帮助我们制定长期战略。同时,我们正在与主要研究机构和业务合作伙伴广泛合作,以改善我们的产品线。

欲了解更多信息,请访问网站www.shenogen.com

关于BioArdis
BioArdis LLC成立于2017年,在圣地亚哥和上海设有业务部门,是一家生物制药公司,致力于为患者发现和开发改变生命的药物,同时也为医疗生态系统带来价值。

我们努力推动一流疗法和一流疗法的发现和开发,从而为具有重大医疗需求的市场确定目标。

我们正在开发有前途的疗法,并通过与世界一流的科学家和商业专业人员建立深厚的关系,并利用最先进的设施和能力,加快其开发为临床前开发候选药物(IND支持前的研究)的速度。

欲了解更多信息,请访问网站www.bioardis.com
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