Boehringer Ingelheim has signed a collaboration and license agreement with South Korean pharma company Yuhan, potentially worth up to $870m , for the latter’s fusion protein for the treatment of Nonalcoholic Steatohepatitis and related liver diseases.
The fusion protein, which is being developed for NASH, utilises the HyFc technology of Genexine. It has been developed in-house by South Korean pharma company.
The fusion protein is a dual agonist that combines GLP-1 and FGF21 activity. It is expected to reduce liver cell injury and also hepatic inflammation through resolution of steatohepatitis.
The molecule, which is also said to have direct antifibrotic effects, complements the research and development (R&D) portfolio of Boehringer Ingelheim in NASH. The partners said that preclinical evidence indicates high efficacy when the gut-derived hormone GLP-1 is combined with FGF21.
The collaboration combines the expertise of the Korean firm in FGF21 biology, obesity and NASH, with the pharmaceutical expertise and commitment of Boehringer Ingelheim to develop drugs for cardiometabolic diseases.
Boehringer Ingelheim board of managing directors member Michel Pairet said: “We are excited about this new opportunity which adds to our longstanding and successful partnership with Yuhan Corporation.
“This partnership brings us closer to next generation treatments for patients with NASH.”
As per the terms of the agreement, Yuhan will be paid $40m (£31.67m) as upfront and near term payments by the German pharma company. Additionally, the company will be entitled to be paid up to $830m (£657.22m) in potential milestone payments and tiered royalties on net sales in the future.
For Yuhan, the collaboration with Boehringer Ingelheim on the molecule marks the first external partnership with biologics. Apart from that, it is also the first out-licensing of biologics targeting NASH from South Korea.
Yuhan CEO and president Jung Hee Lee said: “We look forward to working jointly with Boehringer Ingelheim, with its strong track record of bringing new treatments to patients with cardiometabolic disease. Boehringer Ingelheim’s clinical expertise will now be applied to the development of this drug which has the potential to make a real difference for patients with NASH.”
Earlier this year, the Boehringer Ingelheim acquired ICD Therapeutics, a MacroDel biologics-delivery platform developer, for an undisclosed amount.
勃林格殷格翰（Boehringer Ingelheim）已与韩国制药公司誉衡（ Yuhan ）签署了一项合作和许可协议，可能价值高达8.7亿美元，用于后者治疗非酒精性脂肪性肝炎和相关肝病的融合蛋白。
为 NASH 开发的融合蛋白利用了 Genexine 的 HyFc 技术。它由韩国制药公司自行研发。
融合蛋白是一种结合 GLP-1和 FGF21活性的双重激动剂。通过对脂肪性肝炎的治疗，有望减少肝细胞损伤和肝脏炎症。
该分子也被认为具有直接的抗纤维效应，补充了勃林格殷格翰（Boehringer Ingelheim）在 NASH 的研发（研发）组合。合作伙伴表示，临床前证据表明，当肠源性激素 GLP-1与 FGF21联合使用时，疗效很高。
此次合作结合了韩国公司在 FGF21生物学、肥胖和 NASH 方面的专业知识，以及勃林格殷格翰（Boehringer Ingelheim）开发心血管代谢性疾病药物的制药专业知识和承诺。
勃林格殷格翰（Boehringer Ingelheim）董事会董事总经理 Michel Paret 表示：“我们对这一新机遇感到兴奋，这增加了我们与余杭公司的长期成功合作关系。
“这种合作关系使我们更接近 NASH 患者的下一代治疗。”
对于余汉来说，与勃林格殷格翰（Boehringer Ingelheim）在分子上的合作，标志着首次与生物技术的外部合作。除此之外，它也是第一个针对韩国 NASH 的生物制剂的外部许可。
余安首席执行官兼总裁 Jung Hee Lee 表示：“我们期待着与勃林格殷格翰( Boehringer Ingelheim )合作，凭借其为心脏病患者提供新治疗的良好记录。勃林格殷格翰（Boehringer Ingelheim）的临床专业知识现在将应用于该药物的开发，该药物有可能对 NASH 患者产生真正的影响。”
今年早些时候，勃林格殷格翰（Boehringer Ingelheim）以未披露的价格收购了 MacroDel 生物制剂交付平台开发商 ICD Therapeutics 。