Portfolio | Terns Pharmaceuticals获得礼来三项NASH资产的全球独家开发和商业化权益

加州圣马特奥--(BUSINESSWIRE)-- (美国商业资讯) -- Terns Pharmaceuticals Inc.是一家全球性生物制药公司，致力于治疗肝病和癌症的口服小分子创新药的研发。该公司于2018年4月4日宣布已与礼来公司签署全球性授权协议，获得三个有望用于治疗非酒精性脂肪性肝炎(NASH) 的小分子候选药物的全球独家开发和商业化权益。协议包括临床阶段的法尼醇X受体(FXR)激动剂TERN-101、即将申报IND的氨基脲敏感性胺氧化酶(SSAO)抑制剂TERN-201和一个临床前候选药物（该药物可抑制一个未披露的、已经通过临床验证的NASH靶点）。Terns Pharmaceuticals计划向中国监管部门报批临床开发计划，同时探索在其他全球市场进行临床开发。

Terns总裁兼首席执行官Weidong Zhong, Ph.D.表示：“与礼来签署该协议，我们感到很振奋，因为它完美契合了本公司着眼于向全球缺乏有效药物的广大患者提供创新药物的战略。上述候选药物加入本公司现有的药物开发线后，Terns就拥有了一个针对NASH和癌症的全方位一体化的临床和临床前药物开发阵容。此合作协议还使本公司具备了在临床开发早期进行多类药物联合使用研究的可行性，从而找到针对NASH的最佳治疗方案。”

礼来公司糖尿病研究和临床开发副总裁Ruth Gimeno, Ph.D.表示：“我们很高兴与Terns Pharmaceuticals签署该协议，因为本公司致力于推进深化双方的共同目标，即生产药物来帮助人们生活地更长、更健康、更有活力。礼来致力于改善糖尿病病人的生活，我们认为NASH是糖尿病的一个重要合并症和并发症。Terns在药物研发及在中国从事肝病临床研究的经验将进一步充实本公司内部的研究努力，对于上述潜在药品在中国及世界各国的进一步开发至关重要。

法尼醇X受体(FXR)激动机制和TERN-101

FXR是肝脏和小肠中大量表达的一种核受体。胆汁酸(BA)是FXR的天然配体，胆汁酸与FXR的结合以及对FXR的激活对于调节BA合成、脂质代谢、炎症和纤维化的细胞通路的调控至关重要。科学界普遍认为，FXR激动机制和激活有望成为治疗非酒精性脂肪肝病(NAFLD)和非酒精性脂肪性肝炎(NASH)的新型治疗模式。TERN-101是高效非胆汁酸类FXR激动剂，正在开发用于治疗NASH。

氨基脲敏感性胺氧化酶(SSAO)抑制和TERN-201

SSAO又名血管粘附蛋白-1(VAP-1)，是具有双重功能的胺氧化酶，可促进白细胞在肝脏中的募集，并能导致氧化应激增加、炎症和肝脏纤维化。表面SSAO水平在炎性组织的血管结构中有上调，可溶性SSAO水平在NASH患者中有升高。抑制SSAO有望成为治疗NAFLD、NASH和其他慢性纤维化肝病的有效药物。TERN-201是强效SSAO抑制剂，通过减少氧化应激和白细胞肝内募集，有用于治疗NASH的潜力。

关于NASH

非酒精性脂肪性肝炎(NASH)是非酒精性脂肪肝病(NAFLD)的重症类型，由肝脏中脂肪过多堆积所导致。NASH可导致慢性肝脏炎症和肝细胞损伤，且可导致纤维化、肝硬化，最终导致肝癌或肝功能衰竭。全球NAFLD和NASH发生率正快速攀升，与肥胖发生率攀升有关。据估计，中国成人群体中15%有NAFLD。这些患者中，估计有20%将发生NASH。目前尚无药物核准用于治疗NASH。

关于Terns Pharmaceuticals

Terns Pharmaceuticals是一家全球性生物制药公司，致力于治疗肝病和癌症的分子靶向、口服小分子创新药物的研发，在加州圣马特奥和中国上海（上海拓臻生物科技有限公司 Terns China Biotechnology）设有总部。公司综合其在疾病生物学、药物化学领域的专项技能以及在中国进行临床开发的经验和能力，推进其不断增长的药物产品管线，这些药物经过优化，可抗击经过临床验证或经过大量临床前验证的靶点。公司采用具有高资本效率的药物研发模式，致力于通过具有全球及地区针对性的临床开发项目向全球缺乏有效药物的广大患者提供治疗新药。Terns计划向中国监管部门报批临床开发计划，同时探索在其他全球市场进行临床开发。欲了解进一步信息，请访问www.TernsPharma.com。

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附英文新闻：

TERNS PHARMACEUTICALS ACQUIRES GLOBAL, EXCLUSIVE RIGHTS TO DEVELOP AND COMMERCIALIZE THREE NASH ASSETS FROM LILLY

APRIL 4, 2018

Deal Includes an FXR Agonist, an SSAO Inhibitor and An Additional Candidate Against a Well-Validated NASH Target

Development of Clinical Programs Will Focus on Regulatory Approval in China and Additional Global Markets

SAN MATEO, Calif. ‐ Terns Pharmaceuticals Inc., a globalbio pharmaceutical company focused on discovering and developing molecularly targeted, oral, small molecule drugs to treat liver disease and cancer, announced today it has signed a global, exclusive license agreement with Eli Lilly and Company to develop, manufacture and commercialize three small molecule therapeutic candidates for the potential treatment of non-alcoholic steatohepatitis (NASH). The agreement includes a clinical stage farnesoid  X receptor (FXR) agonist, TERN-101, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, TERN-201, which is nearing IND submission, and a preclinical candidate that inhibits an undisclosed, well-validated NASH target. Terns Pharmaceuticals plans to focus initial development activities on regulatory approval in China and explore clinical development in additional global markets.

“We are excited about this agreement with Lilly, as it perfectly fits our strategy of bringing innovative therapeutics to underserved patients globally,” said Weidong Zhong, Ph.D., President and CEO of Terns. “The addition of these candidates to our current portfolio of discovery projects provides Terns with a fully integrated preclinical and clinical pipeline of products targeting both NASH and cancer. This also positions us well to investigate combination therapies early during clinical development to identify the best treatment regimens for NASH.”

“We are pleased to enter into this agreement with Terns Pharmaceuticals as we work to further our shared goal of making medicines to help people live longer, healthier, more active lives,” said Ruth Gimeno, Ph.D., Vice President, Diabetes Research and Clinical Investigation at Lilly. “We are committed to improving the lives of people affected with diabetes, and we view NASH as an important comorbidity and complication of diabetes. The experience of Terns in drug discovery and clinical development for liver disease in China will complement our internal research efforts and will be critical as these potential medicines are further developed in China and around the world.”

Farnesoid X Receptor (FXR) Agonism and TERN-101

FXR is a nuclear receptor expressed in high amounts in the liver and small intestine. Bile acids (BA) are natural ligands of FXR, and their binding with and activation of FXR is critical to the regulation of cellular pathways that modulate BA synthesis, lipid metabolism, inflammation and fibrosis. It is believed by many in the scientific community that FXR agonism and activation has potential as a new treatment modality for nonalcoholic fatty liver disease (NAFLD) and non- alcoholic steatohepatitis (NASH). TERN-101 is a potent non-bile acid FXR agonist being developed as a therapeutic for NASH.

Semicarbazide-Sensitive Amine Oxidase (SSAO) Inhibition and TERN-201

SSAO, also known as vascular adhesion protein-1 (VAP-1), is a dual-function amine oxidase which promotes recruitment of white blood cells in the liver, and can result in increased oxidative stress, inflammation and hepatic fibrosis. The level of surface SSAO is upregulated in the vasculature of inflamed tissues, and soluble SSAO levels are elevated in patients with NASH. Inhibition of SSAO is believed to have therapeutic benefit for the treatment of NAFLD, NASH and other chronic fibrotic liver diseases. TERN-201 is a potent SSAO inhibitor which provides an additional treatment mechanism for NASH by reducing oxidative stress and recruitment of white blood cells to the liver.

About NASH

Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD), which is caused by the accumulation of excess fat in the liver. NASH is associated with chronic liver inflammation and liver cell injury, and it can lead to fibrosis, cirrhosis and eventually liver cancer or liver failure. Global rates of NAFLD and NASH are increasing rapidly, in tandem with rising rates of obesity. It is estimated that 15 percent of the Chinese adult population has NAFLD. Of those patients, an estimated 20 percent will develop NASH. There is currently no approved medication for the treatment of NASH.

About Terns Pharmaceuticals

Based in San Mateo, CA., and Shanghai, China, Terns Pharmaceuticals is a global biopharmaceutical company committed to discovering and developing molecularly targeted, oral, small molecule drugs to treat liver disease and cancer. The company combines expertise in disease biology, medicinal chemistry and extensive clinical development capabilities in China to advance its growing pipeline of drugs that are optimized against clinically validated targets or targets that have significant preclinical validation. Using a capital-efficient drug discovery model, the company’s mission is to bring promising new therapies to patients in underserved markets via global and region-specific development programs. Terns plans to focus initial development activities on regulatory approval in China and explore clinical development inadditional global markets. For more information, visit www.TernsPharma.com.

Contacts

TernsPharmaceuticals Inc.

US Media Contact

Cory Tromblee, 617-571-7220 or

China Media Contact

Eddy Wu, [phone]

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