Portfolio | 加科思SHP2抑制剂获IIa期临床批件并获FDA的孤儿药认定

—— 加科思SHP2抑制剂获得多种实体瘤的IIa期临床研究批件，并获得美国FDA用于食道癌治疗的孤儿药认定

由北京加科思新药研发有限公司自主研发的原创新药JAB-3068于2018年4月和11月分别在美国和中国启动了多种实体瘤的I期临床试验，并于2019年5月获得IIa期临床研究批件，即将进入多种实体瘤治疗的疗效探索阶段。

2019年2月28日，美国食品药品监督管理局(FDA)授予了JAB-3068治疗食管癌的孤儿药资格认定，可用于支持该药在食管癌适应症上的全球开发。

JAB-3068是一款全新的具有自主知识产权的酪氨酸蛋白磷酸酶抑制剂（Protein tyrosine phosphatase inhibitor, PTPi），全球共有三家制药企业在该领域从事抗肿瘤药的 I 期临床研究。JAB-3068同时具有肿瘤免疫和靶向治疗机制，单独口服给药有非常显著的抗肿瘤作用，同时能够促进肿瘤免疫的功能，可以与PD-1抗体及其它药物联合应用。

关于加科思

加科思新药研发有限公司是一家总部位于北京亦庄，以原创药研发为核心的制药公司，专注于为重大疾病治疗提供突破性创新产品，为人类的健康发展提供更多的解决方案，公司愿景是成长为全球具有影响力的制药企业。公司在美国波士顿设立了研发中心，用以促进和协调全球的新药开发。

礼来亚洲基金是加科思A轮投资人，并持续支持公司发展。 

Jacobio’s  SHP2 inhibitor (JAB-3068) independently developed by Jacobio Pharmaceuticals Co., Ltd. entered human clinical trials for multiple solid tumors in the United States (April 2018) and China (November 2018). A Phase IIa clinical study approval was obtained in May 2019, which will allow the drug to enter the stage of efficacy exploration for multiple solid tumor types.

On Feb 28th 2019,  the US Food and Drug Administration (FDA)  also awarded JAB-3068 orphan drug designation for the treatment of esophageal cancer, providing substantial support for the drug‘s global development for this indication.

JAB-3068 is a novel protein tyrosine phosphatase inhibitor (PTPi) with independent intellectual property rights. To date, three pharmaceutical companies worldwide are engaged in the Phase I clinical studies with anti-cancer agent in this field. JAB-3068 functions through both target therapy and immuno-oncology mechanisms. As an oral monotherapy, it has demonstrated significant anti-tumor activity; it can also promote the tumor-inhibitory immune function, offering opportunities to be combined with PD1 antibody and other drugs.

About Jacobio

Jacobio Pharmaceuticals Co., Ltd., headquartered in Beijing, focuses on the R & D of innovative medicines, It dedicates to provide breakthrough innovations to treat major diseases and bring more solutions to promote human health. The vision of Jacobio is to become a global leader in pharmaceutical industry. Jacobio has established an R & D center in Boston, USA, to strengthen and coordinate the global development of new drugs.

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