原GSK全球副总裁臧敬五:天境获批TJ103,提高国内市场竞争力

时间:2018-08-07 15:12:36 来源: 浏览次数:3 我来说两句(0)字号:TT
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2018年7月,天境生物科技(上海)有限公司(以下简称“天境生物” )宣布其在研项目TJ103 (TG103)注射液近期获得国家药品监督管理局药品审评中心颁发的《药物临床试验批件》。TJ103是创新型重组人源胰高血糖素样肽-1(hGLP-1)Fc融合蛋白,其开发临床适应症为2-型糖尿病。2015年韩国Genexine公司授权天境生物引进该项目,天境生物拥有在中国开发和商业化TJ103的独家权利。

2型糖尿病是一种以血糖升高为特征的常见慢性疾病。根据全球著名的独立市场研究咨询公司Frost & Sullivan(弗若斯特沙利文)的数据分析,中国估计有1.27亿人患有2型糖尿病,但只有47%的患者正在接受治疗,而且许多患者的血糖控制不足。中国毫无疑问已经成为全球糖尿病疾病负担最重的国家之一。预防和控制糖尿病的发生和进展是一个重要的公众健康问题, 未满足的医疗需求仍然很大。

GLP-1类似物在治疗中可能引发低血糖的风险较低,所以已成为一类重要的抗糖尿病药物,2017年全球销售额为72. 4亿美元。目前,国内市场上尚无获批的长效GLP-1受体激动剂,仅有三种短效GLP-1产品占主导地位。TJ103在中国糖尿病市场极具竞争潜力。TJ103可以促进胰岛素和抑制胰高血糖素的分泌,并具有葡萄糖浓度依赖性,可避免低血糖的风险。同时,TJ103的分子设计延长了GLP-1在体内的半衰期,可实现每周一次或每两周一次的皮下给药,显著提高使用的便利性和患者依从性。在临床前研究及Genexine在德国进行的I期试验中,TJ103也证明了更好的安全性。

天境生物希望在TJ103的中国临床研发中全面评价其有效性,安全性、同时研究其长效治疗带来的患者依从性,生活品质改善等指标,最终给国内日益增加的2-型糖尿病患者提供新的更好的治疗选择。

关于臧敬五

原GSK全球副总裁,天境生物董事长兼创始人,毕业于上海交通大学医学院后出国深造,获布鲁塞尔大学的博士学位后成为哈佛大学医学院的博士后研究员。创立天境生物之前,曾经历过医生、科研工作者等角色,也有原GSK全球副总裁这样的职业经理人经历,这20多年的经历,也让原GSK全球副总裁臧敬五积累了许多研发经验和管理经验。后创建的天境生物立足上海致力于打造中国最具创新力的生物创新药研发平台,公司已完成B轮和C轮总计3.7亿美元的融资,计划在2018年底在香港上市。

关于天境生物

天境生物是一家聚焦肿瘤免疫和自身免疫疾病治疗的生物新药研发公司。公司致力于为中国和全球患者提供肿瘤免疫和自身免疫疾病治疗的生物药,专注于打造中国最具创新能力的全球化生物药研发平台。

公司采用内部研发加产品引进的双驱动药物研发模式,构建了针对国际市场,内部研发的Best-in-Class及First-in-Class潜质的重磅药物,治疗领域聚焦在肿瘤免疫和自身免疫治疗方面。目前,天境生物计划2018年在中国和美国申报启动多项临床试验,包括临床二期及三期阶段项目。目前天境生物正朝着一个一体化的公司快速发展。

I-Mab’s Announces China Clinical Trial Approval of Long-acting hGLP-1 To Treat Type 2 Diabetes

In July 2018, I-Mab Biopharma (I-Mab) announced that it received clinical trial approval from the Center for Drug Evaluation (CDE) China National Drug Administration (CNDA) for TJ103 (TG103) injection: an innovative, humanized, long-acting recombinant glucagon-like peptide-1 (hGLP-1) fused with a hybrid Fc (hyFc) for type 2 diabetes treatment. Through a licensing agreement with Korean biopharma Genexine in 2015, I-Mab holds exclusive rights to TJ301 for further development and commercialization in China.

Type 2 diabetes is a common chronic disease characterized by high blood glucose. According to Frost & Sullivan, there are estimated 127 million people with type 2 diabetes in China. However, only 47% of patients are receiving treatment, and many patients have insufficient blood glucose control; therefore this chronic disorder has reached a pandemic level and unmet medical needs remain substantial.

Thanks to its low risk of hypoglycemia, GLP-1 analog is an important class of anti-diabetic drug, with global sales of US$7.24 billion in 2017. Currently, no long-acting GLP-1 agonists have been approved in China, and only three short-acting GLP-1 products dominate the market.TJ103 is believed to have the potential of becoming a competitive anti-diabetic drug in China.

TJ103 promotes glucose concentration dependent insulin secretion and inhibits glucagon production in the body without causing the risk of hypoglycemia. It is also designed molecularly with extended half-life to enable once-weekly or bi-weekly subcutaneous administration, which can significantly improve convenience of use and patient compliance. In preclinical studies, and the on-going Phase I trial conducted by Genexine in Germany, TJ103 demonstrated a better safety profile.

I-Mab Biopharma plans to conduct clinical trials to assess the safety and efficacy of TJ103 in hopes of bringing the innovative drug to patients with type 2 diabetes in China, which can significantly improve the treatment effect and quality of life of the patients.

About I-Mab

Facilitated by a merger between Third Venture Biotech and Tasgen Bio, followed by a Series B financing of US$150 million in 2017, I-Mab has rapidly built a highly experienced team with world-class R&D capabilities. On June 29, 2018, I-Mab announced that it had successfully raised US$220 million in Series C financing with a group of reputable investors led by Hony Capital, one of the largest amounts ever raised in Series C by an innovative biotech company in China.

I-Mab focuses on discovery and development of First-in-Class and Best-in-Class biologics in the areas of immuno-oncology and immuno-inflammation. The company has already initiated a Phase 2 clinical trial and is prepared to submit multiple IND applications for additional trials in China and in the US, including Phase 2 and Phase 3 studies.

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