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，其拟开发的临床适应症为2-型糖尿病。
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）2017年的数据分析，估计有1.2亿中国人患有2型糖尿病，其中44％的患者正在接受治疗，但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。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。
目前在治疗2 型糖尿病的众多药物中，很多有诱发低血糖的风险，而GLP-1类似物在很大程度上降低了这个风险，已成为一类重要的抗糖尿病药物。目前国内市场上的GLP-1产品均为短效，即必须每天注射单次或多次，给病人带来很多不便。TJ103不但可以促进胰岛素和抑制胰高血糖素的分泌，具有葡萄糖浓度依赖性，避免低血糖的风险，还因为其分子设计特点延长了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，从而很大程度上改善患者的依从性。在临床前研究及之前在德国进行的I期临床试验中，TJ103也证明了良好的安全性。
天境生物准备在中国开展相关的临床试验，对TJ103中的有效性和安全性进行全面评价，同时也探讨研究其长效治疗带来的患者依从性的改善及生活品质的改善等指标，最终希望为国内日益增加的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 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
Type 2 diabetes is a common chronic disease characterized by high blood glucose. According to Frost & Sullivan’s data for 2017, there are estimated 120 million people with type 2 diabetes in China. However, only 44% 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.
Many of the anti-diabetic drugs on the markets are liable for hypoglycemia which is a significant safety concern. Thanks to its low risk of hypoglycemia, GLP-1 analog is an important class of anti-diabetic drug. However, currently no long-acting GLP-1 agonists have been approved in China yet, and the short-acting GLP-1 products on the market need to be injected once or twice daily.
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 and as a result to improve patient treatment compliance. In preclinical studies, and the on-going Phase I trial conducted in Germany, TJ103 demonstrated a good safety profile.
I-Mab Biopharma plans to conduct clinical trials in China to comprehensively assess the safety and efficacy of TJ103, as well as exploring the treatment compliance, the quality of life and other potentials, 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.