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。
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.
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.