I-Mab's Announces China Clinical Trial Approval of Long-acting hGLP-1 to Treat Type 2 Diabetes
SHANGHAI, Aug. 9, 2018 /PRNewswire/ -- 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.
SOURCE I-Mab Biopharma