Hua Medicine Ltd., an innovative, clinical-stage biotechnology company in Shanghai, announced the closing of a $25 million Series B financing. The company is developing both best- and first-in-class therapies for the China and worldwide markets. The Series B financing was led by Ally Bridge Group, joined by additional new investors Frontline BioVentures, and TF Capital as well as existing Series A investors ARCH, Venrock, Fidelity, WuXi Ventures, and SAIL. The funds will enable Hua to catalyze the Phase 2 clinical development of its most advanced asset HMS5552 (Sinogliatin), a novel 4th-generation glucokinase activator (GKA) for Type 2 diabetes, and to move forward additional novel assets in its pipeline.
"Hua Medicine represents a great example of world-class innovation in China, where locally-developed innovative drugs at affordable prices are strongly needed, with the additional opportunity of taking such innovation overseas," said Frank Yu, Founder and CEO of Ally Bridge Group. "We are very pleased to help the company accomplish this vision globally."
"We have been following the company since its inception and are very pleased with the progress Hua has made over the past two years" added Leon Chen, Managing Partner of Frontline BioVentures, "we look forward to supporting the strong scientific and clinical efforts of the company along with the outstanding international syndicate of new and current investors."
In addition to completing the GKA Phase 2 clinical trials in China, the Series B capital will also support the company's expansion in to combination therapies with GKA in the US, development of a best-in-class IND candidate for a novel CNS asset, as well as sponsoring several long-term pre-clinical studies to prepare for future Phase 3 trials.
"Given the many compelling, value-creating events in the upcoming year, we are delighted to continue investing in and supporting the growth of the company," added Edward Hu, CFO and Chief Investment Officer of WuXi PharmaTech.
"All the clinical and pre-clinical data show a great safety and tolerability profile, high efficacy and very low risk for adverse effects such as hypoglycemia," affirmed company Chairman Robert Nelsen, Managing Director of ARCH Venture Partners. "Coupled with the fact that Hua owns the world-wide IP rights to its entire pipeline of first-in-class and best-in-class assets make this an exceptional opportunity!"
"Sinogliatin has demonstrated 24-hour glucose control in T2DM patients with excellent regulation of both fasting- as well as post-meal glucose levels. The data also shows preliminary indications of improving beta-cell health and insulin response. Although longer-term studies will be needed, one of our goals during the 12-week Phase 2 trials will be to further expand on these results," explained Dr. Li Chen, President and CEO of Hua Medicine. "Our mission is to ultimately provide diabetes patients with the most effective, novel therapies to control their disease while minimizing unwanted effects."
The company will initiate a multicenter Phase 2 trial in diabetic patients that is expected to complete by YE 2015. Concurrently, the company will also file a US IND by 1Q2015 and complete Phase 1 trials in the US by YE 2015. The Phase 2 multi-center trial will be a 12-week, randomized, double-blind, placebo-controlled trial in approximately 280 diabetic adult male and female patients. In addition to evaluating Sinogliatin's safety and efficacy (as determined by HbA1c lowering at the end of 12-weeks), the trial will evaluate potential improvements in associated hormones and biomarkers of beta-cell health. These results are expected to further support Sinogliatin's novel mechanism of action and give guidance for trial design and optimal patient selection in future Phase 3 trials.