Dear Hua Medicine Board Directors, Advisors, Colleagues, Partners and Friends
It is my great pleasure to announce that phase I clinical study of our novel Glucokinase activator HMS5552 started on September 2, 2013 at Shanghai Zhongshan Hospital Phase I clinical center in partner with TigerMed. It is a major milestone for Hua Medicine as a path finder to develop novel Type 2 diabetes medicine in China for the world.
Benefit from China CFDA special review channel or the “Green Channel” for innovation drug, Hua Medicine received its clinical trial approval from CDE on July 22 and Clinical Trial Permit (CTP) from CFDA on August 15, 2013. Hua Medicine’s CTA package reached CDE on November 28, 2012 and reviewed at CTA Review Meeting in May 2013. This CTA review and approval process represents a significant step forward for China CDE in handling type 1.1 new drug with novel mechanism of action in China.
Yi Zhang, MD/PhD, Director of Clinical Development and Translational Medicine at Hua Medicine, will lead the clinical research on this new molecule. “It is observed that Chinese develop T2D at lower BMI and with earlier-cell GSIR function impairment that is characterized as Impaired Glucose Tolerance (IGT) with high post prandial glucose (PPG) but normal fasting glucose (FPG) in the clinic. HMS5552 presents a unique opportunity to address this unmet medical need.” There are over 100 million T2D patients in China and close to half showed above clinical symptom. “It will be the 1st time to test personalized medicine approach in T2D care and we are very excited to get it started in China”, said Dr. Zhang. “We determined to advance the diabetes care into a new age.”
Hua Medicine takes the advantage of growing drug innovation eco-system in China and the lead in the “Collaborative Innovation” operation model. WuXi PharmaTech is a strategic partner to Hua Medicine and will provide clinical drug supply of HMS5552 and bio-analytical services during the clinical study. Hua Medicine also works closely with Shanghai Institute of Materia Medica, Shanghai Zhongshan Hospital and TigerMed to develop this 1st in class medicine in China under international standard.
Hua Medicine’s Portfolio Advisory Board (PAB) plays an important role in this success. Members of PAB, Professor Christopher Walsh, Drs. Ben Shapiro, James MacDonald, Catherine Strader and Jack Baldwin, provided their critical evaluation and recommendations during the course of in-license and development of HMS5552.
It is critically important to conduct the clinical trial under the guidance of Hua’s Clinical Development Steering Committee (CDSC) led by Professor Dalong Zhu, the Vice Chairman of China Diabetes Association, and Professor Xiaoying Li, Vice Director of Shanghai Institute of Endocrinology. The CDSC team will work together with Hua Medicine during the clinical research and development of HMS5552.
Glucokinase (GK) plays a central role in a whole-body glucose homeostasis. Different from other hexokinases, GK activation is glucose dependent and its function is impaired in T2D patients under high glucose stress. HMS5552 modulate GK activity and restore Glucose Stimulated Insulin Release (GSIR) function in pancreas. At same time, it controls the post prandial glucose (PPG) increase and hepatica glucose production (HGP) in liver. This dual mechanism of action will effectively control the 24-hour blood glucose in T2D patients.
Hua Medicine licensed HMS552 from Roche as the 4th generation GK activator in December 2011. This new molecule demonstrated desirable enzyme kinetic properties and pharmacokinetic parameters to Roche’s Piragliatin which demonstrated expected efficacy in Ph II clinical trials as a single and combination therapy in T2D patients. HMS5552 shows superior pharmacology and safety profiles over Piragliatin in the preclinical studies and has a novel chemical structure which reduces drug metabolite-based safety concerns of Piragliatin.