Hua Medicine (HKEX: 2552), announced today our updated pipeline regarding our core technology targeting glucose homeostasis and first product, a glucokinase activator dorzagliatin (HMS5552).
Hua Medicine – Business & Pipeline Update
As our two Phase 3 registration trials in China remain on track, and with over 600 patients having already completed the 24-week mark (for both trials together), our preparation work for additional trials and studies to support our impending commercialization of dorzagliatin in China, and expansion of its future label continues in earnest. Working with leading key opinion leaders in both China and the United States, we are excited to begin preparations and initiation of these studies now and through 2020.
We expect to initiate our head to head comparison trial (HMM0303) with both sulfonylurea (glimepiride) and the global blockbuster, DPP-4 inhibitor (sitagliptin) in the second half of 2019. We are honored that Dr. Li Xiaoying, Vice President of the Chinese Diabetes Society and Director of Endocrinology at the Zhongshan Hospital will be leading this trial. As sulfonylurea as a class still commands over 8% of the total anti-diabetic pharmaceutical market in China in 2017 (according to Frost & Sullivan), and Januvia® and Janumet® combined generated over US$5.9 billion in global sales in 2018, this trial has the potential to expand and accelerate our commercialization plans for dorzagliatin. We are also grateful for the support of the Shanghai Municipal Science & Technology Commission for providing a government grant subsidy in support of this important trial. For similar reasons, we are also beginning preparatory work for initiation of our head to head comparison trial (HMM0304) between dorzagliatin and α-glucosidase inhibitor, the leading China oral anti-diabetic drug with RMB 8.7 billion annual sales in 2017 in China (according to Frost & Sullivan).
As mentioned previously, we believe the Type 2 diabetes (‘T2D’) drug-naïve population in China provides a huge market opportunity due to the relatively low rate of diagnosis in China (estimated at only 47.7% in 2017 by Frost & Sullivan), and coupled with the government’s explicit announcement to invest in areas outside of Tier 3 cities to increase that rate. We have observed though, that many such Chinese T2D drug-naïve patients have already advanced to a rather late stage of T2D (as measured by their diagnosed HbA1c levels) when finally diagnosed. It is this specific population that we think our combination with insulin could provide a very strong therapy regimen as first-line therapy, and we are excited to initiate this trial (HMM1202) in 2020.
Within the next 12 months, we expect to announce top-line 24-week data for both of our Phase III trials in China, and also the results of our two Phase I combination drug-drug interaction trials in the United States. As of May 31, 2019, we have enrolled 630 patients into our combination with metformin Phase III trial (HMM0302) in China.
This press release contains forward-looking statements including but not limited to statements regarding:
• the advancement of an anticipated clinical development, regulatory milestones and commercialization of our products and drug candidates according to our latest updated product pipeline and
• the expected announcement of top-line data for some of our trials within the next 12 months.
Potential investors and shareholders should be informed that actual results and timing of completion or announcement may differ materially from those indicated in the forward-looking statements as a result of the following:
• any change of product pipeline and timetable could result in increased costs to us and delay or limit our ability to obtain regulatory approval;
• clinical drug development involves a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development;
• our future success depends substantially on the success in China of our only clinical drug candidate, dozagliatin. Our ongoing Phase III clinical trials for dorzagliatin in China may not succeed, or we may not meet our goal of establishing dorzagliatin as a first-line standard of care in China, any of which could materially harm our business
• if safety, efficacy, manufacturing or supply issues arise with any approved Type 2 diabetes drug that we use in combination with dorzagliatin, we may be unable to market dorzagliatin or may experience regulatory delays and supply shortages, and our business could be materially harmed; and
• risks and uncertainties disclosed in the section entitled “Principal Risks and Uncertainties” in our most recent annual report which may affect our results and business operations, some of which are inherent to us, some are inherent to the pharmaceutical sector, and some are from external sources.
Potential investors and shareholders are advised not to place undue reliance on the aforesaid information and are advised to exercise caution in dealing in the securities of the Company.
Dorzagliatin is a first-in-class glucokinase activator, or GKA, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in Type 2 diabetics. By addressing the defect of the glucose sensor function of glucokinase, or GK, dorzagliatin has the potential to repair the impaired glucose homeostasis state of Type 2 diabetics and serve as a first-line standard of care therapy for the treatment of Type 2 diabetes, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.
About Hua Medicine
Hua is a leading, clinical stage innovative drug development company in China focused on novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua advanced a first-in-class oral drug for the treatment of Type 2 Diabetes into NDA enabling stage and started 2 Phase III trials in China. The Company has also initiated product life-cycle management studies of this novel diabetes drug, and advanced its use in personalized diabetes care. Hua's strategy is to leverage the cost-efficient and high-quality drug development capabilities available in China, while working very closely with disease experts and regulatory agencies in China and rest of the world to advance diabetes care solutions for global patients.
For more information:
Emily Yeh, Director of Corporate Finance