Public company info - Hua Medicine , 02552.HK
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Hua Medicine, 02552.HK - Company Profile
Chairman Robert Taylor NELSEN
Share Issued (share) 1,055,000,000
Par Currency U.S. Dollar
Par Value 0.001
Industry Biotechnology
Corporate Profile Business Summary: The Group is principally engaged in developing a global first-in-class oral drug, dorzagliatin or HMS5552, for the treatment of Type 2 diabetes. Performance for the year: For the year ended December 31, 2020, loss before tax decreased by approximately RMB32.1 million or approximately 8% to approximately RMB393.1 million For the year ended December 31, 2020, loss and total comprehensive expense for the year decreased by approximately RMB31.7 million or approximately 7% to approximately RMB393.6 million Business Review： The group is a pre-revenue China-based drug development company currently focusing on the development of dorzagliatin, a first-in-class oral drug for the treatment of Type 2 Diabetes (“T2D”). The group filed an Investigational New Drug (“IND”) application with the National Medical Products Administration of the People’s Republic of China (the “NMPA”) for dorzagliatin under Category 1.1 (New Drug) in 2012 and initiated a Phase Ia clinical study of our novel glucokinase activator dorzagliatin in September 2013. The group also filed an IND application with the U.S. Food and Drug Administration (“FDA”) for dorzagliatin in March 2015. Since then, the group have completed eight Phase I trials in China, four Phase I trials in the United States, one Phase II in China, and two Phase III trials in China. Our two Phase III trials enrolled 1,230 patients across 110 sites throughout China. Both Phase III trials met their primary endpoints, and the safety and tolerability profile of dorzagliatin was good during the trial period. The final 53-week results of both Phase III trials were announced and published in 2020. As the group continue to progress with our development of our lead candidate, dorzagliatin, the group is also moving forward with preparations for the drug’s life cycle management. The group filed method of use patents for use of dorzagliatin in diabetic kidney disease (DKD) patients. The group have initiated multiple studies on dorzagliatin plus existing anti-diabetes therapies at preclinical development and clinical settings. During the year ended December 31, 2020 (the “Reporting Period”), despite the spread of the COVID-19 pandemic globally, the group have continued to move forward with our clinical development and NDA preparations, as summarized below. Successful completion of both pivotal Phase III registration trials in China (SEED/HMM0301 and DAWN/HMM0302). Amidst the COVID-19 pandemic, the group ensured the uninterrupted delivery of dorzagliatin to patients and clinical centers, even during the height of the pandemic in China, and associated national lock-down, in February 2020. Both SEED and DAWN were completed on time and in high quality in 2020. Expansion of dorzagliatin indications. The group completed three Phase I trials to set the grounds for expansion of dorzagliatin’s future indications. Two of the Phase I trials, HMM0112 and HMM0111 investigated the pharmacokinetic and pharmacodynamics characteristics of dorzagliatin with empagliflozin (a SGLT-2 inhibitor), and dorzagliatin with sitagliptin (a DPP-4 inhibitor), both indicating a synergistic effect in efficacy under combination therapy. The third Phase I trial was conducted in patients with end stage chronic kidney disease, demonstrating a desirable pharmacokinetic profile in patients, and indicating the potential use of dorzagliatin among T2D patients with moderate, severe and end stage chronic kidney disease. Collaboration with the leading diabetes partner in China, Bayer. As the group approach the commercial launch of dorzagliatin in China, the group have entered into a commercialization agreement and strategic partnership with Bayer Healthcare Company Limited. Under the terms of the agreement, the group received an upfront payment of RMB300 million in 2020, and additional payments could reach up to RMB4.18 billion if certain milestones are met. The group will pay Bayer tiered service fees based on net sales in China, initially sharing equally in sales, with adjusting sales percentages based on agreed China net sales thresholds. The group will continue to be the market authorization holder of dorzagliatin, and responsible for clinical development, registration, product supply and distribution, while Bayer, as the promotion service provider, will be responsible for the marketing, promotion, and medical education activities in China. Rapid progress for dorzagliatin’s manufacturing scale up in China. In October 2020, the group obtained the drug manufacturing permit for dorzagliatin, indicating that Hua Medicine has established the required systems and capabilities to satisfy national drug quality and pharmacovigilance management standards. The group and our CMOs have completed the requisite manufacturing process validation work related to commercialization of the drug. The drug manufacturing permit is a requisite for submitting the NDA, and the group is among the first group of biotechnology companies that have obtained the permit since the implementation of the new Drug Administration Law on December 1, 2019. In November 2020, the group entered into a commercial supply agreement with Zhejiang Raybow Pharmaceutical as an additional supplier to existing partners, to ensure the API supply of dorzagliatin. Further validation of the glucokinase activator concept. Our senior scientific consultant, Dr. Franz Matschinsky, Professor of Biochemistry and Biophysics at the Institute for Diabetes, Obesity and Metabolism Perelman School of Medicine, University of Pennsylvania, was awarded the Rolf Luft Award 2020 by the Karolinska Institutet. He was recognized for “the discovery that glucokinase (“GK”) is the sensor controlling glucose-stimulated insulin secretion in the pancreatic β-cell”. Specifically, his studies led to the experimentation of GK in correcting metabolic defects in human pancreatic islet cells and other tissues involved in Type 2 diabetes, resulting ultimately in the discovery of novel allosteric GK activators, such as our dorazagliatin (HMS5552) which has completed two Phase III trials in China. Dr. Matchinsky’s comprehensive work has uniquely advanced the understanding of beta-cell biology and insulin secretion in health and in diabetes. Due to the COVID-19 pandemic in 2020, his presentation to the Nobel Forum at the Karolinska Institutet has been postponed to 2021. In addition to our late-stage development efforts with dorzagliatin, the group also continue to develop various other compounds, currently in the pre-clinical stage. One is focused on mGLUR5 for Parkinson’s disease levodopa-induced dyskinesia, and the other is a fructose kinase inhibitor for metabolic disease. The group continue to work closely with and supervise our contract research organizations (CROs), clinical site management operators (SMOs), and contract manufacturing organizations (CMOs), who provide us with a range of services at a consistently high level of quality. Phase III registration trials: SEED/HMM0301 SEED is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naïve T2D patients. Patients were treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks plus one-week follow-up. During the 28-week open-label period, both patient groups were treated with twice-daily doses of dorzagliatin (75 mg). The trial was conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society. (NCT03173391). In November 2019, Hua Medicine announced the trial had achieved its primary efficacy and safety endpoints over the initial 24-week double blinded period. For the 52-week treatment period, the efficacy and safety profiles were sustained based on the topline data analysis. During the 28-week open-label period, patients initially receiving a placebo (i.e., the placebo group) were administered dorzagliatin for the first time. Figure 1 below illustrates the efficacy (as measured by HbA1c reduction) for the two-cohort groups for the entire 52-week period. In addition, data from the 24-week double-blinded treatment period demonstrates that there was significant ß-cell function improvement (as measured by HOMA2-ß1) in the treatment group versus the placebo group – an increase of 2.56% vs. a decline of 0.72% in ß-cell function improvement. The data also indicates significant 2-hour post-prandial glucose reduction (-2.83mmol/L vs -0.50mmol/L, p0.001). DAWN/HMM0302 DAWN is a randomized, double-blind, placebo-controlled Phase III study in 767 Type 2 diabetes patients whose blood glucose cannot be controlled with the maximum tolerated dose of equal or greater than 1500 mg/day of metformin. Subjects were treated with metformin (Glucophage®) at 1500mg/day as basic therapy throughout the whole 52-week treatment period. Patients were given twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period receiving dorzagliatin 75mg twice daily. The primary efficacy endpoint was evaluated at the conclusion of the first 24 weeks. The trial was conducted in 73 clinical sites across China led by Professor Wenying Yang at China-Japan Friendship Hospital. (NCT03141073). In July 2020, Hua Medicine announced the DAWN Trial had achieved its primary efficacy and safety endpoints over the initial 24-week double blinded period. For the 52-week treatment period, the efficacy and safety profiles were sustained based on the topline data analysis. During the 28-week open-label period, patients initially receiving placebo + metformin (i.e., the placebo group) switched to receive dorzagliatin + metformin. Figure 2 below illustrates the fast onset and sustained efficacy (as measured by HbA1clevels) for the two-cohort groups for the entire 52-week period. Similar to observations made in the SEED Trial, conducted with drug-naïve T2D patients with average disease history of one year, a significant increase in HOMA2-ß and reduction in HOMA2-IR over placebo were observed in the DAWN Trial, suggesting a consistent improvement of ß-cell function and reduction in insulin resistance in diabetes patients with average disease history of almost six years and who had failed glycemic control on maximum daily dose of metformin (1,500mg/day). Other clinical trials: HMM0110 demonstrated desirable pharmacokinetics profile in patients with end stage chronic kidney disease, indicating the potential use of dorzagliatin without dose adjustment among T2D patients with renal impairment in mild, moderate, severe and end stage before dialysis. These results supports dorzagliatin as a promising solution and potential supplementary option for T2D patients with diabetic kidney disease, as most current oral anti-diabetic drugs are not readily suitable for patients with renal impairment. HMM0111, dorzagliatin demonstrated the possibility of administration in combination with sitagliptin, the global top-selling DPP-4 inhibitor, with superior blood glucose reduction over sitagliptin or dorzagliatin monotherapy. The trial also demonstrated that dorzagliatin add-on to sitagliptin increases endogenous GLP-1 secretion. HMM0112, which successfully demonstrated the possibility of administering dorzagliatin in combination with empagliflozin, a top-selling SGLT-2 inhibitor, also achieved significantly enhanced glucose lowering effect over empagliflozin or dorzagliatin monotherapy. The positive results of HMM0112 indicate enhanced blood sugar control for T2D patients using the dorzagliatin add-on to SGLT-2 inhibitors, which provides an improved solution to T2D patients who benefit from the cardiovascular benefits and weight loss of SGLT-2 inhibitors. As part of our strategy to establish dorzagliatin as a cornerstone therapy for the treatment of T2D globally, the group is also investigating the combination of dorzagliatin with various approved classes of oral and injectable anti-diabetic medicines as well as other popular medicines commonly taken by diabetes patients to address patients’ personal needs. To date, except for the RMB300 million upfront payment the group received from Bayer in exchange for certain commercialization rights in mainland China as contract liabilities, the group have not yet generated any revenue from the sale of goods or from the rendering of services, recognizing only limited income in the form of government grants and interest income. As of December 31, 2020, the group expect to incur significant losses for the foreseeable future with no product revenues prior to obtaining marketing approval for dorzagliatin from the NMPA and commercializing dorzagliatin. Cautionary Statement required under Rule 18A.08(3) of the Listing Rules: The group may not be able to ultimately develop and market our dorzagliatin successfully. Prospects: The group plan to submit our NDA for dorzagliatin to the NMPA in China in the first half of 2021. In the second half of 2021, the group plan to initiate additional studies for dorzagliatin in DKD and for dorzagliatin combinations, including with GLP-1 and insulin for T2D patients, and insulin for T1D patients. The group is also advancing our fixed-dose combination pipeline for dorzagliatin.

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