August 25, 2022 – China, Shanghai
| Dorzagliatin, an innovative first-in-class drug, in the stage of comprehensive review | |
| Ready for product commercialization |
Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2022 (the "Reporting Period"). The NDA for the company's core product dorzagliatin, an innovative first-in-class glucokinase activator (GKA) is under active review by the NMPA. The company is moving forward with preparations for the drug’s life cycle management for expansion of patient population and entering into new indications.
The first half of 2022 witnessed remarkable achievements of Hua Medicine in clinical research. In May, two peer-reviewed papers on the Phase III clinical trial results of dorzagliatin were published online simultaneously by Nature Medicine, a top international medical journal. This was the first time for Nature Medicine to publish papers on the Phase III clinical trial of a first-in-class diabetes drug with Chinese researchers as the first and corresponding authors, which has attracted wide attention across the globe. In June, at the 82nd American Diabetes Association (ADA) Annual Scientific Session, the Company presented several clinical findings of dorzagliatin, proving the role of dorzagliatin in improving β-cell function, early-phase insulin secretion and glucose sensitivity, as well as remission of diabetes drug discontinuation in patients with Type 2 diabetes (T2D).
The Company has also made positive progress in the commercialization of dorzagliatin. In addition to strengthening the cooperation with partners in go-to-market, production and supply, the Company announced multiple personnel appointments in August, including Mr. Qing Dong, with extensive experience in international commercial management and business development, as the Vice President of the Pharmaceutical Commercialization Division, Dr. Paul Chew and Dr. Ji Zhang, two executives in the industry, as Senior Scientific Advisors to guide the global product development of dorzagliatin.
At present, as the NDA of dorzagliatin has entered the comprehensive review stage, the Company is fully prepared for the commercialization of dorzagliatin in production capacity, supply security and go-to-market. The Company plans to partner with Bayer to list dorzagliatin in the National Reimbursement Drug List (NRDL), and expanding its application as T2D monotherapy or in combination with other approved antidiabetic drugs. The development of fixed dose combinations with dorzagliatin and the second generation of glucokinase activator also continue. The Company is managing patent applications globally, laying a foundation for overseas expansion in the future. The company will also initiate the product development of the second generation of dorzagliatin, and develop once daily oral new drug for the characteristics of European and American populations, so as to promote the internationalization process.
Dr. Li Chen, the founder, CEO and Chief Scientific Officer of Hua Medicine, said, "with our original intention of 'China leads pharmaceutical innovation', Hua Medicine has focused on unsolved clinical needs. In the research and development of glucokinase activator, we put forward an innovative and scientific concept of 'repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes', and took the lead in applying allosteric regulation. As a result, our dorzagliatin, as a drug with new concept, new mechanism, new efficacy, new structure and new technology, is now approaching its market launch. Ten years of hard work urges us to work even harder. Together with our partners, Hua Medicine proactively supports China’s strategic decision on preventing and treating chronic disease, as we seek to establish a chronic disease management platform. Hua Medicine is shaping our business presence for the future while making our contribution to the health of the Chinese people. "
Progress of Clinical Research and Company Operation
| ● | As we await China approval for dorzagliatin, our team has been working earnestly on launch strategy and commercialization preparation with Bayer, our commercialization partner in China, as well as manufacturing and supply preparations with our various strategic partners. | |
| ● | In February 2022, we announced a supply agreement with WuXi STA for the commercial manufacturing of dorzagliatin to further enhance our existing collaboration. | |
| ● | In May 2022, we published two peer-reviewed papers on the Phase III clinical trials results of dorzagliatin in Nature Medicine, an international top-medical journal. These two papers described and analyzed the clinical efficacy and safety characteristics of dorzagliatin monotherapy (SEED) in drug-naïve Type 2 diabetes (T2D) patients and the combination therapy of dorzagliatin and metformin (DAWN) in patients who failed in metformin adequacy therapy for the treatment of T2D respectively. | |
| ● | In June 2022, three research findings on dorzagliatin were presented at the 2022 82nd American Diabetes Association (“2022 ADA”): i) An oral presentation at the 2022 ADA Scientific Sessions on the results of SENSITIZE, a clinical study demonstrating dorzagliatin improved insulin secretion and glucose sensitivity; ii) A post-hoc analysis of the Phase III trials of dorzagliatin to validate the potential of dorzagliatin in improving early phase insulin secretion and restoring glucose sensitivity in type 2 diabetes (T2D) patients; iii) The results of the DREAM study and other researchers in the dorzagliatin monotherapy (SEED) study to explore the potential of dorzagliatin in diabetes remission. | |
| ● | In addition to our preparations for commercialization of dorzagliatin in China, we continue to advance the development of our second generation GKA, with the potential for once daily administration and a more efficient manufacturing process. | |
Financial Highlights
For the year ended June 30, 2022,
| ● | Cash position was approximately RMB586.3 million. | |
| ● | Total expenditures incurred by the Company was approximately RMB142.6 million, of which approximately RMB72.3 million was attributable to research and development expenses. Research and development expenses decreased by approximately RMB25.7 million or approximately 26.2%, compared with the six months ended June 30, 2021. | |
| ● | Loss before tax decreased by approximately RMB60.7 million or approximately 36.7% to approximately RMB104.6 million, compared with the six months ended June 30, 2021. | |
| ● | Total comprehensive expense for the period decreased by approximately RMB60.8 million or approximately 36.8% to approximately RMB104.5 million, compared with the six months ended June 30, 2021. | |
About Dorzagliatin
Dorzagliatin is an oral investigational glucokinase allosteric activator (GKA) targeting on impaired glucose sensor glucokinase (GK) in pancreas, intestine and liver. Dorzagliatin regulates glucose stimulated secretion of the glycemic controlling hormones insulin, GLP-1 and glucagon in diabetes patients which lead to the improvement of early phase insulin secretion and disposition index that are important to restore the glucose homeostasis and achieve diabetes remission. Results from two Phase III registered trials of dorzagliatin monotherapy for drug naive T2D patients and combination of dorzagliatin and metformin in the metformin tolerated T2D patients, together with data from combination studies of dorzagliatin with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor), showed that dorzagliatin significantly improves glycemic control with effective reduction of post prandial glucose and very low risk of hypoglycemia. Dorzagliatin is well tolerated and safe in the patient population tested. Dorzagliatin demonstrated a linear correlation between drug dose and plasma exposure with high target organ distribution in the pancreas, intestine and liver. It showed low renal excretion in human and similar pharmacokinetic profiles at End Stage Renal Disease (ESRD) patients and healthy subjects, which suggest it can be readily used in diabetes kidney disease (DKD) patients without dose adjustment. The unique mechanism of action together with desirable pharmacokinetic and safety profile make dorzagliatin a new class of anti-diabetes therapy which has the potential to bring diabetes to remission either alone or in combination with existing medicines.
About Hua Medicine
Hua Medicine is an innovative drug development company found in China focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. Targeting on glucose sensor glucokinase, dorzagliatin, as its cornerstone product, restores glucose sensitivity in T2D patients and has completed SEED and DAWN registration trials, with its NDA accepted by the National Medical Products Administration (NMPA) in China. This first-in-class glucokinase activator has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.
Forward-looking Statement
This article contains the statements regarding the future expectation, plan and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties or other legal requirements.
For more information
Hua Medicine
Website: www.ytrongmao.com
Investors
Email: ir@ytrongmao.com
Media
Email: pr@ytrongmao.com
Porda Havas International Finance Communications Group
Mr. Bunny Lee
+852 3150 6707
bunny.lee@pordahavas.com
Ms. Louisa Chen
+86 (755)23807432
louisa.chen@pordahavas.com
Ms. Karen Chiu
+852 3150 6726
karen.chiu@pordahavas.com
Disclaimer
This news may contain statements relating to medical conditions, medical treatments or methods and product information, such information will only be used as basic knowledge popularization. Under no circumstances will it replace professional medical guidance in any way, and should it be considered as part of medical advice or diagnosis. This news shall not be construed as containing any advertising or sales intent for products. You shall always seek the advice of your physician or other qualified healthcare professionals with any questions you may have regarding a medical condition.
沪公网安备 31011502013809号 Privacy Statement Terms of Use
