Milestone Development Achieved in Clinical Trials and Commercialization, Hua Medicine's Dorzagliatin Readying for NDA Submission

Mar 19, 2021 15:34 JST

Source: Hua Medicine

SHANGHAI, CHINA, Mar 19, 2021 - (ACN Newswire) - Hua Medicine (HKG:2552), today announces the audited annual results of the Company and its subsidiaries for the year ended December 31, 2020 (the "Reporting Period"). During the Reporting Period, the Company continued to advance various clinical trials and R&D investments, successfully completed two Phase III registration trials for dorzagliatin in China, and achieved remarkable results in preparing for dorzagliatin's commercialization. These 2020 achievements provide a solid foundation for the Company's long-term and stable development in the future. In 2020, the Company incurred approximately RMB367 million in total expenditures, of which approximately RMB221 million was research and development expenses. As of December 31, 2020, the Company's cash position was approximately RMB1,032 million, a decline of only RMB74 million from the 2019 year-end cash balance of RMB1,106 million, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.

Over the past decade, Hua Medicine has focused on unmet medical needs and relentlessly pursued breakthroughs in a major disease area, successfully realizing the world's leading scientific concept into the first-in-class oral glucokinase activator, dorzagliatin, with a breakthrough innovation mechanism. With the successful completion of two registration trials, dorzagliatin's scientific thesis of "Repairing sensors, reshaping homeostasis and fundamentally treating diabetes" has been validated. Hua Medicine has become the first company in the world to complete clinical development of a glucokinase activator. The results of the two Phase III clinical trials demonstrated that dorzagliatin has long-term sustained efficacy, and good safety and tolerability profiles. By repairing the damaged expression of glucokinase in patients with diabetes, dorzagliatin has the potential to improve beta-cell function, reduce insulin resistance and ultimately restore the self-regulation of blood glucose. Dorzagliatin has progressed from 0 to 1 - from a disruptive scientific theory to a potential commercially viable product, propelling Hua Medicine into a new stage of development.

The unique mechanism of dorzagliatin is also expected to create a new era of personalized and precision treatment of diabetes. Results from two Phase I clinical trials, HMM0111 and HMM0112, announced in the first half of 2020 demonstrated that dorzagliatin combined with DPP-4 inhibitors and SGLT-2 inhibitors, respectively, have a clear synergistic effects in blood glucose control, indicating that dorzagliatin has a wide range of application potential in Type 2 diabetes ("T2D") patients with different glucose control needs and at different disease stages. Meanwhile, data from HMM0111 also indicated that dorzagliatin can promote endogenous GLP-1 secretion and improve beta-cell function in patients (specific research results will be presented at this year's ADA Scientific Sessions). In addition, a Phase I study in patients with end stage chronic kidney disease demonstrated that dorzagliatin is a feasible monotherapy for T2D patients who have diabetic kidney disease ("DKD"), who make up about 20% to 40% of T2D patients. This marks the first oral anti-diabetes therapy that could be available for this group of T2D patients, as current oral therapy are either prohibited or require dose adjustment. The Company will initiate additional clinical trials for dorzagliatin in DKD, and combination therapy with additional diabetes drugs, including with GLP-1 RAs and insulin for T2D patients, and with insulin for T1D patients, to expand the addressable market for dorzagliatin. The Company will also continue to expand in three dimensions: expansion of product pipeline, expansion to global, and expansion into new disease areas to take Hua Medicine from 1 to 10. These will support Hua Medicine in becoming a leading biotechnology company with clinical value, social value and investment value.

"In 2020, we experienced the most serious global public health crisis in a century. Despite the pandemic Hua Medicine has still achieved several milestones and breakthroughs in clinical trials and in the prepartion for drug commercialization. We have completed relevant preparation work and will submit the New Drug Application ("NDA") to the National Medical Products Administration ("NMPA") very soon. We hope to work with our partners to further accelerate the NDA and marketing processes of dorzagliatin for the benefit of diabetes patients in China and around the world." said Dr. Li Chen, founder, CEO and CSO of Hua Medicine.

2020 Clinical Highlights:
- Successfully completed SEED, a Phase III registration trial to investigate the efficacy and safety of dorzagliatin monotherapy in drug naive T2D patients. It was the first Phase III trial conducted by Hua Medicine in China. The 52-week topline data demonstrated that dorzagliatin as a monotherapy has long-term sustained efficacy, and good safety and tolerability profiles.
- Successfully completed DAWN, a Phase III registration trial to investigate the combination therapy of dorzagliatin and metformin on T2D patients inadequately glycemic-controlled with metformin. It is the second Phase III trial conducted by Hua Medicine in China. Both the 24-week and 52-week topline results demonstrated that the combination therapy has long-term sustained efficacy, and good safety and tolerability profiles.
- Presented additional data of the 24-week SEED trial at the 80th American Diabetes Association (ADA) Annual Scientific Sessions, demonstrating significant improvements in beta-cell function and 2h-PPG reduction.
- Announced additional data of the 24-week DAWN trial at the Chinese Diabetes Society's 2020 Scientific Meeting, demonstrating improvements in beta-cell function and reduction in insulin resistance.
- Completed HMM0110, which demonstrated desirable pharmacokinetics profile in patients with end stage chronic kidney disease, indicating the potential use of dorzagliatin with no dose adjustment among T2D patients with diabetic kidney disease.
- Completed HMM0111, investigating the pharmacokinetic and pharmacodynamic parameters of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function, in addition to increased secretion of endogenous GLP-1.
- Completed the clinical trial of HMM0112, investigating the pharmacokinetic and pharmacodynamic characteristics of dorzagliatin in combination with empagliflozin (a SGLT-2 inhibitor) and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function.

Operational highlights:
- Entered into a commercialization agreement and strategic partnership with Bayer AG for dorzagliatin in China.
- Entered into a commercial supply agreement with Raybow Pharmaceutical, for Raybow to become an additional manufacturing supplier for commercial launch.
- Granted the Drug Manufacturing Permit for dorzagliatin in China by the Shanghai Municipal Drug Administrative Bureau.
- Announced that global operation headquarters and research and development center in Shanghai's Zhang Jiang Science City officially established.

Financial Highlights: For the year ended December 31,2020
- Cash position was approximately RMB1,032 million, representing a decline of only RMB 74 million from the 2019 year-end cash balance, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.
- Total expenditures incurred by the Company was approximately RMB367.2 million, of which approximately RMB221.0 million was research and development expenses, representing a decrease of approximately 31% (RMB101 million).
- Loss before tax decreased by approximately RMB32.1 million or approximately 8% to approximately RMB393 million.
- Loss and total comprehensive expense for the year decreased by approximately RMB31.7 million or approximately 7% to approximately RMB393.6 million.

Business Outlook
- Plan to submit our NDA for dorzagliatin to the NMPA in China in the first half of 2021.
- Plan to initiate additional studies for dorzagliatin in DKD in the second half of 2021.
- Plan to initiate additional studies for dorzagliatin combinations, including with GLP-1 RAs and insulin for T2D patients, and insulin for T1D patients in the second half of 2021. Advancing the company fixed-dose combination pipeline for dorzagliatin.

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and will submit its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

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Source: Hua Medicine
Sectors: BioTech, Healthcare & Pharm