[NEWS] Hua Medicine Announces 2023 Annual Results

Hua Medicine
Mar 29, 2024

March 29, 2024 - China, Shanghai

Hua Medicine (the “Company”) is pleased to present the following business and financial highlights for the fiscal year ended 2023:

The Company has achieved a certain milestone relating to the development of dorzagliatin and received RMB800 million non-refundable milestone payment. Collective cash balance of the Company was RMB1,461 million on December 31, 2023.
The Company has achieved total revenue of RMB94.2 million from the time of commercial launch of dorzagliatin at the end of October 2022 through the end of December 31, 2023.
HuaTangNing (华堂宁®) (dorzagliatin) has been successfully included in China’s National Reimbursement Drug List for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (the “NRDL”) for Type 2 diabetes by the National Healthcare Security Administration (NHSA). The agreed reimbursed price RMB5.39 per tablet, which approved for twice daily administration equals to RMB10.78 per day, and so far is one of the most favorable price among other reimbursed oral anti-diabetic medicine.
The Company worked with its manufacturing partners and expanded the production of dorzagliatin for ensuring the anticipated demand from the significant increase of 2024 sales. The Company has initiated investment into dorzagliatin manufacturing capability at Changzhou SynTheAll (STA), Zhejiang Raybow and Shanghai Desano after the successful commercialization launch during the initial out-of-pocket stage. The total investment in 2023 and 2024 for commercial drug manufacturing and capacity expansion is expected in the range of approximately RMB400 million.

Hua Medicine (the "Company", HKEx: 2552) today announces the audited consolidated results of the Company and its subsidiaries for the year ended December 31, 2023 (the "Reporting Period"), and the Company’s business progress and outlook.

Dr. Li Chen, the founder and CEO of Hua Medicine, said, “In 2023, Hua Medicine achieved remarkable accomplishment in advancing the commercialization of dorzagliatin. Since successful approval of dorzagliatin, the Company has worked closely with commercial partners across the major channels of on-line drug store, retail pharmacies and hospital pharmacies, achieving substantial growth in sales. Meanwhile, we have continued to expand production capacity to ensure sufficient market supply of dorzagliatin. In December, HuaTangNing (华堂宁®) was successfully included in China's National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration (NHSA), significantly improving the accessibility of dorzagliatin and reducing the financial burden on patients and their families. The inclusion of HuaTangNing (华堂宁®) in the NRDL truly fulfilled our mission of benefiting patients and society and provides a foundation for the future sales growth of the product. In addition, we were also actively promoting the layout of the 2nd generation GKA in overseas markets and submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) at the end of last year. In the future, Hua Medicine will continue to explore and innovate, expand overseas while deepening its presence in China, and contribute to the global healthcare industry and the well-being of humanity.”

Progress of Clinical Research and Company Operations

Through modulating the glucose sensor glucokinase (GK) function and repairing the impaired GLP-1 secretion in patients with diabetes and obesity, dorzagliatin is expected to secure new indication related to endogenous GLP-1 (Nature Comm March 2023).
The Company has also presented the positive effects of dorzagliatin in the prevention of diabetes and memory defect in Goto-Kakizaki rats at the June 2023 American Diabetes Association (ADA) conference in San Diego, California, USA. The Company has advanced R&D programs in new indications of dorzagliatin and has filed patent applications in prevention of developing diabetes and memory defect.
The Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its 2nd generation glucokinase activator (2nd Gen GKA) at the end of 2023 to initiate a Phase I clinical trial. The 2nd Gen GKA is a new molecular entity with improved physical-chemical properties and formulated using Hua Medicine’s proprietary formulation platform for once daily oral administration. The relevant patent applications have been submitted.
The Company has initiated the SENSITIZE II study at Chinese University of Hong Kong (CUHK) to study the opportunity of reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT) in China. IGT is a primary cause of Type 2 diabetes in China, and there are approximately 500 million IGT patients worldwide. The main cause of IGT, especially those with impaired post prandial glucose tolerance, is the impairment of early phase insulin secretion in the pancreas and the defect of glucokinase expression in the liver. Mechanistically, dorzagliatin has the potential of reversing the condition of the IGT to NGT and thereby prevent diabetes.
Both glucokinase negative allosteric modulator (NAM) and mGLUR5 NAM projects achieved proof of concept in animal models. Optimization of the lead series candidates into non-clinical development has been initiated.

Business outlook

The Company expects an increase in sales of HuaTangNing (华堂宁®) after entering NRDL and advances of new indications with dorzagliatin in combinations with existing approved therapy, as well as advance new drug product in fixed dose combination of dorzagliatin with other oral anti-diabetes drugs.
With the positive impact of dorzagliatin on the restoration of insulin and GLP-1 secretion in obese diabetics, we are advancing our 2nd generation GKA into Phase I study in the United States and an accelerated clinical development plan for diabetes patients with obesity.
The Company is continuing to optimize its core technology in allosteric regulation of physiologically important protein targets and advance glucokinase negative allosteric modulator (GK NAM) and metabotropic glutamate receptor NAM (mGLUR NAM) for diseases that have no treatment. This will give us the chance to develop the First-In-Disease (FID) therapies for unmet medical needs.
The Company is also developing technologies in personalized diabetes care with algorithms that can help physicians to enhance their care of such patients.

Financial highlights

For the year ended December 31, 2023,
Bank balances and cash position were approximately RMB1,460.8 million as of December 31, 2023.
Total revenue generated by the Company was approximately RMB76.6 million, reflecting the sales of approximately 251,000 packs of HuaTangNing (华堂宁®).
Total other income generated by the Company was approximately RMB130.6 million, of which approximately RMB65.1 million was attributable to the amortization of Bayer milestone income.
Total expenditures incurred by the Company was approximately RMB383.3 million, of which approximately RMB171.5 million consisted of research and development expenses.
Research and development expenses increased by approximately RMB42.0 million, or approximately 32%, to approximately RMB171.5 million.
Loss before tax increased by approximately RMB7.7 million, or approximately 4%, to approximately RMB211.2 million.
Total comprehensive expense for the year increased by approximately RMB8.1 million, or approximately 4%, to approximately RMB211.5 million.

Forward-looking Statement
This article contains the statements regarding the future expectations, plans 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.

About Hua Medicine
Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (华堂宁®)  (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin on hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine partnered with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing (华堂宁®)  in China, benefiting diabetic patients and their families.

For more information
Hua Medicine
Website:  www.huamedicine.com

E-mail: ir@huamedicine.com

E-mail: pr@huamedicine.com

For the accuracy and completeness of the context, references to information related to products launched in China, especially label or requirements, should follow the relevant documents approved by the Chinese regulatory authorities.
The above information should not be interpreted as a recommendation or promotion of any drug or treatment regimen, nor should it substitute for the medical advice of any healthcare professional. Please consult a healthcare professional for any matters related to medical treatment.

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