SHANGHAI, CHINA, Aug 25, 2023 - (JCN Newswire) -  -- First-in-class glucokinase activator (GKA) HuaTangNing (dorzagliatin) was approved in China in September 2022. Since the launch of commercial sales at the end of October 2022 to June 30, 2023, HuaTangNing achieved total sales revenue of RMB87.9 million. For the first half of 2023, approximately 212,000 boxes of HuaTangNing were sold, and Hua Medicine achieved revenues of RMB70.3 million, representing approximately a 299.6% increase in revenue compared with the second half of 2022.

-- The Company filed an application to include dorzagliatin in China's National Reimbursement Drug List (NRDL) and is preparing the pharmacoeconomic value discussion with regulatory agencies in the near future. According to the National Healthcare Security Administration, dorzagliatin has passed the preliminary formal examination.

-- The Company invested into dorzagliatin scale-up manufacturing capabilities at Changzhou SynTheAll (STA), Zhejiang Raybow and Shanghai Desano upon its successful commercial launch and during the initial out-of-pocket stage of commercialization.

-- The Company has advanced the development of 2nd generation of GKA in overseas markets. Our team is preparing an Investigational New Drug (IND) filing in the United States either by year end 2023 or early 2024.

-- The Company has discovered additional therapeutic advantages of dorzagliatin in medical care, including the restoration of endogenous GLP-1 secretion, prevention of cognitive dysfunction, better glycemic control in obese patients with diabetes, and diabetes prevention enabled by reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT).

-- As of June 30, 2023, our cash balance was RMB881.3 million, representing an increase of approximately 79.6% as of December 31, 2022. The Company received RMB400 million non-refundable milestone payment from Bayer. With additional government funding, our total cash received from Bayer and government funding in the first half of 2023 was RMB402.6 million.

-- On August 17, 2023, the Group and Bayer confirmed the achievement of a certain milestone relating to the development of HuaTangNing. Pursuant to the terms of the commercialization agreement between the Group and Bayer, the Group is entitled to receive a milestone payment of RMB800 million from Bayer.

Hua Medicine (the "Company", HKEx: 2552) today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2023 (the "Reporting Period").

Dr. Li Chen, the founder and CEO of Hua Medicine, said, "the first half of 2023 was a critical stage for Hua Medicine to begin commercialization. Since successful approval and the launch of prescription sales of dorzagliatin, the Company has worked closely with Bayer across the major channels of on-line drug store, retail pharmacies and hospital pharmacies. The result has been substantial growth of sales that is boosting our confidence in faster growth of dorzagliatin in the future."

"As market demand and user numbers increase, we will carry out more real-world studies on dorzagliatin to meet more unmet clinical needs. In addition, Hua Medicine continues to make breakthroughs in exploring new treatment opportunities for dorzagliatin, including a wider range of indications and product pipelines for more countries and regions. Hua Medicine will continue to work with our partners in exploring more paths for the development of first-in-class drugs in China and around the world, and helping people live healthy and fulfilling lives," Dr. Chen said.

Progress of Clinical Research and Company Operations

-- In March 2023, the Company published a research paper in Nature Communications. The paper discusses studies which show that through its modulation of the glucose sensor glucokinase (GK) function and by repairing impaired GLP-1 secretion in patients with diabetes and obesity, dorzagliatin is expected to secure a new indication related to endogenous GLP-1. The study further demonstrated that dorzagliatin restored the impaired glucose homeostasis in T2D patients through its action on GK targets located in the pancreas, intestine, and liver. This may offer a more effective way to achieve diabetes remission in obese diabetes patients through a combination of dorzagliatin with a GLP-1 receptor agonist.

-- In June 2023, the Company presented the positive effects of dorzagliatin in the prevention of diabetes and memory deterioration in GK rats at the June 2023 American Diabetes Association (ADA) Scientific Sessions. The Company has filed patents in this area and will continue to expand its research into the benefit of dorzagliatin in disease prevention.

-- In June 2023, the Company published our results of a prospective SEED-DREAM study in Chinese non-obese diabetes patients in the well-recognized journal, Diabetes, Obesity and Metabolism, in which we have reported a 65% remission probability during 52 weeks in subjects who have improved their TIR (Time-In-Range, a parameter that represents a better homeostasis control) after dorzagliatin treatment. We have further revealed the determinant factors for achieving diabetes remission after dorzagliatin treatment during the SEED study. These factors include a significant improvement of beta cell function and disposition index, reduction of post prandial glucose and significant increase of TIR during the SEED trial. Improvement of TIR is strongly correlated with reducing the risks of various diabetes complications, including heart attack, stroke and renal disease, as well as neurodegenerative disorders.

-- The Company has filed its National Reimbursement Drug List (NRDL) application for dorzagliatin in China and is preparing the pharmacoeconomic value discussion with regulatory agencies in the near future. According to the National Healthcare Security Administration, dorzagliatin has passed the preliminary formal examination.

-- Hua Medicine has worked with its manufacturing partners since the drug approval to manage market needs. We have secured adequate dorzagliatin supply for the 2023 calendar year, and 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 2023-2024 for commercial drug manufacturing and capacity expansion is expected to be in the range of RMB400 million.

-- The Company is investigating the potential of dorzagliatin in diabetes prevention in a clinical study. After the initiation of the SENSITIZE II study at Chinese University of Hong Kong (CUHK), the Company is developing clinical study plans of reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT) in China. IGT is a primary cause of T2D, 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.

Business outlook

-- The Company will continue with our responsibility as market authorization holder (MAH) of dorzagliatin to commercialize dorzagliatin in China with our partner, Bayer, to expand market share in diabetes care, especially among Type 2 diabetes patients with uncontrolled post prandial glucose (PPG) who will benefit from the improvement of beta cell function and time in range (TIR).

-- The Company will continue to invest into dorzagliatin manufacturing capability and into expanding our tier-1 distributor network to drive a three-pronged approach to commercialization in China: hospitals, pharmacies, and on-line drug stores.

-- The Company is seeking entry into the National Reimbursement Drug List (NRDL), to facilitate the entry into hospitals and increase accessibility by physicians in order to demonstrate dorzagliatin's potential to be a cornerstone treatment for Type 2 diabetes as monotherapy or in combination with other approved antidiabetic drugs.

-- The Company is expecting to receive a certain milestone payment from Bayer related to the development of dorzagliatin in the second half of 2023.

-- The Company is also advancing development of our second generation glucokinase activator for potential future international expansion including DKD and diseases associated with impaired glucose homeostasis. Currently, we are actively looking for business partners to advance our R&D programs and commercialization to help more patients globally.

-- The Company will continue to develop new drug candidates of fixed-dose-combination of dorzagliatin with metformin, sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor). It was found in clinical studies that the combination of dorzagliatin with a DPP-4 inhibitor or SGLT-2 inhibitor improved glycaemic control and beta cell function in patients with diabetes and obesity.

-- Additional benefits of dorzagliatin in disease prevention will be further explored in endocrinology and neurodegeneration.

-- Progress has been made in glucokinase candidate targeting congenital hyperinsulinism a rare disease in the United States and China. The AI-based lead optimization will help to advance the program and select clinical candidates with joint effort at AscendRare and Hua Medicine. We are also jointly investigating the opportunity of FKI in different diseases areas and developing sensitive IVD methods for clinical detection of fructose, a sugar component, which contributes to obesity and liver disease. Reduction of the fructose flux into liver could prevent the fatty liver disease and related complications.

Financial highlights

As of June 30, 2023,
-- Since the launch of commercial sales at the end of October 2022, dorzagliatin achieved total sales revenue of RMB87.9 million as of June 30, 2023. The revenue of Hua Medicine for the first half of 2023 was RMB70.3 million, which was an increase of approximately 299.6% comparing to the second half of 2022.

-- Bank balances and cash position were approximately RMB881.3 million.

-- Total expenditures incurred by the Company for the six months ended June 30, 2023, were approximately RMB181.5 million, of which approximately RMB71 million was attributable to research and development expenses.

-- Total comprehensive expenses for the period decreased by approximately RMB14.0 million or approximately 13.4% to approximately RMB90.5 million, compared with the six months ended June 30, 2022.

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, 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. As Hua Medicine's cornerstone product (dorzagliatin tablets), targeting the glucose sensor, glucokinase, restores glucose sensitivity in T2D patients and stabilizes the imbalance of blood glucose levels in patients, it has been approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families. HuaTangNing has also demonstrated its potential of achieving diabetes remission in clinical studies to help millions of diabetic patients around the world.


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