[News] Hua Medicine Announces the Inclusion of Dorzagliatin in the National Reimbursement Drug List (NRDL)

December 13, 2023 – China, Shanghai

Hua Medicine (the "Company", HKEx: 2552.HK) announced today that HuaTangNing (华堂宁^®) (dorzagliatin), its self-developed first-in-class glucokinase allosteric activator (GKA) for diabetes, has been successfully included in China's National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration (NHSA). Dorzagliatin is the first commercialized product of the organization subject to negotiations with healthcare insurance providers. The recent inclusion of dorzagliatin in the NRDL is another key step forward in Hua Medicine's commercialization. The most recent NRDL will go into effect on January 1, 2024.

Dorzagliatin is a first-in-class allosteric GKA medication developed by Hua Medicine based on its innovative scientific approach of "repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes." Dorzagliatin, which targets the glucose sensor glucokinase (GK) in the human body, acts on pancreatic islets, intestinal endocrine cells, liver, and other glucose storage and output organs, and improves impaired GK function in Type 2 diabetes patients, improving β-cell function and reducing insulin resistance. As a result, it has the potential to slow the disease progression and development of Type 2 diabetes complications at its underlying cause by restoring the physiological regulation of blood glucose homeostasis. In clinical trials involving dorzagliatin certain individuals treated with dorzagliatin were able to maintain adequate blood glucose control long after discontinuing the medication, potentially resulting in diabetic remission ^[1].

Dorzagliatin was approved by China's National Medical Products Administration (NMPA) on September 30, 2022, making it the world's first approved GKA medicine. It can be used alone or in combination with metformin hydrochloride in patients with Type 2 diabetes. In September 2023, the NMPA released the "2022 Drug Review Annual Report" on its official website, stating unequivocally that dorzagliatin tablets were the world's first GKA drug for the treatment of Type 2 diabetes, and for the first time officially confirming dorzagliatin's market position as the first-in-class novel drug.

Since the launch of dorzagliatin, the Company has worked closely with production and commercial partners to ensure sufficient market supply. From 2023 to 2024, the Company aims to invest approximately RMB400 million on commercial manufacturing and capacity expansion.

Dorzagliatin is the Company's first product to be listed on the NRDL. It is expected to improve the accessibility and affordability of diabetes medicines and benefit more diabetes patients, truly embodying Hua Medicine's corporate tenet of "For Patients, Global Innovation, Effective Medicines." Joining forces with its commercial partner, Bayer, in China, Hua Medicine will actively collaborate with national departments to promote medical insurance implementation, strengthen commercial production capabilities, and expand coverage in core markets and surrounding areas, and make every effort to meet the medication demand of patients across the country.

"HuaTangNing is a new hyperglycemia solution provided by Bayer in collaboration with Hua Medicine, a domestic novel drug research and development company, to hundreds of millions of diabetic patients and endocrinologists in China," said Ms. Hu Ziping, Senior Vice President of Bayer's Prescription Drugs Division. "HuaTangNing has shown strong glucose-lowing effect and good safety in monotherapy or combination therapy since its launch a year ago, pioneering the new idea of 'steady-state glycemic control' with its novel mechanism of action. Bayer is glad to see HuaTangNing included in the new version of NRDL, which will further decrease the financial burden on patients and provide better medical solutions to more Chinese patients with Type 2 diabetes".

"We're very honored and excited to see the inclusion of dorzagliatin in the NRDL, which is an important milestone in the development of Hua Medicine," said Dr. Li Chen, founder and CEO of Hua Medicine. "This indicates the national healthcare system's acceptance of dorzagliatin's invention and therapeutic application value. We anticipate that by including dorzagliatin in the NRDL, more diabetic patients will be able to access this first-in-class diabetes medicine with a novel mechanism at a low cost via medical insurance. It is expected to reduce the financial burden of patients and their families by providing them with better medical solutions, as well as to reduce the financial strain brought on by diabetes and its complications to the entire society in the long run, thereby realizing Hua Medicine's mission as an innovative pharmaceutical company to actively contribute to the healthcare industry and the country's innovative development. Hua Medicine will keep utilizing all of the therapeutic benefits of dorzagliatin, investigate patient unmet clinical needs, work to advance diabetic remission and prevent complications, and make greater contributions to patients' well-being."

^[1]  https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.15179

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 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. The Hua Medicine's cornerstone product HuaTangNing (华堂宁^®)(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), 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 will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing (华堂宁^®) in China, benefiting diabetic patients and their families.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people and the development of the planet by supporting efforts to overcome the major challenges presented by a growing and aging global population. Bayer is committed to promoting sustainable development and generating positive impact through its business activities. At the same time, the Group aims to increase its earning power and create value through innovation and growth, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses excluding special projects amounted to 5.3 billion euros. For more information, go to www.bayer.com.

About Hua Medicine-Bayer Cooperation
In August 2020, Bayer, a multinational pharmaceutical company, and Hua Medicine, a Chinese innovative drug research and development company, announced a strategic partnership for dorzagliatin, a first-in-class diabetes treatment drug, in China. This partnership aims at leveraging Bayer’s prominent advantages in diabetes management in China and Hua Medicine’s R&D expertise in diabetes treatment. Both parties are committed to benefiting hundreds of millions of China diabetic patients through new therapeutic options. Under the terms of the agreement, Hua Medicine as the market authorization holder (MAH) shall be responsible for clinical development, registration, product supply and distribution, while Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. The Pharmaceuticals China Innovation Center of Bayer facilitated this collaboration. As a global pharmaceutical leader, Bayer is committed to cooperating with external partners to promote breakthrough innovations, bring positive changes to patients, and achieve the goal of "cooperative innovation and joint cure".

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