Hua Medicine's first innovative diabetes drug Dozaglietin NDA was accepted by NMPA!

Hua Medicine (the "Company", Hong Kong Stock Exchange stock code: 2552.

HK) announced today that the NDA application submitted by the first innovative diabetes drug dorzagliatin has been approved by the National Medical Products Administration (NMPA) Accepted by the Center for Evaluation (CDE).
Dozaglietin became the first glucokinase activator (GKA) diabetes treatment drug in the world to submit a new drug marketing application, and it is expected to become the world's first innovative drug (FIC) to be marketed first in China.

Originally inventing the scientific concept of "repairing sensing, rebuilding steady state, and treating diabetes from the source", Hua Medicine has always paid attention to the unmet clinical needs since its establishment, and is committed to developing breakthrough products with subversive concepts , To establish the clinical practice and treatment standards of the disease.

Dozaglietin is the world's first new GKA diabetes drug submitted for NDA, with innovative mechanisms, new targets, new structures, new preparations and new curative effects.

Nowadays, diabetes has become a major public health problem.
According to a survey published by the British Medical Journal (BMJ) in 2020, according to the diagnostic criteria of the American Diabetes Association (ADA), the total number of diabetic patients in China is approximately 130 million.
Compared with the huge number of patients, the awareness rate of type 2 diabetes in China is only 43.
3%, and the treatment rate is only 49.
0%.
In recent years, the state has attached great importance to the prevention and treatment of diabetes.
The "Healthy China Action (2019-2030)" has clearly defined the goal.
By 2030, the awareness rate of diabetes among residents aged 18 and above will reach 60% and above, and the standardized management rate will reach 70%.
And above, diabetes treatment rate, control rate and complication screening rate continue to increase.

In the past decade, the diabetes market has grown rapidly.
In 2019, the global cost of diabetes is about 760 billion U.
S.
dollars; in China, the cost of diabetes is about 109 billion U.
S.
dollars, and the market potential is huge.
With the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)" issued by the Diabetes Branch of the Chinese Medical Association and the "Diabetes Diagnosis and Treatment Pathway (2021 Edition)" of the American Diabetes Association, the concept of "stabilizing sugar" has increasingly become a new approach to diabetes Standard, the development of glucokinase activator with "sugar stabilization" as the core has also attracted much attention.

In December 2020, Hua Medicine announced the successful completion of two phase III registered clinical studies of dozagliflozin.
Among them, SEED (seed study, also known as HMM0301) is a dozagliflozin carried out in patients with untreated type 2 diabetes.
Etin monotherapy trial, DAWN (Dawn Study, also known as HMM0302) is a trial of dozagliflozin combined with metformin in patients with type 2 diabetes who have failed adequate metformin treatment.
Two studies have shown that during the treatment period, dozaglietin can take effect quickly, continuously and effectively reduce glycated hemoglobin, and significantly reduce the blood glucose level two hours after a meal.
It has good safety and tolerability, and can be sustained Improve β cell function and insulin resistance.
Two phase I clinical studies conducted in the first half of 2020 showed that the combination of dozagliflechta and DPP-4 inhibitors and SGLT-2 inhibitors showed a significant synergistic effect in controlling blood sugar, indicating that more Zaxagliptin has broad application potential in type 2 diabetes patients with different sugar control needs and different disease stages.
Another phase I study conducted in patients with end-stage renal impairment showed that dozagliflozin monotherapy can provide treatment opportunities for diabetic nephropathy (DKD), which accounts for about 20%-40% of the population.
It is expected to become an oral hypoglycemic agent for diabetic nephropathy without dosage adjustment.

In the process of promoting the commercialization of dozaglietin, in August 2020, Hua Medicine has reached a strategic cooperation agreement in China with the global pharmaceutical giant and a leader in the field of diabetes treatment in China, and the two parties will join forces.
Hua Medicine’s innovative capabilities and Bayer’s leading advantage in the field of diabetes management in China have enabled this world’s first innovative drug to benefit Chinese diabetic patients as soon as possible; in September, the company has been awarded dozaglietin by the Shanghai Drug Administration "Pharmaceutical Production License" completes the core work of preparation for commercial production.

Dr.
Chen Li, founder and CEO of Hua Medicine said:

"

We are very pleased that the NDA application of Dozaglietin has been accepted by the NMPA.
This is a major milestone event for Hua Medicine.
On the path of innovation that is the world's first and the first in China, Hua Medicine has always strived to stand on the high ground of reform and opening up and at the forefront of pharmaceutical innovation, and contribute to the development of China's pharmaceutical industry and people's health.
Diabetes and chronic disease management is a major task to protect national health.
For 10 years, Hua Medicine has adhered to the original intention of “China Leads Pharmaceutical Innovation” and has actively explored the development and review and approval of China’s first innovative drugs with the Drug Evaluation Center.
The spirit of'Ten Years of Grinding a Sword' has achieved a major breakthrough in the development of innovative drugs.
The development of this world's first innovative drug broke the foreign monopoly of the world's first innovative drug development.
We are very proud of this achievement, and we look forward to working with our partners to jointly promote the marketing of Dozaglietin in China.

"

About Dozaglietin

Dorzagliatin is the world's first dual-acting glucokinase activator under research, which aims to control the development of progressive degenerative diseases of diabetes by restoring blood glucose homeostasis in patients with type 2 diabetes.

By repairing the defects of the glucose sensor function of glucokinase, dozagliflechtin has the potential to restore the impaired blood glucose homeostasis in patients with type 2 diabetes.
It can be used as the first-line standard of treatment for the disease, or as a current approved anti-diabetic drug Basic treatment for combined use.

About Hualing

Hua Medicine is a biotechnology company based in China that develops global original and innovative drugs for the unmet clinical needs of patients with diabetes worldwide.

Forward-looking statement

This article contains statements about the future expectations, plans and prospects of Hua Medicine and the products under development.