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Hua Medicine announced today that the NDA application submitted by dorzagliatin, the first innovative drug for diabetes, has been accepted by the Center for New Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)
.
Dozaglietin has become 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 first global innovative drug (FIC) to be marketed 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
In the past decade, the diabetes market has grown rapidly
.
In 2019, the global cost of diabetes is about 760 billion U.
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.
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, the 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 for Hua Medicine.
It is the
first in the world and in China.
On the path of initial innovation, Hua Medicine has always strived to stand at the forefront of reform and opening up and pharmaceutical innovation, and contribute to the development of China’s pharmaceutical industry and people’s health
