26 April 2021 | News
The world's first glucokinase activator Dozaglietin NDA was accepted by NMPA
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Hua Medicine has announced the first innovative diabetes drug Dozaglietin (The NDA application submitted by dorzagliatin has been accepted by the Center for New Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
Dozaglietin became the first glucokinase activator (GKA) diabetes treatment drug to submit a new drug marketing application in the world, and it is expected to become the world's first innovative drug (FIC) to be marketed first in China.
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. Dozaglietin is the world's first new oral treatment for diabetes launched by a Chinese biotechnology company. Its new mechanism of action directly attacks the underlying cause of type 2 diabetes.
By repairing the damaged glucokinase sensor function of diabetic patients, dozaglietin Tatin can significantly improve the β-cell function and reduce insulin resistance in patients with type 2 diabetes, effectively control the progression of type 2 diabetes, and has broad therapeutic prospects in patients with diabetic nephropathy.
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.