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华领医药-B(02552.HK)动态点评:全球首创新药葡萄糖激酶激活剂华堂宁获批上市

Hualing Pharmaceutical-B (02552.HK) Dynamic Review: Huatangning, the world's first innovative drug, glucokinase activator, was approved for marketing

東方財富證券 ·  Oct 12, 2022 13:06  · Researches

[matters]

Huatangning (doglidine tablets), a new drug called glucokinase activator (GKA), developed by the company, was approved by China's State Drug Administration (NMPA) on October 8. Huatangning has been approved for two indications, including the use of metformin alone in the treatment of untreated type 2 diabetes, or in combination with metformin in the treatment of adult type 2 diabetes in cases of poor blood glucose control.

[comments]

Huatangning, as the first glucokinase activator drug approved to market in the world, is also the first original new drug with a new mechanism in the field of diabetes in recent years.

The mechanism of action is unique, and it has good pharmacokinetic characteristics and safety, and has the potential for remission of diabetes. Based on the unique mechanism of action, it is expected to be combined with other diabetes drugs. A better hypoglycemic effect can be obtained when combined with metformin, cigletine or enoglitazine. After combined treatment, the level of glucose-stimulated insulin secretion is higher than that of each single drug treatment, which can improve the β-cell function of patients.

It is suitable for patients with type 2 diabetes with moderate to end-stage renal function injury without adjusting the dose.

Huatangning has low renal excretion and similar pharmacokinetic characteristics in patients with end-stage renal disease (ESRD) and healthy volunteers. Patients with renal insufficiency do not need to adjust the dose.

The company has entered the commercialization stage, and Huatang Ning is expected to enter the health insurance catalogue next year. The company and Bayer jointly promote the commercialization of Huatangning in China, and focus on promoting negotiations on innovative drugs and health insurance, which is expected to enter health insurance next year. We maintain the company's 2022-2024 EPS forecast of-0.24 pesque 0.21 million 0.08 yuan, maintaining the "overweight" rating.

[risk Tip]

Health insurance negotiations are not as good as expected.

Repeated epidemic situation

The translation is provided by third-party software.


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