Qilu Pharmaceutical s mirabegron sustained release tablets were approved for marketing

Mondo Health Updated on 2024-02-01

Taishan Finance on January 30Recently, Qilu Pharmaceutical's ** overactive bladder (OAB) drug mirabegron sustained-release tablets were approved for marketing by the State Drug Administration and are deemed to have passed the consistency evaluation. Up to now, Qilu Pharmaceutical has a total of 155 products that have passed or are deemed to have passed the consistency evaluation, of which 54 are the first in China.

Mirabegron is a 3-adrenergic receptor agonist that inhibits voluntary contractions by acting on the 3AR on the detrusor muscle during the storage phase, thereby mediating increased bladder compliance and delayed voiding reflex; It can also activate the second messenger, cyclic adenosine monophosphate (CAMP), which reactivates PKA, which in turn phosphorylates key target proteins in the cell, resulting in smooth muscle relaxation and ultimately alleviation of OAB. This product is the first OAB** drug with a new mechanism of action approved at home and abroad in the past 30 years, which can not only be used alone, but also can be administered in combination with existing OAB** drugs, providing patients with a variety of ** choices. Clinical application has confirmed that the efficacy and safety of mirabegron alone or in combination with solifenacin **OAB are good, and the monotherapy efficacy of this product is comparable to that of solifenacin, the most widely used drug in clinical practice, and the efficacy will be significantly improved when combined with solifenacin. In addition, mirabegron is well tolerated, the incidence of adverse reactions is low, and in the case of long-term medication, there are fewer adverse reactions after interruption of ** than solifenacin.

In the research and development process of mirabegron sustained-release tablets, Qilu R&D personnel faced many problems in technology, process, production, quality and other problems, and constantly overcame difficulties to solve many difficulties in R&D and production. Qilu Pharmaceutical's mirabegron sustained-release tablets adopt a hydrophilic skeleton sustained-release structure, and the drug is gradually released with the dissolution of the skeleton structure, and the release is complete in 10-12 hours, which can effectively reduce the fluctuation range of blood drug concentration and maintain the blood drug concentration in the ** range for a long time, which is more conducive to the disease than the immediate-release dosage form. In addition, this product also uses imported raw materials and packaging materials that meet FDA requirements, and the product quality meets the requirements of China and the United States, and has simultaneously passed human clinical trials at home and abroad, fully ensuring the consistent quality and clinical equivalence between self-produced products and original products. The approval of Qilu Pharmaceutical's mirabegron sustained-release tablets will provide patients with more drug options.

Over the years, Qilu Pharmaceutical has always been committed to maintaining human health, taking meeting social needs as its own responsibility, and is committed to making domestic high-quality drugs accessible and affordable to the Chinese people. In the future, Qilu Pharmaceutical will not forget its original intention, continue to meet the current unmet clinical needs, serve patients, and contribute to the construction of a healthy China. (Correspondent Liu Xingyu).

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