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【Pharmaceutical Network Enterprise News】Recently, Luye Pharmaceutical announced that its holding subsidiary Boan Biotech has officially obtained marketing approval for denosumab injection (Boyoubei) for osteoporosis
in postmenopausal women with high-risk fractures.
Boyoubei is a biosimilar of Amgen's Proli, which was launched
in December 2020.
In 2021, Proli generated worldwide sales of $3.
248 billion
.
Boyoubei is currently the first domestic Prolia biosimilar approved for marketing
.
In addition to the application in China, Boan Biotech has also carried out international clinical trials and registration in Europe and the United States, and plans to promote this product to the global market
.
It is worth mentioning that Luye Pharmaceutical's self-developed Toludi venlafaxine hydrochloride sustained-release tablets (Ruoxinlin) have also been approved for marketing a few days ago for the treatment of depression
.
Ruoxinlin is the first class 1 innovative drug
independently developed and owned by China for the treatment of depression.
It is understood that depression is a common mental illness, and the global incidence has increased by 25%
under the influence of the new crown epidemic.
According to the 2022 China Depression Blue Book, there are up to 95 million people with depression in China, with an average of one in 14 people suffering from depression
.
With the increase of the attention of the state and society to psychological problems, people's understanding of depression is getting deeper and deeper, and the understanding of antidepressants is gradually increasing, and the scale of China's antidepressant market is also expanding
.
According to research data, the market size of antidepressants in China in 2020 will be 10.
94 billion yuan, with a growth rate of 16.
01%.
Ruoxinlin, approved by Luye Pharmaceutical, is a triple reuptake inhibitor
of 5-HT, norepinephrine and dopamine.
Compared with double reuptake inhibitors, it helps improve anhedonia, cognitive performance, and sexual function
.
In this regard, the industry believes that the new mechanism of action not only allows patients to have more choices, but also makes Ruoxinlin expected to break the current market pattern of antidepressants dominated by old drugs and generic drugs
.
For Luye Pharmaceutical's two blockbuster new drugs to be listed one after another, industry analysts believe that this is a manifestation
of its vigorous innovation and research and development, and the results have begun to appear.
It is understood that in terms of new products, in addition to the above-mentioned denosumab injection and antidepressant new drug Ruoxinlin, Luye Pharmaceutical also had 3 blockbuster products
approved last year as Ruixintuo (risperidone microspheres for injection (II)), Kingsmine (Ristigmine transdermal patch), and Boyouno (bevacizumab injection).
In addition, in terms of product development, as of June 30, 2022, Luye Pharmaceutical also has 32 products in different stages of development, including 13 oncology products, 12 central nervous system products and 7 other products
.
Among them, 9 projects in the R&D pipeline are in the new drug market review stage, and 9 projects are in the phase III/critical trial/new drug application (NDA) preparation stage
.
Luye Pharmaceutical expects to launch a total of 10 new products in the Chinese, American and European markets by 2024
.
With the intensive listing of more innovative drugs, the industry generally believes that Luye Pharmaceutical may be expected to usher in a new round of high-quality development
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.