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Microspheres are tiny spherical entities with a particle size of about 1-250 microns that are dispersed and embedded in a polymer matrix through microencapsulation technology
.
Because the microsphere preparation can release the drug at a certain rate within a few weeks or months to maintain the effective blood drug concentration, prolong the action time of the drug, improve the drug effect, and can greatly reduce the number of patient administration times, and greatly improve the patient's drug use In recent years, more and more pharmaceutical companies are increasing their deployment in this field
.
From the current point of view, compared with other local companies, Livzon Pharmaceuticals is relatively advanced in this field, and its pipeline products are also very rich
.
Recently, Shanghai Livzon Pharmaceuticals submitted a clinical application for a Class 2.
2 new drug of Alanerlin Acetate Microspheres for Injection.
This is the fifth new drug declared by Livzon this year
.
It is understood that the microsphere technology platform has always been the dominant area of Luye Pharmaceuticals.
Since Livzon’s blockbuster product, leuprolide acetate microspheres for injection, has been on the market, its sales have been surging all the way.
Entering the harvest period, while the sales share of domestic microspheres continues to expand, its status is also constantly improving
.
For example, currently in China’s urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions), the main best-selling domestic microsphere products are Livzon’s leuprolide acetate for injection.
Microspheres
.
Data show that under the influence of the epidemic in 2020, sales will still exceed 1 billion yuan, and the growth rate of 2021H1 will reach 51%
.
It is understood that in recent years, Livzon's product research and development has focused on high-barrier preparations and biological drugs.
In addition to alanorelin acetate microspheres for injection, many microsphere products have already entered the harvest period
.
Prior to this, Livzon submitted an application for the marketing of triptorelin acetate microspheres for injection.
This product is expected to become the company's second microsphere to be approved for marketing.
The indication is locally advanced or metastatic prostate cancer
.
In addition, octreotide microspheres and aripiprazole microspheres are also scheduled to apply for NDA in 2022
.
Due to the loose competitive environment, the domestic microsphere preparation market is in a period of rapid growth
.
Therefore, in addition to Livzon, the current domestic companies in this field include Luye Pharmaceutical, Changchun Jinsai, Shengzhao Pharmaceutical and Qilu Pharmaceutical
.
However, despite the broad prospects of the microsphere pharmaceutical market, due to high R&D barriers, there are not many domestic pharmaceutical companies involved in this field, and only three drugs have been successfully commercialized
.
Specifically, of the 9 microsphere preparations on the market in China, only 3 are from domestic companies, including Boent’s leuprolide acetate sustained-release microspheres for injection and Livzon Pharmaceutical’s leuprolide acetate for injection.
Microspheres, Luye Pharmaceutical's risperidone microspheres for injection (Ⅱ)
.
On the whole, in the future in the field of microspheres, domestic companies will have a long road to research and development
.
However, the analysis believes that in the centralized procurement environment, as ordinary generic drugs enter the era of meager profit, high-tech barrier generic drugs and innovative drugs will become the R&D direction of pharmaceutical companies
.
As a high-tech barrier generic drug, microsphere preparations have significantly lower risks compared to innovative drugs.
Therefore, the market for high-end microsphere preparations is expected to continue to rise.
This will attract more pharmaceutical companies to enter the market, and relevant pharmaceutical companies may also Will usher in more market opportunities
.