In recent years, after years of baptism of national procurement and medical insurance negotiations in China, the competition pattern of the pharmaceutical market has been roughly clear, and the exchange of quantity for price is also requiring various pharmaceutical companies to be more pragmatic
.
In this context, the "involution" of the domestic generic drug market has intensified, and the speed of pharmaceutical companies "going global" has begun to accelerate
.
On October 19, Huahai Pharmaceutical announced that the new drug abbreviated application for dimethyl fumarate sustained-release capsules (ANDA, that is, the US generic drug application) declared to the US Food and Drug Administration (FDA) has been approved
.
Dimethyl fumarate sustained-release capsules are mainly used for the treatment of multiple sclerosis
.
At present, in the United States, the main manufacturers of dimethyl fumarate sustained-release capsules are Viatris, Reddy, Cipla, etc
.
This time, the official approval of dimethyl fumarate sustained-release capsules marks that Huahai Pharmaceutical has the qualification to sell the above products in the US market, and the acquisition of the ANDA document number of the product is conducive to the company's continuous expansion of sales in the US market, strengthening the product supply chain, enriching the product echelon, enhancing the market competitiveness of the company's products, and having a positive impact on
the company's operating performance.
Up to now, Huahai Pharmaceutical has invested about 8.
7 million yuan
in R&D expenses in the dimethyl fumarate sustained-release capsule project.
In fact, before the innovative drugs, Chinese pharmaceutical companies have begun to open the overseas mode, and domestic generic drugs have begun to appear frequently in
the international market.
For example, at the end of May, Hengrui's iodixanol application for ANDA (generic drug marketing) in the United States was approved
.
It is understood that Hengrui Pharmaceutical iodixanol injection is the first generic drug
of this variety approved by the US FDA for marketing.
After this approval, according to the US CGT (competitive generic therapy) bill, Hengrui Pharmaceutical's iodixanol injection will obtain a market exclusivity period of 180 days, which is expected to become a variety
of Hengrui Pharmaceutical with overseas sales of more than 100 million US dollars.
In addition to the above enterprises, since the beginning of this year, Huiyu Pharmaceutical's injection products have also been
approved abroad.
For example, in May, the company's concentrated solution for oxaliplatin injection obtained registration approval
in Germany.
Then, in June, the company's Plansafo injection obtained registration approval in the UK, and it was the first company
to obtain approval for the generic drug in the UK.
Up to now, the company's 4 injections, including sodium valproate concentrated solution, levetiracetam injection concentrated solution, octreotide acetate injection, and Plorxaf injection, have successively obtained registration approvals
in the UK.
In addition, the company has independently held 15 batch products in the UK market
.
Industry analysts believe that in recent years, under the pressure of environmental protection high pressure and consistency evaluation policies, the quality standards of generic drugs in China have been continuously improved, and gradually converged in the high-end direction
.
With the improvement of China's comprehensive production capacity of generic drugs, generic drugs will gain more competitiveness in the global market with their API and quality advantages, and their export prospects will become broader and broader
.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"Share to:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
