Recently, Hengrui Pharmaceutical issued an announcement that the company's application for gadolinium butrol injection ANDA (American generic drug application) has been approved
.
It is reported that gadolinium butrol injection is a contrast agent, and the global sales of related dosage forms are about 495 million US dollars
.
In addition to the original research products in the US market, Hengrui Pharmaceutical's approved product is the first generic drug; Under the U.
S.
Competitive Generic Therapies Act, a 180-day market exclusivity period
will be granted.
It is worth mentioning that this year, Hengrui Pharmaceutical's contrast agent generic drug ANDA has obviously bloout, and the company's gadoterate glucosamine injection and iodixanol injection ANDA have also been approved
by the FDA in April-May.
Among them, iodixanol injection has also become the first generic drug in the US market, enjoying a 180-day market exclusivity period; According to the data, the global sales of iodixanol injection-related dosage forms are about 873 million US dollars
.
In addition to Hengrui Pharmaceutical, in fact, many domestic pharmaceutical companies are also focusing on generic drugs to go overseas in recent years, and have ushered in gains
.
Ruxuantai Pharmaceutical is a high-tech enterprise driven by R&D, mainly engaged in the research and development, production and sales of generic drugs and CRO services
.
At present, in the field of generic drugs, Sinotherapeutics has 4 ANDA drug approvals for generic drugs; Among them, posaconazole enteric-coated tablets are the core products of Sinotherapeutics, which obtained the "first imitation" of the FDA in 2019, mainly used for antifungal infections
.
According to IMS data, in 2020 and 2021, the market share of Sinotherapeutics Posaconazole enteric-coated tablets in the United States was about
40%.
The product is mainly sold through the US distributor LANNETT, and Sinotherapeutics enjoys 55%
of the net profit.
Last year, Sinotherapeutics achieved the first imitation in China and began to deploy
globally.
At present, the layout scope of the drug has involved Australia, Singapore, Mexico, Israel, Canada, Malaysia, Europe, Arabia and other countries and regions, of which it has been approved for marketing
in Australia, Singapore and Saudi Arabia.
In addition, since the beginning of this year, the news of foreign approval of Huiyu Pharmaceutical's generic drug products has also been continuous
.
For example, in May, the company's oxaliplatin concentrated solution for injection obtained registration approval in Germany
.
Then in June, the company's Prosaf injection obtained registration approval in the UK, and it was the first company
to obtain the approval of the generic drug in the UK.
Up to now, Huiyu Pharmaceutical's four injections, including sodium valproate concentrated solution for injection, levetiracetam concentrated solution for injection, octreotide acetate injection, and Prosafur injection, have also obtained registration approval in the UK
.
The company has 15 approved products in the UK market
.
It is worth mentioning that as of April this year, Huiyu Pharmaceutical has obtained more than 200 overseas marketing approvals and submitted more than 160 approval documents for registration (including those held by independent and authorized partners), of which covering 51 countries and regions
.
In recent years, after years of national procurement and medical insurance negotiations, the market competition pattern is generally clear, and the exchange of quantity for price is requiring various pharmaceutical companies to accelerate the expansion of new markets
.
In this context, the speed of domestic generic drugs "going out" is also accelerating
.
The industry expects that in the future, with the improvement of China's comprehensive production capacity of generic drugs, generic drugs will become more competitive in the global market by virtue of their API and quality advantages, and their export prospects will become more and more broad.
However, it should be noted that due to the short development time, the foundation of the domestic pharmaceutical industry is relatively weak, in order to take into account the accessibility of drugs, the compliance and technical management requirements for the pharmaceutical industry are slightly lower than those in Europe, the United States and Japan, and the level of enterprises is uneven, compared with the international leading generic drug companies There is still a gap, so the industry believes that China's generic drug innovation degree and quality standards need to be further improved, and accelerate to the high-end direction
.
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