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【Pharmaceutical Network Industry Dynamics】In recent years, affected by the domestic generic drug market "inner volume" becomes the trend, innovation accelerates, and the stock market under medical insurance control fees begins to be compressed, a large number of pharmaceutical companies have begun to implement the internationalization strategy and accelerate the registration and listing of products overseas
.
For example, Taikang Bio recently signed an exclusive agency agreement with an Indonesian pharmaceutical company, and the two sides reached a cooperation
on jointly promoting the registration, import, promotion, distribution, marketing and sales of Kangtai Bio's 13-valent pneumonia vaccine in the local area.
It is understood
.
Since being approved in China in September 2021, The Kangtai 13-valent pneumonia vaccine has been covered in more than 20 provinces (autonomous regions and municipalities directly under the central government) across the country, and registration has been initiated in the
Philippines.
For this cooperation, the relevant person in charge of Kangtai Biology said that the company's internationalization strategy has made frequent progress in Southeast Asia recently, and has signed pneumonia vaccine cooperation agreements with the Philippines and Indonesia, which reflects that the innovation and quality of the company's products have been recognized
by more overseas markets.
Jianyou shares this year's products out of the sea is also frequently spread good news, August 3 company announced that its injection of vancomycin hydrochloride 500mg / bottle, 1g / bottle of the brief new drug application (ANDA, that is, the United States generic drug application) has been approved by the US FDA in July 2022, for methicillin-resistant serious infections caused by staphylococcus and other bacteria; On June 8, subsidiary Hong Kong Jianyou's Ganirek acetate injection 250 mcg/0.
5 mL was approved by the US FDA for use in women with controlled ovarian stimulation (COS) regimens to prevent premature luteinizing hormone (LH) peaks; On 11 May, its voriconazole 200 mg/bottle for injection was approved by the U.
S.
FDA for the treatment of the following fungal infections
in adults and children 2 years of age and older.
In addition, the performance of Huiyu pharmaceutical products in foreign countries is also very eye-catching
.
In May, its concentrated solution for oxaliplatin injection was approved for registration in Germany; In June, Ploxaf injection obtained registration approval in the Uk, and Huiyu Pharmaceutical became the first enterprise
in the UK to obtain approval for the generic drug.
In addition, its sodium valproate injection for concentrated solution, levetiracetam injection for concentrated solution, octreotide acetate injection, Prasafol injection and other 4 injections have been registered in the United Kingdom
.
At present, Huiyu independently holds 15 batch products in the
BRITISH market.
Among them, in addition to the United Kingdom, Pleshavo injection has also submitted registration declarations in many countries - including China, as well as more than 20 European and North American countries
such as Ireland, Germany, Spain, France, Poland, the Netherlands, Italy and Canada.
As of April this year, Huiyu Pharmaceutical has obtained more than 200 overseas listing approvals, and submitted more than 160 documents for registration and approval (including independent and authorized partners), covering 51 countries and regions
.
It is worth mentioning that in the past three years, the compound growth rate of Huiyu Pharmaceutical's overseas revenue has reached 73%.
In addition to the above-mentioned pharmaceutical companies, a large number of pharmaceutical product clinical trials have been approved by
the FDA this year.
According to incomplete statistics, from May 10 to August 30, more than 18 pharmaceutical companies in Shanghai and Shenzhen have obtained news from the FDA, which is related to the product obtaining the FDA drug clinical trial implied license, obtaining drug registration approval, obtaining approval number, etc
.
The industry expects that in the future, with the growth of the number of innovative drug INDs in China, the increase in the number of clinical trials, and the improvement of the quality and strength of domestic innovative drugs, domestic drugs will be recognized by more and more overseas markets, and pharmaceutical companies will also usher in more and more new market growth points
.
Disclaimer: In no event shall the information or opinions expressed herein constitute investment advice
to any person.