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$2.8 billion in large varieties to meet the fierce enemy, Huahai, Dongguang Medicine... 63 ANDAs were acquired

 Last Update: 2022-11-26
 Source: Internet
 Author: User

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According to data from Minai.
com, from January to October 2022, the FDA approved a total of 514 ANDAs (excluding provisional approvals, the same below), of which 63 ANDAs (54 varieties) came from domestic enterprises, involving 15 pharmaceutical companies (in terms of groups), Huahai Pharmaceutical temporarily ranked first with 17 ANDAs, followed by Fosun Pharma with 12
ANDAs.

In recent years, domestic pharmaceutical companies have been approved by the FDA

Source: FDA official website, company announcements, etc.
, compiled by Minai.
com

From the perspective of the number of ANDA approvals in recent years, it reached the highest level in 2017, and the policy of "going overseas and reporting to China" has increased the speed of approval of relevant generic drugs in China, which will help domestic pharmaceutical companies quickly seize the market
.
The number of ANDA fell slightly in 2018-2019, because CDE accelerated the speed of drug review and approval, and more Chinese pharmaceutical companies began to turn their attention to the domestic generic drug track
.
After 2020, the normalization of centralized procurement has further compressed the profits of domestic generic drugs, and many domestic pharmaceutical companies have the idea of industrial upgrading, and the number of ANDAS is expected to exceed 70 again in 2022
.

From January to October 2022, domestic pharmaceutical companies were approved by the FDA

Source: MINAI.
COM U.
S.
FDA Listed Drug Database, company announcements

From the analysis of the number of approvals obtained by enterprises, Huahai Pharmaceutical temporarily ranked first
with 17 ANDA.
Among them, Fingolimod capsules are multiple sclerosis drugs, and Novartis' original drug has global sales of US$2.
787 billion in 2021 (calculated at the immediate exchange rate, the same below).

At present, no generic drugs of the drug have been approved in the domestic market, and the marketing applications submitted by Dongguang Pharmaceutical and Contini Pharmaceutical are under review
.
Dongguang Pharmaceutical's fingolimod capsules were approved for the first imitation in the United States in 2019, and recently successfully challenged the first generic patent, and have been included in the priority review by CDE; If Huahai Pharmaceutical's product is forwarded to China as an ANDA in the United States, it can also accelerate the listing process
.

Domestic declaration of fingolimod hydrochloride capsules

Source: Minainet new version of the database

Fosun Pharma ranked second, receiving 12 ANDAs, including 9 injections and 3 eye drops/ophthalmic gels, many large varieties of more than US$1.
3 billion such as esomeprazole and lacosamide, and timolol ophthalmic gel
, a first-line treatment for infantile hemangioma.

Global sales of esomeprazole and lacosamide in recent years (US$ billion)

Source: Minai.
com database of multinational listed companies

Hengrui Pharmaceutical continues to deepen the field of contrast agents, and this year has won the ANDA
of two varieties: gadolinium acid glucosamine injection and iodixanol injection.
According to data from Minai.
com, in 2021, the sales of terminal iodixanol injection in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) exceeded 4.
7 billion yuan, a year-on-year increase of 9.
58%, and the market size of gadolinium acid glucosamine injection also exceeded 800 million yuan, a year-on-year increase of 1.
51%.

Sales of terminal iodixanol injection in public medical institutions in China in recent years (: 10,000 yuan)

Source: Minai.
com Competition Pattern of Drug Terminals in China's Public Medical Institutions

It is worth noting that since the beginning of this year, a number of new faces have been added to the internationalization of Chinese pharmaceutical companies, such as Shanghai Pharmaceutical, Shandong New Era, Kyushu Pharmaceutical, etc.
; Gadolinium pentamine contrast agent, iodixanol injection, regardazone injection and other special laboratory drugs, as well as metoprolol sustained-release tablets, ropinirole sustained-release tablets, oseltamivir suspension and other high-barrier preparations have also appeared in the US market.
.
.
A series of indications show that domestic pharmaceutical companies are entering the era
of high-quality development "going to sea".

Source: Minainet database, company announcements, etc

Note: Minai.
com's "Drug Terminal Competition Pattern of Public Medical Institutions in China", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of November 11, manual statistics, if there are omissions, welcome to correct!

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