84ANDA! Pharmaceutical companies continue to "go out to sea" to fight the U.S. market

Medicine Network January 11th 84th! The fall lasted only a year, and China received a record number of official approvals for ANDA in the United States.
According to E drug manager statistics, in 2020 to Fosun Pharma, Jianyou shares, Renfu Pharmaceuticals, Dongsun Pharmaceuticals, Stone Pharmaceutical Group, Qilu Pharmaceuticals, Nantong Union Asia as the representative of the Chinese pharmaceutical enterprises, a total of 84 approvals from the United States ANDA, the number of enterprises involved reached 25.
all 84 numbers are formal ANDA applications and do not include provisional approval.
the new normal of "going out to sea" began in 2018, Chinese pharmaceutical companies in the United States to declare ANDA ushered in an explosive growth.
, China's approval of ANDA has been on a growing trend, but the number is stable.
the whole of 2017, there were 31 official ANDA approvals declared successfully by Chinese pharmaceutical companies in the United States, involving a total of 8 companies, and in 2016, there were 22 official ANDA approvals, the same number of companies.
years from 2012 to 2015, the number ofANDAs taken by Chinese pharmaceutical companies each year remained between 11 and 13, with only five or six companies involved and a few familiar faces each year.
until 2018, 19 Chinese companies have received a total of 80ANDA approvals in the United States, both in terms of the number of enterprises and the number of approval numbers.
Behind this are both the increasing enthusiasm of Chinese pharmaceutical companies to explore foreign markets under the strategy of going to sea, but also by the consistent evaluation policy for the recognition of Common Line products in Europe and the United States to feed the domestic market and many other factors.
Chinese pharmaceutical companies in the United States of America's generic drug approval ushered in a new harvest period.
surprises, the sustained trend is also a concern, as is the key to measuring the level of China's pharmaceutical corps entering the international market.
year figures showed a decline, in 2019 the whole year 76ANDA official approvals in the United States, and from the data to see Huahai Pharmaceuticals, Dongsan Pharmaceuticals, People's Fu Pharmaceuticals and other sea-going "main force" have seen a decline in the number of adjustment phenomenon.
another global outbreak in 2020, but the performance of the Chinese pharmaceutical corps has given people a dose of heart-stopping pills.
a record 84 OFFICIAL APPROVALs, also allowing Chinese pharmaceutical companies to reach 10% of the FDA's share of ANDA approvals for the third consecutive year.
the number of Chinese pharmaceutical companies involved in the sea more and more new faces, the size of the second and third echelons continue to grow.
growing number of "sea-going" legions is becoming the new normal in China's pharmaceutical industry.
202 "out to sea" legion in 2020 approved THEA's largest Chinese enterprises are Fosun Pharma pharma received a total of 18 official approvals.
Fosun Pharma has long been regarded as a representative company for the internationalization of local enterprises.
$1,091 million acquisition of Indian pharmaceutical company Gland Pharma in 2017.
that by 2020, Gland Pharma and its partners will have more than 260ANDA in the United States.
, Fosun Pharma has not only deepened its international layout, but has also been more active in its globalization strategy.
In addition to fostering operational capabilities through establishing subsidiaries in mature markets such as the United States and Europe, Fosun Pharma also cultivates and forms markets and production capacity in emerging markets such as Africa and India through self-build and mergers and acquisitions.
" domestic enterprises are rapidly going out, so in fact, we ourselves, as the earliest batch of global first-in-the-place enterprises, feel a kind of pressure.
of course this is a driving force, and perhaps we need to further strengthen and deepen the foundations of our globalization and do it better faster.
," Wu Yifang, chairman of Fosun Pharma, told E-Drug managers in an earlier interview.
, who received 13 official approvals from ANDA, is the old face of China Pharmaceuticals' overseas corps.
Pharma, which bought Epic Pharma for $529 million in 2016, also relied on overseas acquisitions to win a number of ANDA approvals.
, in addition to its subsidiary Yichang Manfu, also contributed a lot, in 2018 won the first ANDA approval.
but the road to the sea is not plain sailing.
august 2020, People's Fu Pharmaceuticals announced the divestiture of non-core assets, returning funds to focus on the main industry, which has nothing to do with its previous large-time purchase of overseas pharmaceutical companies.
2020 momentum for another frequent visitor to the U.S. ANDA list of Chinese generics.
jianyou shares listed on the market, gradually tilted the focus of its main business from API to higher-tech preparation business.
the last three years, Jianyou shares have been declared at an average annual rate of 10 products, with a cumulative number of more than 40 declared products, while more than 20 have been registered in the international market.
, the U.S. has been the focus of Jianyou's joint-stock business.
its sterile preparation research and development in the country the first batch of FDA certification, but also through the acquisition of Meitheal, the formation of a local sales team, to achieve a sales breakthrough in the United States.
more than that, said Huang Xiwei, president of Jianyou AG, "to be one of the most important players and even leaders."
plans to expand to 30 or 40 countries and regions in other regions of the world over the next two years.
market, ANDA's approval also provides a stage for business transformation.
Pharmaceuticals received an official FDA approval letter on October 27, 2020.
other Dara non-tablet indications, "the treatment of erectile dysfunction," filed an ANDA application with the FDA in 2016 and were approved for more than four years, according to the Step Pharmaceuticals bulletin.
Pharmaceuticals said the project had invested about $1.4 million.
as one of the leading companies in China's Chinese medicine industry, Step Pharmaceuticals has formulated three major transformation strategies in 2018, one of which is the transition from china's localization to globalization.
said in a press release that the approval was "both an important milestone in the company's breakthrough in generics and a driving force and confidence to further advance the implementation of the three strategic transformations."
is similar to Ering Pharmaceuticals.
in the reform process of health care policy, Chinese medicine enterprises have faced great challenges.
to this end, Ling Pharmaceuticals in the choice of bet on new research and development direction at the same time will also look overseas.
in the ANDA varieties, in 2020 to Ling Pharmaceuticals has 4 products approved, a total of nearly 10 varieties have been approved by the U.S. FDA and some have been formed in the U.S. market for sale.
the impact of the collection of chinese medicine enterprises.
East China Pharmaceutical's Akapo sugar tablets in November 2018 through the generic drug consistency evaluation, that year for East China Pharmaceuticals contributed more than 2 billion yuan in sales, the company's revenue of about 30.6 billion yuan (of which the pharmaceutical industry of 8.238 billion yuan, the pharmaceutical business of 22.349 billion yuan).
data show that in 2018, East China Pharmaceutical Acapo sugar tablets in the domestic market share of nearly 30%, second only to the original research manufacturer Bayer.
January 17, 2020, East China Medicine's Akapo sugar in the second batch of national collection, the core single product after the failure of the company immediately launched the relevant marketing plan: Akapo sugar chewing tablets to do a good job in the national marketing work, and strive to enter more than 90% of the domestic three-level hospitals.
on the other hand, overseas becomes another export.
East China Pharmaceuticals, with the help of the international business that is being vigorously developed in recent years, has successfully promoted the approval of the FDA for Acapo sugar, which is the second ANDA product after the injection of sodium gazole freeze-dried powder needle.
, however, it is important to note bayer's sales, which in the first half of 2020 were 156 million euros ($1,234 million), mostly from China.
, how much is the global sales of acapo sugar? Is it a good business to collect products and go out to sea? Can the decline be reversed or slowed? All this seems to remain to be seen.
other company to watch is Huahai Pharmaceuticals.
, China's generic drugs to the United States ANDA list has more than 60 U.S. ANDA Huahai Pharmaceuticals has been at the top of the list.
the number of APPROVEDAs approved in 2018 has dropped to six, de 2018, as a result of the Sandantan incident and the FDA ban.
2020, although the impact of the incident has been diluted, but Huahai Pharmaceuticals still only two products have been officially approved by ANDA, not much.
, however, it also provides an opportunity for Huahai Pharmaceuticals, which accounts for a large proportion of overseas sales, to expand its domestic market.
In 2020, Huahai Pharmaceuticals' domestic preparation business grew significantly, with revenue of RMB1.57 billion reported in the third quarter of 2020, up 15.2% YoY, and net profit up 48.1% YoY to RMB260 million.