China’s export of western medicine products reached USD36.883 billion in 2018, wherein, the export of western medicine preparations reached USD4.100 billion, growing by 18.64% year on year.

Related: Dual tailwinds for the injection export of Chinese pharmaceutical enterprises to the U.S.

Among all the drug dosage forms exported, the quality standards for injections exported to countries with regulated markets are the strictest as injections are directly injected into bodies. The strong regulation of the FDA over sterile injections has led to a generic injection drug market with high concentration and incomplete competition, and compliant generic injection drugs have become scarce resources with high barriers but also bringing high income.

According to statistics, there are only 8 Chinese pharmaceutical enterprises that have received injection ANDA approvals from the FDA, wherein, only the 4 preparation exporters: Hengrui Medicine, King-Friend, Qilu Pharmaceutical, and Poly Pharm can continuously supply to the U.S. market.

Source: The FDA

Hengrui Medicine

The oncology drug irinotecan produced by Hengrui Medicine passed the certification of the U.S. FDA in Dec. 2011 to become the first Chinese-produced injection marketed in the U.S. Hengrui Medicine has continued to increase the R&D investment in recent years and built its quality system according to standards of the U.S. FDA, to promote the "going out" international strategy of Chinese-produced preparations.

So far, Hengrui Medicine has a total of 10 injection ANDA approval numbers from the FDA, tying for the first place with King-Friend, being a leader in the internationalization of Chinese-produced injection products; many of its injection varieties have achieved large-scale sales, and the exported injection products are based on oncology drugs and anesthetics in which Hengrui Medicine has advantages.

Source: The FDA, company announcements

King-Friend

King-Friend, a pioneer in the internationalization of injection products in China, has laid out the international project of injections as early as 2010, with products such as enoxaparin injection and unfractionated heparin injection among the first batch applied for.

King-Friend has now 3 injection production lines that have passed the FDA certification, with 10 injection ANDAs approved by the FDA, including 2 of Nanjing King-Friend and 8 of Chengdu Kindos, wherein, the heparin sodium injection series is the core product of King-Friend, which has 8 specifications that cover the mainstream specifications of the heparin sodium products marketed in the U.S. King-Friend’s product chain centers on enoxaparin/unfractionated heparin and extends to small molecule oncology drugs, anesthetics, anti-infectious agents, and other injection product areas.

Source: The FDA, company announcements

Qilu Pharmaceutical

Qilu Pharmaceutical has been promoting the international strategy in recent years, with exported products expanded from API to preparation. In the area of injection export to the U.S., Qilu received the first ANDA approval for Ondansetron Hydrochloride Injection in Sep. 2014. It has now received a total of 8 relevant ANDA approvals from the FDA, with the products mainly in the anti-infectious and anticancer areas.

Source: The FDA, company announcements

Poly Pharm

Poly Pharm, one of the enterprises earliest in exploring preparation internationalization in China, started to lay out the preparation export in 2005, focused on the export varieties of generic injection drugs at the beginning, and started to transform the injection workshop according to the FDA standards in 2008.

Poly Pharm has more than 30 overseas approval numbers for injection production so far and 6 varieties that have received the U.S. injection ANDA approvals later than those of injection products of the above three enterprises. It's worth mentioning that vancomycin recently approved in the U.S. is the first blockbuster injection variety approved of Poly Pharm. The Bloomberg Terminal sales data of vancomycin exceeded USD600 million in 2018. Vancomycin Hydrochloride for Injection is currently in short supply in the U.S., and the marketing of the product of Poly Pharm is expected to bring a new performance growth point for the company’s exported products.

Source: The FDA, company announcements

Keep Reading:

Dual tailwinds for the injection export of Chinese pharmaceutical enterprises to the U.S.

About  the Author:    

Xiaoyaowan, a pharmaceutical industry practitioner, a word carrier in the We-media era focusing on changes of the pharma industry.

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