A Review of U.S. ANDA Approvals Received by Chinese Pharmaceutical Enterprises in the First Half of 2019

How time flies! Half of 2019 has gone. I wanted to talk more about my feelings, but I’m a "feelingless" writer, so, may you achieve your goal for 2019 in the remaining days of this year.

Joking apart, the middle of the year is a good time to have some reviews. Now, let’s review the U.S. ANDAs received by Chinese pharmaceutical enterprises in the first half of 2019.

Chinese pharmaceutical enterprises have received a total of 41 U.S. ANDA approval numbers in the first half of 2019, which could be called a new high compared to the total of 78 U.S. ANDA approval numbers received in the full 2018.

 (Source: FDA)

From the perspective of pharmaceutical enterprise, Hisun ranked first with 7 approvals, followed closely by HEC Pharm with 6 approvals, and then Novast Laboratories and Qilu separately with 4 approvals; in 2018, Humanwell, HEC, Huahai, and CSPC ranked the top 3 separately with 13, 12, 6, and 6.

 (Source: FDA)

From the perspective of variety, there are 38 varieties in total, wherein, separately two pharmaceutical enterprises received approvals of tadalafil and olmesartan medoxomil, showing the fierce competition.

Furthermore, there are many blockbuster varieties including apixaban, ticagrelor, cisatracurium besylate, tadalafil, and fingolimod, etc. among varieties approved.

Varieties receiving U.S. ANDA approvals have bright prospects in China

According to the Technical Guidelines for Accepting Overseas Clinical Trial Data of Drugs issued by the NMPA on July 10, 2018, the fully evaluable bioequivalence data of generic drugs developed overseas can also be used for pharmaceutical product registration applications in China.

The review standards of the U.S. FDA have been the benchmark of the industry and the NMPA much recognizes the approval data thereof, therefore, enterprises holding U.S. ANDA approvals can rapidly introduce their products to the Chinese market by virtue of the said Guidelines.

Apixaban of HEC can take a shortcut to enter the Chinese market

Here I’d like to focus on the ANDA variety: apixaban approved for HEC in the first half of this year, which can rapidly enter the Chinese market by virtue of the Technical Guidelines for Accepting Overseas Clinical Trial Data of Drugs. If you want to get more information on ANDA, you could access to Pharmasouce, a professional pharma platform.

As an oral, selective, activated factor Xa inhibitor developed by BMS and Pfizer, apixaban (trade name: Eliquis) entered China in 2013 and entered the new edition of medical insurance drug catalog of China in 2017 and is mainly used for the prophylaxis of venous thromboembolism in adult patients who have undergone elective hip or knee replacement. Apixaban has the "Best-in-Class" clinical trial results, with significant effects in reducing the risk of major bleeding and safety and effectiveness exceeding drugs in its class.

BMS applied for the compound patent of apixaban in 2003, with the international publication No. of WO2003/049681; the compound patent thereof in China will expire on Sep. 17, 2022 (CN1578660A). Apixaban reached sales of USD9.872 billion in 2018, making it a well-deserved "best-selling anticoagulant".

There are up to 27 Chinese manufacturers developing common apixaban tablets, and 8 have applied for the marketing, including 7 applying for the marketing according to the new Class 4: Chiatai Tianqing, HEC, Kelun, and Qingfeng, etc., and 1 applying for the marketing according to Class 3: Qilu Pharmaceutical. Hansoh’s apixaban tablets has been included in the Catalogue of Marketed Drugs according to the new registration class this Jan., to successfully become the first generic, however, despite NMPA’s approval for the first generic of Hansoh’s apixaban, as the original patent of apixaban has not expired, Hansoh still cannot sell apixaban although it has received the approval therefor.

HEC’s successful receipt of the U.S. ANDA number for apixaban this time is likely to accelerate its approval in China, to make it the 2^nd apixaban generic drug approved in China.

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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