PharmaSources/CaicaiJuly 16, 2019
Tag: 2019 , apixaban , pharmaceutical , ANDA
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.
Application No. | Generic name | Dosage form | Pharmaceutical enterprise name | Approval date/ announcement date |
207494 | Doxycycline hyclate* | Oral delayed-release tablets | Huahai Pharmaceutical | June 20, 2019 |
212017 | Niacin | Oral extended-release tablets | Humanwell Healthcare | June 15, 2019 |
209026 | Potassium chloride | Oral extended-release capsules | Huahai Pharmaceutical | June 11, 2019 |
209826 | Melphalan hydrochloride | Injection | Fosun Pharma | May 28, 2019 |
211007 | Heparin sodium | Injection | Nanjing King-friend | May 28, 2019 |
209333 | Solifenacin succinate | Oral tablets | Qilu Pharmaceutical | May 20, 2019 |
211423 | Solifenacin succinate* | CSPC | Mar. 13, 2019 | |
206062 | Doxorubicin hydrochloride | Injection | Hisun Pharmaceutical | May 13, 2019 |
207375 | Rosuvastatin calcium | Oral tablets | Shandong | May 7, 2019 |
209922 | Potassium chloride | Oral extended-release tablets | Huahai Pharmaceutical | Apr. 30, 2019 |
204800 | Felodipine | Oral extended-release tablets | Yungshin Pharm | Apr. 29, 2019 |
206195 | Daunorubicin hydrochloride | Injection | Hisun Pharmaceutical | Apr. 25, 2019 |
208759 | Apr. 12, 2019 | |||
211669 | Cisatracurium besylate | Injection | Nanjing King-friend | Apr. 25, 2019 |
211668 | ||||
208250 | Azithromycin | Oral tablets | CSPC | Apr. 17, 2019 |
210599 | Duloxetine hydrochloride | Oral enteric capsules | Baheal Pharmaceutical | Apr. 17, 2019 |
208972 | Buspirone hydrochloride | Oral tablets | Humanwell Healthcare | Apr. 16, 2019 |
208759 | Dacarbazine | Injection | Hisun Pharmaceutical | Apr. 12, 2019 |
204795 | Losartan potassium | Oral tablets | Hisun Pharmaceutical | Apr. 4, 2019 |
210612 | Estradiol; norethindrone acetate | Oral tablets | Novast Laboratories | Apr. 3, 2019 |
207939 | Fingolimod* | - | HEC Pharm | Apr. 2, 2019 |
209524 | Pantoprazole sodium* | Injection | Zhongmei Huadong | Apr. 1, 2019 |
211335 | Tadalafil | Oral tablets | HEC Pharm | Mar. 26, 2019 |
210420 | Qilu Pharmaceutical | Mar. 26, 2019 | ||
210126 | Bimatoprost | Ophthalmic drops | Fosun Pharma | Mar. 22, 2019 |
210614 | Nifedipine | Oral extended-release tablets | Novast Laboratories | Mar. 12, 2019 |
211030 | Calcitriol* | - | Fosun Pharma | Mar. 6, 2019 |
209675 | Clonidine hydrochloride | Oral extended-release tablets | Novast Laboratories | Mar. 5, 2019 |
211049 | Olmesartan medoxomil Olmesartan medoxomil | Oral tablets | HEC Pharm | Feb. 22, 2019 |
210552 | Oral tablets | Qilu Pharmaceutical | Jan. 10, 2019 | |
207843 | Telmisartan | Oral tablets | Hisun Pharmaceutical | Feb. 19, 2019 |
207516 | Risedronate sodium | Oral tablets | Minsheng Pharmaceutical | Feb. 15, 2019 |
209548 | Ethinyl estradiol; ethynodiol diacetate | Oral tablets | Novast Laboratories | Feb. 11, 2019 |
209944 | Apixaban | Oral tablets | HEC Pharm | Feb. 8, 2019 |
204968 | Levofloxacin | Oral tablets | HEC Pharm | Feb. 5, 2019 |
209864 | Eptifibatide | Injection | Poly Pharm | Jan. 25, 2019 |
208575 | Ticagrelor | Oral tablets | Hisun Pharmaceutical | Jan. 23, 2019 |
209528 | Carfilzomib | Injection | Qilu Pharmaceutical | Jan. 18, 2019 |
206021 | Prasugrel hydrochloride | Oral tablets | HEC Pharm | Jan. 16, 2019 |
210339 | Propafenone hydrochloride | Oral extended-release capsules | Sinotherapeutics | Jan. 4, 2019 |
(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.
2019上半年国内药企获批美国ANDA数量 | Quantity of U.S. ANDA Approvals Received by Chinese Pharmaceutical Enterprises in the First Half of 2019 |
海正药业 | Hisun Pharmaceutical |
东阳光 | HEC |
南通联亚 | Novast Laboratories |
齐鲁制药 | Qilu Pharmaceutical |
复星医药 | Fosun Pharma |
华海药业 | Huahai Pharmaceutical |
南京健友 | Nanjing King-friend |
人福医药 | Humanwell Healthcare |
石药 | CSPC |
百洋制药 | Baheal Pharmaceutical |
民生药业 | Minsheng Pharmaceutical |
普利制药 | Poly Pharm |
山东药业 | Shandong |
宣泰医药 | Sinotherapeutics |
永新药品 | Yungshin Pharm |
中美华东 | Zhongmei Huadong |
(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 2nd apixaban generic drug approved in China.
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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