According to the data of China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), China’s export of western medicine preparations to the U.S. exceeded USD 90 million in 2018 Q1, wherein, the total export of the top 5: Hengrui Medicine, Huahai Pharmaceutical, Novast, Humanwell Healthcare, and Qilu Pharmaceutical accounted for 67% thereof.
Huahai Pharmaceutical, Hengrui Medicine, and CSPC continued to be among the top 5 by annual preparation export in the past three years. From the perspective of the global generic drug market, the EU, U.S., and China are the top 3 generic drug consumers in the world. Chinese pharmaceutical enterprises’ export of western medicine preparations has shown a rising trend in recent years as they receive more and more U.S. ANDA approvals.
Concentrated approvals, small overall scale of preparation export
According to report, the road of Chinese pharmaceutical enterprises’ application with FDA can be traced back to 1974 when Humanwell PuraCap Pharmaceuticals applied for Methocarbamol Tablets (removed from market), and in 1979 that followed, Huahai Pharmaceutical also started its overseas application road with FDA with methocarbamol.
Chinese pharmaceutical enterprises had a total of 278 U.S. ANDA approvals by August 20, including 255 approvals and 23 pre-approvals.
The approvals of the top 9 Chinese pharmaceutical enterprises totaled 243, centralizing 87.4% of the total, wherein, Huahai Pharmaceutical, Humanwell Healthcare, and Fosun Pharma were the top 3, followed by Novast and Hengrui Medicine.
|
No.
|
Pharmaceutical enterprise
|
Number of ANDAs
|
Number of approvals
|
Number of pre-approvals
|
|
1
|
Huahai Pharmaceutical
|
58
|
54
|
4
|
|
2
|
Humanwell Healthcare
|
49
|
49
|
0
|
|
3
|
Fosun Pharma
|
41
|
40
|
1
|
|
4
|
Novast
|
34
|
32
|
2
|
|
5
|
Hengrui Medicine
|
16
|
15
|
1
|
|
6
|
CSPC Ouyi
|
15
|
12
|
3
|
|
7
|
Hisun Pharmaceuticals
|
11
|
10
|
1
|
|
8
|
Qilu Pharmaceuticals
|
11
|
9
|
2
|
|
9
|
HEC Pharma
|
8
|
6
|
2
|
Chinese API and preparation manufacturers have now exceeded 4,000, with nearly 170,000 pharmaceutical product approval numbers, wherein, more than 95% are for generic drugs that include western medicine generic drugs and TCM generic drugs. By contrast, the 278 U.S. ANDA approvals involve only less than 40 Chinese pharmaceutical enterprises.
Chinese pharmaceutical enterprises exported USD 310 million western medicine preparations to the U.S. in 2017, accounting for less than 9% of the total export of western medicine preparations; China’s total export of western medicine APIs reached USD 29.117 billion in the same year; the situations in 2015 and 2016 were similar. Wester medicine APIs are still the main products among the western medicine products exported from China, and the scale of western medicine preparation export is small.
|
西药制剂出口情况
亿美元
2015年，2016年，2017年
西药制剂对美出口额
西药制剂出口总额
西药原料药出口总额
|
Situation of Western Medicine Preparation Export
USD 100 million
2015, 2016, 2017
Export of western medicine preparations to U.S.
Total export of western medicine preparations
Total export of western medicine APIs
|
The 278 ANDA approvals cover 216 varieties in different dosage forms, wherein, the tablets account for over 60%, injections account for 27.3%, and inhalation solution, topical solution, suspension, powder, and premix separately account for less than 1%. Overall, there are not so many dosage forms of preparation varieties exported to the U.S.
|
Dosage form
|
Quantity
|
Proportion
|
|
Tablet
|
172
|
61.9%
|
|
Injection
|
76
|
27.3%
|
|
Capsule
|
23
|
8.3%
|
|
Inhalation solution
|
2
|
<1%
|
|
Topical solution
|
2
|
<1%
|
|
Suspension
|
1
|
<1%
|
|
Powder
|
1
|
<1%
|
|
Premix
|
1
|
<1%
|
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