Western Medicine Preparation Exportation of Chinese Pharmaceutical Enterprises to the U.S.(1)

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.

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.

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.

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