中國藥企熱衷對美出口仿製藥

Chinese pharmaceutical companies are stepping up their push into the US generic drugs market with the number of approvals for copycat medicines almost doubling last year.

中國製藥公司正加大力度打入美國仿製藥市場，去年中國藥企獲批的仿製藥品種增加近一倍。

In 2017, Chinese drugmakers won US Food and Drug Administration approval for 38 generic drugs, cheaper versions of treatments for which patents have expired, up from 22 a year earlier. This month, Jiangsu Hengrui Medicine, China’s largest pharmaceutical company with a $35bn market capitalisation, became the latest to win approval for its generic of anaesthetic desflurane.

2017年，中國藥企共有38款仿製藥（專利已過期、其他藥企可以仿製的較低價藥品）獲得了美國食品藥品管理局(FDA)的批准，而上一年這個數字爲22款。本月，市值350億美元的中國最大藥企江蘇恆瑞醫藥(Jiangsu Hengrui Medicine)憑藉其仿製麻醉劑地氟烷(desflurane)，成爲最新一家獲FDA認證的中國藥企。

The number of approvals is small in comparison to India — the world’s largest exporter of generic drugs with $16.4bn of offshore sales in 2016 — which last year accounted for 300 of the 927 generic drugs granted US approval. But the first China-made generic drug was granted US approval in 2007, a decade after India.

中國藥企獲FDA批准的仿製藥與印度相比還較少——印度是世界最大的仿製藥出口國，2016年海外銷售額達到164億美元——去年在美國獲批的927款仿製藥中，印度佔300款。首款獲美國批准的中國產仿製藥是在2007年獲批的，這比印度晚了10年。

Manufacturers in China have traditionally made low-cost generics for domestic use. But they see sales in the US — the world’s largest generics market, worth $114bn in 2015 — as a way to boost revenues and prove their quality to Chinese patients who place greater trust in imported drugs.

傳統上，中國製藥公司製造的低成本仿製藥供應國內市場。但中國藥企認爲，把產品投放美國市場是一條提升收入、並向更信任進口藥的中國患者證明其產品質量的途徑。美國是世界最大的仿製藥市場，2015年市場規模達到1140億美元。

Increased generics exports contributed to an 8 per cent year-on-year rise in exports of western medicines from China in 2017 to $3.5bn, according to Chinese officials, though that figure includes drugs made by multinationals in China.

據中國官員介紹，仿製藥出口增加幫助中國在2017年實現西藥出口同比增長8%，至35億美元，儘管該數據包含了在華經營的跨國公司製造的藥品。

“From a manufacturing standpoint, many Chinese facilities have approval from the FDA or European drug authorities, so are on the same level as overseas companies,” said John Lin, a partner at consultancy Roland Berger.

“從生產角度而言，很多中國藥廠已經獲得了美國FDA或者歐洲藥品監管機構的批准，因此與海外公司處於同一水平，”諮詢機構羅蘭貝格(Roland Berger)合夥人林江翰(John Lin)說。

Jiangsu Hengrui Medicine has gained half a dozen FDA approvals in the past year, including two that are the first generic alternatives to existing products and command higher margins than other, later generics.

過去一年，恆瑞醫藥有6款藥品獲得了FDA的批准，包括兩款率先替代原研藥、能夠比其他後上市的仿製藥帶來更高利潤率的首仿藥。

The company, which will release its annual results this month, predicts US approvals helped its overseas revenues grow at “near to double digits” last year, said Zhang Lianshan, the company’s president of global research and development.

用其全球研發總裁張連山的話說，本月將發佈年度財報的恆瑞醫藥預計，其產品在美國獲批，幫助該公司2017年實現“近兩位數”的海外收入增長。

The Price difference between a branded drug and the generic can be significant. According to the US National Average Drug Acquisition Cost database, the cost of a single tablet of Lipitor, a statin that lowers the risk of heart attack, is more than $10 for a 20mg pill, whereas the generic form costs just 6 cents.

品牌藥和仿製藥之間的價格差異可能極大。據美國全國平均藥物購置成本(US National Average Drug Acquisition Cost)數據庫，立普妥（Lipitor，一種可降低心臟病風險的他汀類藥物）片劑的單價超過10美元/片（每片20毫克），而仿製藥的片劑單價僅爲6美分。

Prices have fallen in the US generics market in the past year due to consolidation among drug retailers, squeezing margins for manufacturers. But Hengrui believes exports can also boost domestic sales.

過去一年，由於藥品零售商之間的整合，美國仿製藥市場的價格下降，對製藥企業的利潤形成擠壓。但恆瑞醫藥相信，出口也能提振國內銷售。

“You can generate revenue outside of this country but also you give the Chinese patients assurance quality-wise and that’s good for sales in China,” said Mr Zhang. The company is focusing on exports of injectable and inhalable products, which have higher manufacturing standards than tablets and so command higher margins.

張連山說：“你可以在國外創造收入，同時向中國患者做出質量保證，這對中國市場的銷售是有利的。”恆瑞醫藥專注於注射用和吸入用藥品的出口，這兩類產品的生產標準比片劑更高，因此利潤率也更高。

Apart from Hengrui, Chinese companies exporting generics include Zhejiang Huahai Pharmaceutical, which gained eight FDA generic approvals last year, and CSPC Hebei Zhongnuo Pharmaceutical, based near Beijing, which gained five. Shanghai-based Fosun Pharma paid $1.1bn for a majority stake in India’s Gland Pharma last year, which will boost its US generics presence.

除了恆瑞以外，出口仿製藥的中國藥企還包括浙江華海藥業(Huahai Pharmaceutical)和石藥集團中諾藥業（石家莊）公司(CSPC Hebei Zhongnuo Pharmaceutical)，去年這兩家公司分別有8款和5款仿製藥獲得FDA批准。去年，總部位於上海的復星醫藥(Fosun Pharma)斥資11億美元收購印度Gland Pharma的多數股份，這將擴大復星醫藥在美國仿製藥市場的地盤。

Hengrui is considering assembling its own sales force in the US rather than relying on third parties, Mr Zhang said, as the company seeks to overcome the advantage enjoyed by India where “the environmental costs are lower and wages are lower”.

張連山說，恆瑞正考慮在美國組建自己的銷售團隊，而不是依賴第三方；該公司正尋求抵消“環境成本更低，薪資水平也更低”的印度的藥企所享有的優勢。