中国药企热衷对美出口仿制药

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.

中国制药公司正加大力度打入美国仿制药市场，去年中国药企获批的仿制药品种增加近一倍。

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，中国药企共有38款仿制药（专利已过期、其他药企可以仿制的较低价药品）获得了美国食品药品管理局(FDA)的批准，而上一年这个数字为22款。本月，市值350亿美元的中国最大药企江苏恒瑞医药(Jiangsu Hengrui Medicine)凭借其仿制麻醉剂地氟烷(desflurane)，成为最新一家获FDA认证的中国药企。

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.

中国药企获FDA批准的仿制药与印度相比还较少——印度是世界最大的仿制药出口国，2016年海外销售额达到164亿美元——去年在美国获批的927款仿制药中，印度占300款。首款获美国批准的中国产仿制药是在2007年获批的，这比印度晚了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 2017 — as a way to boost revenues and prove their quality to Chinese patients who place greater trust in imported drugs.

传统上，中国制药公司制造的低成本仿制药供应国内市场。但中国药企认为，把产品投放美国市场是一条提升收入、并向更信任进口药的中国患者证明其产品质量的途径。美国是世界最大的仿制药市场，2017年市场规模达到1140亿美元。

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.

据中国官员介绍，仿制药出口增加帮助中国在2017年实现西药出口同比增长8%，至35亿美元，尽管该数据包含了在华经营的跨国公司制造的药品。

“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.

“从生产角度而言，很多中国药厂已经获得了美国FDA或者欧洲药品监管机构的批准，因此与海外公司处于同一水平，”咨询机构罗兰贝格(Roland Berger)合伙人林江翰(John Lin)说。

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.

过去一年，恒瑞医药有6款药品获得了FDA的批准，包括两款率先替代原研药、能够比其他后上市的仿制药带来更高利润率的首仿药。

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.

用其全球研发总裁张连山的话说，本月将发布年度财报的恒瑞医药预计，其产品在美国获批，帮助该公司2017年实现“近两位数”的海外收入增长。

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.

品牌药和仿制药之间的价格差异可能极大。据美国全国平均药物购置成本(US National Average Drug Acquisition Cost)数据库，立普妥（Lipitor，一种可降低心脏病风险的他汀类药物）片剂的单价超过10美元/片（每片20毫克），而仿制药的片剂单价仅为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.

过去一年，由于药品零售商之间的整合，美国仿制药市场的价格下降，对制药企业的利润形成挤压。但恒瑞医药相信，出口也能提振国内销售。

“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.

张连山说：“你可以在国外创造收入，同时向中国患者做出质量保证，这对中国市场的销售是有利的。”恒瑞医药专注于注射用和吸入用药品的出口，这两类产品的生产标准比片剂更高，因此利润率也更高。

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.

除了恒瑞以外，出口仿制药的中国药企还包括浙江华海药业(Huahai Pharmaceutical)和石药集团中诺药业（石家庄）公司(CSPC Hebei Zhongnuo Pharmaceutical)，去年这两家公司分别有8款和5款仿制药获得FDA批准。去年，总部位于上海的复星医药(Fosun Pharma)斥资11亿美元收购印度Gland Pharma的多数股份，这将扩大复星医药在美国仿制药市场的地盘。

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”.

张连山说，恒瑞正考虑在美国组建自己的销售团队，而不是依赖第三方；该公司正寻求抵消“环境成本更低，薪资水平也更低”的印度的药企所享有的优势。