外资药企鼎盛时代终结

Profit margins for multinational pharmaceutical companies in China are being met with big pains on expiring patents and policy changes. President of the Pharmaceutical Association Committee Zhuo Yongqing said foreign and domestic pharma companies are experiencing slower growth. And while international companies once saw surging profits in years past, a slew of challenges have resulted in a turning of the tides. Drug giants Bristol-Myers Squibb and GlaxoSmithKline have each laid off some 1,000 employees in the past few years, attributing the moves to changes in their business model. Meanwhile, dismissed employees have said the layoffs were due to profit declines. In February, Merck ended a joint venture with its Chinese partner, cutting some 300 jobs in China. Big Pharma has made large investments in China since 2010 to tap booming demand. But according to PharmAsia News, GSK reported a 3 percent decline in sales in China in the first quarter of this year. Eli Lilly and Co. reported 6 percent growth for first-quarter sales of this year, down from 21 percent in 2014. Around the world, drug makers are also coming up against a clock running out on patents for some of their best-selling drugs. Foreign drug makers in China have also long contended with lengthy approval processes to enter the market. For new drugs to enter the market, a senior executive at a drug company said it takes five to eight years for registration and then another two years for the drug to appear in state drug procurement catalogs. For Caixin Online, this is Diana Bates. 长久以来，外资药企在中国一直享受“超国民待遇”，其背后的单独定价权、高额利润和超高的市场占有率颇受争议。中国社科院日前发布的《中国药品市场报告》显示，2010年，中国医药市场预估为9261亿元人民币，而2020年将达到2万亿元。目前，在二级和三级医院市场占有率排名前10的企业，均是外资或者以合资药企为主。 但是，以2013年7月葛兰素史克爆出商业贿赂案为分割点，近两年外资药企出现了政策趋紧、降价弃标、新药上市难等困境。由40家跨国制药企业组成的RDPAC（中国外商投资企业协会药品研制和开发行业委员会）执行总裁卓永清对财新记者表示：“无论是外资制药企业还是国内制药企业，近期均出现增速减缓，这与当前经济状况和部分政策调整有关。同时部分企业由于战略或者结构调整等问题，也出现短期下滑。” 外资药企的鼎盛时代已经告终。“外资药企正在经历内忧外患。内忧就是‘专利悬崖’、新药上市难；外患是原研药单独定价权取消，招标压价严重。” 北京鼎臣医药管理咨询中心负责人史立臣对财新记者表示，受此影响，不少外企选择剥离、出售外围产品线，削减成本予以应对。 外资药企的专利药被称为“重磅炸弹”，在其专利到期后，丰厚利润面临骤降风险，这被称为“专利悬崖”。 “有数据显示，从2012年到2016年全球有多达631个专利药到期。全球最畅销的前20个处方药中有18个将要专利到期，这18个处方药每年全球销售额为1420亿美元。”一位外资药企负责人对财新记者表示。 失去专利保护，意味着企业不得不面临仿制药的巨大冲击。“2014年堪称‘专利悬崖’最集中的年份。”一位被外资药企裁员的销售人员对财新记者表示。 新药审批难还导致外资药企在中国市场常常力不从心。外资药品进入中国，一般新药注册需要五到八年，招标、进入国家和各省市医保需要两年，再进入医院需要一到两年，战线很长. 卓永清分析说，“对研发制药企业而言，新药审批的滞后导致其在中国的分支研发机构往往难以参加全球同步开发。这不仅限制了这些研发中心在中国的发展和企业的持续投入，也使得中国医生部分丧失了参与国际多中心临床试验的机会。”