政策和创新推动国内仿制药行业发展

China's generic drug industry has entered a golden era with growing innovative ability and Chinese drug companies are expected to surpass their Indian counterparts in the near future, industry insiders said on Tuesday.

近期，中国现象级黑色喜剧电影《我不是药神》在中国大陆各大影院上映，上映后引发了国内关于廉价印度仿制药进口和国内仿制药制造业的热议。据环球时报7月10日采访业内人士表示，“中国仿制药行业已进入创新能力不断提升的黄金时期，中国制药企业有望在不久的将来超越印度同行”。

The comments came after the Chinese black comedy Dying to Survive, which hit Chinese mainland theaters Thursday, set off a nationwide debate about cheap Indian generic drug imports and the domestic generic drug manufacturing industry. 

Shares of major pharmaceutical firms showed good performance on Tuesday, with Jiangsu Hengrui Medicine up by 0.82 percent, while those of Sino Biopharmaceutical Group were up 0.84 percent as of closing.

与此同时，受此次电影带来的行业关注影响，中国国内主要医药公司股价周二表现良好，江苏恒瑞医药上涨0.82％，中国生物制药集团股价上涨0.84％。中欧国际工商学院医疗研究员蔡江南周二受访环球时报时表示：“印度的仿制药，特别是抗癌药，质高价低，而国内仿制药长期以来因其质量‘不可靠’而广受批评。国内仿制药生产企业也因为利润低而不愿生产高质量的仿制药”。

"India's generic drugs, especially anti-cancer ones, are cheaper and of good quality, while domestic generic drugs have long been criticized for their 'unreliable' quality. Domestic generic drug manufacturers are also reluctant to produce high-quality drugs due to low profits," Cai Jiangnan, a healthcare research fellow at the China Europe International Business School, told the Global Times on Tuesday. 

India is the largest provider of generic drugs globally, with Indian generics accounting for 20 percent of global exports in terms of volume, said a report published on the website of the India Brand Equity Foundation. 

 "In India, generic drugs are not subject to a patent protection period, thus enjoying a policy advantage in the earlier stage, making it stronger," Cai told the Global Times on Tuesday.

Cai added that China should not copy this "irregular path."

印度品牌资产基金会在网站上发布的一份报告称，印度是全球最大的仿制药供应商，印度仿制药占全球出口量的20％。蔡江南表示“由于仿制药在印度不受专利保护期限制，因此在药物研发上市的早期即享有政策优势，因而使得印度仿制药制造工业更强大”，随即蔡江南也表示“对于印度政府政策支持下的这种“非常规途径”，中国不能照搬。”

But there are some things that China should learn from, for example, clear policy guidance, said Li Tianquan, co-founder of domestic healthcare big data platform yaozh.com.

Some Indian pharmaceutical companies have opened a sales channel to Europe and the US by targeting high-quality generic drugs, Li told the Global Times Tuesday.

China is now heading in the right direction, as Chinese regulators have been regulating the drug review process, and domestic drug companies have also been improving their innovative abilities, according to Li.

Li also pointed to the method of consistency evaluation for generic drugs, which was released by the China Food and Drug Administration in 2016 to evaluate the quality and effect of generic drugs, saying that "the evaluation method would ensure quality of domestic drug products, leading the industry to a sound development mode."

而国内医药大数据服务平台药智网的联合创始人李天泉表示中国应该从中学习一些东西，例如明确的政策指导”。李天泉周二受访环球时报时说道，“一些印度仿制药公司已通过瞄准优质仿制药从而开辟了通往欧洲和美国的销售渠道。同时中国现在正朝着正确的方向迈进，因为中国监管机构一直在对药物审查程序层层把控，国内制药企业也适时不断提高其研发创新能力”。李天泉还指出了2016年由中国食品药品监督管理总局发布，用于评价仿制药质量和疗效一致性评价的方法，该方法称“评价方法将确保国内仿制药质量，引领行业走上更为完善的发展模式。”

The country's leading pharmaceutical firms have already made some breakthroughs.

For example, Jiangsu Hansoh Pharmaceutical Group told the Global Times on Tuesday that Xinwei, a generic anti-cancer drug it produces, has officially passed the country's consistency evaluation for generic drugs, proving that its quality and effects could already compare to the original drug Gleevec, which is produced by Swiss pharmaceutical giant Novartis.

"With almost the same effect, we sell for only one-tenth of the price of Gleevec," said the company. 

Data showed that in 2017, the sales volume for Xinwei was 210 million yuan, accounting for a market share of 10 percent, while at the same time, the sales volume for Gleevec was 1.5 billion yuan, with almost 80 percent of the market.

Li said the market share for generic drugs is expected to surpass 50 percent as soon as the drugs pass the consistency inspection.

"We are in the best era for developing and producing drugs in China, which we feel lucky about," said the Hansoh Group.

"It's not realistic to surpass India in the short-term, but in eight or ten years, there will be a breakthrough in the domestic generic drug industry,"  Li said.

截至目前，中国制药企业的领军者已经取得了一些突破。例如，江苏豪森制药集团负责人7月10日受访环球时报时表示，其公司生产的通用抗癌药物“昕维”已正式通过仿制药一致性评价，证明其质量和效果已经可以与由瑞士制药巨头诺华公司生产的原研药“格列卫”进行比较。并且该仿制药在同等药效的情况下，价格却只有“格列卫”的十分之一。数据显示，2017年，“昕维”的销售额为2.1亿元，占市场份额的10％，同时“格列卫”的销售额为15亿元，占近80％市场份额。李天泉受访时进一步表示，仿制药一旦通过一致性评价，其市场份额预计将超过50％。豪森集团负责人表示，我们正处于中国药物研发和生产的最佳时代，对此我们感到很幸运。李天泉在受访时表示，国内仿制药行业在短期内超过印度还不切实际，但在未来十年八年内，或许会有新的突破。

翻译：药王steven