中药企业寻求通过临床试验证明中药疗效

Traditional Chinese medicine needs to prove its worth through rigorous clinical trials, according to the head of one of China’s largest herbal remedy companies, as a contentious new law to boost the $40bn sector comes into effect.

在引发争议的《中医药法》正式施行之际，中国最大中药企业之一的负责人表示，中药需要通过严格的临床试验证明其价值。这部新法旨在提振400亿美元的中药行业。

Traditional Chinese medicine is estimated by analysts to account for a third of sales in China’s $117bn pharmaceutical market, the world’s second largest.

分析师估计，中药在中国1170亿美元的医药市场中占销售额的三分之一。中国是全球第二大医药市场。

But most of those sales are of relatively cheap over-the-counter drugs, with many Chinese hospital doctors reluctant to prescribe TCM remedies because of the lack of evidence for their effectiveness.

但中药销售大多数都是相对廉价的非处方药，许多中国医生不愿开中药处方，因为缺乏证据证明这些中药的疗效。

China’s first law promising equal status for TCM and western medicine in the country’s state-dominated healthcare system comes into effect this weekend. Provisions include encouragement for hospitals to set up TCM centres, and a licensing system for practitioners.

上周末，中国首部承诺在国家主导的医疗体系中给予中药和西药平等地位的法律开始生效。条款包括鼓励医院设立中医药科室，以及中医医师执业注册制度。

“This law is very important for securing the status of TCM,” said Wu Yiling, chairman of Yiling Pharmaceutical, a company that makes herbal remedies based on traditional recipes in the northern province of Hebei.

“这部法律对于确保中药的地位非常重要，”以岭药业(Yiling Pharmaceutical)董事长吴以岭说。位于中国河北省的以岭药业是一家基于传统配方生产中药的企业。

Listed in Shenzhen, Yiling has a market capitalisation of Rmb20.7bn ($3bn). Mr Wu, the son of a herbal practitioner, controls a family fortune of $1.6bn, according to the Hurun rich list.

深圳上市的以岭药业市值达207亿元人民币（合30亿美元）。胡润(Hurun)富豪榜显示，出身中医世家的吴以岭控制着16亿美元的家族财富。

Mr Wu is both a proponent of the nature of Qi — the mystical energy force that provides the basis for much of TCM theory — and the clinical trials crucial to western pharmaceutical companies. “TCM needs to develop?.?.?.?using modern research methods,” he said.

吴以岭既重视中医所谓的“气”（为大部分中医药理论提供基础的神秘能量），也倡导对西方制药公司来说至关重要的临床试验。“中药需要发展……要利用现代研究方法，”他说。

For instance, researchers from Peking and Cardiff Universities tested the health benefits of Yiling’s herbal medicine Yangzheng Xiaoji, publishing papers in the International Journal of Oncology that showed the drug can slow the growth of cancer tumours.

例如，来自北京大学和卡迪夫大学(Cardiff University)的研究人员测试了以岭药业的中药“养正消积胶囊”的治疗效果，他们在《国际肿瘤学期刊》(International Journal of Oncology)上发表的论文显示这种药可以减缓癌症肿瘤的生长。

“The theory and recipe is TCM, but in practice the evaluation of our medicines is carried out according to western evidence-based methods,” Mr Wu said.

“理论和配方是中医药的，但在实践中，我们对药物的评估是根据西方以证据为基础的方法进行的，”吴以岭说。

Yiling and other TCM companies are attempting to gain credibility in the domestic market through pursuing overseas approvals. The company increased sales of its flagship anti-cold drug by a quarter last year after it reached the second phase of clinical trials with the US Food and Drug Administration.

以岭药业及其他中药企业正尝试通过寻求海外认证的方式在国内市场获得信誉。在进入美国食品药品监督管理局(FDA)第二期临床试验后，该公司的旗舰抗感冒药去年的销量提高了四分之一。

A compound made by Shanghai-listed Tasly Pharmaceutical in December became the first Chinese herbal drug to pass the FDA’s phase-three clinical trials, causing a spike in the company’s share price.

去年12月，上海上市的天士力制药(Tasly Pharmaceutical)生产的一种复方药，成为首个完成FDA三期临床试验的复方中药，引发该公司股价飙涨。

Analysts say such tests can help win over sceptical hospital doctors and boost prescriptions. “Doctors need strong evidence that drugs definitely work,” said Serena Shao, healthcare analyst at brokerage CLSA.

分析师表示，此类试验有助于说服持怀疑态度的医生增加中药处方。里昂证券(CLSA)医疗卫生分析师邵莹(Serena Shao)说：“医师需要强有力的证据证明药物确实有效。”

“Some of these companies are currently doing clinical trials, and getting proof that their drugs have the same efficacy as chemical drugs. That’s the way to go,” she added.

“一些中药企业目前正在进行临床试验，而且正在获得证据证明自己的药品与化学药品具有相同疗效。这是正途，”她补充说。

The TCM law has been greeted with scepticism from China’s western-schooled medical establishment, which points to a lack of rigorous training for TCM doctors, and a recent series of scandals involving herbal injections alleged to have been harmful.

这部《中医药法》受到中国接受西式培训的医疗人士的质疑，他们提到了中医医师缺乏严格培训，以及近期一系列涉及据称对健康有害的中药注射剂的丑闻。

Officials “will try and encourage TCM, but also will be very cautious about what kinds of TCM they use in hospitals”, added Ms Shao.

邵莹还表示，官员们“将尝试并鼓励中药，但也会对医院使用何种中药非常谨慎。”