认证网　中药国际化认证难 药企走出去动力不足
Certification certification to the internationalization of Chinese medicine pharmaceutical companies out of insufficient to power
继商务部和国家中医药管理局前不久明确表示将完善中医药贸易相关政策法规，培育中医药国际知名品牌之后，中央高层日前再次强调将促进中医药在海外发展，推动更多国产药品进入国际市场。
The Ministry of Commerce and the State Administration of traditional Chinese medicine recently made it clear that it will improve TCM trade related policies and regulations, after cultivating TCM international famous brand, the central leadership has again stressed that the promotion of Chinese medicine in overseas development, promote more domestic drugs to enter the international market.
关于中药走出去或中药国际化的议题由来已久，不过长期以来，中药走出国门始终受到诸多限制。如目前A股55家上市中药企业中，业绩报告中明确披露存在跨境贸易的中药公司仅有17家，且多数公司中药外贸不足年营收的10%，其业务仍局限在国内市场。
About traditional Chinese medicine go out or the internationalization of Chinese medicine long-standing issues, but for a long time, traditional Chinese medicine go out of the country has restrictions. Such as the A shares of 55 listed Chinese companies, the performance report clear disclosure of traditional Chinese medicine company in cross-border trade of only 17, and the majority of Chinese foreign trade companies lack of annual revenue 10%, its business is still confined to the domestic market.
境外认证难有突破
Foreign certification difficult to have a breakthrough
3年前，天士力拳头品种复方丹参滴丸通过美国食品与药品监督管理局（FDA）Ⅱ期临床试验，由此成为国内首个通过该项试验的中成药品种。当时，天津政府甚至还与前卫生部专门举办了声势浩大的报告会。FDA认证是全球主要的药品认证之一，相当于药品在全球范围内流通的通行证。
3 years ago, the fist variety of Compound Danshen Dripping Pills by the United States Food and Drug Administration (FDA) phase II clinical trials, thus become the first domestic varieties by traditional Chinese medicine study. At that time, Tianjin government and even before the Ministry of health held great in strength and impetus of the special report. FDA authentication is one of the world's leading drug certification, a circulation in the global scope for drug pass.
然而3年之后，除与美国精鼎医药等公司签订复方丹参滴丸III期临床研究合作意向外，复方丹参滴丸再无更多消息，天士力作为中药现代化的先驱也一度沉舸。今年6月份，天士力董事长闫希军曾表示，截至目前，国内并无以治疗性药品角色通过FDA认证的中药。
Yet after 3 years, in addition to signing of Compound Danshen Dripping Pills phase III clinical study of cooperation with the intention of the United States of America JINGDING pharmaceutical company, compound Danshen dripping pills no more news, as the pioneer of the modernization of traditional Chinese medicine was also sunk barge. In June this year, the chairman Yan Xijun said, as of now, there is no role to traditional Chinese medicine in the treatment of drug FDA certification through the.
而据记者了解，曾申请过FDA临床认证的中药企业也寥寥无几，大多折戟于前期的临床试验。如即将于10月份被国药集团收编的同济堂早在2007年就启动了FDA认证程序，结果直到公司被复星医药从纽交所私有化退市，同济堂也未完成FDA认证。而在同一期间，国内不少原料药甚至生物制药先后通过了FDA认证，如千红制药的肝素钠原料药、恒瑞医药抗肿瘤药来曲唑片、浙江震元的抗菌原料药西索米星等。
And understand according to the reporter, had applied for traditional Chinese medicine enterprise FDA clinical certification is scanty, most of the early clinical trials failed to. Such as the upcoming October is China Pharmaceutical Group Incorporation Tongjitang as early as 2007 started the FDA certification program, the results until the company is Fosun medicine from the NYSE privatisation delisted, Tongji has not completed the FDA certification. While at the same time, many domestic raw materials and biological pharmacy has passed the FDA certification, such as Cha pharmaceutical heparin sodium API, Hengrui medicine antitumor drug letrozol tablets, Zhejiang Zhenyuan antibacterial drug sisomicin magnitude.
境外营收占比仅1.8%
Overseas sales accounted for only 1.8%
值得一提的是，中国医药商会相关负责人曾于2002年表示，即便未获FDA认证，中药也可以在国际市场有所作为。随后的11年事实证明，中药在未获国际认证的情况下始终难以形成突破性进展。
It is worth mentioning that, Chinese Medical Association relevant responsible person said in 2002, even without FDA certification, Chinese medicine can also dosomethinpreviouslyunreleased in international market. 11 years later in fact, traditional Chinese medicine has not been international certification of the case has always been difficult to form a breakthrough.
以今年上半年为例，在已披露中报的中药类上市公司中，仅有片仔癀、精华制药、佛慈制药、中新药业、桂林三金、中恒集团等极少数药企列明了境外业务收入。除片仔癀境外营收接近1.5亿元之外，其余中药企业境外营收并不高，其中，中恒集团上半年境外营收仅有85万元。
In the first half of this year as an example, in the Chinese listing Corporation have disclosure center daily news, only Pien Tze Huang, the essence of the pharmaceutical, foci pharmaceutical, new pharmaceutical, Guilin Sanjin, constant group and a handful of companies listed overseas business income. In addition to Pien Tze Huang overseas revenue nearly 150000000 yuan, other traditional Chinese enterprises overseas revenue is not high, the first half of the year, constant group overseas revenue only 850000 yuan.
而在去年涉及境外业务的17家中药企业中，有包括广州药业、太极集团、天目药业在内的10家公司境外营收占比不足5%，云南白药、以岭药业、香雪制药等公司境外营收占比甚至低于1%。
17 Chinese enterprises involved in overseas business last year, 10 companies including Guangzhou pharmaceutical, Tai Chi Group, Tianmu pharmaceutical, overseas sales accounted for less than 5%, Yunnan Baiyao, Yiling pharmaceutical, Hornsey pharmaceutical company overseas revenue accounted for less than 1%.
数据显示，上述17家中药企业去年境外总营收仅有21.74亿元，这在55家上市中药企业去年高达1190亿元的总营收中占比仅1.8%，几乎可以忽略不计。这也直接反映出目前中药企业的主战场仍然局限在国内市场。
Data shows, the 17 Chinese enterprises overseas revenues last year only 2174000000 yuan, the 55 listed Chinese enterprises total revenues last year amounted to 119000000000 yuan accounted for only 1.8%, almost negligible. This is a direct reflection of the current main battlefield medicine enterprises is still limited in the domestic market.
海外销售体系待建立
Overseas sales system to be established
按照商务部的规划，中医药跨境贸易将逐步得到政策推动，然而就当前情况来看，若中药企业仍无法在国际认证方面获得实质性进展，那么中药企业在国外的发展仍将停滞不前。
According to the Ministry of Commerce planning, cross-border trade of Chinese medicine will gradually be policy driven, but on the current situation, if the Chinese enterprises are still unable to obtain international certification of substantive progress, so Chinese enterprises in overseas development will remain stagnant.
同时，仔细考量17家拥有境外业务的中药企业则不难发现，相当一部分企业实际上充当的是医药中介的角色，即在国内采购中西药再转而到海外销售，真正意义上的中药销售体系并未大规模建立。
At the same time, carefully consider the 17 Chinese enterprises with overseas business, it is not difficult to find, a considerable part of the enterprise actually act as a pharmaceutical intermediary role, namely the western medicine in the domestic procurement to turn to overseas sales, the real meaning of the Chinese traditional medicine sales system is not large-scale building.
华南一家上市中药企业证券部人士对记者表示，中药行业在国内仍维持着30%~50%的平均毛利率，且未出现显著的发展瓶颈，而国外市场则充满不确定性，从这个意义上来讲，会有不少中药企业在海外拓展问题上保持谨慎态度。
A Southern China listed Chinese medicine enterprise securities department the personage expresses to the reporter, Chinese medicine industry in China is still maintain a 30%~50% average gross margin, and did not appear the bottleneck of the development of significant, while the foreign market is full of uncertainty, in this sense, there will be cautious many medicine enterprises expand in overseas.
认证网　中药国际化认证难 药企走出去动力不足
Certification certification to the internationalization of Chinese medicine pharmaceutical companies out of insufficient to power