方恩医药董事长张丹博士，副总裁熊海山博士参加高端医药会议， 分析中国加入ICH后的医药国际化进程
中国新晋成为ICH成员国会产生何种影响是制药企业高管心目中所思考的前沿和核心问题，基于这一点，方恩医药在过去的一周参加了两次高级别会议，并在会议中介绍了我们对这一主题的见解。
2017医药创新与发展国际会议于9月17-18日在美丽的海滨城市烟台举行。“千人计划”专家、方恩医药董事长张丹博士发表了题为《ICH带来的机会与挑战》主题演讲。张博士指出中国加入ICH是顺势而为，国家食品药品监督管理总局公布的52、53、54、55号公告，从临床试验机构认证改为备案制，优化审查程序、接受境外临床试验数据等政策都是与ICH接轨。此外包括已经推行的上市许可持有人制度等多项政策，都可以看出CFDA早已为加入ICH进行铺垫。
中国在某些方面离ICH仍有差距，其中包括技术指南的数量、临床研究人员的经验、可开展临床研究机构的数量等等。
有差距同样有挑战。对于药企来说，ICH落地后该怎么做，要开发什么样的产品才能适应并借助ICH的浪潮？如何寻找有经验的临床研究机构和操作团队是一大挑战。加入ICH后，在新环境下，资本的关注方向会不会改变，哪类产品更容易融资，药企和投资人都面临相应的挑战。中国加入ICH后，国外公司及其产品短期内不会快速进入中国，在这个期间，国内相应的产品能否上市，是否可以适应新的竞争？这就需要投资人和药企对自己的产品进行梳理。
对中国而言，加入ICH是利大于弊的，对国内医药界来说，加入ICH首先使得全球新的药物或者是孤儿药，可以更容易进入国际市场，能够在更大的市场范围内兑现自己的投入。由于形成了统一的研发市场，做全球投资特别是买中国区权利将会更有价值，很多临床试验不用重复做，投资从某种角度来说更有效率。对投资人来说，作价更合理。加入ICH能够提高中国整体的新药原研能力。
加入ICH，谁会是赢家呢？首先最大的赢家是患者，国内患者可以比过去更早使用到国际新药。其次是医生，他们可以给患者更多的选择，并且中国可以与国外同步进行临床早期试验，可以让医生更早接受创新药，也让研究人员更容易创新。第三是CRO，不只是临床CRO，包括SMO、CMO等整个CRO产业链都会是赢家。第四是创新药企业，国内药企要生存发展，不能只盯中国市场，需要走向世界，加入ICH正可以提供这一契机，将“中国新”变成“世界新”。最后，赢家就是中国的原研能力，加入ICH会促使中国在早期就加入到全球创新性研发活动中去，促进中国的原研能力提高。
The impact of China's new ICH membership is front and center in the minds of Pharma executives. Case in point, FMD attended two high level conferences this past week and presented to our insights into this topic.
Dr. Dan Zhang, Chairman of FMD， delivered a speech at the 2017 International Conference on Pharmaceutical Innovation and Development - The opportunities and challenges posed by ICH.
The 2017 International Conference on Pharmaceutical Innovation and Development was held in the beautiful coastal city of Yantai on 17-18 September. Dr. Dan Zhang, chairman of FMD, expert of “Thousand Talents Plan”, delivered a keynote speech entitled "opportunities and challenges brought by ICH".
Dr. Zhang pointed out that the CFDA has been carefully preparing for the ICH for some time. In the past 3 years, the agency released a multitude of policies in line with ICH standards, such as No. 52, 53, 54, 55 Guidance Documents (Draft), replacing certification of clinical trial institutions by record-keeping system, optimization of inspection procedures, accepting of foreign clinical trial data, and so on. Through the implementation of Marketing Authorization Holder (MAH) system and many other policies, we can see that the CFDA has long been paving the way for joining the ICH.
Of course China still has a long way to go to bring itself fully in line with ICH, including the number of technical guidelines, the experience of clinical researchers, the number of clinical research institutions.
Challenges represent opportunities. For pharmaceutical companies, what will they do after ICH implementation? What kind of products will they develop to take advantage of the new environment? And how to find experienced clinical research institutions and operation team? For the investors, joining the ICH presents a real challenge of taking a fresh look at the overall strategy. Pharmaceutical companies and investors are both facing the corresponding challenges. Moreover, whether ICH would allow foreign companies and their products to enter China in a shorter time is a key indicator that everyone will pay special attention to. To domestic drug companies, this is a real threat to their business model. All of these challenges require investors and pharmaceutical executives to re-think their businesses.
For China, joining ICH will do more good than harm to the domestic pharmaceutical industry. New drugs or orphan drugs can now more easily enter the international market, accessing much larger markets to recoup investments. As a result of a unified R & D market, global investment, especially in China, will be more valuable. More widely clinical data sharing make it possible to reduce repeated clinical trials. Investment is, in some ways, more efficient at a reasonable valuation. China's accession to the ICH will improve the overall research capabilities of new drugs.
Who will be the winner? First of all, the biggest winners are patients. Chinese patients can access new and better drugs earlier than before. Doctors can offer patients more choices. Moreover China can participate in early phase clinical trials, allowing doctors to experience innovative drugs earlier, making it easier for researchers to innovate. Third winners are CROs, not only the clinical CROs but also the SMO, CMO and others in the value chain. Fourth is innovative pharmaceutical enterprises. Facing stiff challenges from both foreign and domestic peers, Chinese drug companies need to globalize to survive and develop. Joining ICH can just provide this opportunity, turning "China's new" into "Global new". Finally, the winner is China's innovative research capability. Joining the ICH will enable China to participate in the global innovative research and development activities at an early stage, fostering more interests into the innovative R&D.
同时，在中国西部，数以百计的科学家和高管于2017年9月16日齐聚中药重镇贵阳，参加2017第四届诺贝尔奖获得者医学峰会。 5位诺贝尔奖得主、10余位中美院士、100余位权威专家一道与海内外生物医药产业新锐领袖、资深投资机构汇聚一堂，围绕“科学：事实与虚构的博弈(Science-Fact and Fiction)”这一主题共商医学科技创新大计。
方恩医药副总裁熊海山博士发表了一篇关于中国加入ICH将产生何种影响的专题演说。熊博士专注于市场趋势的战略和实际操作层面，他总结说：制药行业正在成为一个单一的全球市场，那些投资于创新并准备承担执行风险的企业将在这个市场蓬勃发展。
稍后熊博士参加了一个关于跨境投资的专题座谈会，方恩医药在其10年历史中已经多次进行跨境投资。专题座谈会成员之一是诺贝尔奖得主、美国前能源部部长Steven Chu朱棣文博士，该专题座谈会充满活力，吸引了许多与会者。
Meanwhile in western China, hundreds of scientists and executives gathered at the 4th World Nobel Laureates Medical Summit on September 16th, 2017 in Guiyang, an area known for its traditional medicine prowess. Five Nobel prize winners, more than ten Chinese and American academicians, over 100 distinguished experts, together with prominent leaders and senior investment institutions from biopharmaceutical industry in and outside of China participated in the summit, circling round the theme “Science-Fact and Fiction” to discuss the major program of medical science and technology.
FMD's Vice President Dr. Haishan Xiong gave a featured speech on ICH impact. Dr. Xiong focused on the strategic and the practical aspects of the trends in the market. He concluded that the drug industry is becoming a single global market. Those enterprises who invest in innovation and are prepared to take on the execution risks will thrive in this market.
Later Dr. Xiong participated in a panel discussion on cross boarder investment, which FMD has done a couple of times in its 10-year history. One of the panelists is Nobel Laureate Dr. Steven Chu, former Secretary of the Department of Energy of the USA. The panel was vibrant and attracted many participants.
关于方恩
方恩（天津）医药发展有限公司方恩（天津）医药发展有限公司2007年注册，注册资金150万美元，是国内目前唯一一个能够提供全方位与国际标准接轨的临床开发服务CRO公司。方恩在天津、北京、上海、南京、广州、成都、沈阳、香港、台湾、美国宾州及亚美尼亚、日本和韩国建立了分支结构。方恩现有员工1400多位，中国大陆的临床运营团队分布在全国36个城市，目前还在不断的发展壮大中，致力于为国内外生物制药或医疗器械客户提供高质量低成本的全方位的临床研究服务。
方恩自成立以来，参与并承担了“十一、五”及“十二、五”重大新药创制项目，通过了国内外大中型制药企业的数十次稽查，为许多国内外领先的医药企业及全球一些非盈利机构和一些新兴的生物医药公司提供临床研究服务。至今为止，方恩已支持提交国内外15个新药证书并有11个已经批准；承接了200多项临床试验项目包括多个治疗领域下的入组10000例的上市后研究；与亚洲300多家临床试验机构保持着良好的合作关系；目前已经为分布于中国大陆、香港、台湾和韩国的各阶段临床试验入组了近60000例受试者。
Fountain Medical Development Ltd was registered in 2007 with the capital of $1.5 million, which is currently the only CRO company that can provide all-round clinical development services in line with international standards. FMD has more than 1400 employees throughout the stablished branches in Tianjin, Beijing, Shanghai, Nanjing, Guangzhou, Chengdu, Shenyang, Hongkong, Taiwan, Pennsylvania, Armenia, Japan and South Korea. In China, our clinical operation teams are distributed in 36 national cities, we are committed to providing domestic, foreign pharmaceutical and medical equipment customers with high quality and low cost clinical study services of full range.
FMD has participated in and undertaken major drug discovery projects of "eleventh five-year plan" and "twelfth five-year plan", and has passed through the inspection of dozens of large and medium-sized pharmaceutical enterprises at home and abroad, we have offered clinical study services to prominent domestic and foreign pharmaceutical enterprises, some of the world's leading nonprofit organizations and some of the emerging bio pharmaceutical companies. So far, FMD has assisted with submission of 15 new drug certificates at home and abroad and 11 have been approved; and has carried out more than 200 clinical trials including PMS study of 10000 enrolled samples in multiple therapeutic areas; We have been keeping good cooperative relationship with more than 300 Asian clinical trial institutions; In mainland China, Hongkong, Taiwan and South Korea, we have recruited nearly 60000 subjects in various phases of clinical trials.