专栏名称: 医药代表
本号为正版MRCLUB「医药代表」微信,谨防山寨!——医药行业的那些事儿,新手指导,招聘信息,业内新闻推送,25万药代会员及医药市场销售管理人员每天从我们这获得职业指导及业内动态。
目录
相关文章推荐
癌图腾  ·  在太平洋深处发现意想不到的结构 ·  2 天前  
drpei  ·  流感高峰应该过去了 ·  4 天前  
51好读  ›  专栏  ›  医药代表

趋势 | 多家跨国药企为何专门为中国研发新药?

医药代表  · 公众号  · 医学  · 2017-07-08 22:48

正文

西方制药公司发现,利润丰厚中国的市场正渐行渐远,因此近几年纷纷从引进旧药转向在本地研发新药。

来源/新浪财经


北京时间6日下午WSJ讯 全球大型制药公司正投入数十亿美元研发新药,试图攻克在中国高发的不同于西方的致命疾病。


瑞士诺华制药(Novartis, NVS)正试验一种药物分子,用于治疗一种在中国南方多发的头部和颈部肿瘤。美国强生公司(JNJ)也在研发新型药物,用于治疗中国高发的肺癌和乙型肝炎。法国赛诺菲集团(Sanofi, SNY)虽然最初遭遇挫折,但仍在寻找治疗肝癌的新方法。肝癌也是中国常见的癌症类型之一。


诺华制药位于上海的研发中心。诺华制药在2009至2014年投入10亿美元,将上海一处原有设施转化为新的研发中心。诺华制药位于上海的研发中心。诺华制药在2009至2014年投入10亿美元,将上海一处原有设施转化为新的研发中心。

这些行动表明,全球大型制药公司改变了过去几十年来向拥有十多亿人口的中国销售现有药物的旧策略,它们希望深耕中国业务。西方制药企业长期以来一直难以在中国这个全球第二大药品市场站稳脚跟。


据世界卫生组织统计,肺癌、肝癌和胃癌位居中国致死率最高的疾病之列,每年因这三种疾病死亡的患者人数超过100万人。日本、韩国等国家每年因上述疾病死亡的人数也达数十万人,意味着制药公司也能将针对中国研发的药物销往临近市场。相比之下,阿尔兹海默症和其他类型的痴呆症在美国人中致死率较高。


中国患者群体庞大,对药品的需求尚未得到满足,但这并非制药公司研发新治疗方法的唯一原因。监管障碍使外资制药公司难以在中国销售最新药物,主要原因在于这些药物是在海外研发的。


近年来曝光的多起腐败丑闻导致外国制药公司在中国销售旧药的难度越来越大。2014年,葛兰素史克(Glaxosmithkline, GSK)被一家中国法院判处近5亿美元罚款,原因是这家英国制药公司的中国分支机构向医生行贿。诺华制药去年同意支付2500万美元罚款,以了结美国证券交易委员会对该公司涉嫌行贿的指控。


西方制药公司发现,利润丰厚中国的市场正渐行渐远,因此近几年纷纷从引进旧药转向在本地研发新药。


强生公司2012年在上海成立了一家研发实验室,目前正研究治疗肺癌、血癌和乙肝的新药。与中国不同的是,丙肝在美国更普遍。该实验室计划明年对首个突破性进展进行临床试验,并期待能通过肺癌或乙肝项目研发出复方药物。


诺华制药在2009至2014年投入10亿美元,将上海一处原有设施转化为新的研发中心。该公司去年10月开始在中国、韩国患者身上对第一个本土研发成果(一种用于治疗鼻咽癌的小分子药物)进行临床试验。


诺华制药中国研发团队负责人李恩表示,他们很快会对另一种治疗肝硬化的复方药物进行临床试验。他带领的一支600名科学家的团队同时还在从事至少十几个项目,目标是研发治疗肝癌和胃癌等疾病的新药。


直到几年前,中国用于药物研发的人力都还很匮乏。但在政府项目的支持下,过去十年来已有数千名在西方学成的中国科学家回国工作,促使大型药厂开始深化研究。


贝恩策略顾问(Bain & Co.)亚洲医疗保健实践负责人Vikram Kapur表示,正如长期以来西方制药公司低价委托中国工厂代工生产药物,在中国进行药物研发的成本也要低很多,这意味着大型制药公司将越来越多地利用中国实验室来推动全球研发计划。


强生和诺华表示,他们开发出来的药物虽然主要针对中国,但也会在西方患者身上测试,以便需要时在西方市场销售。比如英国和美国的肺癌情况就很普遍。


当然也并非每个药物项目都有收获。负责赛诺菲中国研发活动的张愚(Alex Zhang)表示,约三年前,公司准备测试一种新的药物分子用于治疗肝癌,但没等到临床试验就被搁置。


在人体上试验药物风险很大,失败的可能性要多于成功的可能性。生物技术创新组织(Biotechnology Innovation Organization)称,2006-2015年美国试验的药物中,最终只有十分之一能最终上市销售。


赛诺菲并不是在自己的实验室研发新分子药物,而是与中国学术界建立合作关系。张愚表示,公司正与中国大学开展约10个项目,侧重于寻找肝癌、乙肝和糖尿病的治疗方案。这些合作仍处于早期,他预计两年内不会有成果。英国公司阿斯利康(AstraZeneca, AZN)也加入了与中国大学合作的行列,正在研发治疗胃癌和慢性肾病等疾病的新药。


满足大量临床要求的药物更有机会被纳入政府报销范围,使患者更能担负得起这些价格高昂的药物,也让这些药物更难以被医生忽略。


中国本地初创公司也没有落后多少。香港亿万富翁李嘉诚旗下的和黄中国医药科技有限公司(Hutchison China MediTech)已在中国内地获准生产其首款药物─一种治疗直肠癌的复方药。将该药物用于肺癌和胃癌治疗的试验也在计划当中。


和黄中国医药科技首席执行长贺隽(Christian Hogg)称,重要的是,无论是大型药企还是像和黄中国医药这样的初创公司,都在专门为中国患者研制药物,患者绝对是赢家。


原文:


Why Big Pharma Is Targeting China's Deadliest Diseases

By Preetika Rana


SHANGHAI – Big Pharma is investing billions of dollars to tackle deadly diseases prevalent in China, developing new drugs to combat a lineup of top killers that differ from those in the West.


Swiss drugmaker Novartis AG is testing a molecule to combat a rare head and neck cancer widespread in southern China. American rival Johnson & Johnson is creating innovative drugs to tackle lung cancer and hepatitis B, endemic in China. And France's Sanofi SA is researching a new way to treat liver cancer -- one of the most common forms of cancer here -- despite early setbacks.


The move is a switch from a decades-old strategy of selling existing drugs to China's billion-plus people, and is aimed at gaining a stronger foothold in the world's second-largest drug market which has long eluded Western companies.


Lung, liver and stomach cancers are among China's top killers, according to the World Health Organization, accounting for more than a million deaths every year. Those diseases kill hundreds of thousands of people in countries like Japan and South Korea too, offering an opportunity for drugmakers to sell China-tailored treatments in neighboring markets. Alzheimer's and other forms of dementia are among the top causes of deaths in the U.S. in comparison.


But large unmet needs aren't alone driving companies to discover new therapies here. Regulatory hurdles have made it tough for foreign firms to quickly launch their newest treatments in China, largely because they are discovered overseas.


Recent corruption scandals have made it harder for companies to market older drugs that are approved for sale here. A Chinese court slapped a nearly-$500 million fine on GlaxoSmithKline PLC in 2014 after it found the U.K.-based company's local unit guilty of bribing doctors. Novartis last year agreed to pay $25 million to settle a Securities and Exchange Commission Investigation into bribery allegations in China.


Western firms found China's lucrative market slipping away, and in recent years many began moving from bringing existing drugs to discovering new cures here.


J&J in 2012 opened a discovery lab in Shanghai, and is now working on new medicines for lung cancer, blood cancers and hepatitis B. Hepatitis C is more common in the U.S. The lab is planning to test its first breakthrough on patients over the next year, and expects the compound to emerge from its lung cancer or hepatitis B programs.


Novartis injected $1 billion between 2009 and 2014 to convert an existing Shanghai facility into a new discovery center. In October, it began testing its first China discovery -- a molecule to treat nasopharyngeal cancer -- on Chinese, Korean and Taiwanese patients.


En Li, Novartis' research head in China, said the company will soon test another compound, to treat liver fibrosis. His team of 600 scientists are running at least a dozen other projects aimed at finding new treatments for diseases such as lung and stomach cancer.


Until a few years ago, China lacked the manpower needed for drug discovery, a process that involves searching for compounds with medicinal potential. But a government program encouraged thousands of Western-trained Chinese scientists to return over the past decade, encouraging Big Pharma to deepen research.


Like drug production -- Western firms have long contracted Chinese factories to manufacture their drugs inexpensively -- the cost of drug discovery is cheaper in China, too, meaning companies will increasingly use labs here to advance their global pipeline, according to Vikram Kapur, who leads Bain & Co.'s health-care practice in Asia.


J&J and Novartis say their discoveries, while targeted at China's needs, will also be tested on patients in the West so they could be sold there if needed. Lung cancer, for example, is widespread in the U.S. and the U.K.


Not every project will produce a new discovery. Sanofi was preparing to test a new molecule to treat liver cancer some three years ago, but the program was shelved before it could be tried on patients, said Alex Zhang, who oversees the company's research activities in China.


The process of testing discoveries on people -- called drug development -- is also risky, with projects more likely to fail than succeed. Roughly one out of every 10 discoveries tested in the U.S. between 2006 and 2015 eventually made it to market, according to trade body Biotechnology Innovation Organization.


Instead of developing new molecules in its own lab, Sanofi is striking partnerships with academia in China. Mr. Zhang said the company is running roughly 10 projects with Chinese universities, focused on finding treatments for liver cancer, hepatitis B and diabetes. The collaborations are still in early stages, and he doesn't expect to see results before two years. The U.K.'s AstraZeneca PLC has also joined with universities in China, and is creating new drugs for stomach cancer and chronic kidney disease, among others.


Drugs that meet large clinical demand stand a better chance at being reimbursed by the government, making otherwise costly medicines more affordable for patients. They are also harder for doctors to ignore.


Local upstarts aren't far behind. Hutchison China MediTech Ltd., which counts Hong Kong billionaire Li Ka-shing among its backers, has sought approval for its first drug in China -- a compound to fight colorectal cancer. Additional tests are planned for the same drug to work on patients with lung and stomach cancer.


"What's important -- whether it's Big Pharma or companies like ours -- is that drugs are now specifically being designed for Chinese patients," said Chi-Med's Chief Executive Christian Hogg. "Patients are absolutely going to be the winners in this."


MRCLUB原创作者招募中

数十万精准会员每日阅读,助您快速提升个人品牌,扩大在医药行业及社会化媒体的影响力!(详情请访问网站http://wemr.club)

医药代表 伴您成长!