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癌症新药,中国制造

更新时间:2018-1-4 19:47:07 来源:纽约时报中文网 作者:佚名

Made in China: New and Potentially Lifesaving Drugs
癌症新药,中国制造

SHANGHAI — One new drug promises to stop cancer from spreading to other organs. Another would treat blood cancer. A third would use the body’s immune system to kill tumors.

上海——一种新药有望阻止癌细胞扩散到其他器官;另一种可以治疗血癌;还有一种利用人体的免疫系统来杀死肿瘤。

All three show encouraging results, and need just one more step to be approved for use in the United States. The drugs have something else in common: They were created in China.

这三种药都展示出令人鼓舞的效果,只需再过一道关坎就能获得在美国上市的批准。这些药还有另一个共同特点:它们都是中国创造的。

For years, China’s drug industry concentrated on replicating Western medicines. Getting new drugs approved was a frustrating and time-consuming process. Companies thought plowing millions of dollars into research and development was risky and stuck to safer revenue streams.

多年来,中国的制药业一直把注意力集中在仿制西药上。让新药获得批准是一个令人沮丧且耗时的过程。企业认为,将数百万美元投入药物研发风险大,不如把精力放在更安全的收入来源上。

The country is now pushing to play a bigger role in the global drug industry. Millions of people in China have cancer or diabetes, and the government has made pharmaceutical innovation a national priority. Officials have promised to speed up drug approvals, and to reverse a brain drain by luring scientists back home. The authorities are providing land, grants and tax breaks, and investing in research.

现在,中国正努力在全球制药业发挥更大的作用。中国有数百万癌症或糖尿病患者,政府已把创新药物作为国家重点。官员已承诺加快药品审批速度,为了扭转人才外流,还在大力吸引科学家回国工作。当局为研发提供土地、拨款、税收减免以及投资。

The three new drugs will have to clear American regulatory hurdles. If they do, they can stand as proof of China’s growing ability to produce cutting-edge treatments, part of a broader transformation of the country’s economy as it moves into higher-value and increasingly complex sectors.

这三种新药仍需通过美国监管这道难关。如果通过的话,它们将成为中国生产前沿疗法的能力越来越强的证明,提高这种能力是中国经济向高附加值及日益复杂的行业进行更大范围转型的一部分。

China’s drug development is in the earliest stages compared to the broader industry. Some experts say, however, that it is only a matter of time before China’s medical companies stand alongside Big Pharma giants like Pfizer and AstraZeneca.

与更大范围的工业相比,中国的药物研发仍处于早期阶段。但一些专家说,中国制药企业与辉瑞(Pfizer)和阿斯利康(AstraZeneca)这些制药巨头平起平坐只是时间问题。

“It’s not whether they are going to,” said Jonathan Wang, senior managing director of OrbiMed Asia, a health care investment fund. “They are going to.”

“这不是他们做得到、做不到的问题,”医疗投资基金奥博亚洲(OrbiMed Asia)的资深董事总经理王健说。“他们一定能做到。”

For now, access to quality drugs remains a problem in China. Many people buy medicines from Hong Kong and Macau — territories governed by separate laws. Online forums are devoted to discussing smuggling generics from India. Others buy the raw ingredients to make the drugs at home. Those who can afford it fly to the United States.

直到现在,在中国得到高质量的药品仍是个问题。许多人从香港和澳门购买药物,港澳地区受不同的法律管辖;网上有专门讨论从印度走私仿制药的论坛;还有人购买原材料在自己家里制药;出得起这笔钱的人飞到美国去看病。

A growing number of companies are trying to address that shortfall. Hutchison China MediTech, a firm backed by Hong Kong’s richest man, Li Ka-shing, started out in 2000 trying to develop the herbal drugs used in traditional Chinese medicine. In 2005, the company, known as Chi-Med, started developing cancer drugs.

越来越多的公司正在试图解决药品短缺的问题。得到香港首富李嘉诚支持的和黄中国医药科技(Hutchison China MediTech)2000年成立时曾尝试过中草药的开发。2005年,和黄医药开始研发抗癌药物。

At its main laboratory in Shanghai, upward of 350 scientists are surrounded by rodents in testing rooms. More than half the scientists are at work trying to discover new drugs.

在上海的主要实验室里有多达350名科学家,他们被测试室中的啮齿类动物环绕着。半数以上的科学家正在努力寻找新药。

In October, Chi-Med reported that more than 60 percent of patients in second-stage clinical trials had responded positively to its drug, savolitinib, which it is developing together with AstraZeneca. Savolitinib — the first drug of its kind — can be used to treat lung, kidney, gastric and colorectal cancers; it is often used in combination with other AstraZeneca drugs to shut down pathways that allow the cancer to spread.

去年10月,和黄医药报告说,在二期临床试验中,60%以上的患者对公司与阿斯利康共同研发的savolitinib有积极反应。Savolitinib是首种可用于治疗肺癌、肾癌、胃癌和结肠直肠癌的药物,通常与阿斯利康的其他药物一起使用,把允许癌症扩散的信号传导通路阻断掉。

Chi-Med is awaiting more data. But if further tests get positive results, the company will apply for what is known as breakthrough therapy designation from the United States Food and Drug Administration.

和黄医药正在等待更多的数据。如果进一步试验有积极的结果,公司将申请美国食品和药物管理局(简称FDA)所谓的突破性疗法认定。

It still needs to run Phase 3 trials, the last step before seeking full approval from the F.D.A., but breakthrough therapy status would allow the final stage to be sped up. The trials involve drugs being tested, often against placebos, for their safety and effectiveness on as many as several thousand patients.

公司仍需要做第三期临床试验,这是得到FDA全面批准之前的最后一步,但突破性疗法认定可缩短这个最后阶段的时间。第三期临床试验需要在多达几千名的患者身上检验被测试药物的安全性和有效性,通常是与安慰剂做对照。

Laura Nelson Carney, an Asia-Pacific health care analyst at Bernstein Research, said that based on the industry average, the probability of success in Phase 3 trials is 60 to 70 percent.

伯恩斯坦研究公司(Bernstein Research)亚太医疗行业分析师劳拉·纳尔逊·卡尼(Laura Nelson Carney)说,第三期临床试验的成功率从行业平均水平来看是60%到70%。

If all goes according to plan, regulatory approval could come in late 2019, at the earliest, said Christian Hogg, Chi-Med’s chief executive. “It takes 20 years to get an overnight success, and that’s where we are at the moment,” he said.

如果一切都按计划顺利进行,监管部门最早可能在2019年底批准,和黄医药首席执行官贺隽(Christian Hogg)说。“花了20年的时间,才能突然成功,这就是我们此刻的情况,”他说。

The last time China produced a new drug for the global pharmaceutical industry was in the 1970s, when the Chinese scientist Tu Youyou was credited with the discovery of artemisinin after Mao Zedong asked her to come up with a cure for malaria. But global recognition did not come until much later, after the Swiss drug maker Novartis bought the Chinese patent and started producing it in the late 1990s. Ms. Tu was eventually awarded a Nobel Prize in 2015.

中国上次为全球制药业开发出新药是在1970年代。在毛泽东号召中国科学家研发新的治疗疟疾药物之后,发现青蒿素的功劳归给了屠呦呦。但是,青蒿素在很多年后才得到全球的认可,那是在瑞士制药公司诺华(Novartis)在1990年代末购买了中国专利、开始生产该药之后。屠呦呦最终在2015年获得了诺贝尔奖。

That is changing. Along with Chi-Med, another company, BeiGene, is already in Phase 3 trials globally for a drug used to treat a variety of lymphomas, the most common form of blood cancer, and an immunotherapy drug that aims to destroy tumors. It has also teamed up with Celgene and Merck to develop cancer drugs.

这一切都在改变。除了和黄医药,另一家名为百济神州(BeiGene)的公司已在对两种药物在全球进行第三期临床试验,一种是用于治疗一种最常见的血癌、淋巴瘤的药物,另一种是以消灭肿瘤为目的的免疫治疗药物。百济神州还在与赛尔基因(Celgene)和默克公司(Merck)合作开发抗癌药物。

Ms. Carney said she expected 20 or 30 Chinese-made drugs to seek Phase 3 trials in the United States, the world’s biggest market for cancer drugs, within the next five years. Those that make it through will very likely be cheaper than those made by foreign companies, she said, based on current pricing patterns in China.

卡尼说,她预计在未来五年内,将有20或30个中国制造的药物在美国申请进行第三期临床试验。美国是世界上最大的抗癌药物市场。她说,从中国目前的定价模式来看,那些试验成功、获得批准的药物很可能会比外国公司生产的药物价格更低。

Meanwhile, Big Pharma is setting up its own labs here. Johnson & Johnson, Novartis and Sanofi have all opened research centers in Shanghai to create drugs for Chinese patients. Executives say that the government has made inroads in toughening protections of pharmaceutical patents.

与此同时,大型制药企业纷纷在中国建立自己的实验室。强生(Johnson & Johnson)、诺华和赛诺菲(Sanofi)都已经在上海成立了为中国患者制药的研究中心。高管表示,中国政府已经在加强保护制药专利方面取得了进展。

And the pace of approvals has also quickened. In worst-case scenarios, drug companies needed to wait up to two years to get permission just to start clinical trials, which would then take several more years. The comparable waiting period in the United States is typically 30 days.

批准的步伐也已加快。在最糟糕的情况下,制药公司需要等两年,才获得开启临床试验的批准,临床试验本身需要几年的时间。在美国,获得临床试验批准的等待期通常是30天。

Under Bi Jingquan, who was appointed the head of China’s Food and Drug Administration in 2015, the agency has begun cracking down on companies making low-quality drugs and agreed to accept foreign data for clinical trials.

2015年,毕井泉被任命为中国食品药品监督管理局局长,在他的领导下,中国药监局已经开始打击生产低质量药物的公司,并同意接受国外的临床试验数据。

Now, thanks to those shifts, as well as incentives offered by the government, scientists trained overseas are returning to China.

由于发生了这些转变,加上政府提供的激励措施,现在,在海外受过训练的科学家正在回国工作。

After 20 years in the United States with Eli Lilly and Pfizer, Joan Shen moved to Shanghai in 2011 to lead clinical trials for Pfizer. She now heads research and development for a Chinese biotech firm, I-Mab Biopharma. The local government has helped secure funding for the company, and provided laboratory space in a high-tech business park.

2011年,在美国的礼来公司(Eli Lilly)和辉瑞公司工作了20年之后,申华琼(Joan Shen)回到上海,领导辉瑞的临床试验部门。她现在负责中国生物技术公司泰康生物(I-Mab Biopharma)的研发工作。当地政府帮助这家公司获得了资金,并在一个高技术园区为公司提供了实验室空间。

“The funds are chasing us,” she said, comparing the investment environment between China and the United States, “instead of us having to spend numerous hours convincing investors.”

申华琼在比较中美两国的投资环境时说,“这里是钱来找我们,而不是需要我们花大量时间去说服投资者。”

Despite the optimism, Chinese pharmaceutical companies that want to go abroad still face obstacles. Competition among drugmakers in major markets like the United States is intense, and Chinese companies are hamstrung in particular by a lack of money committed to research.

尽管前景乐观,但想要走出国内的中国制药公司仍面临着障碍。在美国这样的主要市场,制药公司之间的竞争十分激烈,中国企业尤其受到缺少研究资金的妨碍。

Jiangsu Hengrui, a Chinese company that has been moving toward developing new drugs from making generic ones, has the largest research budget of all Chinese drug firms. But its $180 million annual outlay pales in comparison with the $7.8 billion that Pfizer spent in 2016.

中国公司江苏恒瑞医药目前正在从生产仿制药向开发新药转型,这家公司的研究预算是所有中国制药公司中最大的。但与辉瑞2016年花费的78亿美元的年度研究支出相比,江苏恒瑞1.8亿美元的年度研究支出相形见绌。

Still, with several drugs in early-stage testing, it is targeting what Zhang Lianshan, the company’s head of research and development, described as its “ultimate goal”: regulatory approval in the United States.

尽管如此,恒瑞医药已有几种进入早期试验的药物。用研发主管张连山的话说,公司的“最终目标”是获得美国监管部门的批准。

“If you have a drug approved by the U.S. F.D.A.,” Mr. Zhang said, “that’s a true demonstration of innovation.”

张连山说,“如果你有一个得到美国FDA批准的药物,那才是创新的真正表现。”

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