诺华携手中国科技巨头,共拓中国市场
全球知名的医药健康公司诺华近日表示,未来将为中国市场引入更多的创新药物,同时加强与中国本土生物技术公司及科技公司的合作,进一步推动数字化医疗的发展。
诺华全球首席执行官万思瀚预测“未来几年中国将成为诺华全球三大市场之一”。他表示,随着中国政府进一步扩大改革开放,并不断加速新药的审批,诺华计划在今后几年内将有逾十种创新药物引入中国。
“在过去的二十年里,中国从一个主要生产仿制药和疫苗的国家已经逐渐发展成为一个在创新药物方面有出色表现的国家。中国在医药健康行业不断扩大的市场准入和对创新保持的开放态度,将使中国的患者持续获益,同时也鼓舞着诺华这样的跨国医药健康企业在华持续扩大投资。
近几年来,尤其是最近五年里,中国的监管机构精简和加速了新药审批流程,例如,增加了新药审批的人员并加快了临床急需用药和罕见病治疗药物的审批。
在近期结束的2019年中国发展高层论坛上,国家药品监督管理局药品注册管理司司长王平透露,2018年中国通过了48个新药的审批,并将审批周期缩短了一年。
万思瀚认为,“目前中国的审批周期几乎与欧美处于同一水平”。实际上,在过去的两年里,诺华就有9款新药在中国获批,获批速度远远快于以往。”
诺华每年在研发领域投入超过九十亿美元。在上海,诺华拥有一个投资高达十亿美元的研发中心。研发中心里的700 多名科研人员,主要关注于中国及亚洲地区的高发癌症和肝病等领域的新药研发项目。目前这个研发中心在新药研发领域发挥着重要的作用。
万思瀚认为,“我们在创新方面的投资正在产生巨大的回报。未来三年我们在中国将迎来一系列创新药的上市。”
目前,中国是仅次于美国的世界第二大医药市场。专注于医药健康行业的数据信息公司艾昆纬(IQVIA)早前曾预测中国的医药市场将于2022年达到1450亿美元至1750亿美元。2017年这一数据为1226亿美元。
万思瀚表示,诺华正在与中国药品监管机构和国内合作伙伴紧密接触,致力于将细胞和基因疗法引入中国。目前,细胞和基因疗法被认为是解决许多疑难病症的革命性疗法。
2018年9月,诺华宣布与西比曼生物科技集团达成战略许可和合作协议,致力于在华生产制造Kymriah® 。这是一种治疗癌症的CAR-T细胞疗法(嵌合抗原受体T细胞免疫疗法)。Kymriah®目前已在欧洲、加拿大和澳大利亚获批上市,诺华也正在推动该药物尽快进入中国。
万思瀚还表示:“我相信通过我们和中国伙伴的共同合作和努力,将帮助中国成为在细胞与基因疗法领域新兴市场中的领导者”。在2019年中国发展高层论坛上,万思瀚代表诺华针对细胞和基因疗法向中国政府提供了一系列建议,内容涵盖了监管框架、研发和应用的要求,以及建立灵活的支付机制和替代性的出资模式等。
万思瀚认为数字技术已经成为推动诺华在中国持续拓展业务的主要动力之一。
目前,诺华在中国已经与40多家生物技术公司开展了合作。同时也正在积极拓展与本土科技公司的合作伙伴关系。
3月22日,诺华与腾讯签署了一项全球战略合作协议,将致力于通过整合运用大数据、人工智能和社交媒体技术为慢性病患者提供更好的管理和服务。
去年开始掌舵诺华的万思瀚,一直致力于将诺华打造成为一家由数据科学和数字化技术为核心驱动的医药健康公司。在他的领导下,诺华已经启动了一系列措施,利用数字技术推动自身的变革,并重塑医药健康行业。
万思瀚介绍道:“(去年),我们与腾讯在心衰领域开展了合作,协助寻找需要医疗救助的患者并帮助患者选择合适的药物。现在我们正在扩大合作范围至所有慢性病。这是我们全球范围内最先进的合作模式之一,也将成为其他市场的典范。诺华在中国的战略将聚焦于增长、创新和数字化技术。”
以下英文原文刊登于2019年4月2日《中国日报》第16版,记者:刘志华
Novartis to team up with Chinese tech giants
Swiss pharmaceutical giant Novartis AG is looking to further tap into China's healthcare market by bringing more innovative drugs, while enhancing collaborations with local biotech and technology companies to further digital transformation of healthcare, a top company official said.
Vas Narasimhan, CEO of Novartis, said he expects China to "become one of the top three markets for Novartis by sales in the coming years". The company is ready to bring more than 10 innovative medicines to China over the coming years, thanks to the country's commitment to further reform and opening-up, and its ongoing efforts to speed up new drug approvals, he said.
"Over the last 20 years China has been able to evolve from a country that was primarily focused on generic medicines and vaccines to now being able to bring the latest innovations," he said.
"China's strategy of opening-up to our industry and opening-up to innovation will benefit Chinese patients and also enable companies like us to keep investing in China."
In recent years, especially from five years ago, Chinese regulators have been streamlining and accelerating new drug approvals, with efforts such as increasing the head count of staff for new drug reviews and speeding up approvals for drugs in urgent clinical need or for treating rare diseases.
At the recently closed China Development Forum 2019, Wang Ping, director general of the department of drug registration under the National Medical Products Administration, revealed that China approved 48 new medicines in 2018, and reduced the approval period by a year.
"Now China's regulatory timelines are at the same level of what we see in the United States or in Europe," Narasimhan said, adding that Novartis got nine new medicines approved in China in the past two years alone, at a pace faster than ever.
Novartis, which spends more than $9 billion on research and development every year, runs an innovation hub in Shanghai, with an investment of $1 billion. The campus, with more than 700 scientists focusing mainly on research of cancer and liver diseases prevalent in Asia and China, is now playing an increasingly important role in new drug development.
"I think our investment in innovation is bringing a number of new launches to China in our portfolio over the next three years," Narasimhan said.
China is now the world's second-largest market for pharmaceuticals, second only to the United States. Iqvia, a healthcare information company, earlier said China's pharmaceutical market will reach $145 billion to $175 billion by 2022, compared with $122.6 billion in 2017.
The CEO said Novartis is also engaging with Chinese regulators and local partners to bring cell and gene therapies to China, which have been heralded as a breakthrough in treating many intractable illnesses.
Last September, Novartis announced a deal with Shanghai-based biotech company Cellular Biomedicine Group, for manufacturing Kymriah, a CAR-T cell therapy, or chimeric antigen receptor cell therapy, treatment for cancer. Kymriah has already been approved in Europe, Canada, and Australia and Novartis is looking to bring the same to China soon.
"I believe our collaboration with Chinese partners can help China become the leader among the emerging markets in bringing cell and gene therapies to countries," said Narasimhan, who presented a policy paper at the CDF 2019 with a wide range of recommendations to the Chinese government, including the regulatory framework, requirements for the research and applications, as well as the establishment of flexible payment mechanisms and alternative funding models.
Narasimhan said that digital technologies have been a major driver fueling the company's business expansion in China.
In addition to 40 biotech companies that Novartis currently has partnerships with, the company is also planning partnerships with technology companies in China.
On March 22, the company signed a global strategic partnership deal with Chinese tech giant Tencent to apply integrated big data, artificial intelligence and social media technologies for better patient outcomes on chronic diseases.
The CEO took the helm at Novartis last year and has envisioned a focused medicines company that's powered by data sciences and digital technologies and has launched a number of initiatives to transform Novartis while reshaping the healthcare sector using digital technologies.
"We began the partnership with Tencent in cardiovascular diseases to help identify patients who need care and help patients stay on the right medicine," said Narasimhan.
"Now we are expanding the collaboration to cover all the chronic diseases. This is one of our most advanced partnerships in the world and a model for the rest. Our strategy in China is about growth, innovation, and digital technologies."