In depth innovation of Chinese medicine: is this winter or summer?

The unexpected chill is not only from the afterwave of Changchun Changsheng vaccine case, but also from the doubts of enterprises about the sustainability of the reform policy of drug review and approval system, as well as the doubts of enterprises about the access of medical insurance and centralized procurement, which cause a sharp decline in drug prices after the establishment of the National Medical Security Bureau Drug regulatory policy determines the capacity of emerging markets in the future, while medical insurance policy determines the profit space of emerging markets Now, entrepreneurs, scientists and investors in the field of pharmaceutical innovation interviewed by health point are worried that the market capacity and profit space will be under great pressure It will take about 15 minutes to read the full text If you have any inspiration from this article, please click the comments at the end of the article More than a month after Bi Jingquan, the former Secretary and deputy director of the Party group of the General Administration of market supervision, resigned due to the "vaccine incident", the CPC Central Committee decided that Zhang Mao, the director of the General Administration of market supervision, would concurrently hold the post of the Secretary of the Party group of the General Administration of market supervision On September 25, Zhang Mao made a statement to the organization: actively create a relaxed and convenient access environment, a fair competition market environment, and a safe and secure consumption environment Subsequently, as the state drug administration directly under the General Administration of market supervision, it is also making a voice On June 26, Xu Jinghe, deputy director of the State Food and drug administration, gave a new formulation of "four unswervingly" when attending the 2018 global regulatory science and Technology Symposium: we should adhere to deepening the reform of the review and approval system; we should adhere to comprehensive and strict supervision; we should adhere to comprehensive and intelligent supervision; and we should adhere to comprehensive and legal administration Those who are familiar with Chinese political culture will naturally study the "three environments" and "four unshakable", words and words, sentences and paragraphs, front and back, light and heavy After the Changchun Changsheng vaccine event and the National Health Insurance Bureau organized "purchasing with quantity", the Chinese pharmaceutical innovation has undergone irreversible changes Although it's too early to judge the brightness and gloom of China's pharmaceutical innovation, the polarization has shown signs - on the one hand, the giants of listed companies that rely on generic drugs to create new drugs are facing great challenges, on the other hand, the "global new" overseas returnees start-ups will continue to gain dual support of policy and capital ◆ winter: uncertainty, coldness "When it's warm and cold at first, the economic environment seems to make the innovators feel a little cold Only when they keep warm, can they last." Song Ruilin, executive chairman of China pharmaceutical innovation promotion association, said during the third China Pharmaceutical Innovation and investment conference In terms of drug supervision policies, health point has previously reported that on August 16, after the outbreak of the vaccine case, the central government asked Bi Jingquan, the party secretary and deputy director of the General Administration of market supervision, to resign Since then, the public opinion in the industry has been most worried about and repeatedly discussed: will the reform of drug review and approval system launched since 2015 have a conservative resurgence? Will it repeat the previous round of "drug administration earthquake" after Zheng Xiaoyu's case, the examination and approval efficiency become low and the registration application backlog? For this reason, song Ruilin, together with Professor Jiang Hualiang, academician of the Chinese Academy of Sciences, and Professor Wu Xiaoming, Professor of the Chinese Pharmaceutical University, wrote an article in NEJM medical frontier, calling for "the new deal must continue" "In the past three years, China's drug regulatory reform has touched on the deep-seated problems in the development of China's pharmaceutical industry, and inevitably involved the interests of some people," the article said However, it has been proved that the direction of this reform is correct It is really a contribution to the present age and a benefit to the future It is worthy of high praise and full support from all walks of life No storm should be a reason for us to give up halfway " Song Ruilin revealed in an interview with the health center on September 18 that after this article was published, leaders at all levels saw it and gave positive feedback "We can't rely on a leader for a reform," Song said The success of 40 years of reform and opening up is reflected in the system level The reform of drug review and approval system has also been transformed into the strategic decision-making of the Party Central Committee and the State Council, which is reflected in the "36 items" of the central and state-owned offices All reform measures are known, and the rest is to implement them " "Bi Jingquan's resignation will certainly have an impact on pharmaceutical innovation, but it will not have a big impact." Song Ruilin said, "nine bends of the Yellow River, eighteen bends, galloping to the sea I believe that there is no way out without reform, and there is no future without reform " The drug regulatory policy is farsighted, while the medical insurance policy is near worry Health point understands that from October, the National Health Insurance Bureau will officially launch the pilot drug centralized procurement organized by the state, involving 4 municipalities directly under the central government, 7 sub provincial cities or cities with separate plans According to the previous report of health point, some analysts believe that the market capacity of these 11 cities is expected to account for about 60% of the domestic market share of related drugs The chairman of a listed company that invests in innovative drug varieties said frankly that the market value of the whole industry affected by the "volume purchase" organized by the state health insurance bureau is about 500 billion yuan, while the medical insurance fund has only saved 200 million yuan, which is questionable The chairman pointed out that under the influence of multiple factors such as macro-economy, Sino US trade war, and "volume procurement", the pharmaceutical sectors of A-share and Hong Kong stock once fell sharply, and Hengrui pharmaceutical, Shiyao group and China biopharmaceutical (Zhengda Tianqing) were all affected The most important test for pharmaceutical listed companies is just the durability of carrying the bad policy Yin Zheng, founder partner of Sany innovation venture capital fund, said that the three enterprises are all transforming from traditional pharmaceutical enterprises to innovative drug research and development, adopting the strategy of "small step and fast running", not building "global new" pipelines at once, usually using the own funds of traditional pipeline sales to support and create new drugs If the traditional business of these listed pharmaceutical companies has a sharp drop in revenue and profit due to the bad health insurance policy, it is likely to affect the cash flow of the next round of innovative drug investment Early innovative drug research and development is a highly capital intensive industry Wu Xiaobin, President of Baiji Shenzhou China, raised a question at a recent forum: I discussed this issue with leaders related to health insurance, whether health insurance is "basic" or "innovation" There are 1.4 billion people in China, and the cost of medical insurance is very tight If the innovative medicine comes, the medical insurance fund for an innovative medicine may be countless times of "basic insurance" What should we do? For Wu Xiaobin's question, Luo Yongqing, President of Gilead China, gave the "standard answer" to innovative pharmaceutical enterprises: relevant leaders of the state have made it clear that basic medical insurance should focus on basic medical needs, and at the same time, meet the growing medical and health needs of the people with the vision of development According to Luo Yongqing, if a medical service or treatment plan is valuable and cost-effective, it is basic medical service We can't judge whether it is "basic" simply from the price Therefore, there is basically no fundamental conflict between insurance and medical insurance reimbursement of innovative drugs Of course, how to ensure the sustainability of medical insurance funds and truly balance "do what you can" requires the courage and wisdom of all parties to explore together But the National Health Insurance Bureau and health care experts believe that "purchasing with volume" should not be the "back pot" of the stock market crash Chang Feng, deputy director of the medical security policy research center of China Pharmaceutical University, told healthpoint that the reason for such a big fluctuation in the stock market is mainly because of the macro-economy and trade war Even if it is related to volume procurement, it is not because of the procurement of 31 varieties this time, but because of the expected expansion of the procurement scope (including regions and varieties) in the future However, this is based on Unnecessary and excessively pessimistic interpretation On the contrary, he believed that if the local innovative medicine enterprises started by the generic drugs, if they could pass the consistency evaluation and become the winning variety with "quantity purchase", they had very large market share and profits In the same forum, Hu Zhengguo, CO CEO of Wuxi apptec, compared the access environment differences between China and the United States: after a new drug was launched in the United States, sales came the next day Because before the new drugs go on the market, the payment method has been discussed In China, it is a long process for new drugs to enter the medical insurance catalogue, the basic drugs catalogue and the bidding procurement catalogue Can China's pharmaceutical companies' valuations be far higher than those of the US, he asked? Song Ruilin said that the ultimate goal of medical, medical insurance and pharmaceutical departments is to realize the interests of patients We should constantly fill in the gaps, realize clinical substitution, and make patients affordable, accessible to new drugs and good drugs The pharmaceutical innovation community should strengthen capacity building: on the one hand, there is a significant breakthrough in the efficacy of innovative drugs, and more first in class drugs should be developed; on the other hand, once the patents of foreign original research drugs expire, they should be quickly copied to China, so as to realize the replaceable efficacy of generic drugs, and produce high-quality and cheap public drugs ◆ summer: from "young wind chaser" to "travel in the wind", although there is a chill, the investment community is still immersed in the harvest joy of harvesting the fruits of innovative drugs In September, in an internal salon during the third China Pharmaceutical Innovation and investment conference, early investors were full of bright faces for a group of high-quality biotechnology innovation companies that had been "bottom copied" before 2015 Up to now, more than 30 biomedical innovation enterprises, which have not yet made profits or even have not listed new drugs, are queuing up for IPO on the Hong Kong stock exchange The IPO Carnival also opened a feast of capital gains Tian Yuan, a partner in Yuanming capital management, said that China's experience in the past 40 years shows that the economy is cyclical The Asian financial crisis in 1997, the global financial crisis in 2008 and 2018 will be another obstacle In the period of economic downturn, the biomedical sector, which is not synchronized with the economic cycle, is an ideal "haven" Yao Jiangtao, chairman of AVIC trust, a giant outside the industry with assets of 400 billion yuan, said frankly that most trust companies invest in traditional businesses and only participate in the real estate industry forum In the post industrial era, if we still pay attention to traditional industries (industry, real estate), but do not pay attention to biomedicine, we will not keep up with the times Therefore, AVIC trust should be arranged in advance Fresh blood is still pouring in Hu Zhengguo, CO CEO of Wuxi apptec, the largest research and development outsourcing (CRO) Company in China, said that in the first half of this year, the company added 811 new customers, many of which have never heard of their names and are new biotech companies Not long ago, Liang Yi changed from vice president of AstraZeneca China and head of cancer business department to zaiding pharmaceutical, serving as chief business officer and President of Greater China He also lamented that after his job hopping, he found that in addition to traditional enterprises and transnational pharmaceutical enterprises, there is a group of enterprises in China with the latest concept of biotechnology institutions Health point found that these biotechnological institutions can be further divided into two categories: one is the pharmaceutical research institutes and enterprises established by key universities and scientific research institutes Assuming that the new drug products are listed in the national "863" and "973" plans, with originality and perfect intellectual property (IP), it will have stable return expectations for the investment institutions One investor joked that such projects, even if they have money, are better off not relying on relationships