Four major difficulties hinder Chinese pharmaceutical innovation

Recently, Zhuo Yongqing, Executive Director of RDPAC (China Association of Enterprises with Foreign Investment in Drugs Development and Development), Yu Mingde, President of the China Association of Pharmaceutical Enterprise Management, and Yu Weishi, Chairman of Beijing Yuekang Pharmaceutical Group, said that at present, the pharmaceutical market in China 90% are generic drugs, and the market share of innovative drugs is very small. China's pharmaceutical companies do not take the road of innovation, which means that development has stagnated and is always at the end of the industrial chain.

Objectives: Research and development capabilities are close to world-class standards. With regard to innovation goals, Zhuo Yongqing provided a copy of the data: The country hopes to obtain more than 30 new drug product certifications for original medicines under the support of “significant new drug innovation projects” by 2015. More than one generic new drug species, completed the transformation and upgrading of more than 200 pharmaceutical varieties. At the end of the “Twelfth Five-Year Plan” period, China ranks among the top three in the global publishing of biotechnology patents and dissertations, and its annual export growth rate reaches 20%. The investment in R&D of key enterprises has increased from around 1% of current sales revenue to 5% of sales revenue. the above. By 2020, it will strive to achieve industrial R&D capabilities that are close to world-class standards.

Dilemma: There is still a lot of difficulties before we can hope to achieve this goal. Innovation is a key step.

Dilemma 1: Most pharmaceutical companies rely mainly on Mingde in order to produce generic drugs. Innovation falls into two categories: original innovation and reinvention. Reinvention is the achievement of the scientific and technological achievements that humanity has made and it is used by the Chinese people as soon as possible. The role played by the first generic medicine is to take the medicine that has passed the pharmaceutical patent period in foreign countries to China to produce it successfully, and let the Chinese enjoy the benefits of science and technology. This is of course also remarkable. However, only the original innovation can show the peak level of the development of pharmaceutical companies to compete with multinational companies. “We now have a big gap between original innovation, and innovation is the strength of Chinese companies. That is, if you have, I have taken a look, or I learned a bit and I can do it.”

However, the actual situation is that the threshold of quality standards for the small molecule chemical and pharmaceutical industry is set too low, resulting in thousands of companies in China currently engaged in the production of chemical generic drugs. In the case of excess capacity, many companies have launched price wars, and some of them have sacrificed quality to reduce costs in order to win. If these pharmaceutical companies can meet the standards of China's pharmaceutical production quality management standards, but do not meet the international standards, these companies will not have the motivation to meet international standards, they can not enter the international market.

Dilemma 2: The patient's waiting time for the new drug is too long. Ming De pointed out that at present, it takes about 20 months for the new drug to apply for the pre-clinical record or request approval process, but it takes only a little more than a month in foreign countries. This obviously shows the efficiency. The difference. The number of applications for approval and the number of approval personnel are few. In some cases, it takes three to four years to line up. In addition, many medicines need to enter the medical insurance area two years later or even three years later, affecting the timeliness of patients' medication.

Let's take the pharmaceutical industry's innovative drug icotinib hydrochloride as an example. The R&D project was launched in 2002. It went through preclinical, animal experiments and clinical studies. It was completed in 2010 and officially launched in 2011. There are 10 years before and after. After the listing, they encountered difficulties in sales and it was difficult to enter the hospital. Because new medicines are introduced into hospitals through tenders and biddings, each province is actually different, and the cycle is very long. Now that ecritinib has been listed for more than a year and a half, Zhejiang has only five or six provinces through bidding, and most provinces It has not yet passed the bidding and can not be sold yet, which is very unfavorable for a prescription drug.

Difficulties 3: The price upside down affects the safety of drugs. It is a good policy to use drugs with good curative effect, small side effects, and reasonable prices for ordinary people. However, in the implementation process, pharmaceutical companies also have taboos, but also want to base drugs, afraid of the base drugs. Because the current bidding process of medicines leads to the price inversion of some medicines after they enter the base medicine, the company has no profit, or the price is too low, and the interests of basic medical units cannot be guaranteed, and eventually the hospital is unwilling to use the medicine.

The state still needs further improvement in the drug bidding system. Once the drugs are included in the base drug, they should be based on the market conditions, to do a basic price budget, and will not carry out low-price bidding. In this way, after purchasing medicines, the emphasis is on the quality of medicines, the integrity and scale of enterprises, and ensuring that patients eat quality-assured safe medicines, not just cheap drugs.

Difficulties 4: The risk of developing new drugs is greater than VST's belief that innovation is risky, but it is different from gambling. Innovation must be based on a scientific basis, but due to the many uncertainties in the development of new drugs, there may be unexpected situations in each link. This risk requires medical companies to bear. In the path of innovation, we must be fine-tuned and we must not be fortunate. “For example, our country’s policies are constantly changing and we are constantly improving. In the R&D process, we must keep up with the situation in the country, and even have to do something in front of it so that we don’t go into production after we put it into production. I think this It is a strategy that every new drug comes out without more than ten years is impossible.The process of these ten years is very arduous, and it is necessary to invest manpower, material resources, and energy. In the end, it is not possible to have clinical treatment in Phase III. some."

Methods: In-depth solution to problems at all levels to enhance the research and innovation capabilities of Chinese pharmaceutical companies, three experts gave three suggestions.

First, build a regulatory system and provide policy support. Zhuo Yongqing suggested that China could consider adjusting regulatory regulations appropriately, strengthening consistency with global regulatory paradigms, and strengthening clinical support facilities to lay a good foundation for local companies to enter the international market. Shorten the time for the application of clinical trials (CTA). Let go of imported new drugs to carry out a phase 1 clinical trial control in China. With reference to the rigorous standards of the International Regulatory Association for Human Use Registration (ICH), the supervisory process and requirements are unified. Established a system of market licensors for drug approval. Improve drug evaluation and approval processes, improve quality standards and regulatory norms.

Yu Mingde believes that the development of innovative drugs is difficult and the state should give policy support. These policies include medical insurance, advanced medicine, etc. The state should give lenient policies. R&D should be used immediately, or it should not be limited, so that companies can taste the sweetness of returns and increase the enthusiasm of corporate innovation. Improve approval efficiency. At present, it takes about 20 months for new drugs to be filed before the application for clinical record or request for approval, and it takes only a little more than 1 month for foreign drugs. This obviously shows the difference in efficiency. This is less than the total number of people in our country who are responsible for the specific approval work. The government can increase the manpower for approval or delegate power to the provinces. Both ways can increase the efficiency of the examination and approval.

In addition, there is a gap between the health insurance system and the system that supports innovation, and they should be linked together. The reason why the state cannot immediately allow innovative drugs to enter health insurance is because of insufficient financial resources. Therefore, we must consider not only the financial burden of the country, but also the consideration of supporting enterprise innovation. We may wish to introduce a proportional payment policy. Support innovative medicines into health insurance, basic medicines, and new rural cooperative medicine, and then reduce the proportion of payments according to the size of financial resources. For example, 75% of other generic medicines may be reimbursed, and new medicines may be 60%, 50%, or even 30%, and they adopt the attitude of supporting innovative medicines into health insurance.

Second, formulating incentive mechanisms and reasonably rewarding innovative innovations require incentives to encourage them. Zhuo Yongqing believes that it is possible to ensure the sustainability of R&D activities through effective measures such as pricing, market access, and tax incentives. Encourage innovation through rapid market access to help patients benefit from new drugs as soon as possible. Reward innovation through reasonable pricing and ensure that patients receive quality and safe medicines. Constantly improve GMP standards and increase enforcement efforts to implement differentiated pricing for first generic and differentiated generics, such as maintaining a 30% spread.

In response to this, Yu Mingde also discussed his own view: Rewards also require financial support from the government. For example, increase fiscal and tax incentives for innovation activities, strengthen taxation incentives for R&D activities, and encourage private capital to invest in innovative pharmaceutical companies. The financial power of the government is now much stronger. At present, China’s fiscal revenue has reached 11.7 trillion yuan, which is equivalent to more than five times the end of the 1990s. The government has the ability to support corporate innovation. Under these circumstances, what pharmaceutical companies must do is understand the situation, grasp the conditions, and do their own technical work.

Third, improving the intellectual property environment, protecting innovation and protecting intellectual property rights is a respect for innovation. First of all, to reduce the ambiguity of the definition of new drugs. Better integrate the regulatory approval process of innovative drugs with the patent management system, strengthen the patented networking system, and avoid or reduce time-consuming and labor-intensive legal disputes. Second, we must follow the international intellectual property protection practices, maintain and strengthen the protection mechanism for pharmaceutical intellectual property, and ensure that the intellectual property rights of biomedical products are fully protected. For those who infringe on intellectual property rights, they should be held responsible and given corresponding punishment. Third, strengthen cooperation among industry, universities, and scientific research institutions, accelerate the pace of industrialization, and increase research and development capabilities. Broaden the channels of international cooperation and promote the establishment of strategic partnerships between local companies and multinational corporations to jointly develop new products and enter the global market.

At the same time, innovation can not do without talent, we must strengthen the attraction and training of talents, strengthen the introduction of overseas talents, and encourage the development of industrial professional training. In the past, the low level of innovation of enterprises was related to their poor ability. In the absence of survivability, generic drugs do not pass the standards, not to mention innovation. Now that there is a technical foundation as well as a material basis, there are a large number of first-rate talents sent to foreign countries in the process of reform and opening up. Now that they are back, they can provide enormous technical and intellectual support for the innovation of pharmaceutical companies in China.