Affected by the frustration of domestic PD-1 products at sea, the market value of Chinese innovative drug enterprises has fallen sharply since the beginning of the year, and some investors even said that the pharmaceutical industry is “bad”.
On February 21, song Ruilin, executive president of China Meheco Group Co.Ltd(600056) innovation promotion association, told the media including the daily economic news that this means that Chinese pharmaceutical enterprises go international, including many uncertain factors in addition to the known technical quality. In the future, when going international, the Chinese market should play a greater role in the development of Chinese innovative pharmaceutical enterprises.
In addition, song Ruilin said that there is no need to simply blame the capital for the sharp decline in the market value of innovative drug enterprises. The market should realize that the national innovation support policy is the basis of the industrial spring. In the future, the national “innovation driven” strategy needs to be broken down into all links step by step. Each department should reflect on the role of policies on innovation and take the initiative to reform. As long as the pharmaceutical innovation market continues to improve, the capital that should come back will come back.
domestic PD-1 is frustrated at sea, and the innovative drug returns to cold in spring
On February 11, Cinda Biology (01801. HK) disclosed that its PD-1 drug was frustrated when it went to sea. The U.S. Food and Drug Administration (FDA) tumor drug advisory committee (ODAC) requires Cinda biology to supplement additional clinical trials to eliminate the two shortcomings of the current product “no international multi center clinical research and no head-to-head trial”.
This inevitably surprised pharmaceutical companies and their investors.
Two years ago, pazdur, director of the FDA cancer Excellence Center, visited China and publicly supported Chinese companies to bring low-cost PD-1 / L1 inhibitors into the U.S. market based on Chinese clinical trial data. Two years later, pazdur publicly issued a document emphasizing the view that there are problems in the listing application using single national clinical data, which is contrary to the remarks made two years ago.
Song Ruilin believes that the change of FDA’s attitude towards Chinese innovative pharmaceutical enterprises going to sea is the key point to touch the industry, which means that in the future, in addition to the known technical quality, Chinese pharmaceutical enterprises will also include many uncertain factors. However, the core and essence of pharmaceutical innovation are clearer, that is, to solve the unmet clinical needs guided by clinical value.
At present, there are six PD-1 products approved for listing in the United States, of which five have been approved for non-small cell lung cancer, which is also the indication of Xinda biology’s application this time. When the market is not eager to obtain the declared products to meet its unmet needs, the means that can be taken is usually to improve the standards. Therefore, Cinda’s declaration is not at fault, but the FDA’s review strategy has changed.
“The United States is not in a hurry to need PD-1, so clinical value orientation is very important in the sea strategy.” Song Ruilin believes that Xinda biological PD-1 is frustrated when it goes to sea, which can not be simply interpreted as that Chinese innovative drugs kick the iron sector when they go to sea. The key is to judge whether the drugs go to sea can fill the unmet local clinical needs.
If the enterprise drug is not unique to the overseas market, the enterprise must be fully prepared to face the changing review requirements, including the “head-to-head test” with the world’s best therapy as the control group. In fact, this is consistent with the guiding principles for clinical research and development of antitumor drugs guided by clinical value issued by the drug examination center (CDE) of the State Food and Drug Administration last year.
“Some people say (Chinese pharmaceutical enterprises) can’t get out, but I don’t think so. If we can screen out a number of capable enterprises in the future and reach this level, isn’t that to stand out? When everyone can’t get out, the stars we really see are the ones we go out.” Song Ruilin said.
how to deal with “windy days”? Market guidance and hard internal skills
In 2015, the State Council issued the opinions on reforming the review and approval system of drugs and medical devices. The China Meheco Group Co.Ltd(600056) industry entered a golden age of development, and batches of innovative drugs began to emerge. During this period, the financing platform led by the Hong Kong stock exchange was established, and all kinds of capital successively joined in the development of China’s innovative drug industry, which made the industry prosperous.
The failure of domestic PD-1 at sea sounded an alarm in the industry. In the face of the turbulent discussions in the industry, song Ruilin believes that it is better to spend more energy on doing their own things well. For example, China Meheco Group Co.Ltd(600056) innovation can no longer innovate for innovation, but must enter the era of high-quality development. Let the market become a major force leading industry innovation after policy driven and capital empowerment.
“All investments are market behavior, and what we need is return. When a product fails to get the return originally expected by the market after it is listed, the first one is to scare away investors, and the second one is to frustrate the enthusiasm of innovators.”
Therefore, song Ruilin believes that the industrial policy of cultivating pharmaceutical industry clusters should not “just stay at the door of enterprise factories”, but also extend to the market and establish a whole chain drug policy system.
On the one hand, we should encourage drug innovation and make it truly valuable; On the other hand, the Chinese market should be able to leave more space for the landing of high-quality innovative products. For example, medical insurance should pay more attention to whether drugs fill the clinical gap, implement effective substitution, and reflect price support and tolerance for such products. We should give better play to China’s institutional advantages and benefit innovators through strong market guidance ability.
Song Ruilin also pointed out that it is unrealistic to use basic medical insurance to support the expensive innovative cancer therapies such as car-t. the market needs the joint cultivation of social medical insurance, commercial insurance and enterprises.
“Enterprises also need to emancipate their minds. Now some enterprises take the practice of gambling. If patients use the product and have no effect, they will be refunded. I think in this way, some demand will be driven.” Song Ruilin said.
follow-up innovation is still dominant, and policies need to be broken down to all departments for implementation
Since the biological industry has been listed as a national strategic emerging industry, its innovation and development has gone through more than 10 years. While the problems such as insufficient R & D power of enterprises have been improved, there is also a new pain of clustering R & D targets.
According to the annual report on the current situation of clinical trials of new drugs registered in China (2020) issued by the drug examination center (CDE) of the State Food and drug administration, in 2020, the total number of clinical trials of the top ten targets was close to 500, accounting for nearly 20% of the total clinical trials. Nearly 100 clinical trials were carried out with PD-1 monoclonal antibody alone, which was jokingly called “internal volume” in the industry.
In this regard, song Ruilin said that the internal factor is that everyone wants to take the fast lane, which is a short-term behavior, and the industry and investment circles need to reflect. However, this situation also reflects that the industrial policy playing the role of “traffic command light” needs to be improved. Including a series of reforms such as review and approval, medical insurance reimbursement and hospital medication system.
“If an innovative drug already has several varieties with the same target, mechanism and indication listed, does the variety subsequently applied for listing still fill the clinical gap? Can it be included in the accelerated review? Should the medical insurance price the latecomers differently?”
Song Ruilin believes that in addition to making a more detailed distinction between the accelerated review of new drugs, the further improvement of the reimbursement system and the hospital medication system is also worthy of attention. In short, any policy that prevents patients from sharing the achievements of pharmaceutical innovation as soon as possible needs to be changed in the future.
“The rapid development of our pharmaceutical innovation depends on our institutional advantages.” Song Ruilin said that in the initial stage of China Meheco Group Co.Ltd(600056) innovation, we should recognize that basic research is the short board of China Meheco Group Co.Ltd(600056) innovation. Under this background, it is not objective and practical to require rapid leadership of global innovation. China now needs to follow-up innovation and make valuable innovation.
Song Ruilin reminded that from the perspective of the sharp decline in the market value of Chinese innovative drug enterprises, enterprises may face difficulties in the future financing environment, which requires the management departments formulating macro policies to adapt to the situation and adjust policies reasonably.
“We need to think about how China’s innovative enterprises can go global if they can’t grow in the Chinese market. Now we need to decompose the national innovation driven strategy step by step into all links. Each department should reflect on the role of specific policies on innovation and take the initiative to reform.” Song Ruilin said.
