How to make "action guide" for pharmaceutical enterprises and investors?

Author: [guide] although we can grasp the overall situation, we still need to understand the changing medical environment from a more micro level In other words, how to find the action guide that can be followed under the action program has become something that people in the medical circle should think about further The effective date of the new drug administration law of 2019 is near December 1 After the first revision in 2001, the highest legal norms of the pharmaceutical industry issued in 1984 finally ushered in the second systematic and structural major adjustment In a way, through this amendment, we can see the profound changes in China's pharmaceutical industry Under the influence of medical insurance control, the price pressure of drugs has been released rapidly due to the policy norms such as bidding, secondary price negotiation, linkage of the lowest price and volume purchase Taking the recent expansion of purchasing with volume as an example, compared with the lowest purchasing price in 2018 in the alliance region, the proposed mid-term selection price will decrease by an average of 59%; compared with the "4 + 7" pilot mid-term selection price level, the average decrease will be 25% For most pharmaceutical companies, the only way out of the dilemma may be innovation When it comes to innovation, with the continuous promotion of a series of policies, such as MAH, related examination and approval of pharmaceutical excipients for drug packaging materials, priority review, and ectd, the "new force" of China's pharmaceutical industry is more guaranteed The newly revised Drug Administration Law also mentioned that it will optimize the approval process from clinical trials, drug importance and conditional approval, so as to improve the approval efficiency and quality Although it is easy to grasp the overall situation, on the other hand, we still need to understand the changing medical environment from a more micro level In other words, how to find the action guide that can be followed under the action program has become something that people in the medical circle should think about further According to the main body of innovative drug research and development, the current domestic participants are roughly divided into three categories: one is big pharmaceutical company (big) Pharma), such as Hengrui pharmaceutical, dongyangyao, hausen pharmaceutical, Zhengda Tianqing, Fosun Pharmaceutical, Shiyao group and other giants; the second is biotechnology, including Geli pharmaceutical, Baiji Shenzhou, Hualing pharmaceutical, Cinda biology, Junshi biology and other non profitable new drug R & D enterprises landing in Hong Kong stocks; the third is universities and scientific research institutions in China The Institute of medicine, Shanghai Institute of medicine, Shanghai Institute of medical technology, China Pharmaceutical University, Shenyang Pharmaceutical University, Sichuan University, etc It is worth noting that universities and scientific research institutions have no pressure to generate income, and most of the research and development achievements are for publishing papers and concluding reports In terms of R & D mode, they usually cooperate with the first two types of pharmaceutical companies So to some extent, the development of big pharma and biotech can become the wind vane of the market-oriented pharmaceutical industry According to Shi Dongfang, chairman and CEO of new element medicine, thanks to the advantages of volume, big Pharma usually has stable cash flow to support sustained R & D investment, so it also has a large degree of freedom in layout For biotech, the R & D investment is mainly from external financing In order to avoid long-term and high-cost development risks, they mostly adopt cooperative forms such as independent R & D and license in to develop new drugs It's hard to say which is better In fact, the two domestic PD-1 monoclonal antibodies approved for listing in December last year were developed by unprofitable Junshi biology and Xinda biology, nearly half a year earlier than the approval of Hengrui medicine In terms of biological similar drugs, Fosun Pharmaceutical has successfully won the first place in "zero breakthrough" of domestic biological similar drugs by virtue of its innovative drug research and development platform Fuhong Hanlin These are different "genes" under the influence of pharmaceutical companies for their own research and development path choice In addition, pharmaceutical companies also need to carefully consider the specific direction of R & D "A very special situation in our country is that many kinds of treatment drugs for major diseases do not make money Many good projects are" dying of thirst by the Yangtze River " It is clear that there are a large number of patients, but there is no way to measure them." Xiao Fei, investment manager of Ameda, believes that this part is related to the economic level Most of the biotechs that have sprung up in the past two years are in the expensive tumor drug market "If [these new drugs] can't get into the medical insurance, they will also face difficulties in sales." Xiao Fei, investment manager of Ameda, added Li Jing, founder of Yaodu Jingwei, also pointed out that among the different influencing factors such as payment system, medication habits and doctors' cognition, "medical insurance is the key to new antibody drugs" Therefore, before the new drug is approved, pharmaceutical enterprises should weigh the advantages and disadvantages of different links of new drugs, such as production cost and price, market pattern when the products are on the market, research and development cycle, clinical focus, etc., so as to avoid falling into the black hole of profitability "In terms of targets and indications, most of the monoclonal antibodies in China are relatively clustered at present Under the premise of a certain number of patients, this market segment will soon have a red sea of competition " Li Jing broke a basin of cold water for the hot PD-1 recently, "there is no chance to do PD-1 now, unless you choose some areas with less clustering." In April last year, the most significant reform of the listing mechanism in Hong Kong market in nearly 25 years was implemented, and biotechnology companies that have not yet made profits or gains were allowed to go to Hong Kong for listing Soon, A-share market also started to support IPO Financing of unprofitable Biopharmaceutical Enterprises To some extent, the science and technology innovation board officially opened in July this year is a highlight of this change It is obvious to all that, driven by the policy, the domestic capital market is accelerating to embrace a batch of emerging innovative pharmaceutical enterprises In an exclusive interview with yiou health, Lu Xianping, chairman of microchip biology, once said that new drug R & D not only needs the support of capital, but also requires a good "relay" of capital between different stages of R & D, and a diversified financing path, which is bound to provide a strong guarantee for the iteration of the domestic pharmaceutical industry However, some insiders are worried that the field of new drugs is mostly a "false fire" at this stage After the tuyere, it is bound to leave behind a lot of innovative losers "The homogenization of domestic new drug me too is very serious, there is no 'differentiated value', and the only way to end is to compete for price; on the other hand, after the research and development of domestic innovative drugs is too late, with the accelerated entry of similar competitive products into China, those pharmaceutical enterprises that lack core competitiveness and cannot win at the same time will face more severe competition." So said Shi Dongfang Therefore, for the capital side, how to "laugh to the end" innovative drug project under the dividend of industrial change will be the key to obtain returns in this field Xiao Fei also pointed out that "small innovations" such as me too and me better aimed at optimizing the design of individual targets will not only be easy to "crash" with peers, but also face increasing price pressure under the continuous promotion of volume procurement "The mechanism of biological action is the same when the target is the same Most of the me better strategies change the drug treatment window, but the improvement of these factors can only improve the orr (objective remission rate) at most, and there is no correlation between the approved clinical end point OS (total survival) and PFS (survival time without progression)." Chen Feng, a partner of preferred capital, said that tumor heterogeneity, tumor evolution and drug resistance mechanism are still under constant research In the face of a constantly changing and evolving disease enemy, it is difficult for me better's strategy to achieve significant differences in tumor However, in the field of non-tumor me better strategy is worthy of our efforts In short, an insightful investor needs to see the unmet demand depressions in the current and future drug markets "What is the real unmet medical need? Is it an incurable disease, a rare disease, or an urgent disease? On the other hand, is it a real unmet need for long-term and safe chronic disease drugs? All of these should be considered as the premise of differentiated investment strategy " Chen Feng added.