Industry: The "bubble" of innovative drugs will burst, and a large number of Biotech companies may disappear!

[Pharmaceutical Network Market Analysis] In recent years, with the continuous introduction of domestic policies to support pharmaceutical innovation, China's innovative drug industry has ushered in rapid development, the number of domestic new drug listing applications has continued to increase, and the overall CAGR (compound annual growth rate) from 2019 to 2021 ) up to 47%, and domestic drugs will account for 76% in 2021, a change from the past trend of "half of the country" dominated by imported drug varieties
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At the same time, funds are also optimistic about the development of domestic innovative drugs, and continue to increase their investment in this field
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The data shows that the financing amount of innovative drugs in the primary market in 2021 has exceeded 100 billion yuan, and investors favor ADC technology, cell therapy, gene therapy, and solid tumor immune cell therapy
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Industry: The "bubble" of innovative drugs will burst, and a large number of Biotech companies may disappear! (Photo source: Pharmaceutical Network) It should be noted that China's innovative drug industry started late, and most pharmaceutical companies are in the stage of replicating foreign ready-made technologies or introducing foreign late-stage clinical products, lacking hard-core technological innovation
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For innovative drug companies, although the introduction of domestic late-stage clinical products is a shortcut, there are also many cases where the products failed for various reasons after entering the clinic, resulting in the empty basket of water
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And even if the clinical trial of the product is successful, the later commercialization is also a big challenge
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Taking the hot research and development of PD-1 drugs as an example, some pharmaceutical companies have already terminated the development of PD-1 mAbs because of the fierce competition on the track, thus losing market opportunities, and this is also the dilemma faced by most domestic PD-1 latecomers.

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 　　In terms of policies, pharmaceutical companies are also encouraging real innovation, rather than "pseudo-innovation"
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For example, on July 2, 2021, the Center for Drug Evaluation issued a notice for soliciting opinions on the "Guidelines for Clinical Research and Development of Anticancer Drugs Oriented to Clinical Values", pointing out the chaos of anticancer drug innovation and emphasizing the research and development of anticancer drugs.
Starting from the establishment of the topic, seeking "newness", and constantly paying attention to the dynamic changes in treatment needs, improving drug safety and treatment experience; in the clinical trial stage, the trial design requires "subject safety", etc.
After this principle was released, The industry generally believes that the difficulty of innovative drugs passing through clinical trials has been greatly increased, which will play a role in eliminating "pseudo-innovation" to a certain extent; Review Work Procedures (for Trial Implementation)" (Draft for Comments), clarifies that the approval process for innovative drugs is accelerated, the scope of applicable drug varieties is innovative drugs included in the breakthrough therapy drug program, and the time limit for communication and exchange is 30 days, and the time limit for variety review The time limit for the same priority review varieties is 130 days
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This policy will help shorten the time to market for innovative drugs and benefit those pharmaceutical companies that are truly innovative, but at the same time, the quality requirements for drugs will be greatly improved
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 　　Some analysts pointed out that under the impetus of the above-mentioned new policies and regulations, the "bubble" of innovative drugs will burst.
In the future, only those products with true innovation, true efficacy, safety, and better varieties than existing standard treatments or on the market will be available.
It is possible to pass the clinical trial standards and enjoy the green channel
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This also means that the pattern of innovative drugs in China will change in the future, and "innovation" may appear in three, six, nine and so on, and a large number of Biotech companies may disappear by then
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 　　So, which Biotech companies can survive the cold winter? From the perspective of the industry, the pharmaceutical industry is a high-investment industry, so the financial strength of the company is very important
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It is only possible to see the way forward if there are sufficient funds - at least to support R&D expenditures for at least 2 years
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Relatively speaking, the strong are always strong.
Compared with small and medium-sized pharmaceutical companies, the leading innovative pharmaceutical companies are more forthright in terms of R&D investment, and their hematopoietic capabilities are also relatively strong
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In the context of industry chaos and shuffling, small and medium-sized pharmaceutical companies can also adopt the method of holding a group to warm up to integrate or be acquired at a low price
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 　　Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
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