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    Home > Active Ingredient News > Drugs Articles > Killing Me-too companies, Chinese medicine is heading for nirvana and rebirth!

    Killing Me-too companies, Chinese medicine is heading for nirvana and rebirth!

    • Last Update: 2021-08-09
    • Source: Internet
    • Author: User
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    On July 2, 2021, an ordinary Friday evening, people who have been deeply involved in the pharmaceutical industry have become accustomed to the "see you on Friday" of the supervisory authority, but the string has been tight


    On that day, CDE issued a notice regarding the public solicitation of the "Guidelines for Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development" (hereinafter referred to as the "Opinions").


    However, the capital market has already heard the news


    "Because of the big waves scouring the sand, a strong decline will wipe out those companies that specialize in generic drugs and Me-too


    However, an expert who once served on the National New Drug Advisory Committee believes that the document itself has no new meaning.


    Previously, a scientist in the industry who focused on source innovation said in an exclusive interview with an E-pharmaceutical manager: The root cause of homogenization is that only 1% of domestic investment institutions are truly capable and willing to invest in true source innovation.


    In fact, the CDE "Opinions" published by itself is more meaningful than the "multiple eyeballs" of the stock market's rise and fall, which will trigger the capital's long-term thinking.


    01 Nirvana rebirth, Hengrui takes the lead to cut CLDN18.


    "In the entire development of Chinese biomedicine, everyone thinks that they are Me-better, not Me-too


    "Don't always think about "overtaking in a curve", 99.


    In the highland of biomedical innovation—universities, the situation seems a bit "malformed


    Ding Ke, Dean of the School of Pharmacy of Jinan University, has been committed to the research and development of innovative drugs since he returned to China in 2006, and has now transferred 8 Class 1 new drugs


    Dink has been reflecting


    Facing the difficulties in the transformation of academia, what is the situation of the park? The director of a domestic biomedical park said, "In general, there has been some improvement, but the probability is still relatively poor


    The above situation has been hidden deep in the industry


    In the previous article, the scientist doing source innovation gave an example of his own personal experience to the E-pharmaceutical manager.


    "A few years ago, we found that China's new drug creation is on an improper path.
    Everyone is making imitations
    .
    So we communicated with the drug regulatory department.
    The government should take a higher perspective and make top-level design.
    Formulate some regulations or guiding principles
    .
    " Li Jin said
    .

    What this stock market crash reflects is exactly the change in investors' thinking and ideas on new drug creation after the country’s recent guidelines were promulgated
    .
    This change may be a rebirth of Nirvana, a necessary process for China's biopharmaceuticals from imitation to creation to innovation
    .

    At the same time, the introduction of this policy is also to prevent bad capital, CRO and pharmaceutical companies from jointly digging the "wall foot" of "2030 Healthy China"
    .
    Only by letting the pharmaceutical industry embark on a healthy development path can the ideal of "2030 a healthy China" be realized as soon as possible.
    Therefore, the China Food and Drug Administration has made a heavy strike this time, and will make a move when it is time to make a move
    .

    Li Jin pointed out that there are 87 companies engaged in PD-1 and PD-L1 monoclonal antibodies, and nearly 180 claim that they have PD-1 and PD-L1.
    In this case, some policies must be introduced to correct them.

    .

    In Li Jin’s view, the situation faced by PD-1 and PD-L1 has become a common phenomenon in the industry.
    "In addition to PD-1/PD-L1, there is also Claudin 18.
    2.
    There are not many patients with gastric cancer and pancreatic cancer.

    .
    But there are nearly 18 companies that are under development, have been approved, and are preparing to declare
    .
    There are many more similar targets squeezed on the same track.
    If dozens of products are competing at the same time, it will be beaten.
    Bloody, is this valuable?" The company seems to be aware of the problem Li Jin said.
    When Hengrui Medicine celebrated its 50th anniversary two or three weeks ago, it had already terminated Claudin 18.
    2
    .

    He pointed out that FGFR, TIGIT, CD19 and even a variety of double antibodies have become targets for pharmaceutical companies to get together.
    From the overall data point of view, a total of 458 anti-tumor clinical studies in 2020 have 77% originals, compared with 2014 A year ago, the bioequivalence studies of generic drugs have been greatly improved
    .
    However, most of them are still modified dosage forms, and some are only modified by the structure and the efficacy is not improved.
    Most of the old targets are concentrated, so "77% of the originals are originals with quotation marks
    .
    "

    02 How does China's new drug creation go?

    If there is no core competitiveness, where will China's new drug creation go?

    First, the government must have a top-level design for risk prevention.
    The new policy issued by the CDE this time reduces the risk of the biopharmaceutical industry and proposes to focus on clinical benefits and clinical value
    .

    What is the core of clinical value? In Li Jin's opinion, there are actually two:

    One is to do a head-to-head randomized controlled clinical study
    .
    "Who is head-to-head with? Of course, it is compared with the United States.
    If you don't compare with the United States, and compare with Myanmar and Vietnam, it is not really "head-to-head
    .
    " "Head-to-head" drug development should be compared with the current best standard treatment
    .

    Second, one-arm tests should be done reasonably
    .
    "Clinical value-oriented clinical trials once again emphasize that single-arm is only suitable for end-line treatments without standard treatment
    .
    If there is standard treatment, letting patients do single-arm treatment will harm him
    .
    " Li Jin believes that only drugs with outstanding efficacy are used.
    It is suitable for a single arm, and the "outstanding curative effect" is more curative than the current standard treatment
    .
    "If the current standard treatment is 30% effective, then you must be 50%-60%; if the current standard treatment is 50%, then you must be 80%; if the current efficacy is 90%, you must be 100% Or 99.
    9% can be listed, otherwise the chances of listing may be less
    .
    " This undoubtedly puts forward higher requirements for China's new drug creation
    .

    The experts of the Chinese New Drug Advisory Committee stated that the development of new drug research and development must have strict regulatory guidance and scientific and stable review
    .
    "PD-1 Why is China so much, why did not the United States? The key is whether the legislation enforcement
    .
    There are zebra crossing, who went through a red light fined
    .
    "

    Second, companies must be aware of risks
    .

    "A few Chinese companies are dedicated to digging the socialist "walls" to jeopardize the creation of new Chinese medicines
    .
    He has a daughter to marry three husbands, designing five different molecules for one drug and one target and selling them to different manufacturers.
    How can it be possible to create a new drug in China in this way?" Li Jin criticized

    Enterprises should prevent thunderstorms in drug development
    .
    Li Jin believes that companies can introduce products when their R&D capabilities are not strong, but their scientificity, advancement, and feasibility must stand the test, and the most important thing is to have originality
    .
    "The company has to sign the contract when buying it.
    Is this product the only one in the world? If it is the only one, then pay; if it is not the only one, it will be sold to a second company.
    Sorry, this drug is considered a double Double or triple compensation cannot be demanded
    .
    Only in this way can the behavior of one woman marrying two husbands be curbed
    .
    "

    In his view, China's new drug creation has three important factors: funding, innovation and clinical research
    .
    Regarding clinical research, Li Jin particularly pointed out that China's innovative drug companies have limited design capabilities, and clinical design schemes have no bright spots of their own design.
    They are copied and copied, and the phenomenon of active teams in the lack of experienced spiritual bed research is prominent
    .
    "Recently, it was discovered that several products were not approved by CDE because of the poor quality of clinical research
    .
    So everyone must be careful to look for PIs, and they must look for PIs that are serious and responsible
    .
    Maybe this PI may not be particularly famous, but he must be serious and responsible.
    It's very scientific, you can ask him to do it
    .
    Otherwise, the approval will fail, and hundreds of millions of dollars will be lost
    .
    "

    "China is now when it is time to emphasize research.
    Research has two signs.
    I think there is a need for a team instead of one or two people to do it to become a real research.
    This is especially necessary for immunotherapy in the future
    .
    "The academician in the previous article also called on the R&D team to stick to it, and the creation of new drugs requires long-term accumulation
    .

    Speaking of the specific track, Li Jin believes that the current dual-antibody targets are all concentrated in PD-1 and PD-L1.
    It is not a good thing for everyone to squeeze on the same track.
    New joint methods should be found for basic research and clinical trials.
    Before research, do not rush for quick success, and do clinical development after sufficient evidence is shown to prove its effectiveness
    .
    In cell therapy, different targets and methods must be developed, including CAR-NK
    .
    Scientists need to discover more precise target proteins to make CAR-T and CAR-NK
    .
    Without the success of basic research science, there would be no success in the creation of new drugs
    .
    "I hope you will cooperate more with university scientists
    .
    In addition, tumor cells have more than 300 genes related to the occurrence and development of tumors.
    We currently have only a dozen targets.
    Can we develop more targets?"

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