pharmaceutical companies: from "treatment" to "prevention"

At present, various medical insurance fee control policies are encouraging pharmaceutical enterprises to transform to innovation. Looking back on 2021, the Government Work Report pointed out that more drugs and high-value consumables should be brought into VBP. The Clinical Value-oriented Guidelines for Clinical Development of Antitumor Drugs encourage enterprises to change product development from Me too to FIC. A total of 67 drugs in the national health insurance catalogue were successfully negotiated, with an average price drop of 62%, including 8 monoclonal antibody drugs, 7 orphan drugs. Under the dual effects of downward price pressure and demand for innovative drugs, enterprises are faced with the situation that only innovation can achieve sustainable development.

2022,"Government Work Report" pointed out: "It is necessary to improve technological innovation capabilities, increase enterprise innovation incentives, and enhance the core competitiveness of the manufacturing industry", this includes: "implementing the ten-year plan for basic research, implementing the three-year plan for the reform of the science and technology system, promoting international scientific and technological cooperation, implementing tax incentives for enterprises to invest in basic research, promoting enterprises to increase R & D investment, and focusing on cultivating" specialized and special new "Enterprises, launch a number of industrial infrastructure reconstruction projects, and promote the upgrading of traditional industries".

at the same time,The basic principles of the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" also emphasize the "adherence to innovation and leadership", in the key content, it is also proposed to "promote enterprises to increase investment and develop innovative products around unmet clinical needs.support enterprises based on local resources and advantages, facing the global market, focusing on new targets, new mechanism drugs to carry out research and development layout, and actively lead innovation ".

pointed out in detail the key development areas of chemical drugs and biological drugs, including "antisense oligonucleotides, small interfering RNA, protein degradation technology (PROTAC) and other new technology platform drugs" in chemical drugs, and "antibody drugs, vaccines, recombinant protein drugs, and other new targets and new indications" in biological drugs.cell therapy, gene therapy, etc ".

, under such policies and general environment, the continuous emergence of competing products, the accelerated examination speed and the negotiation of medical insurance will prompt the development of Me too drugs to face severe challenges in the next five years. The value of Me too drugs will decline, and FIC or BIC drugs will become the core competitiveness of pharmaceutical enterprises.

mainly includes three stages:

, pharmaceutical companies entered the pharmaceutical field with a large number of Me too drugs, and followed up the targets or mechanisms that have been listed;

, pharmaceutical companies began to gradually establish their own innovation ecosystem. The products are mainly Me better and Me faster, which have more advantages in molecular design and follow up the targets that have not yet been confirmed;

, the products are mainly FIC, which can develop new targets and mechanisms of action and occupy the forefront in the world.

At present, domestic pharmaceutical enterprises are transforming to the second stage, and the product research and development is still dominated by Me too drugs.PharmaCube data show that the number of FIC drugs and Me too drugs in China has increased simultaneously. From 2010 to 2021, the proportion of FIC drugs developed in China has basically stabilized at 20-25%, so the domestic drug innovation research and development mode has not changed significantly. Nevertheless, the number of FIC pharmaceutical companies in China is rising, including emerging biotechnology companies such as Baiji Shenzhou, Cinda Bio, Junshi Bio, etc., as well as companies developing new therapeutic methods (cell therapy, gene therapy) such as Boshengji and Tianyako.

the current domestic innovative drug research and development to small molecules and antibodies-based, emerging therapies gradually heating up.PharmaCube data show that small molecules and antibody drugs accounted for 55% and 22% of the first IND new drugs in the past 10 years, respectively. At the same time, emerging therapies have also started and gradually heated up in China. For example, cell therapy has started to rise since 2017 and once reached IND accounting for 12.4 percent in 2018. In addition, small nucleic acid drugs and gene therapy have started in China, accounting for 0.2 and 0.6 of IND in 2021, respectively, with a total of 22 and 8 in the past 10 years.

Specifically, among chemotherapy drugs, the number of small molecular chemical drugs is absolutely dominant, and emerging therapies such as PROTAC are IND in China for the first time. Among antibody drugs, monoclonal antibody drugs are absolutely dominant, double antibody and ADC drugs show explosive growth, and emerging tertiary/quaternary antibody is IND in China for the first time. In cell therapy, stem cell therapy and TCR-T gradually enter the clinical stage, and the number of CAR-T tends to be stable, and emerging CAR-NK and tumor infiltrating lymphocyte (TIL) therapy for the first time in China IND.

from the drug target point of view, single target aggregation phenomenon is serious. For example, in the new drugs that first applied for IND in 2021, the dual antibody targets are concentrated in PD-1, TGF-β, PDL1, CD47, etc., and the small molecule drug targets are concentrated in KRAS, G12C, etc. Among the new drugs declared for IND for the first time in the past ten years, the number of new drugs related to TOP20 targets has reached 716, accounting for 29%. The homogenization phenomenon is serious. Such hidden problems will bring fierce market for these drugs in the future.

In terms of indications, the development of new drugs is increasingly biased towards diseases such as tumors, immunity, and blood. Autoimmune diseases such as systemic lupus erythematosus and atopic dermatitis have also been hot spots in drug development in the past two years.

apart from that,from "treatment" to "prevention" will become another major innovation trend of domestic pharmaceutical companies."Opinions of the State Council on Implementing Healthy China Actions" and the major decisions and deployments made by the 19th National Congress of the Communist Party of China to implement the Healthy China Strategy both emphasize that prevention is the most economical and effective health strategy. It can be seen that the adjustment of my country's health strategy will pay more attention to prevention, and it is foreseeable that there will be more policies and funding in the field of prevention in the future.

, for example, in the field of vaccines: after the outbreak of the new crown epidemic, the public's overall awareness of vaccines has increased, which has also stimulated the overall growth of the demand for non-immune planning vaccination, such as HPV, 23-valent pneumonia, influenza, herpes zoster vaccine, etc. have become products with greater demand for vaccination, and the market prospects for non-immune planning vaccines have been further enlarged.

In terms of disease diagnosis: for example, cancer early screening, most enterprises are in the early stage of technology development, and some enterprises in the front end have initially started commercialization, such as Changweiqing, Leithning, HCCScreen, etc. On the whole, several early screening products with faster progress have entered the preparation stage of product listing one after another, and it is expected that the next 3-5 years will usher in a period of performance explosion.

Although most of the new drugs in China are still Me too drugs, the development of Me better or Me faster drugs has become the general trend. In addition to traditional treatment methods, new treatment fields such as cell therapy and gene therapy have also started, and "disease prevention" has gradually become a new focus in the medical field. For domestic pharmaceutical companies, rational analysis of their own advantages, choose the right product track is the most important. For companies that are strong and interested in expanding their business in emerging therapeutic areas, they need to accelerate their research and development progress and seize market opportunities.