To "fake" and "true", how to break the situation with innovative drugs

With the acceleration of drug review and approval and the in-depth promotion of medical insurance reform, domestic innovative drugs have entered a dividend period. According to relevant data, in 2020, the Drug Review Center accepted a total of 1,062 applications for the registration of 1 innovative drugs, an increase of 51.71% year-on-year; and the number of approved innovative drugs in the first half of this year has approached the level of last year.

The continuous outbreak of innovative drugs, accompanied by the serious homogenization of innovative drugs, overcapacity, and crowded tracks, some popular targets, and even 100 pharmaceutical companies are studying, resulting in a serious waste of pharmaceutical research and development resources. Looking at today's pharmaceutical industry, the "inner volume" of innovative drugs has been hit on the public screen.

Under the bubble of the "inner volume" of innovative drugs, the dispute over the "authenticity" of innovative drugs has gradually surfaced.

The crisis under the bubble of "pseudo" innovative drugs

In recent years, the development of China's innovative drugs has indeed made great achievements, promoting China's generic drug powers to take a big step towards innovative drugs, but at the same time, we must acknowledge a reality: China's innovative drugs are intensifying, and the phenomenon of capital accumulation, target duplication, and overcapacity is slowly engulfing the benign ecosystem of innovative drugs.

1. The hot targets are too concentrated, and the drug innovation is seriously "inner volume" self-consumption

Making innovative drugs on the basis of existing scientific theories is the most cost-effective choice, so few pharmaceutical companies are willing to spend years looking for new and effective drug molecules.

According to data from all parties, the concentration of domestic innovative drug projects in terms of targets and indications is high, and the clinical projects represented by PD-1/PD-L1, CD19, HER2, VEGF/VEGFR and other targets have reached hundreds, and most of them are concentrated in tumor indications. One of the most concentrated research targets is the PD-1 monoclonal antibody.

According to Glonhui statistics, as of September 2020, the number of clinical trials of PD-1 antibodies in China has reached 4400, a threefold increase from two years ago. By the first quarter of 2021, of the 154 PD-1 monoclonal antibodies under development worldwide, 85 products were developed or developed by Chinese companies, accounting for 55%. At present, there are more than 100 enterprises in China that are developing PD-1 products, and more than 50 PD-1 models have entered the clinical stage.

And this scene of research and development has appeared in the field of CAR-T and gene therapy. According to KPMG's previous statistics, the number of clinical trials of CAR-T cell therapy in China has reached 335 in 2020, a tenfold increase in 5 years. Among them, CAR-T clinical trials targeting CD19 accounted for more than 40%. In addition, according to Clinical Trials, the number of clinical trials of CAR-T treatments worldwide exceeds 600, more than half of which are from China.

These so-called innovations are essentially just "pseudo-innovations" for "tracking innovations" of known foreign targets, which not only waste resources, but also miss the opportunities given by the times to the development of the pharmaceutical industry, which is a serious "inner volume" self-consumption behavior.

Industry insiders not only question: when will the "civil war" of domestic innovative drugs end?

2. Capital is piled up, and innovative pharmaceutical companies usher in a wave of "breaking"

In addition to the clustering of targets, there has also been a huge bubble in pharmaceutical investment. Since the beginning of this year, there has been a "breaking tide" in hong Kong stocks and A-share pharmaceutical companies. Especially in December, the IPOs of innovative pharmaceutical companies frequently "broke".

On December 10, Kai Laiying, Beihai Kangcheng, Di Zhe Pharmaceutical (688192. SH) three pharmaceutical companies landed on the capital market for IPOs on the same day, but these three pharmaceutical companies broke through at the opening of the market. Subsequently, on December 15, BeiGene successfully landed on the Science and Technology Innovation Board and became a biomedical company that opened the "U.S. stock + H share + A share" three-place listing model, but the BeiGene IPO did not usher in a red start on the day but broke.

Previously, the Health Bureau counted that in the three years since the implementation of the New Deal for Hong Kong stocks, among the more than 30 pharmaceutical companies that have not been successfully listed for profit, 26 pharmaceutical companies are in a state of "breaking".

A large number of innovative pharmaceutical companies are listed in a concentrated manner, which makes the capital market doubt the pharmaceutical market, resulting in the pharmaceutical stock price always going up, and there are a large number of bubbles in the industry, which is the superficial reason for the frequent bursting of innovative pharmaceutical companies. The deep reason lies in the "blindness" of capital to innovative drug investment.

Many domestic investment institutions, because of their lack of understanding of the innovative drug profession, only through a few doctors or expert teams to circle a few popular targets, they began to invest. This kind of rapid investment in innovative drugs has led to a large influx of capital into several hot targets, competition has become fierce, and gradually, the blue ocean has become a "blood sea".

There are also some investments, in order to achieve short-term interests, sit and wait for the listing to directly cash out "leaving", this kind of only care for immediate interests and do not plan for long-term development, will overdraft the development of innovative industries, to the original unstable foundation of the innovation ecology fatal blow.

3. Low-level replication, serious homogenization

According to industry insiders, if you look deeply, many of the innovative drugs currently listed in China that are even under research are me too innovative drugs, with the same target, basically the same indications and efficacy, but the structure is different. The focus of new drug research and development is not to discover new effective drug molecules, but to focus on the study of drugs that have been listed, trying to modify the molecular structure, so that without reducing the efficacy, effectively circumvent patent restrictions, so that other people's innovative drugs can become their own innovative drugs.

This low-level replication innovation has led to serious homogenization of pharmaceutical innovation and overcapacity, which has seriously caused the waste of pharmaceutical research and development resources.

"True" innovation broke the game

The "pseudo" innovation of medicine has brought about a "crisis" gradually emerging, and more and more pharmaceutical people have begun to think about the correct direction of future innovation in the pharmaceutical industry.

At the national level, a series of actions have also opened a gap in the "real" innovation situation of domestic innovative drugs.

In July this year, the Drug Review and Approval Center (CDE) of the State Food and Drug Administration issued the "Notice on Publicly Soliciting Opinions on the Guiding Principles for the Clinical Research and Development of Anti-tumor Drugs Oriented to Clinical Value" (hereinafter referred to as the "Notice").

The Notice points out: "New drug research and development should be the highest goal to provide patients with better treatment options, when selecting non-optimal treatment as a control, even if the clinical trial reaches the preset research objectives, it cannot mean that the trial drug can meet the actual needs of patients in the clinic, or cannot prove the value of the drug to patients." ”

The notice pointed out that the domestic innovative drug targets are piled up, the proliferation of "Me-too" (similar to innovative drugs), low-level repetition, lack of real innovation and other issues, requiring pharmaceutical companies to develop new drugs "with patient needs as the core and clinical value as the guide".

With the country's crackdown on ineffective innovative drugs, the space for "pseudo" innovation is getting smaller and smaller, and the homogenized "pseudo" innovative drugs will gradually lose their competitiveness, while the development space given to truly innovative pharmaceutical companies is increasing, which plays an important role in the benign development of the domestic innovative drug competition pattern.

On the other hand, many small and medium-sized domestic pharmaceutical companies have jumped out of the "cage" of "pseudo" innovation and hit hard towards the situation of "real" innovation.

On December 15 this year, people's daily in the 15th page of the position, with the title of "Rongchang Biology - Continuous Increase in Investment and Focus on Innovative Drugs", reported on the experience and practice of Rongchang Biopharmaceutical (Yantai) Co., Ltd. in devoting itself to original and leading scientific research and creating a number of original biological new drugs with great clinical value.

The report pointed out that since 2008, Rongchang Bio has aimed at the field of major diseases, focused on the research and development of new drugs in the spirit of ten years of grinding a sword, and created a number of new drugs with major clinical value.

This report once again shows the importance that the state attaches to the original innovative drugs, the affirmation and encouragement of new drugs with great clinical value, and also illustrates from the side that only real innovative drugs are the right direction for national support and enterprise development.

In September 2021, Shimai Pharmaceutical won the championship of the 2021 "Maker China" Zhejiang Division and the "Zhejiang Good Project" Small and Medium-sized Enterprise Innovation and Entrepreneurship Competition, and the company has developed more than 20 single/double source innovative products at different stages by virtue of the three most globally competitive core technology platforms independently established by the company.

This year, the company's newly developed innovative drug SMET12 was clinically approved. This is a dual antibody drug that can target high tumor antigens and effector cells at the same time, a globally competitive dual antibody drug, which is used for the treatment of advanced gastrointestinal malignant tumors, lung cancer and other diseases, becoming the first in the world.

For pharmaceutical innovation, we must understand one reality:

Innovative drug research and development is a race against time, from academic research to enterprise research and development, until the final listing, to experience at least 10 years of time, less than 1 billion investment, if you can run in the front, the return will naturally be very rich, but if the first echelon has eaten the dividend almost, the back of the enterprise to do research and development, is undoubtedly to eat "leftovers residue", not only can not make money, but also will have no return.

How to accelerate the pace of post-market commercialization of innovative drugs is also an urgent problem for innovative pharmaceutical companies to solve. Mace Medical is the first batch of medical and commercial digital innovation enterprises in the industry, providing professional services for the doctor group, the awareness rate of the Chinese doctor group is as high as more than 80%, and most innovative pharmaceutical companies in China have cooperated to help innovative drugs accelerate to patients through digital tools.

Therefore, in today's situation of "inner volume" of innovative drugs, the high-quality development of innovative drugs is the key to breaking the situation. Pharmaceutical companies should learn to precipitate, accumulate thick and thin, and develop new drugs from the starting point of truly benefiting clinical value and meeting the treatment needs of patients, from homogenization to differentiation, from following innovation to source innovation; instead of being a "slave" of capital, becoming a victim under the capital bubble.

Resources:

1. Pharmaceutical Investment Tribe: "The New Deal Is Coming!" "me-too" drugs may usher in a life-and-death test! 》；

2. E Pharmaceutical Wisdom Research: "Innovative Pharmaceutical Enterprise Inner Volume?" There are several that do "real" innovations;

3. Jianzhi Bureau: "Innovative Pharmaceutical Companies "Breaking" Spell, Which Will Continue Next Year";

4. Ruixin Consulting: "How can pharmaceutical companies solve the strategic dilemma?" 》；

5. Medicine Cube: "China's Innovative Drugs: Why It Got Here, Where It Went".

6. Pharmaceutical Network: "The IPOs of domestic innovative pharmaceutical companies frequently "break"! 》；

7. E drug manager: "Biopharmaceutical serious "inner volume"! Hot targets are too piling up! Why does China talk about innovation second if it doesn't solve these problems? 》。