21st Century Business Herald's Zhao Na reports from Shanghai

Antibacterial drugs have been widely used in the field of medical and health care, and play an important role in the treatment of infectious diseases, saving patients' lives and ensuring public health safety.

However, in recent years, the global development of antimicrobial drugs is in a dilemma: first, bacterial resistance appears faster, and second, the reserve of new antibacterial drugs is insufficient and the research and development motivation is insufficient.

"At present, WHO has listed the problem of bacterial resistance as one of the top ten global health threats to human beings, and the contradiction between the increasingly serious problem of drug resistance of existing drugs and the lack of new antibacterial drugs is becoming a serious challenge in the field of global anti-infection." But at the same time, there is a shortage of new antibacterial drugs in the world, especially in China, where there are only a handful of antimicrobial drug research and development companies." A venture capital partner who focuses on investment in the field of biomedicine pointed out to reporters.

Due to the increasing threshold of antimicrobial drug research and development with clinical value and differentiation advantages, enterprises with relevant product research and development capabilities are being sought after by venture capital institutions. The 21st Century Economic reporter learned in a recent interview that more and more venture capital institutions have begun to pay attention to the antimicrobial drug research and development track, which to some extent indicates that their investment strategy is quietly "turning".

In the past five years, the vast majority of venture capital institutions prefer new concepts and trends in pure biotechnology, and have rushed into hot tracks such as cell therapy and gene therapy, but whether some of these seemingly disruptive biotechnology technologies have practical application scenarios, and the long cycle between theoretical research and the final market has brought great uncertainty to investment.

Especially with the reduction of the entry threshold of the secondary market, more investment institutions begin to pay more attention to the profitability of biotechnology companies and the commercialization prospects of new drugs. At this time, such as the research and development of antibacterial new drugs has a definite application scenario to solve specific diseases, and has a clear market demand for innovative drug research and development track. Because of the sustainability of its business model and the "certainty" of future profit space, it is becoming a sub-track in the biomedical field that is heating up.

Venture capitalists favor antimicrobial drug research and development

Over the past 60 years, the world has yet to develop a broad spectrum of antibiotics with new mechanisms of action, leading to a growing problem of antimicrobial resistance. According to the WHO, "superbugs" will kill 10 million people by 2050, even more than cancer.

Among them, the average annual growth rate of antimicrobial resistance in China is 22%, much higher than 6% in the United States, and the irrational use of antimicrobial drugs for special groups such as children, pregnant women and the elderly still exists, and there is an urgent need for new antimicrobial drugs, especially for severe patients.

At the same time, the development risk of antibacterial drugs (including antibiotics) is larger and longer than other types of drugs, often taking more than 10 years, resulting in many small and medium-sized biotechnology companies in the research and development of antibacterial new drugs failed to wait for the "new drug", and went bankrupt halfway. From the market side, the most stringent "anti-resistance order" issued in China in 2012 also once cooled the investment heat of antimicrobial drugs. However, in recent years, with the increasing resistance of existing drugs on the market, the urgent need for research and development of next-generation antimicrobial drugs with new mechanisms or new structures is "warming up".

"We've been through all the challenges of the drug discovery process." Ma Zhenkun, founder and executive president of Danuo Medicine, told the 21st Century Business Herald. As a representative enterprise in the field of small molecule new drug research and development in the field of bacterial infection and metabolic related diseases in China, Danuo Pharmaceutical is no stranger to the situation that the progress of new drug research and development is not smooth.

Fortunately, with the original multi-target coupling molecular technology platform, Danopiate can eventually not only make the new compounds have high drug resistance, but also form obvious advantages in efficacy and resistance. Ma Zhenkun told reporters that Danuo Medicine has paid great attention to the use of differentiated technology to solve the worldwide problem of "anti-infection" in the field of medicine from the beginning. At present, through exclusive multi-target coupling technology, it has developed a number of products around Helicobacter pylori infection, implantable medical device infection, cirrhosis of the liver and encephalopathy and other common clinical problems that are difficult to solve. At present, it is in the leading position of R&D pipeline at home and abroad in the above fields.

Ma Zhenkun revealed that as of April this year, Danuo Pharmaceutical has two new drug products into the phase 3 clinical trial stage, a new drug product into the phase 2b clinical, the fastest progressing product is expected to submit a domestic new drug listing application in 2024, the earliest in 2025 approved in the domestic market.

Reviewing the past financing, it can be seen that Danuo Pharmaceutical completed a total of more than 330 million yuan of D and D+ round financing last year, with the participation of venture capital institutions such as Yanchuang Group, Gaotejia, North Venture Capital and Borun Investment. It is understood that the company has opened a new round of financing.

Danuo Medicine started the E round of financing, an important reason is that the world's first new drug for the treatment of Helicobacter pylori infection developed by Danuo Medicine (TNP-2198) completed domestic phase 2 clinical trials in 2022, and recently obtained the qualification of qualified anti-infection products by the US FDA. At present, a multicenter, randomized, double-blind, bismuth quadruple controlled phase III clinical trial is being carried out, which is expected to become the world's first rigorously validated clinical antimicrobial new product for the treatment of helicobacter pylori. In addition, the Series E financing can also help Danuo to accelerate the development of other new drug products in the pipeline.

The reporter also learned in this interview that Danuo Medicine or plans to achieve the listing of the science and technology innovation board in the next 2-3 years.

Biomedical investment strategy is quietly shifting

In the view of many venture capital industry insiders, the reason why Danuo Pharmaceutical has quickly completed multiple rounds of equity financing since last year has invisibly highlighted the "quietly turning" of venture capital institutions' investment strategy in the biomedical field.

According to the prediction of relevant professional research institutions, the scale of China's antibacterial drug market has remained stable at more than 130 billion. At present, antimicrobial therapy faces two major challenges: the gradual increase in resistance of last-line drugs and the limited use of drugs with safety, and there is an urgent need for a batch of next-generation antimicrobials with new mechanisms or new structures to solve these problems. Therefore, the development of new antimicrobial drugs to bring better clinical results for patients is the main trend of the future development of antimicrobial drugs market.

In the past, many venture capital firms have concentrated on investing in hot tracks such as cell therapy or gene therapy, especially those with disruptive biotech innovations. With the recent dramatic adjustment of the stock price of listed biotechnology companies, more and more venture capital institutions have also realized that the capital market attaches more importance to the profitability of enterprises and the "certainty" of product commercialization development, and have begun to look for more diversified subdivisions in the biomedical field, such as the track with a clear market demand for antimicrobial drugs, and the investment heat is "heating up".

"At present, there are only a handful of antibacterial drug research and development enterprises with strong innovative technology research and development capabilities in the world." Wang Wei, executive general manager of Yanchuang Group, pointed out to reporters that behind this, antibacterial new drug research and development enterprises need to have two major competition thresholds.

The two competition thresholds mentioned by Wang Wei are as follows: First, the team should have profound accumulation in anti-infective drug research and development, including in-depth understanding of disease mechanism and target, efficient new drug design and screening platform, and professional support provided by many well-known experts in the field of antibacterial infection at home and abroad as scientific consultants; The second is the unique new drug research and development technology developed by the company, which needs to prove that it can have significant advantages in both efficacy and drug resistance. This has discouraged many antimicrobial drug research and development enterprises.

Ma Zhenkun also told reporters that in the process of communication between Danuo Medicine and the industry's head venture capital institutions, investors are most concerned about the company's new drug research and development strategy, research and development capabilities and technical advantages in the field of anti-infection. Among them, whether the team has the core R & D innovation ability, whether the R & D direction solves the clinical needs, and how the enterprise realizes the commercialization of the product have become important factors in the investment decision.

The aforementioned venture capital partners who focus on investment in the biomedical field also told reporters that their research and development found that many global antimicrobial drug R&D companies are "processing" on the basis of existing antibiotics, but this has led to significant improvements in the efficacy of related antimicrobial new drugs, and such drugs are often regarded as "standby drugs" by doctors in the actual treatment scenario. The room for growth is quite limited.

A head brokerage biomedicine analyst told reporters that antibacterial drug research and development in China is still facing due to the long research and development cycle, difficult research and development, new antibacterial drug market prices will be much higher than other varieties with the same indication, from the perspective of production and research, difficult R & D path and high R & D investment and high market pricing is a reasonable response, but for medical institutions and patients, Cost differences are often the most important factors for priority selection, which will undoubtedly affect and restrict the research and development enthusiasm of innovative pharmaceutical companies. Therefore, it is urgent for the government to issue more targeted and active policy support.

In recent years, Sequoia Capital, Qiming Venture Capital, Yanchuang Group and other investment institutions have been looking for unique research and development technology, can carry out antibacterial new drug research and development for the huge clinical disease treatment needs of enterprises in Wang Wei's view, in the field of antibacterial new drug research and development, China and European and American enterprises are currently in the same "starting line". If venture capital institutions can actively support relevant domestic enterprises to continue to improve the research and development capabilities of new technologies and solve the pain points of antimicrobial drug research and development, it will help relevant domestic enterprises to "emerge" in the international market and build China's strong strength in the field of antimicrobial drug research and development.

Source: 21st Century Business Herald