Author | Wu Zhongxue
Editor | Xinling
2021 is the second year of our struggle with COVID-19, and the health care industry is still in the limelight.
According to the data analyzed by start-up Bang Rui BeastThere were 2456 financing incidents in the health care industry in 2021, up from 1367 and 1234 in 2020 and 2019.In fact, from the perspective of financing events, health care has become the second largest track in the venture capital circle after corporate services, surpassing artificial intelligence and intelligent manufacturing.
This year, many major events have taken place in the industry: artificial joint collection, CXO concussion, mRNA therapy craze, License out outbreak. The concussion of the entire medical and health industry is actually quite obvious, of course, the whole situation is still booming, which remains the same.
We have singled out 10 representative cases, including breakthrough technology, hot tracks, and some policy adjustments, all of which have changed and impacted the industry to varying degrees as a small summary of the big health industry in 2021.
The mRNA therapy craze that cannot be ignored
Looking back on this year, mRNA is an indispensable key word. In February, the Massachusetts Institute of Technology Review (MIT Technology Review) released a list of the world's top 10 breakthrough technologies, with mRNA vaccine at the top of the list. In September 2021, the Lasker Award awarded the Clinical Research Award to two scientists, Katalin Karik and Drew Weissman, for their contributions to mRNA vaccine technology over the past decade.
With the success of COVID-19 vaccine, Moderna Inc's market capitalization once exceeded 190 billion US dollars, and the current market capitalization is about 100 billion US dollars. BioNtech's market capitalization once exceeded $100 billion and now has a market capitalization of about $60 billion. Pfizer Inc returned to the No. 1 position in the pharmaceutical world with COVID-19 vaccine in cooperation with BioNtech.
MRNA has also become a track sought after by capital in China, and Abe Bio has completed three rounds of financing of more than 1.1 billion US dollars in one year. Microbes have also received nearly $200 million in financing. In addition, Livanda biology, Mino Hengkang, blue magpie biology, thick storage nano, Reggie biology, Jiachen West Sea and other players have also attracted varying degrees of attention.
In terms of pipeline progress, COVID-19 mRNA vaccine ARCoVaX, jointly developed by the Institute of military Medicine of Abe Biology and Academy of military Sciences and Watson Biology, has made the fastest progress and has now entered the clinical III phase.
Summary:COVID-19 vaccine let everyone know mRNA, and it has become one of the hottest tracks this year, so apart from COVID-19 vaccine, what will mRNA bring to us next? This should be a point that everyone is curious about, and let's wait and see.
CDE issues guidelines for clinical research and development
On November 19th, CDE (Drug Evaluation Center of State Food and Drug Administration) formally issued and implemented the guiding principles of Clinical value-oriented Clinical Research and Development of antineoplastic drugs (hereinafter referred to as "guiding principles").
The guiding principles suggest that new drug research and development should provide patients with better (more effective, safer or more convenient) treatment options as the highest goal. The concept of antineoplastic drug research and development with patients as the core is not only reflected in the improvement of patients' needs, feedback collection and analysis methodology, but also from determining the direction of research and development to carrying out clinical trials, we should implement the concept of clinical demand-oriented drug research and development, and carry out patient-centered drug research and development, so as to realize the fundamental value of new drug research and development-to solve clinical needs and maximize patients' benefits.
It is worth mentioning that as early as July 2 when the guiding principles were consulted, it caused an uproar in the industry.
Summary:The release of the guiding principles undoubtedly puts forward higher requirements for the research and development of innovative drugs, and also breaks a basin of cold water for the hot and serious homogenization of the innovative pharmaceutical industry, thus promoting the innovative pharmaceutical industry to gradually transform from me-too to me-better and then to a completely independent innovation path.
The number of domestic innovative drugs License out hit a new high.
The most exciting part of the overseas licensing deal for domestic innovative pharmaceutical companies, namely License out, in 2021.
If 2020 is the first year of License out, 2021 should be said to be the year of License out. According to the statistics of the Rubik's cubeA total of 53 License out cases against overseas companies occurred in China's pharmaceutical industry in 2021, far more than 24 in 2020.
Since the beginning of this year, with the release of a series of national reform policies and the improvement of the R & D capability of domestic innovative pharmaceutical companies, our innovation has been gradually recognized by the international market, and License out trading has become more and more active.
Summary:The number of License out is more and more active, on the one hand, it reflects that domestic innovative drugs have become a general trend, on the other hand, it also reflects that the R & D capability of domestic innovative drugs is getting more and more recognized, which is the only way for Chinese innovative drugs to go to the world stage. In short, the journey is long, domestic innovation should be self-improvement.
Prediction of protein structure by artificial intelligence
On December 17, the authoritative international academic journal Science announced the results of the top ten scientific breakthroughs in 2021. "artificial Intelligence to predict protein structure" won the first place. The result was also selected in the UK's Nature magazine Science News 2021.
In July, Deep thinking, a world-renowned artificial intelligence team, announced that it had used AI program AlphaFold to predict the structure of almost all proteins expressed in humans, as well as almost complete proteomes of 20 other organisms. At the same time, the source code of AlphaFold2 was made public, and a paper was published in Nature to explain the technical details of AlphaFold2.
The researchers point out that the technology may have changed the rules of the game of structural biology and is expected to accelerate scientific discoveries in the life sciences as much as frozen electron microscopy, which could be of great significance for the study of a variety of diseases.
"the structure of proteins is not static, they bend as they work, and modeling these changes is still a challenge. But technological advances driven by artificial intelligence will change biology and medicine forever. "
Summary:Protein structure prediction is an important "holy grail" of biology. In the past, protein structure can only be determined by painstaking laboratory analysis, but now with the development of artificial intelligence, tens of thousands of proteins and interacting protein complexes can be quickly calculated, triggering a medical revolution.
Controversy over approval of new drug for Biogen Alzheimer's disease
In June 2021, FDA approved Biogen's new AD (Alzheimer's disease) drug Aduhelm, the first approved treatment for AD since 2003, aimed at reducing amyloid plaques in the brain to slow cognitive decline. The data show that it took 15 years from research and development to submitting an application for marketing.
However, six months after the application was submitted two years ago and was approved, the discussion on Aduhelm has not stopped.
It is understood that before it was approved, Aduhelm had conducted two phase III clinical trials, both of which showed unsatisfactory results at the initial stage of the trial. At that time, a drug review committee made up of FDA external experts voted overwhelmingly against approving the drug. But FDA finally approved it in a rare way.
However, the industry is not convinced, with comments saying that regardless of whether Aduhelm itself is effective, its approval will lead to a lot of similar drugs taking shortcuts to get to market, while crowding out the research and development space for other different types of Alzheimer's drugs, and this harm is long-term.
Aduhelm's post-IPO sales are not ideal, with target sales of $14 million in the third quarter of this year, only 2% completed, which is really dismal. In addition, its entry into the European market was also rejected a few days ago.
Summary:Life has not been easy for Biogen, which is pinning its hopes on the listing of Aduhelm, whose share price has been depressed so far this year. Recently, there are media reports that Samsung is in contact with Biogen to negotiate a merger, but there is no definite news yet.
Internet Medical Care will enter the era of Supervision
COVID-19 epidemic in the past two years has undoubtedly greatly changed and promoted the development of the Internet medical industry, whether it is the construction of Internet hospitals, or all levels of Internet online diagnosis and treatment, have ushered in a great growth. Take Internet hospitals as an example, according to statistics, there were only more than 100 Internet hospitals in China in December 2018, soaring to more than 1100 in 2020, and about 500 in the first half of 2021 alone.
However, in the past, it has been criticized because of lack of supervision and unclear medical responsibility, which has hindered the development of the industry to a certain extent.
On October 26, the National Health Commission issued a public announcement on the detailed rules for the supervision of Internet diagnosis and treatment (draft for soliciting opinions). The content covers the supervision of medical institutions, personnel, business, quality and safety, supervision responsibility and other aspects of Internet diagnosis and treatment.
It is believed that the formal rules for the supervision of Internet diagnosis and treatment will be issued in the near future.
Summary:The year 2021 should be a milestone for the Internet medical industry. with the continuous improvement of regulatory policies, Internet medical care will bid farewell to the past "barbaric growth" and enter a standardized era.
Medical AI finally ushered in the first share.
In 2021, the medical AI industry ushered in the listing barrier, and several leading medical AI companies submitted their forms one after another: Keya Medical delivery form HKEx in March, Eagle pupil Technology delivery form HKEx in June, presumptive Medical delivery form HKEx in August, and Jukun Technology delivery form in September. It is worth mentioning that as early as November 2020, Yitu Technology submitted a prospectus to Science and Technology Innovation Board.
However, the overall listing is not going well, and the IPO status of technology according to figure became "terminated" in July. In August, its medical team was acquired by Shenrui. In September, Keya Medical went public and became "ineffective".
Until November, Eagle pupil successfully landed on the Hong Kong Stock Exchange, China's medical AI industry finally ushered in the first share, which is undoubtedly a great boost to the industry.
Summary:Trapped by the slow process of commercialization and other factors, medical AI enterprises have had a difficult time in the past two years. Nowadays, with the approval of medical AI products one after another, the process of commercialization begins to accelerate. According to statistics, by the end of November 2021, more than 20 medical AI products have been certified by the State Drug Administration (NMPA).
BeiGene, Ltd. listed in three places
BeiGene, Ltd. landed on Kechuang Board on December 15, raising more than 22 billion yuan, becoming the world's first "N+H+A" biomedical company listed in three places, and the road to capital market has been successfully concluded. According to statistics, since the listing of US stocks in 2016, BeiGene, Ltd. has raised more than 60 billion yuan.
However, on the first day of Science and Technology Innovation Board's listing, Baiji fell by more than 20%, and some investors believed that its R & D efficiency was inefficient and that its business model of generating large amounts of revenue through drug listing or external licensing was not sustainable.
How to prove that you can succeed commercially? This is a challenge that Baiji and all innovative pharmaceutical companies must face in the future.
Summary:In the field of innovative drugs, Baiji should be said to be the top match in the industry, whether it is capital, team or other resources, which is an advantage that is difficult for most innovative drug companies to reach. But observing its growth path, at least as a case of reverse thinking, if you do not have certain abilities, what kind of play should be taken in order to survive, this is worth thinking about.
Sun Piaoyang returned and took charge of Heng Rui again.
If you want to vote for the head of an enterprise with the greatest pressure on medical and health care, I'm afraid Sun Piaoyang must be among them. For a whole year, Heng Rui has been at the forefront of the storm. Affected by collection and other factors, Heng Rui's performance is under pressure, and its share price has been depressed since 2021, and the company's market capitalization has lost more than 200 billion yuan in half a year.
On the evening of July 9, Hengrui Medicine announced that Zhou Yunshu had resigned as chairman and general manager for medical reasons. Sun Piaoyang, who stepped down as chairman for only one and a half years, returned to the spotlight to perform his duties as chairman until the board elected a new chairman. As soon as the news came out, the medical circle immediately exploded.
As the soul of Heng Rui, Sun Piaoyang has led Heng Rui to gradually transform from generic drugs to innovative drug research and development in the past few decades, which can be said to be one of the forerunners and leaders of innovative drug research and development in China. However, as he said, the speed of transformation can not keep up with the speed of change in the industry, Heng Rui is going through a period of labor pains, and no one knows how long it will be.
Summary:Every successful enterprise has a soul, just like Jobs to Apple Inc, Ren Zhengfei to Huawei and Lei Jun to XIAOMI. Sun Piaoyang is back in charge of Heng Rui again, let's return the core point of attention to people, a great enterprise must have a soul leader, a successful enterprise must also have a strong team. People are always the driving force behind all innovation and achievements.
A number of COVID-19 specific drugs have been approved to be put on the market.
COVID-19 epidemic is not over, in addition to vaccines, scientists have been working on specific drugs.
On December 22nd, the US Food and Drug Administration approved the paxlovid drug produced by Pfizer Inc, which is also the first oral drug that can be used urgently to treat novel coronavirus infection. It can be used to treat adults and children aged 12 and above who suffer from mild to moderate coronary disease, as well as people with a higher risk of severe disease. Earlier, Pfizer Inc announced that paxlovid could reduce the risk of hospitalization or death of patients with mild or moderate COVID-19 by about 89 per cent.
In fact, as early as November 4, the British Drug and Health products Administration announced that it had approved the application for emergency use authorization for the antiviral oral drug Molnupiravir developed by Merck & Co Inc and ridgeback. This is also the first anti-novel coronavirus drug on the market in the world that can be taken orally at home. According to Merck & Co Inc's previous announcement, Molnupiravir reduced the risk of hospitalization or death by 50 per cent in phase III clinical trials.
Domestic innovative drug companies are not willing to lag behind. On December 8th, China's first anti-novel coronavirus specific drug, the combination of ambavirin and romisovir, was approved by the China Drug Administration (NMPA). Clinical trial data show that the drug can reduce the hospitalization rate and mortality rate of high-risk COVID-19 outpatients by 80%. At the same time, antibodies can remain in the human body for 9 to 12 months, which also plays a role in preventing infection.
Summary:With the global vaccination of the vaccine and the successful approval of a number of COVID-19 special drugs, it is believed that the day will come when we defeat COVID-19.