Original production of "Polypeptide Chain".Written by Yan RuiNeedless to say, innovative drugs have become the strongest backbone of the long-term operation of China's pharmaceutical industry.
After experiencing the capital winter and the disruption of the epidemic in the primary and secondary markets, the "cold adjustment" has brought China's innovative drug industry back to rationality, and the market environment is about to usher in a warm spring with the marginal decline of the impact of medical reform.
Under the warm spring, what kind of innovative pharmaceutical companies can outperform the general trend and the future?
Observing the industry, there are many companies that can be watched, each with its own eyes and strengths. The industry is also always debating the differences and growth of "biotech", "biopharma" and "bigpharma".
Compared with the mature markets of the United States and Europe, although the most competitive super pharmaceutical companies are in the absolute minority in terms of numbers, they can influence the direction of the global pharmaceutical market with their ability to lead industry innovation.
Therefore, the rise of China's innovative drug industry will inevitably require a group of seed players who can become super "big pharma". In fact, there are only a handful of companies listed in this scope.
Compared with Hengrui Pharmaceutical (600276SH), Fosun Pharma (600196sh|02196.HK), the chaebol is fiercely expanding CSPC Pharmaceutical Group (01093.HK), an extraordinarily low-key health element (600380SH) is the one that is easy to overlook.
However, the low profile does not prevent Jianxingyuan from laying out cutting-edge technologies and innovative drug pipelines.
Founded 30 years ago, after completing several major transformations, it finally focused on unmet clinical needs and regarded "innovative drugs and complex preparations with high barriers" as its development strategy.
This simple and clear strategic formulation is constantly being shown through various details, releasing to the market the belief of becoming "China's leading comprehensive pharmaceutical company with continuous innovation and development".
One|Acceleration
BD-style leapfrogging
When the domestic innovative drug industry begins to develop towards involution, technological breakthrough is no longer the only way to determine the outcome.
In October this year, Jianxingyuan released the news that it signed an exclusive licensing agreement with Guangzhou Fermion Technology *** hereinafter referred to as "Fermizi") for the latter's new analgesic drug FZ008-145 in Chinese mainland and Hong Kong and Macao.
In the innovative drug industry, this kind of "license-in" cooperation is nothing new, and even some biopharma companies make a living from it, and they have already played very slippery.
But for the health element, this is a multi-effect "magic hand", in which the details are worth playing.
The first is the "exclusive authorization" method, and the health yuan has obviously opened another window. In the past, the company has always emphasized the accumulation of self-developed technology, and "license-in" is rarely used.
However, in the past one or two years, while continuing to invest heavily in R&D and self-research, Jianxingyuan has begun to accelerate its layout by cooperating with biotech companies to develop. Diversified means are more efficient and less risky than relying solely on self-development, and the pipeline and product coverage will be wider
In addition, the small molecule innovative drug FZ008-145, which has been exclusively licensed by Jianxingyuan, is a highly selective second-generation N**18 inhibitors of analgesic drugs. This brings a new piece of the puzzle to the health meta-drug development pipeline.
"Analgesia" is also an area with significant clinical need – opioid-dependent on moderate to severe acute pain** is evolving into a disaster in North America and around the world, and innovative solutions are urgently needed to replace it.
In terms of market size, the market size of the global analgesic drug industry in 2022 will be about 911400 million US dollars, the market size of China's analgesic industry is about 122.6 billion yuan (Zhiyan Consulting data).
Obviously, Health Yuan is also coveting the ample potential of the analgesic market.
From the perspective of innovative drug targets, n**18 has been shown to be a promising analgesic target. In fact, a number of multinational pharmaceutical companies such as Pfizer, Eli Lilly and AstraZeneca have favored this target and have developed innovative drugs for neuropathic pain.
FZ008-145 n**1At present, 5 POC validated clinical data have been obtained for 8 targets, and in October this year, Fermion submitted an IND application to CDE. The "stuck point" of the health element is just right.
I have to say that this year's BD work of Healthy Yuan seems to have the feeling of "a big explosion in the small universe", and it must be "added to chicken legs".
ExceptIn addition to FZ008-145, Healthy Yuan BD has also introduced the anti-influenza innovative drug TG-1000 with a "reasonable **", as well asTwo clinical drugs, one preclinical respiratory track innovative drug, and several projects in the final negotiation stage.
It must be mentioned here that in March this year, Jianxingyuan also signed the exclusive license of Taijing Biologics' new influenza antiviral drug TG-1000 in Chinese mainland, Hong Kong and Macao in the form of "license-in".
TG-1000 is not only effective in blocking the replication and transmission of influenza viruses, but also has the potential to overcome the problem of drug-resistant virus strains, and also has a wide effective period. In short, it can solve a series of problems caused by the current mutation of influenza viruses.
At present, TG-1000 has entered the third phase of clinical trial. The large-scale influenza and respiratory infections in the autumn and winter of this year have also verified the "precise" layout ability of the Healthy Yuan BD Working Group to introduce TG-1000 to expand the R&D pipeline.
Whenever we talk about the core competitiveness of innovative pharmaceutical companies, we will always focus on the breakthrough of original technology and original new drugs, but for a comprehensive pharmaceutical company driven by innovation, such as Jianxingyuan, it is probably more important to obtain innovative technologies and products through BD methods such as licensing, joint development, equity investment, and asset mergers and acquisitions.
Throughout the development history of global pharmaceutical giants, which one is not through BD to become bigger and stronger, and create more brilliance?
Now, China's bigpharmas are aware of this. From the crazy poaching of BD talents in the market, it can be seen that the BD ability behind the layout of the R&D pipeline is the key to telling the story of new drugs in the future.
IIOctopus
Pipeline matrix
One word to describe the innovation of the health element must be "diversification".
With a history of more than 30 years, the fields involved in Jianxingyuan span chemical preparations, biological products, traditional Chinese medicine preparations, APIs, diagnostic reagents and health foods, and there are mature and multi-level R&D institutions.
Such a wide market coverage is not without a clear main line logic.
In fact, it adheres to the two-wheel drive of "innovative drugs + high-barrier complex preparations", closely following the "unmet clinical needs".Take this as the main lineofThe health element is like an "octopus".Respiratory, analgesic, digestive tract, assisted reproduction, psychiatry, tumors and other diseases with significant clinical needs radiate their tentacles and are in advantageous areasConstantly enriching itProduct & R&D Pipeline.
Among them, the most beneficial health element is in the direction of respiratory diseases.
Through more than 10 years of R&D investment and technology platform construction, Jianxingyuan has 8 varieties and 12 specifications of marketed products in inhalation preparations, as well as 30+ varieties under research in the field of respiratory medicine.
Jianxingyuan's marketed product matrix and pipeline in the respiratory field cover all categories of asthma and COPD inhaled drugs**. With such a layout, there are no comparable enterprises in China at all.
Last year, the new drug tobramycin inhalation solution (Jianketo), independently developed by Jianxingyuan, was approved for marketing, becoming the world's first inhaled drug for bronchiectasis. Jianketo is not only the first inhaled antibiotic in China, but more importantly, it solves the clinical dilemma of patients with bronchiectasis.
Not only is it a breakthrough in self-research, but the introduction of innovative drugs by BD is also becoming a "routine" for health elements
As mentioned earlier, this year, in the field of respiratory diseases, Jianxingyuan has harvested TG-1000, which has entered phase III clinical studies for influenza A and B, and XYP-001, which is being clinically conducted in phase I clinical trials, for idiopathic pulmonary fibrosis (IPF) and other new drugs.
In the field of respiration, the idea of the introduction of healthy element BD is also very clear: one is to focus on new targets and new mechanisms, and find the right time to focus on macromolecular biological drugs and small molecule oral drugs;The second is to pay close attention to the new drug delivery method, and there are layouts for injections, inhalation preparations, and oral drugsThe third is to expand in new indications, especially in clinical phase II and III varieties.
Independent R&D + external introduction, cooperative development and other methods constitute a relatively complete R&D innovation management model of Jianxingyuan, which not only pushes up the barriers of its complex preparations, but also greatly improves the layout efficiency of its R&D pipeline, laying a solid foundation for sustainable performance growth in a longer cycle.
In fact, the last thing to worry about is the commercialization ability of Health Element, whose sales network covers all provinces in China and 80 countries and regions around the world.
From the cultivation of health care product brands in the early days, to the incubation and operation of star drugs, and then to the systematic sales construction of innovative drugs, the "shortest board" of most innovative pharmaceutical companies is not short at all.
Judging from some of the public information released by its official release, one of the most important contents of the ongoing digital strategic transformation of Health Yuan is to upgrade the "patient-centered" digital marketing ecosystem, and quickly replicate and extend the digital marketing model tested in the field of respiratory medicine to the advantages of health elements such as digestive tract and spirit.
And the so-called new model of digital marketing, is:"Empower all aspects of education, screening, diagnosis, and drug monitoring, open up the closed loop of doctors, hospitals, patients, and pharmaceutical companies, leverage the huge market of out-of-hospital chronic disease management with private domain traffic, and realize real-time interaction between consumers and brands", which is also the confidence of Jianxingyuan to continue to introduce innovative drugs in the future.
Of course, the rise of China's super bigpharma must rely first and foremost on the local market, but it is also time to accelerate the exploration of the international market.
Last year, the listing of Healthy Yuan GDR on the Swiss ** Exchange is a clear signal that it is time to speed up the pace of going out. On the other hand, the company's BD is also continuing to promote international cooperation and external licensing of innovative products and pipelines.
Three|Standing at the head of the tide
Expand the innovation ecosystem
The growth curve of a true bigpharma company must be depicted by a systematic, systematic drive for innovation. So how does HealthElement continue to deliver on its innovative value?
Self-research as the base, the introduction of assistance, this is only the main structure of the current stage of the health meta strategic framework, but in fact, the health of the yuan and its other listed company, Livzon Group (000513SZ) is also investing in more cutting-edge technology fields in the form of large-scale equity investment.
The R&D and industrialization system is becoming more and more completeSelf-developedIntroducedParticipationThe layers are progressive,ConductedShort mediumLong-term products withTechnical layoutof, which is its top-notchBigPharma's gradual growth channel.
For example, in the field of AI medical and pharmaceutical applications, where the market growth rate has soared rapidly in the past two years, AI-assisted new drug research and development and AI-assisted tumor diagnosis and treatment are two market segments that large integrated pharmaceutical companies are eyeing up.
In the second half of this year alone, pharmaceutical companies such as Fosun Pharma, CSPC Pharmaceutical Group, and Yunnan Baiyao have reached strategic partnerships with AI technology companies such as Insilico Medicine, XtalPi, and Huawei to advance the design, R&D, and clinical research of their AI innovative drugs.
At the beginning of 2021, Jianxingyuan reached a strategic cooperation with Tencent Quantum Lab to jointly build a microbial synthetic biology research and related drug research and development system empowered by quantum AI computing.
The cutting-edge technologies such as biological big data analysis, protein computational simulation and structure**, and genome-wide customized creation covered by this systematic research direction, as well as the research on small molecules, macromolecules, and even microbial living cell drug-related expression components and molecular structure simulation, are almost all new popular paths for innovative drug research and development.
AI drug research is undoubtedly the inevitable technical direction of pharmaceutical companies in the future, in this field, Jianxingyuan also through its holding subsidiary Livzon Group, participated in Beijing Infinair Intelligent Pharmaceutical Technology *** In June this year, Infinair Intelligent Pharmaceutical released the first GPT system in China's pharmaceutical field - PharmGPT, which can stabilize the success rate of drug research and development at more than 20%.
Source: Infinairy
According to a report released by a global biotechnology industry organization, the average success rate of the 9,704 drug clinical development projects monitored by the report between 2011 and 2020 from Phase I to FDA approval was only 79%, with an average time of up to 105 years.
Obviously, this drop in AI drug research is of great strategic value to Jianxingyuan in the field of innovative drugs.
In addition, Jianxingyuan also participated in the early investment of Lunglife AI in the United States and Zhuhai Shengmei Biodiagnostic Technology***, two companies in the field of AI medical diagnosis, the former is constantly improving in the research of model data for early screening and diagnosis of lung nodules and lung cancer, and the latter is good at providing digital health management solutions for early diagnosis of lung cancer.
Judging from the current development, the application of AI diagnostic technology in the early diagnosis of lung cancer is likely to be the first direction to achieve "qualitative change" in the early screening and early diagnosis of tumors. Jianxingyuan's participation in the above two companies has undoubtedly allowed itself to step on the "outlet" of AI diagnosis and treatment.
In terms of "focusing on unmet clinical needs", Healthyuan is also expanding its own innovation ecosystem. Especially in the hottest field of small and large molecule innovative drug research at present.
Elicio Therapeutics (ELTX.)NASDAQ) landed on the NASDAQ market in June this year, and its main focus is the first-class cancer vaccine, which is quite imaginative in the market.
There are also new elements for the research and development of small molecule oral new drugs for chronic goutShanghai Keentai Biotech, which has an academician background and focuses on the development of next-generation kinase inhibitor drugs, these two domestic companies are star companies in the field of small molecule innovative drugs.
In the field of macromolecule drugs, Beijing Luzhu Biological, in which Livzon Group participated, was listed on the main board of the Hong Kong Stock Exchange in early MayShanghai Jianxin Biotech, another company that develops bispecific antibodies for solid tumors, has two of its products selected for the poster of the 2023 American Clinical Oncology Annual Meeting (2023 ASCO).
The products and pipelines of the above-mentioned companies will also further enrich the "project pool" of new drugs introduced by Healthy Yuan BD, thereby bringing more commercial value that can be realized.
In the direction of gene editing, cell**, synthetic biology and other technologies that are likely to bring revolutionary technologies to medicine and medical treatment and even life engineering, Healthyuan has also participated in global investments such as Beam Therapeutics (BEAMNASDAQ), Carisma Theapeutics and other leading companies.
It's not hard to get a glimpse,Jianxingyuan has penetrated almost all trending cutting-edge technology fields, and its bidders are also global top companies in their respective fields.
For example, the expansion of the innovation ecosystem is also in line with the global cutting-edge innovation system, which is more conducive to expanding business and cooperation models in the international market in the future.
ENDS