In the past year, there have been many major events in the Chinese biomedical industry. For example, at the beginning of the year, Cinda PD-1 ran into the customs and FDA and failed to get approval. A series of constraints imposed by US policies have become invisible obstacles for local pharmaceutical companies to go overseas. The "14th Five-Year Plan" for the development of pharmaceutical industry has basically laid the foundation for the future trend of local innovative drugs.
Under the influence of the epidemic, the global investment and financing in the field of biomedicine is facing a difficult winter. Both MNC and Biotech are looking for a new way out. However, there are both dangers and opportunities. This year, there are a lot of big mergers and acquisitions, and good projects are being targeted. Biotech kept thinking about growth during the crisis. "Not all Biotech must be Bigpharma" became an industry consensus, deepening the division of labor in the industry. Finally, the novel coronavirus pandemic, which has lasted for three years, has finally come to an end.
Perhaps no year has impressed us as much as 2022, so let's take a look at the "key words of the Year 2022 in the pharmaceutical industry" and learn from history.
01 Key words: New technologies emerge
Despite the challenges in the pharmaceutical industry in 2022, global biopharmaceutical startups continue to raise funds, and money continues to pour into new technologies and products.
In 2022, the FDA's Center for Drug Evaluation and Research (CDER) approved 37 new drugs, including 22 new molecular entities and 15 biologics, according to FDA public data. In addition, the Center for Biologics Evaluation and Research (CBER) has approved two vaccines, one cell therapy and four gene therapies, and one microbiome therapy. Compared to previous years, the number of new drugs approved by the FDA this year is lower, but the level of innovation is extremely high, and the types of biologics approved include monoclonal antibody, double antibody, ADC, TCR therapy, and enzyme replacement therapy.
In 2022, the China Food and Drug Administration (NMPA) approved 49 new drugs, including 30 imported and 19 domestically produced. The approval of a number of new drugs on the market not only marks a harvest period for local pharmaceutical companies, but also represents that China's innovative drug development system is closer to the international advanced level.
02 Key words: "Go to sea" big test
Under the background of profound changes in the industry and ever-evolving policies, China's entire pharmaceutical industry has been pushed to the sea, the entrance of a magnificent era. Innovative drugs are mainly divided into two categories: one is independent sailing, the other is the so-called licenseout, that is, authorized license.
2022 was supposed to be the first year of the internationalization of innovative drugs. However, the road to direct marketing of domestically developed drugs abroad has not been smooth.
In 2022, Cinda Biotics' PD-1 product Sindiglimab was not approved by FDA, Junsil Biotics' PD-1 product triprilimab was required by FDA to make a change in the quality control process that the company thought was easier to complete, and the marketing application of Sopantinib by GMatina was under review by FDA. Were also asked to include more international multi-center clinical trials representing patient populations in the United States.
In 2022, only Legendary Bio and Johnson & Johnson's BCMACAR-T cell therapy drugs were approved by FDA. At a time when domestic new drugs, such as PD-1, have encountered setbacks in the market, confusion and doubts have plagued China's innovative drugs. The approval of Legendary Biology is a shot in the arm in an almost exemplary way: Chinese innovation can go beyond world-class biotech.
In License-out, the number of transactions increases while the amount of a single transaction increases. After the phenomenon of $5 billion cooperation with Kangfang Biotechnology, Kelun Pharmaceutical and Merck reached overseas rights and interests authorization of 7 preclinical ADC drugs, with a total milestone of up to $9.3 billion, which is regarded as a major milestone in the development of innovative drugs in China by the industry.
According to statistics, in 2022, the total amount of license-out transactions in China's innovative medicine/new technology reached a record high of 17.42 billion dollars, an increase of 22.8% compared with 2021, and the number of transactions also increased compared with 2021. It can be seen that local innovative drugs have been verified by "real money", gained global recognition and participated in global competitions.
03 Key words: merger boom
After the bubble burst, Biotech valuations returned to cool. This is not bad for the money Biopharm, may be the best time to fish bottom. In 2022, Amgen announced the acquisition of HorizonTherapeutics for $28 billion, making it the largest merger in the pharmaceutical industry that year.
According to incomplete statistics of public data, in 2022, despite the low market temperature under the epidemic, mergers and acquisitions in the global pharmaceutical field remained high, with a total of 103 mergers and acquisitions, among which, according to the disclosed amount of mergers and acquisitions, the total amount of mergers and acquisitions is about $114,935 million.
In addition, companies from the global TOP20MNC (Top20 in 2021 revenue) initiated 21 mergers and acquisitions, with a total amount of $700.68 billion, accounting for 60.96% of the annual total amount of mergers and acquisitions. The fields with the largest number of M&A projects are rare diseases and cancer, followed by infection and blood.
For example, Amgen will acquire HorizonTherapeutics, the largest merger and acquisition in the pharmaceutical and health sector in 2022, which will strengthen the combination layout of rare disease drugs. BMS acquired the rights to repotrectinib with its $4 billion acquisition of TurningPointTherapeutics; Actively layout the oncology field; Pfizer's acquisition of GlobalBloodTherapeutics (GBT) for $5.4 billion complements and strengthens Pfizer's expertise and leadership in the blood pipeline......
On the whole, enterprises constantly promote their own development through mergers and acquisitions to further improve their overall competitiveness and achieve industrial integration and structure rationalization.
04 Key words: new industry cycle
The new industrial environment also makes the biomedicine industry enter a new industry cycle. In 2022, some pharmaceutical companies began to implement strategic contraction: adjusting R&D pipeline, promoting optimal R&D pipeline, and stabilizing cash flow. The directors of Biotech also began to think about how to go higher and further to the next stage.
In fact, a series of events have made the argument that "not all Biotech has to be Bigpharma" the consensus in the industry. In the process, both Biotech and Pharma's positions are becoming clearer.
Just standing at this point in time, whether from the perspective of industry or from the perspective of innovation, the pharmaceutical industry has begun a new cycle, after a bubble, the tide receded to know who is really naked swimming, a group of excellent enterprises can begin to cash growth, a group of globally competitive companies, began to show.
05 Key words: policy frequency
Of course, the past 2022 has left us with regrets as well as hopes. On May 10, 2022, the National Development and Reform Commission issued the 14th Five-Year Plan for the Development of Biological Economy, which is China's first five-year plan for the development of biological economy, including detailed deployment of high-quality development of the biomedical industry: We will strengthen the listing cultivation of biological enterprises, further increase the support for biological enterprises to be listed in the domestic capital market, and attract high-quality biological enterprises to be listed on the main board and the Science and Innovation Board.
Under the background of domestic R&D cluster and internal innovation, the supply-side reform of innovative drug track has also been started. As early as November 2021, the Drug Review Center of the State Drug Administration officially released the "Clinical Value-Oriented Guidelines for Clinical Research and Development of antitumor drugs", aiming at implementing the clinical value-oriented drug research and development and promoting the scientific and orderly development of antitumor drugs. After the release of this document, the innovative drug circuit began to bubble.
On 8 November 2022, the CDE issued Technical Guidelines for Benefit - Risk Assessment of New Drugs for public solicitation, stating that the benefits of an innovative drug applying for marketing must outweigh the risks compared with existing therapies/products. It also means that me-too products will be harder to bring to market in the future, and the criteria for me-better drugs and bestinclass will become clearer and the gold content will probably increase.
It is also worth noting that the review and approval of new drugs in China is accelerating, and innovative drugs are landing at an accelerated pace. At present, the deregulation of epidemic control may also be conducive to the development of innovative drugs. Supply-side reform is the only way to long-term development. The most pessimistic time for innovative drugs has passed. The products in the pipeline will have their own living space as long as they have certain clinical value.
06 Key words: digital transformation
Driven by the goal of "The 14th Five-Year Plan" to accelerate digital development and build a digital China, digital economy has become a current boom. In recent years, with the outbreak of the novel coronavirus and other public health events, people pay more attention to life and health. As an important pillar of the people's livelihood, pharmaceutical enterprises are naturally affected by the demand of market environment, medical technology innovation and the boom of digital economy.
Under the constraints of traditional research and development, production, commercial circulation and extensive marketing construction and management, pharmaceutical enterprises have been unable to maintain a stable existence of high gross profit and high profit. With automation, the Internet of Things, artificial intelligence, big data and other digital technologies, more and more pharmaceutical products will have to consider new research and development, production, marketing and other processes. Therefore, digital transformation has become the only way for pharmaceutical manufacturing enterprises to improve innovation and research and development ability, improve product quality, reduce operating costs, and build competitive advantages.
In 2022, MNC pharmaceutical companies have begun to move frequently. For example, during the Fifth CIIF, Novartis China and Ali Health reached a number of cooperation in the field of digitalization. They upgraded the cooperation content again, jointly adhering to the concept of "patient-centered", continued to expand the access to medication for patients through digitalization, and provided one-stop health management services for patients. Takeda cooperated with Amazon Cloud Technology and Accenture to jointly explore and build a full-cycle industrial cooperation model from incubation to commercialization in the digital medical field. Ogalon cooperated with Ali Health to jointly explore the innovation of "Internet +" chronic disease management mode, and jointly enable online diagnosis and treatment and disease management ecology, so as to improve patients' diagnosis and treatment compliance; Boteng takes "intelligent research and development, intelligent factory, digital intelligent project operation, digital marketing" as its foothold to fully explore the digital intelligent scene in the company's actual business. In 2021, the company launched an intelligent production digital system. At the same time, the 109 workshop of Chongqing Changshou production base has realized 75% automation of process operation unit, reaching the benchmark level of CDMO industry. As the only factory in the pharmaceutical industry, this base won the "Chongqing Innovation Demonstration Smart Factory". Botten continues to create more possibilities in the era of Industry 4.0...
07 Key words: COVID-19 is stepping down from the stage of history
The novel coronavirus epidemic still lasted throughout the whole year of 2022. On December 26, 2022, the National Health Commission issued the latest announcement, saying that the novel coronavirus infection will be adjusted from "Class B A tube" to "Class B B tube" from January 8, 2023. Since then, the "strict management and control" of the novel coronavirus epidemic has stepped down from the historical stage and officially become the past.
The three-year epidemic has harried the world, posing huge challenges to the medical and health systems of all countries in the world. It has also made the world see the urgency and necessity of the development of the pharmaceutical and biological industry, and the importance of the pharmaceutical and biological industry to residents' safety, social security and even national security has become increasingly prominent. However, the medical biology field still exists in the field of high import ratio and technical bottlenecks. In terms of drugs, although the number of domestic innovative drugs approved has continued to increase in recent years, there is still a gap between us and overseas leading companies in some blockbuster drug sectors.
Therefore, when the epidemic ends in 2023, the biomedical field will also usher in a new dawn.
conclusion
Despite the difficulties and challenges in 2022, we are still making breakthroughs and innovations. 2022 has passed, 2023 has begun; A new chapter and a new beginning. May all medical professionals keep their original intention and forge ahead! Let good medicine benefit the public earlier!
