Health Times Tan Qixin
Looking back at 2021, most of the medical people have mixed feelings in their hearts. At the beginning of the year, according to Wind data, the valuation level of the pharmaceutical sector first hit a record high of 68.29 times, and then all segments stepped on the brakes together, and as of December 31, 2021, the overall valuation of the pharmaceutical and biological sector was 35 times, down 48.7%. However, at the end of the year, a number of research reports such as Industrial Securities and Capital Securities have analyzed that the pharmaceutical sector will begin to bottom out in 2020.
A number of interviewed industry insiders said in an interview with the Health Times reporter that in 2022, the pharmaceutical industry will move towards maturity and rationality on the basis of the improvement of the overall adaptability.
Profile picture, courtesy of Cao Zihao.
In the year of the industry's bumper harvest, 25 local innovative drugs were listed
2021 is a bumper year for China's pharmaceutical industry.
According to the website of the State Drug Administration, as of December 30, 25 local innovative drugs have been approved for listing in 2021, setting a new high in the past three years. That's 14 in 2020 and 16 in 2019.
The Health Times reporter combed and found that most of the 25 local new drugs approved this year were approved for listing through accelerated channels such as priority review and emergency approval, and have certain clinical value. For example, China's first new crown neutralizing antibody combination therapy, the first "first-in-class" system lupus erythematosus new drug tetaczep, the first selective MET inhibitor sivotinib, the first antibody-coupled drug vidicetizumab independently developed by a Chinese company, and the revolutionary cancer treatment program CAR-T product.
At the same time, since the first covid-19 vaccine was urgently approved at the beginning of the year, a total of 7 vaccines have been urgently authorized for use, of which Kerring's Kerraf inactivated COVID-19 vaccine sold $10.98 billion in the first half of the year, ranking second in the world's best-selling drugs, and this is also the first time that "China Research and Development" has entered the top 10 list of global best-selling drugs.
Behind this is a new high for R&D investment in the entire industry. According to data from The Intranet, 319 A-share and Hong Kong-listed pharmaceutical companies announced that the total amount of H1 research and development investment in 2021 was nearly 50 billion yuan, and Hengrui Pharmaceutical, Fosun, CSPC Pharmaceutical Group, Cinda and other heavy-1 new drugs were reported. 98 pharmaceutical companies invested more than 100 million yuan in R&D, and 9 exceeded 1 billion yuan (5 in the same period of 2020); nearly 80% of pharmaceutical companies showed positive growth in R&D investment, with 27 soaring by more than 100%; led by innovative enterprises, 9 pharmaceutical companies accounted for more than 100% of revenue.
In the view of Han Qi, an expert in the development strategy of the bio-industry at the Macroeconomic Research Institute of the National Development and Reform Commission, the people's pursuit of higher quality of health security is the fundamental driving force for the long-term development of the industry, especially the changing epidemic situation in 2021, which has also become a catalyst for the prosperity of the entire industry's innovation situation. On the one hand, the continuous mutation of the virus requires related R&D pharmaceutical companies to maintain a high degree of sensitivity and improve response efficiency, on the other hand, the emergence and export of therapeutic means such as new crown neutralizing antibody combination therapy/Chinese vaccine have had an impact on the global pharmaceutical industry pattern, which has greatly enhanced the international influence of China's pharmaceutical innovation.
"In the long run, the epidemic will eventually pass, and the growth of some segments brought about by the epidemic may not necessarily be sustained for a long time, but the ability of the entire industry to respond to external changes will provide a steady stream of drivers for innovation." Han Qi said.
Back to rationality, the valuation bubble burst
July 6, 2021 is an unforgettable day for many pharmaceutical people, the pharmaceutical and medical stocks that have continued to rise on the same day suddenly fell cold, the whole line fell sharply, the main capital outflow was nearly 30 billion, CRO, medical devices, generic drugs, Traditional Chinese medicine, biological vaccines, pharmaceutical business and other sectors were not spared. Since then, the overall trend of the market has continued to be sluggish.
Ding Sheng, dean of the School of Pharmacy of Tsinghua University and director of the Global Health Drug Research and Development Center (GHDDI), believes that behind the cold market is the short-term correction of capital's value to the development of the industry, and the series of drug supervision and medical insurance control policies that have been intensively launched this year are one of the main influencing factors. Among them, the "Guidelines for The Clinical Research and Development of Anti-tumor Drugs" released on July 2 for comments is regarded by the industry as a boulder thrown into the pond of innovation in China's pharmaceutical industry.
"The guiding principles make it clear that new drug research and development should be 'clinical value-oriented', when there is BSC (the best supportive treatment), BSC should be given priority as a control, which puts forward higher requirements for enterprises that conduct me-too and me better drug research and development, which also means that some scattered, inefficient, repetitive low-level research and development will accelerate the withdrawal from the historical stage, which will trigger the adjustment of the capital market's development cognition of the innovative drug industry in the short term." Ding Sheng explained.
At the same time, 2021 is the year with the highest national and local collection frequency, and the pressure of price reduction and control fee control is stronger than in previous years, and the impact is far beyond industry expectations. Including the sixth round of national collection (insulin special) that has just been baked, four times of pharmaceutical equipment collection have been carried out this year, and the collection variety has expanded from a single generic drug to high-value consumables such as insulin biological drugs, coronary stents and artificial joints, and the price reduction has reached more than 50%.
Local provincial and inter-provincial joint procurement mushroomed rapidly throughout the country, a total of 8 inter-provincial alliance procurement throughout the year, the number of generic names of purchased drugs is also relatively large, the latest Guangdong 16 provincial alliance procurement involves 256 generic names of drugs, covering chemical drugs, proprietary Chinese medicines and biological drugs.
Ding Sheng believes that from the perspective of the long-term development curve of the industry, the short-term downturn of the stock market in the pharmaceutical sector is not a bad thing. In the first half of 2021, the pharmaceutical industry market has seen unprecedented heat, the valuation is too high, resulting in a bubble, and it is normal to return to rationality after overheating, and the pressure of policy has also accelerated the bursting of the bubble.
De-falsification and preservation of truth, differentiation and internationalization will become a new trend
"After the development of innovative drugs in China has experienced blind homogeneous competition from scratch, it has gradually entered the knockout match in the second half from the audition in the first half, and the innovative concept has been false and true." Under the big logic of innovation and development, differentiation and internationalization will become the direction of the future for a long time. Looking forward to 2022 in the pharmaceutical industry, Ding Sheng analyzed.
Differentiation, i.e. targeting the needs of clinical indications that are not currently met. PD-1, CD47, etc. continue to face a situation of excessive competition, cancer drug development target homogenization competition is intensifying, forcing latecomers to actively explore diversified new technologies and new drugs, highlighting competitive advantages.
Internationalization, that is, me-better or even first-in-class drugs to break into the international market. The head pharmaceutical companies are accelerating the pace of internationalization, such as Cinda Biologics, which has made PD1 listing declarations based on domestic clinical data, and Hengrui Pharmaceutical, which has accelerated its access to FDA IND approvals in the past two years.
At the end of 2021, the State Food and Drug Administration led the eight national departments to jointly issue a blockbuster document "14th Five-Year Plan for National Drug Safety and Promoting High-quality Development", which clearly supports the high-quality development of the industry The regulatory environment is more optimized, the reform of the review and approval system continues to deepen, a number of innovative drugs urgently needed in clinical practice are approved, and the listing of innovative drugs with clinical value is accelerated.
"It is foreseeable that after a year of uncertainty and challenges, 'seeking stability' will become the key word in the coming year, both from a regulatory and industry perspective." Han Qi told reporters that he expects that future supervision can give the industry more 'reassurance pills' in top-level design/system design, and individuals in it can get rid of restlessness and uneasiness and firmly walk out of a path of independent innovation.
