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China Times Chen Yanpeng |Wen.
If you use two words to describe the domestic innovative drugs in 2023, it is "tenacity";If you can describe it in four words, it is "tenacious".
If you don't talk about the far, let's talk about the near, December 29 is the last trading day of 2023. The Shanghai Composite Index is the first of 3 for the whole year7%, SZSE Component Index**1354%, and the GEM is even more ** 1941%, while the innovative drug sector for the whole year**575%, chemical and pharmaceutical sector**656%, Chinese medicine sector **661%。Under the sound of "falling", innovative drugs outperformed the Shanghai Composite Index by 945 percentage points, outperforming the Shenzhen Component Index by 1929 percentage points, outperforming the GEM by 2516 percentage points, outperforming in an all-round way, innovative drugs are so tenacious!
This year, a total of 34 domestic Category 1 new drugs were approved, an increase of 156% compared with 2022, and also set a new historical record of 32 in 2021. This year, more than 40 new Chinese drugs were approved by the US FDA, and the total number also hit a new high in the past four years. The first domestic PD-1 anti-cancer drug has successfully gone overseas, and Hengrui Pharmaceutical has achieved 4 BDs in 2023, which once again confirms that the independent innovation ability of "Pharmaceutical First Brother" has global competitiveness. This year, overseas licensing transactions of domestic innovative drugs appeared frequently, and the number of transactions and the amount of transactions increased significantly. According to incomplete statistics, in 2023, the number of overseas licensing transactions of domestic innovative drugs will exceed 50, with a potential total transaction value of more than US$40 billion, far exceeding that in 2022.
You must know that a year ago today, we have not completely walked out of the haze of the new crown epidemic, the frequent outbreak of the domestic epidemic has reduced the daily diagnosis and treatment business of a considerable number of medical institutions, from research and development to clinical and new drug commercialization, the innovative drugs that are inseparable from the hospital have been more affected, and Shanghai, where the epidemic is more serious in 2022, is the base camp of innovative drugs, and the impact on the innovative drug industry chain can be imagined. Who would have thought a year ago that the recovery of the domestic innovative drug industry chain from the trough could be so strong?
But this is only the first year that the value of innovative drugs has returned. The return of value is the main title of the special issue of the 2nd China Health Industry Development Conference published in January 2023, which is our judgment on the trend of innovative drugs in 2023 at that time. Now, we still adhere to this judgment.
On January 8, 2023, the country announced that the new coronavirus infection officially returned to "Category B and B Tube". The hospital environment on which innovative drugs rely has been restored to normal, and the author believed at the time that "the return of the new crown epidemic prevention and control to Class B and B is a lifesaver for innovative drugs, which marks that innovative drugs have embarked on the road of value return." According to data from the National Health Commission, the number of diagnoses and treatments in China's medical and health institutions in the first three quarters of 2023 increased by 6% compared with the same period in 2022 and 12% compared with the same period in 20194%, not to return to the pre-epidemic level but to exceed the pre-epidemic level, thanks to the adjustment of epidemic prevention and control, affected by this positive impact, the drug sales of PDB sample hospitals have also continued to improve.
More importantly, the state has given more room for domestic innovative drugs. In March 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued a work specification aimed at "accelerating the review and approval of innovative drug varieties", and the adjustment of the simplified renewal rules for medical insurance negotiations in July is conducive to the realization of price for volume for innovative drugs. The just-announced results of the adjustment of the 2023 National Medical Insurance Drug List also release a signal to encourage innovative drugs. In this national medical insurance negotiation, the success rate of innovative drug negotiations is high, the average reduction rate is low, and 70% of innovative drugs have been renewed at the original price. Compared with previous years, the first negotiations in 2023 have less gunpowder smell, however, the competitiveness of new drugs is stronger, and many original drugs, even the world's first new drugs, have entered the medical insurance catalog through negotiations.
With the support of policies, the R&D investment of domestic pharmaceutical companies has continued to grow rapidly, and the R&D investment rate has exceeded 15%, gradually approaching the 20% level of multinational pharmaceutical companies. A significant change is that the proportion of innovative drugs in the revenue of domestic pharmaceutical companies is increasing, and this proportion will continue to increase, because there are still 80 domestic Class 1 new drugs in the marketing application stage, and these varieties are expected to be approved for marketing in China in the next one or two years.
Although the innovative drug sector will perform well in 2023, the Bank of China ** research report pointed out that overall, the pharmaceutical industry is currently at the bottom of history. There are two reasons for this:
On the one hand, the overall risk of the industry has been basically cleared, and the impact of policies that had a greater impact on the industry in the past, such as centralized procurement and anti-corruption, is getting smaller and smaller, and the risk is controllableOn the other hand, the growth of the pharmaceutical industry is still very good, with the aging and the breakthrough of many new technologies, many unsolved clinical problems in the industry have been solved, and these emerging fields are expected to grow rapidly in the future.
In the current environment, whether it is the industrial end or the clinical side, the demand for innovative products is very large, and the volume of innovative products is expected to exceed market expectations, and 2024 is expected to become the first year of innovative products.
Domestic innovative drugs, tenacious and full of stamina!
The author is a member of the editorial board of China Times and director of the Health News Department).