how many hurdles will the innovative drug market have to pass from 16 months to 50 days to reach rmb 1.7 trillion?
2024-10-01
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from generic drugs to innovative drugs, my country's biopharmaceutical companies have entered a new stage, and accelerating the review and approval of innovative drugs has become a key part of the innovation and development of the pharmaceutical industry. recently, at the 8th china (tianjin) nucleic acid drug conference hosted by the china biochemical pharmaceutical industry association, participating experts discussed the review and approval of innovative drugs and the development of nucleic acid drugs. since the reform of the medical system in 2015, the development of domestic innovative drugs has accelerated significantly, and the average approval time has been significantly shortened from the past 16 months to about 50 days. the approval time limit for clinically urgent drugs has been greatly shortened, creating a favorable environment for the development of the innovative drug industry. condition. among these, nucleic acid drugs have become a front-runner.
nucleic acid drugs are considered to be the third generation of innovative drugs after small molecule drugs and monoclonal antibodies. they have the advantages of short development cycles and low resistance to drug resistance. the improvement in approval efficiency has cleared the way for innovative drugs to move from the laboratory to the market. . as of september 2024, the global innovative drug market will reach 1.7 trillion yuan, showing the huge potential and growth momentum of the innovative drug market.
99.8% completion rate
kong fanpu, chief researcher at tsinghua university and former director of the drug evaluation center of the state food and drug administration, revealed at the meeting that since the reform of the drug review and approval system in 2015, the state food and drug administration has encouraged and promoted drug innovation to meet patients’ clinical drug needs. provides a series of policy guarantees and technical support. before the 2015 reform, it took an average of 16 months to approve a clinical trial, which is a quite lengthy process for pharmaceutical companies. now with the implementation of the licensing system, this time has been significantly shortened.
"this change did not happen overnight, but was the result of a series of efforts including in-depth internal reforms, strengthening technical requirements, strengthening pre- and post-event communication, unifying approval standards, and increasing monthly project management scheduling meetings and management efforts," kong fanpu said.
according to kong fanpu, since its full implementation in 2019, the on-time completion rate of clinical hospital licensing has remained above 99%. during 2020-2022, the completion rate is as high as 99.8%. at the same time, the average approval time has been significantly shortened from the past 16 months to an actual 50 days.
in addition, the state food and drug administration has also formulated a series of procedures to accelerate the launch of innovative drugs, and at least six procedures are currently under study. among them, the priority selection process is one of the four major indicators of the state food and drug administration and has been playing an important role since its establishment in 2017. "this program is evaluated based on the priority level of 18 items. although 50% of the items failed to fully meet the time limit during the implementation process, its overall effect is still significant." kong fanpu added.
in kong fanpu’s view, the next stage should focus on verification and inspection and improvement of drug transparency. this reform aims to speed up the early introduction of drugs with significant impact to the market. comparing before and after the reform, the average approval time for common varieties in 2018 was about 620 days, but by 2022, this time has been shortened to an average of 144 days. the approval time for other varieties is only 1/3 of the past, including a significant reduction in actual running time and efficiency improvements brought about by structural optimization.
nucleic acid drugs rush ahead
the improvement in approval efficiency has created conditions for the iteration of innovative drugs. among these, nucleic acid drugs have become a front-runner.
nucleic acid drugs include antisense oligonucleotides (aso), small interfering rna (sirna), microrna (mirna), small activating rna (sarna), messenger rna (mrna), rna aptamer (aptamer), etc. in recent years market popularity continues to rise. according to data from chichi consulting, the global small nucleic acid drug market size was us$362 million in 2020, and the market is expected to reach us$25 billion in 2030. china's small nucleic acid drug market is expected to be approximately us$4 million in 2022, and is expected to reach more than us$300 million in 2025, with a compound annual growth rate of over 300%.
nucleic acid drugs have set off a wave in the field of biomedicine and are also regarded as the key development direction of future medical care. zhang lihe, academician of the chinese academy of sciences and professor of peking university school of pharmacy, said that nucleic acid drugs are considered to be the third generation of innovative drugs after small molecule drugs and monoclonal antibodies. they have the advantages of short development cycles and are not prone to drug resistance. nucleic acid drugs have multiple products on the market in 2023, including drugs targeting low-density lipoprotein and als.
at the conference, tan weihong, academician of the chinese academy of sciences and director of the hangzhou institute of medical sciences of the chinese academy of sciences, also pointed out that there are many types of nucleic acid drugs, which can be screened, synthesized and modified through laboratory screening, and have the potential to replace traditional drugs. in tan weihong's view, the research on nucleic acid drugs brings new opportunities to the field of biomedicine.
in addition, domestic innovative pharmaceutical companies have also made significant progress in the international market. a number of innovative drugs have been approved by the us fda and have entered the commercialization stage. at the same time, domestic innovative drug companies have completed multiple license-out transactions, and their partners include many leading international pharmaceutical companies. this indicates that the influence and competitiveness of china's innovative drugs in the international market are increasing.
according to wind data, as of september 2024, the global innovative drug market will reach 1.7 trillion yuan, showing the huge potential and growth momentum of the innovative drug market.
shorten the time it takes to start drug clinical trials
through the optimization of a series of policies and procedures, the speed of the launch of innovative drugs has been accelerated, and the approval time limit for urgently needed clinical drugs has been greatly shortened, creating favorable conditions for the development of the innovative drug industry.
in recent years, my country's innovative drug approval mechanism has undergone multiple reforms to speed up the launch of new drugs and meet clinical needs. on july 31, 2024, the state food and drug administration issued the "pilot work plan for optimizing the review and approval of clinical trials of innovative drugs", proposing to optimize the review and approval mechanism for clinical trials of innovative drugs, strengthen the main responsibilities of drug clinical trial applicants, and improve drug clinical trials. trial stakeholders have the ability to identify and manage risks in innovative drug clinical trials, enabling them to complete the review and approval of innovative drug clinical trial applications within 30 working days, shortening the time it takes to start drug clinical trials. the pilot work lasts for one year. during the pilot period, the clinical trial application review and approval of at least 10 varieties in the pilot area will be completed and clinical trials will be initiated.
li li, director of the state food and drug administration, pointed out at a press conference on promoting high-quality development recently held by the state council information office that since its establishment in 2018, the state food and drug administration has released 357 drugs and 494 medical device review technologies. the guiding principles exceed those of the past few decades combined, providing strong support for pharmaceutical device r&d innovation and technical review.
according to reports, from january to august this year, the state food and drug administration approved 31 innovative drugs and 46 innovative medical devices, an increase of 19.23% and 12.16% respectively over the same period last year. innovative drugs in the fields of small molecule targeted therapy, immunotherapy, cell therapy and other fields have made substantial progress abroad, and the global market is increasingly recognizing china's innovative drugs. high-end medical devices such as surgical robots, artificial hearts, and carbon ion therapy systems have been launched successively, and some products are in leading positions in the world.
beijing business daily reporter wang yinhao
(source: beijing business daily)
