In today's global healthcare field, cardiovascular disease is one of the primary public health challenges, and its prevention and treatment is of great importance. With the aging of the population and the changes in social life patterns, the burden of cardiovascular diseases in China is becoming increasingly heavy, which poses a huge test to the public health system. In order to effectively address this challenge, the R&D, approval, marketing and quality improvement of cardiovascular drugs in China have become key links.
Based on the latest China Cardiovascular System Drug Analysis Report in 2024, this article aims to deeply discuss the development trends of cardiovascular system drugs in China in recent years, especially focusing on the undertaking of innovative drugs and improved new drugs, the cycle and success rate problems faced by R&D, the trend of new drug launches, the distribution of drug markets, the progress of generic drug consistency evaluation, as well as the performance of industry leaders and the market potential of varieties that have not been centrally procured.
Through a comprehensive analysis of the above aspects, we strive to paint a comprehensive and detailed picture of the current situation of China's cardiovascular drug field, reveal the development trends and policy directions behind it, and provide valuable reference and insight for relevant researchers, medical professionals, policy makers and industry investors. In this era of rapid change, it is of great significance to understand and grasp the latest progress in the field of cardiovascular drugs to promote medical innovation, optimize resource allocation, and improve public health.
1. Cardiovascular innovative drugs/improved new drugs
In recent years, China's cardiovascular system drug field has shown strong R&D vitality. According to the statistics of Yaorong Cloud Database, from 2013 to 2022, the number of registration applications for innovative drugs/improved new drugs in China's cardiovascular system has shown an increasing trend year by year, with a compound annual growth rate of 22.5%. Despite this, a total of 31 cardiovascular drug applications were accepted by the Center for Drug Evaluation (CDE) in 2022, accounting for only 2.42% of the total CDE acceptance volume that year, which reflects the high threshold for new drugs to enter the market due to factors such as low clinical success rate and long R&D cycle of cardiovascular drugs.
Image source: Pharmaceutical Finance Consulting, "China Cardiovascular System Drug Analysis Report"
Second, the R&D cycle of cardiovascular system drugs is long and the success rate is low
Compared with other drugs, cardiovascular drugs are more complex in the development process, with a lower success rate and longer time to develop. According to the analysis of Biomedtracker data, the R&D cycle of cardiovascular drugs is as long as 11.6 years, second only to urological drugs, and the success rate of all clinical stages is lower than average: the success rate of clinical phase I is 50%, phase II is 21%, phase III is 55.2%, and the success rate of new drug application (NDA) submission is 82.5%. Complex pathological mechanisms and strict efficacy safety standards make the development of cardiovascular drugs more difficult and time-consuming.
3. New drugs for the cardiovascular system
Since 2022, China's cardiovascular system has ushered in the launch of four new drugs, namely Novartis' Inclisiran injection, Innovent Pharmaceutical's tolecimab injection, Bayer's Finerenone film-coated tablets and Vericiguat tablets, highlighting the progress in the field of cardiovascular disease treatment in China. It is worth noting that among the four new drugs, only tolecimab injection is a self-developed product in China.
Tolecimab injection - the first anti-PCSK9 monoclonal antibody drug originally developed in China
Tolecimab Injection (trade name: Symbila ®) is the first original anti-PCSK9 monoclonal antibody drug independently developed by Innovent Biologics Group, and the first original innovative cardiovascular biologic in China, for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia.
As the first anti-PCSK9 monoclonal antibody drug in China and the third in the world, Tolecimab injection has the longest half-life among marketed products, and a single dose can reduce LDL-C for three weeks, providing a flexible medication regimen of 2 weeks, 4 weeks, and 6 weeks with three treatment intervals, which can further rapidly reduce LDL-C by about 50% on the basis of medium-dose statins, with a maximum reduction of 66%, while taking into account Lp(a), with a maximum reduction of 47.6%, which can reduce LDL-C and Lp(a) The achieved dual lipid management will also bring more cardiovascular benefits to patients.
4. Approval and marketing of cardiovascular drugs
According to the statistics of the China Drug Evaluation Database of Yaorongyun, from 2018 to 2022, a total of 692 cardiovascular drugs were approved for marketing by the National Medical Products Administration, showing a continuous growth trend.
Among them, drugs acting on the renin-angiotensin system, lipid regulators and heart disease treatment drugs occupied a dominant position, accounting for 25.87%, 22.98% and 16.18% respectively. In contrast, the number of drugs in the categories of vasoprotectants, peripheral vasodilators, and diuretics was small, with a total of 81, accounting for 12.57% of the total.
5. Progress in the consistency evaluation of drugs in the cardiovascular system
In the field of generic drugs, the consistency evaluation of drugs for cardiovascular diseases is also accelerating. Since 2017, the number of applications and approvals for consistency evaluations undertaken by CDE has increased year by year.
In 2022, a total of 385 generic drug consistency evaluation applications were undertaken by CDE, of which 92 were consistency evaluation applications and 293 were newly registered generic drug applications. Since 2017, a total of 1,691 applications for consistency evaluation of generic drugs in the cardiovascular system have been undertaken by CDE, with a compound annual growth rate of 52.35%. (Data as of June 30, 2023)
Data source: Yaorong Cloud Database (data statistics as of 2023.6.30)
In 2022, a total of 184 generic drugs passed/deemed to have passed the consistency evaluation application, of which 74 passed the consistency evaluation and 110 were deemed to have passed the consistency evaluation. Since 2017, a total of 849 generic drugs in the cardiovascular system have passed the consistency evaluation application, with a compound annual growth rate of 75.75%. (Data as of June 30, 2023)
6. Top 10 enterprises in the consistency evaluation of cardiovascular system drugs
Since 2017, among the many companies participating in the consistency evaluation of drugs in the cardiovascular system, Zhejiang Huahai Pharmaceutical, Zhejiang Nuode Pharmaceutical, Ningbo Menova Tiankang Pharmaceutical, Beijing Fuyuan Pharmaceutical, Ningbo Kerkang Menova Pharmaceutical, Qilu Pharmaceutical and other enterprises have performed outstandingly, and the number of consistency evaluation applications and passes are in the forefront.
Top 10 enterprises applying for consistency evaluation of cardiovascular system drugs
In particular, Zhejiang Huahai Pharmaceutical Co., Ltd. applied for 35 consistency evaluations, and 25 consistency evaluations passed to occupy the top spot.
The consistency evaluation of cardiovascular system drugs passed the TOP10 enterprises
Zhejiang Huahai Pharmaceutical Co., Ltd. was founded in 1989 and is headquartered in Zhejiang, China. It is mainly engaged in the R&D, production and sales of generic drugs, biological drugs, innovative drugs and characteristic APIs in multiple dosage forms, and is a pharmaceutical enterprise integrating pharmaceutical R&D, manufacturing and sales. The products cover cardiovascular, psychiatric, antiviral and other fields, and it is one of the world's major manufacturers of cardiovascular and psychiatric health medical products.
Huahai Pharmaceutical's cardiovascular products include: Anlai · irbesartan tablets, Beiyue · irbesartan hydrochlorothiazide tablets, Yali · fosinopril sodium tablets, Beiyi · losartan potassium tablets, huayito· rivaroxaban tablets, huayitan· ambrisentan tablets, Beze· valsartan tablets, Noplyl · lisinopril tablets, Amolan · olmesartan cilexetil hydrochlorothiazide tablets, valina Yue · valsartan amlodipine tablets, etc.
7. Information on varieties of cardiovascular drugs that are not included in centralized procurement
According to the Pharmaceutical Finance Cloud Database, as of October 31, 2023, among China's cardiovascular system drugs, 51 varieties have passed the consistency evaluation of five manufacturers or more, and only 4 of them have not been included in centralized procurement.
The consistency evaluation of these varieties not included in the centralized procurement (esmolol hydrochloride injection, sacubitril-valsartan sodium tablets, digoxin injection, and tolvaptan tablets) is later than August 2023.
Epilogue:
In general, China's cardiovascular drug market is booming, with an increase in innovative drug applications, and despite the difficulty and long cycle of research and development, the launch of new drugs has accelerated, and the consistency evaluation process of generic drugs has accelerated, improving the accessibility and quality of drugs. In the market, new drugs continue to emerge, generic drug competition is intensifying, and high-concern varieties that have not been collected indicate new opportunities in the market. The achievements of leading enterprises in consistency evaluation lead industrial upgrading and promote the development of the industry to higher quality. Looking at the overall situation, China's cardiovascular drug field is actively responding to challenges and contributing to the improvement of national cardiovascular health through policy promotion, scientific and technological innovation and market optimization.
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