On May 20th, International Clinical Trials Day, the National Medical Products Administration's Center for Drug Evaluation (referred to as the Drug Evaluation Center) released the "Annual Report on the Progress of China's New Drug Registration Clinical Trials (2023)."
The report screenshot shows that the total number of annual registrations on the Drug Clinical Trial Registration and Information Disclosure Platform has reached a record high, surpassing 4000 for the first time to reach 4300 (based on clinical trial registration numbers). This marks an increase of nearly 1000 registrations compared to the previous year when it first exceeded 3000. In the clinical trials first disclosed in 2023, domestic sponsors accounted for over 90% of the total. The drug registration classification is predominantly Class 1, accounting for about 70% of the total, with traditional Chinese medicine, chemical drugs in Class 1 at 31.6% and 66.6% respectively, and therapeutic and preventive biological products in Class 1 at 79.2% and 49.6% respectively.
Class 1 drugs are mainly anti-tumor drugs.
In recent years, the proportion of new drug clinical trials for chemical drugs and biological products has been relatively high when classified by chemical drugs, biological products, and traditional Chinese medicine, with chemical drugs being the highest at over 50% and biological products at around 40%. Traditional Chinese medicine accounted for 3.3% in 2023.
In terms of registration classification analysis, in 2023, a total of 1606 trials of Class 1 drugs were registered, accounting for 69.1% of the total registered trials, with chemical drugs having the highest proportion at 53.7%. Class 1 innovative drug clinical trials continue to focus mainly on anti-tumor drugs, accounting for 40.6% of the total. In 2023, there were 81 registered clinical trials for cell and gene therapy products, almost doubling from 2022 (46 trials), mainly focusing on domestic Phase I anti-tumor drugs. The number of clinical trials for medical imaging drugs totaled 14, the highest in recent years.
When classified by new drug clinical trials and bioequivalence trials, new drug clinical trials accounted for 54.0% in 2023, while bioequivalence trials accounted for 46.0%. Domestic sponsors accounted for over 90%, reaching 91.7%.
The report highlights that in 2023, the target indications for chemical drugs and biological product clinical trials mainly focused on the anti-tumor field, followed by anti-infective drugs, dermatological and ophthalmological drugs, drugs for neurological disorders, preventive vaccines, endocrine system drugs, and hematologic disease drugs. Traditional Chinese medicine mainly focused on indications related to respiratory, digestive, dermatological and ophthalmological, and psychiatric-neurological areas.
Phase I clinical trials have the highest proportion.
In 2023, the overall distribution of clinical trials by phase was similar to 2022, with Phase I clinical trials having the highest proportion at 42.1%; in Class 1 innovative drug clinical trials, Phase II and Phase III clinical trials saw a slight increase compared to the previous year, at 21.3% and 15.8% respectively. There were 104 clinical trials conducted specifically for children. The number of clinical trials for rare disease drugs showed a significant growth trend, with expanded indications including anti-tumor drugs, hematologic diseases, neurological disorders, respiratory diseases, anti-allergy drugs, rheumatic diseases, and immunomodulatory drugs.
In 2023, the leading units and participating units for clinical trials were mainly located in Beijing, Shanghai, Jiangsu, Hunan, and Guangdong provinces. Among them, the leading units for pediatric clinical trials were mainly concentrated in Beijing.
The report reveals that in 2023, China approved a total of 40 innovative drugs, with domestic holders of marketing approvals accounting for over 90.0%. Innovative drugs were mainly chemical drugs and biological products, with 19 (47.5%) and 16 (40.0%) varieties respectively, including a total of 14 (35.0%) anti-tumor drugs. Five traditional Chinese medicine varieties were approved, covering indications in dermatology and ophthalmology, digestive system, respiratory system, and psychiatric-neurological areas. The average time for innovative drugs approved for marketing in 2023 was 7.2 years, similar to the previous year.
Lastly, the report points out that the number of new drug clinical trials in China continues to increase annually, with improvements in the efficiency and quality of clinical trial implementation. Innovation and efficiency coexist, indicating significant development potential in the Chinese innovative drug industry. With China's encouragement of innovation policies and proactive measures by research and development enterprises, the pace of new drug approvals is expected to accelerate, better meeting the medication needs of Chinese patients.
