**: China ** newspaper.
Since 2024, the R&D enthusiasm of innovative drug companies has remained high, and a number of innovative drugs have been approved for marketing. At the same time, the ability of domestic innovative drug companies to go overseas has been significantly improved, and there have been more than 10 external licensing transactions since the beginning of this year. Industry insiders said that the investment and financing of the pharmaceutical industry have gradually recovered, pharmaceutical companies have increased R&D investment, and the number of clinical applications for innovative drugs has continued to reach a new high.
According to the "2023 Drug Evaluation Report" released by the State Food and Drug Administration a few days ago, 40 varieties of Class 1 innovative drugs will be approved for marketing in 2023.
The pace of the review was accelerated.
In 2023, the number of drug registration applications will continue to grow. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (hereinafter referred to as the "Center for Drug Evaluation") accepted 18,503 registration applications of various types, a year-on-year increase of 3584%。
In 2023, the drug review center will complete a total of 15,713 registration applications, a year-on-year increase of 2880%。Among them, there were 14,523 applications for the registration of pharmaceutical preparations, a year-on-year increase of 2779%。Among the 14,523 registration applications for pharmaceutical preparations, 10,642 were registration applications for technical review, a year-on-year increase of 2575%。
In terms of drug types, there were 878 applications for registration of traditional Chinese medicines, a year-on-year increase of 13105%；There were 7,725 applications for chemical drug registration, a year-on-year increase of 2488%, accounting for 72 of all technical review and review59%；There were 2,030 applications for registration of biological products, a year-on-year increase of 741%；9 applications for registration of drug-device combinations.
The Drug Evaluation Center has taken a variety of measures to improve the efficiency of the review, speed up the speed of drug review, and provide patients with more drug choices based on clinical value. In 2023, 40 varieties of Class 1 innovative drugs will be approved for marketing. Among them, 9 varieties were approved for marketing through the priority review and approval process, and 8 varieties were included in the breakthrough drug program in the clinical research stage.
In 2023, 45 varieties of drugs for rare diseases will be approved (excluding 4 types of drugs for rare diseases such as chemical drugs). Among them, 15 varieties have been accelerated through the priority review and approval process, and 1 has been conditionally approved for marketing. 92 varieties of children's medicinal products were approved throughout the year. Among them, 26 varieties have been accelerated to market through the priority review and approval process; In addition, 20 varieties were approved to expand the indications for children. During the year, 3 CAR-T cell ** products were approved, including the conditional approval of Igneucel injection and nalkine autoleucel injection, and the conditional approval of axileucel injection to add new indications.
The Drug Review Center strengthens guidance and promotes drug research and development. In 2023, the Drug Evaluation Center received a total of 286 applications for breakthrough drug procedures, and 70 applications were approved for inclusion in the breakthrough drug program, accounting for 24 of the total number of applications5%, an increase of 43% from 2022. The top three drugs are anti-tumor drugs, drugs for nervous system diseases and drugs for digestive diseases.
The speed of approval and marketing of innovative drugs has accelerated. In the first half of 2023, 24 innovative drugs and 28 innovative medical devices were approved for marketing, exceeding the whole of 2022.
Enter the quality improvement stage.
Driven by policies, innovative drug companies have increased R&D investment in recent years, and some pharmaceutical companies have entered the harvest period. In 2023, the Center for Drug Evaluation will formulate and revise 74 guiding principles, release 60 new guidelines, and issue a total of 482 drug technical guidelines.
Industry insiders believe that under the guidance of the innovation-driven strategy, China's independent drug innovation has been significantly accelerated in recent years, the R&D capacity has been rapidly improved, and the number of innovative drugs on the market and the number of clinical trials have increased significantly. The Drug Evaluation Center has issued technical guidelines, which have laid the foundation for standardizing and guiding the new drug research and development procedures and promoting the establishment of an innovation ecosystem. The R&D of domestic innovative drugs has entered the stage of quality improvement.
Entering 2024, the R&D enthusiasm of innovative drug companies is still high, and the products of many pharmaceutical companies have been approved for marketing. On the evening of January 31, Hengrui Pharmaceutical announced that it had recently received the "Drug Registration Certificate" approved and issued by the State Food and Drug Administration, and approved the company's self-developed Tygelidine Fumarate injection to be marketed for moderate to severe pain after abdominal surgery. This is China's first self-developed Class 1 opioid analgesic innovative drug, providing patients with a new first-class solution.
Previously, Hengrui Pharmaceutical has successively approved 3 innovative drugs for marketing, including abiraterone acetate tablets for prostate cancer, hengpagliflozin metformin sustained-release tablets for improving blood sugar control, and irinotecan hydrochloride liposomal injection for pancreatic cancer.
Both Sihuan Pharmaceutical and Qijin Pharmaceutical have been approved for marketing of innovative drugs. Among them, Sihuan Pharmaceutical announced on January 23 that the sodium-glucose transporter 2 inhibitor (SGLT-2 inhibitor) developed by its non-wholly-owned subsidiary, Huisheng Biotech, and the national Class 1 innovative drug proline plus agliflozin tablets were approved by the State Food and Drug Administration for the use of **type 2 diabetes.
Some listed companies have updated the progress of relevant product research and development. On the evening of February 4, Hengrui Pharmaceutical announced that the SHR-A1811 for injection of its subsidiary Suzhou Shengdia Biopharmaceutical*** was proposed to be included in the list of breakthrough varieties by the Drug Review Center. In addition, the company's SHR-A1811 for injection has received breakthrough designation in four indications**.
Expand overseas markets.
While the R&D capabilities of domestic innovative drug companies continue to improve, their ability to go overseas has been significantly enhanced.
In addition to product approvals, there are frequent transactions between domestic pharmaceutical companies and overseas giants. Donghai** said that according to incomplete statistics, from 2021 to 2023, there will be at least 120 overseas licensing transactions of China's innovative drugs, with a total transaction value of nearly 85 billion US dollars.
Entering 2024, innovative drug companies will set off another boom in going overseas. Pharmaceutical companies such as WuXi Biologics, Mabwell, Anrui Biologics, and Ribo Biologics have announced cooperation with overseas pharmaceutical companies, with a total of more than 10 external licensing transactions.
Industry insiders said that the intensive expansion of innovative drug companies shows that the R&D capabilities of Chinese innovative drug companies have been recognized by overseas markets. With the adjustment of the industry structure, it is expected that transactions and mergers and acquisitions between pharmaceutical companies will become more frequent in 2024. (Fu Suying).