Industry insiders indicate that global innovative drug research and development is entering an era of rapid change and competition, and domestic and foreign pharmaceutical companies are continuously increasing investment and innovation, driving a large number of clinical applications and new drug launches.

 

 

 

It is reported that in recent years, the National Medical Products Administration has deepened the reform of the drug evaluation and approval system, encouraged, guided, and served drug innovation and research and development, continuously improved standards, optimized procedures, increased efficiency, and improved services, and released the policy dividend of accelerating the launch of "new drugs and good drugs". A large number of innovative new drugs and medical devices have been approved for market.

 

 

 

According to relevant statistics, since 2022, 82 innovative drugs and 138 innovative medical devices have been approved. Only in the first five months of 2024, 20 innovative drugs and 21 innovative medical devices have been approved, including new biotechnology products such as CAR-T and monoclonal antibodies, innovative traditional Chinese patent medicines and simple preparations, artificial heart products using full magnetic suspension technology, and CT image aided detection software using artificial intelligence technology. According to relevant sources, both in terms of quantity and quality, the development momentum of innovative drugs in China is strong, and the future is promising.

 

 

 

In addition, according to the "Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2023)" released by the Drug Evaluation Center of the National Medical Products Administration on May 20, a total of 40 innovative drugs were approved in 2023. The clinical trials of Class 1 innovative drugs continue to focus on anti-tumor drugs, accounting for 40.6% of the total.

 

 

 

It is reported that under the support of the national favorable policies, many pharmaceutical enterprises in China have made a breakthrough in the research and development of innovative drugs by virtue of their innovative ability and stable market layout.

 

 

 

Taking Zhongsheng Pharmaceutical as an example, in 2023, Zhongsheng Pharmaceutical's Lairuitewei tablets (trade name: Lerui Ling) ®) A class of innovative drugs approved for market and included in the national medical insurance catalog. Another innovative drug used to treat influenza A, Angravir tablets (Anruiwei) ®)， The NDA application has been submitted and is expected to be approved for listing within the year at the earliest. In the field of anti diabetic and metabolic diseases, the company is accelerating the progress of clinical trials for the long-acting GLP-1 drug RAY1225. In February of this year, two phase II clinical studies on blood sugar reduction and weight loss were launched. Another small molecule innovative drug ZSP1601 for the treatment of MASH is currently undergoing Phase IIb clinical trials. In the future, it is expected to bring new growth points to Zhongsheng Pharmaceutical.

 

 

 

As of now, Zhongsheng Pharmaceutical has 6 innovative drug projects in the clinical trial stage, 1 innovative drug project has been approved for market, and the new drug application for 1 innovative drug project has been accepted.

 

 

 

For example, Hengrui Pharmaceutical, a leading enterprise in the domestic pharmaceutical industry, has actively promoted the transformation of innovative drugs in recent years. Data shows that in recent years, Hengrui Pharmaceutical has continuously increased its innovation efforts and maintained a high level of research and development investment. In 2022, the company's total research and development expenses reached 6.346 billion yuan, accounting for 29.83% of its revenue. In 2023, Hengrui Pharmaceutical's cumulative R&D investment reached 6.15 billion yuan, accounting for 26.95% of its revenue. In the first quarter of this year, its research and development expenses reached 1.22 billion yuan. At present, Hengrui Pharmaceutical has abundant pipeline reserves in research and development, and the internationalization process continues to accelerate. It is reported that Hengrui Medicine has a rich R&D pipeline in the field of oncology, and has also made extensive layouts in areas such as autoimmune diseases, pain management, cardiovascular diseases, metabolic diseases, etc.

 

 

 

Data shows that Hengrui Pharmaceutical has launched 16 innovative drugs and 4 Class 2 new drugs in China, and more than 90 independent innovative products are currently under clinical development. Nearly 300 clinical trials are being conducted both domestically and internationally.

 

 

 

It is reported that since the beginning of this year, there have been continuous policies supporting the development of innovative medicine in China. The recent approval of the Implementation Plan for Supporting the Development of Innovative Drugs in the Whole Chain signifies that more forces will be involved in promoting the development of innovative drugs in the future. The industry believes that with the comprehensive strength of the country and the huge scale of the domestic innovative drug market, world-class innovative drug companies will definitely emerge in China in the future.