According to the incomplete statistics of the State Food and Drug Administration and the announcements of various enterprises, Hengrui Pharmaceutical's emaxitinib sulfate tablets, Chia Tai Tianqing Pharmaceutical's TQ-B3525 tablets, Haisco's HSK16149 capsules, and Kelun Pharmaceutical's Tetelimab injection ......53 domestic Category 1 new drugs are expected to be approved for marketing within this year.
It may take more than ten or twenty years for an innovative drug to go from preliminary research and development to clinical trials to approval and marketing. The review and approval of innovative drugs in 2023 is based on 5 or even 15 years ago. Chen Hao, director of the Drug Policy and Management Research Center of Tongji Medical College of Huazhong University of Science and Technology, told the People's ** Health Client reporter, "Since the drug review reform in 2015, China's clinical trial application and new drug review processes have been greatly shortened, so the approval of innovative drugs in 2023 is the result of the reform in 2015." ”
The reporter of the people's ** health client noticed that in the pipeline of innovative drugs under development, Hengrui currently has 6 Class 1 new drugs entering the sprint period for listing. In terms of the first category, anti-tumor and immunomodulators, digestive system and metabolic drugs are the majority, with 2 respectively, and 1 sensory system drug and 1 cardiovascular and cerebrovascular system drug. In CP Tianqing Pharmaceutical's focus on building a leading anti-tumor new drug product line, 4 anti-tumor Category 1 new drugs are expected to be approved for marketing this year, including 3 small molecule chemical drugs and 1 large molecule biological drug.
In 2015, the "Measures for the Administration of Drug Registration (Revised Draft)" was proposed, and the special approval process for new drugs created and new drugs for difficult and critical diseases was further optimized. The launch of the reform has ushered in an opportunity for the rise of the innovative drug industry. Today, China's local pharmaceutical innovation has gone through the initial stage of "savage growth" and is ushering in the development stage of "big waves and sands", and innovative drugs with real clinical value will be left behind.
Chen Hao said that the state encourages innovative drugs in policy, and there is an objective demand, because there are still a large number of clinical needs that cannot be met. However, in fact, innovation needs to be rewarded, and there are three prerequisites: first, a relatively complete intellectual property protection system is required, second, there must be the ability or willingness to pay a relative premium for innovation, and third, an atmosphere of respect for innovation in the whole society must be formed.