Today (March 5), CDE will Jiangsu Kangyuan Pharmaceutical Co., Ltd. *** hereinafter referred to as "Kangyuan Pharmaceutical").Dragon Seven capsulesVarieties to be included in the priority review, functional indications:Dispel phlegm and eliminate stasis, clear the lungs and eliminate accumulation。It is used for cough, phlegm, phlegm blood, wheezing (shortness of breath), chest tightness, chest pain, and can relieve pain caused by phlegm stasis obstruction of lung cancerShrinks or stabilizes tumorsto prolong the survival time without disease progression and improve the quality of life.
CDE official website.
The innovation of traditional Chinese medicine has increased
Clinical research accelerated
In recent years, China's policy support for the pharmaceutical industry has increased significantly, promoting the rapid development of the industry in the direction of high quality and innovation. At the same time, as a national treasure that has been precipitated for thousands of years in China, the inheritance and innovation of traditional Chinese medicine has received special attention from the industry and the national level. According to the "2023 Drug Evaluation Report", according to the statistics of drug types, the number of applications for registration of traditional Chinese medicines reached 1,163 throughout the year, of which the number of innovative Chinese medicine INDs increased significantly compared with last year.
With the increase of policy support and the improvement of the level of enterprise innovation, the innovation of traditional Chinese medicine has reaped a number of fruits. In 2023,A total of 5 innovative Chinese medicine drugs have been approved for marketing by the NMPAIndications cover depression, pediatric bronchitis, dyspepsia, etc.
NMPA official website.
Professor Wu Chengyu, a national famous teacher of traditional Chinese medicine, researched and developed the "Dragon Seven Capsule", which is also oneInnovative Chinese medicine, which has been studied for diseases such as lung cancer. According to relevant reports, Longqi Capsule was declared for clinical trial in 2005, and a series of clinical studies were carried out after approval, and in 2011, it was approved by Jiangsu Province as a project for the transformation of scientific and technological achievements in Jiangsu Province.
According to the official website of CDE, Kangyuan Pharmaceutical's Longqi capsule is in accordance with the "Measures for the Administration of Drug Registration".Special Provisions on the Registration and Administration of Traditional Chinese Medicinesand other documents, which are proposed to be included in the priority review varieties. Longqi Capsule has been approved by CDE for priority review, which is expected to further accelerate the listing process.
Deeply cultivate the field of traditional Chinese medicine
There are abundant pipelines under development
Kangyuan Pharmaceutical Co., Ltd. is a company thatInnovative research and development of traditional Chinese medicineAs the main body, and actively deploy chemical drugs, biological drugs and other fields of traditional Chinese medicine ace pharmaceutical companies, product line focusRespiratory and infectious diseases, ** diseases, cardiovascular and cerebrovascular diseases, orthopedic diseasesand other advantageous areas of traditional Chinese medicine. As of June 2023, Kangyuan Pharmaceutical has obtained a total of 207 drug production approvals, including:46 drugs are exclusive varieties of traditional Chinese medicine, and a total of 4 protected varieties of traditional Chinese medicine.
On this basis, Kangyuan Pharmaceutical has further accelerated the pace of innovation in traditional Chinese medicine and has built a rich pipeline of products under development.
Kangyuan Pharmaceutical's 2022 report.
In addition, in 2023, the clinical research of a number of TCM projects of Kangyuan Pharmaceutical will make progress.
Children's spleen granules
In October 2023, Kangyuan Pharmaceutical announced 1Class 1 innovative drugs of traditional Chinese medicineChildren's spleen granulesApproved for clinical trials, clinical trials will be conducted for children with functional dyspepsia, spleen deficiency, and food stagnation syndrome. The prescription of the drug originates from:Clinical experienceKangyuan Pharmaceutical has independent and complete intellectual property rights.
The turtle returns the particles
August 2023, 1Class 1 innovative drugs of traditional Chinese medicineThe turtle returns the particlesIt has been approved for clinical trial, and clinical trials will be carried out for patients with early-onset ovarian insufficiency with TCM syndrome differentiation and kidney yin deficiency syndrome. According to the announcement of Kangyuan Pharmaceutical, the prescription originated fromProfessor Xia Guicheng, a master of traditional Chinese medicine, has clinical experienceThe main pharmacodynamic studies in preclinical studies have shown that it has a significant effect on the premature ovarian failure model.
At the same time, in addition to traditional Chinese medicine innovative drugs, Kangyuan Pharmaceutical is also accelerating its promotionChemical innovative drugs, biological innovative drugsThe research process, including CD38 monoclonal antibody KYS202002A, has been approved for the study of multiple myeloma and systemic lupus erythematosus disease.
Conclusion
In February 2023, the General Office of ** issued the "Implementation Plan for Major Projects for the Revitalization and Development of Traditional Chinese Medicine", giving clear instructions for the revitalization of traditional Chinese medicine. In the future, with the re-optimization of the drug review and approval system and the acceleration of the pace of innovation, China's traditional Chinese medicine will reap more innovative fruits.
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