Author:Qingfeng Pharmaceutical Group
Posted Time:2024-11-28 00:00
On November 28, the National Healthcare Security Administration (NHSA) announced the results of the 2024 adjustments to the National Medical Insurance Drug List. Qingfeng Pharmaceutical’s Oranti® Citrus Aurantium Total Flavonoid Tablets and QingRuiTan® Brivaracetam Tablets were officially included.
Aurantii Fructus Immaturus Total Flavonoids tablets (Natural Gastrointestinal Motility Drug)
Aurantii Fructus Immaturus Total Flavonoids tablets are an innovative TCM developed by Qingfeng Pharmaceutical over a period of more than ten years. Its primary ingredient, Citrus Aurantium Total Flavonoid Extract, is used to treat functional dyspepsia. It is the world’s first natural gastrointestinal motility drug and China’s first 1.2-class innovative TCM.
Compared with new chemical drugs and biologics, there have been very few innovative 1.2-class TCMs approved for market in recent years. Under the current rules and evaluation systems, achieving both scientific rigor and clinical value in innovative TCMs is no easy feat.
Especially for the development of new TCM drugs classified as 1.2, modern technological methods are required to extract and screen effective components from the complex natural substances, before a modern preparation can be formulated. However, the development must be based on traditional Chinese medicine theory while still adhering to modern drug evaluation standards, with sufficient preclinical and clinical research. This is a significant challenge for most drug innovations derived from natural TCM products.
The global prevalence of functional dyspepsia is more than 10%, with patients experiencing a 24.81% reduction in quality of life compared to healthy individuals[1]. When combined with other gastrointestinal diseases, the impact on the patient’s quality of life is even more significant[2].
Two Phase III clinical trials show that Citrus Aurantium Total Flavonoid Tablets effectively treat four key symptoms of functional dyspepsia: postprandial bloating, early satiety, epigastric burning, and upper abdominal pain[3]. Current treatments, both chemical and traditional Chinese medicines, have not ye fully addressed the high recurrence rate of functional dyspepsia[4]. In comparison to other treatment options, innovative TCM offers unique therapeutic advantages in this field.
With the inclusion of Aurantii Fructus Immaturus Total Flavonoids tablets in the medical insurance catalog, more patients with functional dyspepsia will have access to differentiated, safe, and effective treatments. This will improve the experience for those who have not achieved satisfactory results with previous treatments, reduce recurrence, extend the duration of patient benefits, and further reduce the financial burden.
QingRuiTan® Brivaracetam Tablets (A New Generation Antiepileptic Drug)
QingRuiTan® Brivaracetam Tablets, a third-generation antiepileptic drug developed by Qingfeng Pharmaceutical, was approved for market on June 28 this year. It fills a gap in domestic treatment options, offering an additional tool for managing epilepsy in China.
Brivaracetam Tablets have now been approved for monotherapy and adjunctive treatment of partial seizures in patients aged 16 and older. The product’s prescription information also includes recommended dosages for pediatric patients, enabling weight-based dosing for children. Brivaracetam has proven to be an important treatment option for both pediatric and adult epilepsy patients. Widespread clinical practice in regions where it is available shows that it can effectively control or improve seizures, enhancing quality of life for patients[5-7].
Brivaracetam, one of only two SV2A-targeted drugs available in the world , binds to SV2A with high affinity and selectivity[8], delivering a stronger and more sustained effect. It improves patients’ cognitive functions and quality of life over the long term. Due to its high lipid solubility, Brivaracetam rapidly crosses the blood-brain barrier [9], reaching peak plasma concentration within approximately one hour of administration, allowing it to quickly provide antiepileptic effects.
Brivaracetam has been used clinically for 8 years throughout the world[10], with its safety and tolerance widely recognized. It has been recommended in both domestic and international guidelines, such as the "Chinese Expert Consensus on the Combined Use of Antiepileptic Drugs" and the "NICE Guidelines for Epilepsy in Children, Adolescents, and Adults" (NG217), for both monotherapy and adjunctive treatment of seizures[11-12]. As a more established SV2A-targeted drug, Brivaracetam is also widely used as a replacement therapy for patients who have inadequate responses or cannot tolerate the side effects of Levetiracetam.
QingRuiTan® Brivaracetam Tablets were included in the National Medical Insurance Catalog just four months after launch, significantly improving drug accessibility, meeting urgent clinical needs, and reducing the treatment burden on patients.
Focusing on Clinical Value, Putting Patient Benefit First
In recent years, Qingfeng Pharmaceutical has actively responded to the national call for fulfilling its social responsibilities, embracing national drug procurement policies and medical insurance negotiations. The company has had more than 10 drugs included in the national centralized procurement list, as well as several drugs in the National Medical Insurance Catalog.
This time, Aurantii Fructus Immaturus Total Flavonoids tablets and QingRuiTan® Brivaracetam Tablets successfully participated in national medical insurance negotiations and were included in the updated National Medical Insurance Catalog. This will further improve the clinical accessibility of these two drugs, reduce the burden on patients, and increase benefits.
Moving forward, Qingfeng Pharmaceutical will continue to uphold its mission of "providing outstanding services for human health," focusing on unmet clinical needs and striving to provide more effective and accessible high-quality medicines to patients.
[1] Li Junxiang, Chen Xuan, Li Yan. Consensus on Integrated Traditional Chinese and Western Medicine Treatment for Functional Dyspepsia (2017) [J]. Chinese Journal of Integrative Medicine and Digestive Diseases, 2017, 25(12): 889-894.
[2] Cao Jiayi, Guo Rui, Xiong Hanhua, et al. The Relationship Between Psychological Factors, Quality of Life, and Symptoms in Patients with Functional Dyspepsia [J]. Chinese Journal of Internal Medicine, 2005, (11): 853-854.
[3] Summary Report of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Safety and Efficacy of Oranti® Citrus Aurantium Total Flavonoid Tablets in Treating Functional Dyspepsia.
[4] Lu Xiaofang, Zhang Shengsheng. Research Progress on Traditional Chinese Medicine in the Treatment of Functional Dyspepsia [J]. Chinese Journal of Integrative Medicine and Digestive Diseases, 2023, 31(06): 405-410.
[5] Kotagal, P., Koh, S., Frontera, A., et al. Clinical experience with Brivaracetam in a series of 46 children. Epilepsy & Behavior. 2020 Apr; doi:10.1016/j.yebeh.2020.04.003.
[6] Gil-Nagel, A., Burd, S., Toledo, M., et al. Efficacy, safety, and tolerability of adjunctive Brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Seizure. 2021 Jun; doi:10.1016/j.seizure.2021.06.001.
[7] Brodie, M. J., Parain, D., Hallstr?m, Y., et al. Treatment with Brivaracetam in children. Pediatric Neurology. 2020 May; doi:10.1016/j.pediatrneurol.2020.05.002.
[8] Gillard M, et al. Eur J Pharmacol. 2011 Aug 16;664(1-3):36-44.
[9] Naganawa et al. EJNMMI Research (2022) 12:71
[10] Markham A. Drugs. 2016. 76(4): 517-22.
[11] NICE guideline Published: 27 April 2022
[12] Chinese Society of Neurology. Chinese Journal of Neurology. 2024;57(2):108-117.
