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Supporting the application of levalbuterol for national medical insurance will accelerate the domestic substitution of inhaled formulations of Health Yuan.
Published Time：
2020-09-29
Respiratory diseases such as asthma, COPD, and rhinitis have become common chronic diseases worldwide. In China, there are more than 100 million potential asthma and COPD patients. Among them, COPD is the "number one killer" of respiratory chronic disease patients in many parts of the country. Among the many drugs used to treat respiratory chronic diseases, inhalation preparations are currently recognized as the standard medication.
What are inhalation preparations?
Inhalation preparations are a type of drug formulation in which the drug is delivered directly into the respiratory tract through a special delivery device to exert local or systemic therapeutic effects. The physiological characteristics of the lungs determine the characteristics and advantages of inhalation preparations in achieving drug delivery through the lungs.
First, for lung diseases, inhalation preparations are a local method of drug administration, Its advantage is that it can quickly and directly improve drug efficacy, thereby reducing the dosage and reducing adverse reactions caused by the drug.
Secondly, because the lungs have a large lung surface area, a permeable alveolar epithelium, and a rich vascular network, and the chemical and enzymatic degradation activity in the lungs is low, it is conducive to the administration of large biomolecules such as proteins and nucleic acids, so inhalation preparations are also suitable for systemic drugs such as insulin, vaccines, and growth hormone.
Healthy Yuan accelerates the layout of the respiratory field and accelerates the domestic substitution of inhalation preparations.
Currently, there are about 100 million patients with chronic obstructive pulmonary disease in China, and about 45.7 million adult asthma patients, with a large patient base. In the global asthma and COPD drug market, common administration methods include intravenous injection, inhalation, and oral administration, among which the proportion of inhalation formulations is about 80%, This means that the domestic market space for inhalation preparations is huge.
However, for a long time, more than 90% of the market for respiratory disease-related inhalation preparations in China has been occupied by multinational pharmaceutical giants, directly leading to the high cost of long-term treatment for respiratory chronic diseases, which has burdened many families. At the same time, this market has always been called by the industry " the most high-end and difficult sub-segment in the generic drug field ", with high technical barriers to development and complex production processes. Even globally, there are few companies that focus on the development of such formulations.
In order to accelerate the reversal of the long-term dominance of imported brands in the Chinese inhalation preparation market, domestic pharmaceutical companies have entered the market one after another, focusing on research in areas such as formulation research, invention of disruptive technologies, and mastery of core technologies, using "combination of innovation and imitation + independent innovation" model, striving to minimize the cycle of breaking through the weak links in drug research and development. In recent years, with more and more domestic inhalation agents being approved for listing, the domestic substitution process of inhalation preparations is also being carried out vigorously.
After years of persistence and efforts, some domestic companies have achieved domestic substitution in this field, In terms of the first imitation of inhalation preparations, Healthy Yuan Pharmaceutical Group is in the forefront.
Healthy Yuan not only leads the inhalation preparation industry in research and application declaration varieties, but its approved products also lead the terminal market for inhalation preparations. Up to now, Healthy Yuan (including subsidiaries) has 4 inhalation agents approved for production and deemed to have passed the evaluation These are ipratropium bromide solution for inhalation, budesonide suspension for inhalation, compound ipratropium bromide solution for inhalation, and levalbuterol hydrochloride nebulization solution. Among them, the first three varieties are among the top ten best-selling inhalation agents in China's public medical institutions in 2019, Levalbuterol hydrochloride nebulization solution has filled the gap in the domestic market.
Commonly used inhaled salbutamol in China often causes headaches, tachycardia, and other adverse reactions. Levalbuterol is the active ingredient of salbutamol, removing the harmful dextrorotatory component. While ensuring clinical efficacy, it reduces the dosage and has higher safety.
In September 2020, Lishutong ® (levalbuterol hydrochloride nebulization solution) was jointly recommended by the "Standardized Diagnosis and Treatment Suggestions for Childhood Bronchial Asthma" and the "Expert Consensus on the Integrated Traditional Chinese and Western Medicine Prevention and Treatment of Childhood Asthma";
In August 2020, Lishutong ® (levalbuterol hydrochloride nebulization solution) children's special small-specification dosage form was approved;
On July 23, 2020, 0.5mg budesonide suspension for inhalation—Wushu ® was approved for listing through new Class 4 registration, becoming the first small-specification budesonide in China to pass consistency evaluation, and made a significant appearance at the 2020 China Respiratory Forum on August 15;
In September 2019, Lishutong ® (levalbuterol hydrochloride nebulization solution) was approved for registration of new Class 3, becoming the only domestic nebulization variety;
In April 2019, Shutanlin, Healthy Yuan's first respiratory product ® (compound ipratropium bromide solution for inhalation) was approved for listing, becoming the first respiratory disease inhalation preparation in China to pass consistency evaluation.
Please support the application of "levalbuterol hydrochloride nebulization solution" to enter the 2020 National Medical Insurance Catalog.
Lishutong developed by Healthy Yuan ® (levalbuterol hydrochloride nebulization solution), as the first new Class 3 registered nebulization solution in China, is the first levalbuterol preparation to be listed in China.
Compared to ordinary salbutamol, Lisu Tong ® has fewer side effects, better efficacy, and lower dosage etc. The efficacy of 0.63mg levosalbutamol is equivalent to 2.5mg salbutamol, It is the only SABA nebulization inhalation product with children's specifications officially recommended in the 2020 revised "Standardized Diagnosis and Treatment Suggestions for Childhood Bronchial Asthma", and it does not need to be halved.
◆ Lisu Tong ® Removes harmful dextrorotatory isomers. The incidence of blood potassium reduction exceeding 0.8 mEq/mL is reduced by 76% compared to salbutamol, and the incidence of side effects is lower;
◆ Lisu Tong ® For children, the improvement level of FEV1 peak value is 53% higher than that of salbutamol, which can effectively promote symptom improvement, and the outpatient hospitalization rate of children is 20% lower than that of salbutamol;
◆ Lisu Tong ® It is specially designed for children, with obvious advantages in dosage form, 0.31mg/dose (National Drug Approval Number H20205016), which is the recommended dose for 6-11 years old children for each nebulization inhalation, and can treat or prevent bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years old.
It is worth noting that on June 6, 2018, the list of the 29th batch of drug registration applications included in the priority review procedure announced by the Center for Drug Evaluation of the National Medical Products Administration included 3 children's drugs, and Lisu Tong developed by Jiankangyuan ® (Levosalbutamol hydrochloride nebulization inhalation solution) is among them. Since the registration application was included in the priority review procedure, the National Medical Products Administration approved Lisu Tong in only one year and two months ® for market launch This highlights the profound technical R&D background of Jiankangyuan's R&D team and the urgent market demand for this drug.
Please pay attention to the rationality, accessibility, and necessity of pediatric drug use;
Please support the application of "Levosalbutamol hydrochloride nebulization inhalation solution" to enter the 2020 National Medical Insurance Catalog!
Currently, Jiankangyuan's marketed and under-research products in the field of inhalation preparations are in a "ladder-type" explosive stage. After these drugs are launched, they will gradually expand the types of domestic respiratory inhalation preparations, break the monopoly of multinational pharmaceutical companies' original research drugs, and meet the needs of a large number of patients with respiratory chronic diseases for drug safety, efficacy, and economy multiple needs, providing more high-quality drug choices for more than 100 million asthma and COPD patients in China, helping more people realize their wish for smooth breathing!
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