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Health Yuan's terbutaline sulfate nebulizer solution has been approved, adding a new member to the inhaled preparation product matrix.
Published Time：
2022-06-13
On the evening of June 10, Jiankangyuan (600380.SH) announced that it had recently received the "Drug Registration Certificate" issued by the National Medical Products Administration for its independently developed terbutaline sulfate nebulization solution, with the acceptance number CYHS2100104. As of the announcement date, the cumulative R&D investment in Jiankangyuan's terbutaline sulfate nebulization solution is approximately RMB 9.2268 million.
It is introduced that terbutaline sulfate nebulization solution is mainly used to relieve bronchospasm combined with bronchial asthma, chronic bronchitis, emphysema and other lung diseases, and is suitable for adults and children. Terbutaline is a β2-receptor agonist that relaxes bronchi by selectively exciting β2-receptors. Terbutaline can increase the mucociliary clearance function reduced by obstructive lung disease, thereby accelerating the clearance of mucus secretions. Nebulization inhalation administration has the advantages of direct action on the target organ, rapid onset, good efficacy, and low adverse reactions. Inhaled terbutaline can take effect within minutes and the effect lasts for 6 hours.
According to IQVIA's sample statistics and estimated data, the terminal sales amount of terbutaline sulfate nebulization solution in China in 2021 was approximately 744 million yuan.
In recent years, the incidence of asthma and chronic obstructive pulmonary disease in China's respiratory disease field has continued to increase. According to statistics from the comprehensive database of industrial production and R&D in the pharmaceutical terminal market, the market size of asthma/COPD in China in 2019 was approximately 24.5 billion yuan. However, Academician Wang Chen pointed out in the "Healthy China Action (2019-2030)" that only 5.6% of patients regularly use ICS; the awareness rate of COPD is only 2.6%.
Inhalation preparations are the preferred route of administration for the treatment of respiratory diseases such as asthma and COPD, and are varieties that the country prioritizes and encourages and supports research and development. However, due to the high R&D and production barriers of inhalation preparations, the difficulty of imitation is relatively high, and the vast majority of the domestic market share has been occupied by imported manufacturers for a long time.
As an innovative and comprehensive pharmaceutical group integrating the R&D, production, sales, and service of pharmaceutical and health products, Jiankangyuan focuses on the needs of patients and grasps the development opportunities of the respiratory drug market. In recent years, it has consistently focused on innovative, high-barrier, complex preparation R&D technology platforms such as inhalation administration, continuously deploying in the respiratory field. After years of development, Jiankangyuan has now formed a focused and clear product R&D pipeline, and its inhalation preparation business has entered the harvest period.
In March 2021, the 2020 National Medical Insurance Catalog was officially implemented, and Jiankangyuan's key product, the only domestically produced inhalation preparation "Lishutong" that participated in the national negotiation, achieved rapid market coverage and sales growth. In June of the same year, three inhalation preparation varieties under Jiankangyuan—"Wushu," "Shutanglin," and "Liwu'an"—were included in the fifth batch of national centralized procurement, accelerating the opening up of the domestic sales market and improving market share. In 2021, Jiankangyuan's respiratory field achieved an increase in sales revenue of 577 million yuan, a year-on-year increase of approximately 658%.
From the research records released by Jiankangyuan, it can be seen that the key varieties in the company's inhalation preparation R&D pipeline, tobramycin inhalation solution (Class 2.4), and formoterol fumarate inhalation solution (Class 3, a nationally encouraged imitation variety), have also entered the production reporting stage. There are also some exclusive varieties: formoterol fumarate inhalation aerosol (Class 2.2), mometasone formoterol inhalation aerosol (Class 3), levalbuterol hydrochloride isoproterenol inhalation solution (Class 2.3), and arformoterol inhalation powder aerosol (Class 2.2), etc., which have obtained clinical trial approval notices.
From: "Daily Economic News"
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