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Major Technological Breakthrough! Health Yuan's Adibromide Inhalation Powder is Approved for Clinical Trials
Published Time：
2021-06-21
Since the development of the pharmaceutical manufacturing industry, people have paid close attention to the drug treatment of asthma, while chronic obstructive pulmonary disease (COPD) is quietly spreading among the population. It is predicted that with the increase in smoking prevalence and population aging in various countries, the prevalence of COPD will increase in the next 30 years.
On the evening of the 20th, the group issued an announcement stating that recently, the company received the "Drug Clinical Trial Approval Notification" for the inhaled powder aerosol of aclidinium bromide from the National Medical Products Administration.
The company's first submission for registration of this product was accepted on April 1, 2021, with the acceptance number CXHL2100218. According to the "Pharmaceutical Administration Law of the People's Republic of China" and relevant regulations, after review, the aclidinium bromide inhalation powder aerosol meets the relevant requirements for drug registration, and the clinical trial of this product for chronic obstructive pulmonary disease (COPD) is approved.
As early as 2020, Healthy Yuan's inhaled ipratropium bromide solution (Shutanlin) for the treatment of chronic obstructive pulmonary disease was approved for marketing and became the first approved inhaled preparation since the country launched the consistency evaluation of generic drugs. In order to overcome the "bottleneck" problem of domestic substitution in respiratory drug use, the group has taken inhaled preparations as the company's key research and development direction, focusing on the needs of respiratory patients and starting from clinical practice, and has successively provided many high-quality product choices for respiratory system drug use in China.
The aclidinium bromide inhalation powder aerosol approved for clinical trials this time is an independently developed product of the group and is supported by a national major scientific and technological project. As of the date of the announcement, Healthy Yuan has cumulatively invested approximately RMB 14,556,400 in the research and development of aclidinium bromide inhalation powder aerosol.
According to the website of the Center for Drug Evaluation of the National Medical Products Administration and the Xinda database, As of now, in China, a total of 2 companies (including the company) have been approved for clinical trials, and no manufacturer has obtained a production license. 。
From the perspective of drug properties, aclidinium bromide is a new type of long-acting inhaled anticholinergic drug (LAMA). This drug is a bronchodilator, mainly used for the maintenance treatment of chronic obstructive pulmonary disease (COPD). In addition, the developed dosage form of this product is an inhaled powder aerosol, which has significant advantages such as good stability, easy portability, and convenient use, which can improve patient medication compliance and more effectively solve the problem of compliance between chronic disease patients and medical advice.
It is understood that aclidinium bromide inhalation powder aerosol is a Class 2.2 improved new drug. Existing LAMA inhaled preparations in China include tiotropium bromide powder aerosol, tiotropium bromide spray, and glycopyrrolate powder aerosol. According to IQVIA's sample statistical estimation data, the terminal sales amount of LAMA-related preparations in China in 2020 was approximately RMB 935 million. Among them, tiotropium bromide powder aerosol was approximately RMB 803 million, tiotropium bromide spray was approximately RMB 132 million, and there is no sales data for other products. From a market perspective, since there are no sales of related inhaled preparations, the market space remains to be filled.
From the perspective of future development, the group's R&D pipeline is being realized in the market, and the strategic layout is becoming increasingly clear, and the R&D growth and iteration capabilities are also extending from product dosage forms and drug targets. With the improvement of the research and development and production quality of domestic biopharmaceutical manufacturing enterprises, the voice of domestic enterprises in respiratory drug use will become increasingly louder. Especially in the asthma and COPD drug market, the monopoly situation dominated by imported drugs will gradually be replaced by domestic products.
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