Author:
Li Xiangdong
On February 9th,
Author:
Li Xiangdong
On February 9th, Health Yuan announced that the State Administration of Pharmaceutical Products had recently accepted the application for the registration and marketing license of salmeterol fluticasone inhalation powder in China. According to reports, the original research variety of salmeterol and fluticasone inhalation powder is Suletide of GlaxoSmithKline (GSK). It is a compound inhalation powder of salmeterol and fluticasone propionate. Salmeterol is a long-acting β2 receptor agonist, which can relax bronchi for a long time. Fluticasone propionate is a glucocorticoid, which can control inflammation and reduce acute attacks. Salmeterol fluticasone inhalation powder aerosol is used for routine treatment of reversible obstructive airway diseases, including asthma and chronic obstructive pulmonary disease.
First imitation of seretide? Recognized local enterprises
Seretide? It is a dry powder inhaler. The medicine is stored in the medicine storage pool in the form of dry powder, and the patient inhales the medicine quantitatively through the drug delivery device. Seretide? 200 1 was approved for import for the first time in China, and it is a Class B drug of national medical insurance. According to Yaozhi's data. Com, 202 1 The global market is Seretide? Its sales amount is about RMB 654.38+02.009 billion. According to IQVIA sampling statistics, domestic seretide? In 20021year, the terminal sales amount was about 863 million yuan. In recent years, although many pharmaceutical companies have begun to lay out seretide? Imitation, but today, the domestic market is still the world of original drug research, and its imitation difficulty can be seen. According to professionals, Seretide? Its imitation is much more difficult than the improved new drug. On the one hand, it is difficult to be equivalent to the original drug in vivo and in vitro during the research and development of this product; On the other hand, to develop the imitation of this drug, it is necessary not only to study the drug combination itself, but also to equip with appropriate drug delivery devices, which greatly increases the difficulty of imitation.
According to the website of Drug Evaluation Center (CDE) of the State Administration of Pharmaceutical Products, since CDE issued the Guiding Principles for Bioequivalence Research of Oral Inhalation Generic Drugs from June 5438 to February 2020, Healthy Yuan became the first enterprise in China to submit the application for the marketing license of this product and was accepted. The acceptance of the listing application is another significant progress in the long-term layout of the Health Yuan Respiratory Preparations Board, which also means that the domestic salmeterol fluticasone inhalation powder aerosol has entered the countdown.
The product matrix of inhaled therapeutic agents is becoming more and more perfect, or will continue to contribute to the improvement of performance.
Respiratory disease is the third chronic disease in China after cardiovascular disease and diabetes. Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic respiratory diseases. According to public information, there are about 30 million asthma patients in China, mainly children. The overall prevalence rate of 0- 14-year-old children is 3.02%, and it shows a rapid upward trend. The number of patients with chronic obstructive pulmonary disease exceeds 1 100 million, and the prevalence rate increases with age. The prevalence rate of people over 70 years old is as high as 35.5%.
Environmental problems, coupled with the influence of aging, will promote the increase of the prevalence rate, and the increase of the prevalence rate+long-term drug use will inevitably create a huge market space. In terms of market size, PDB data shows that the market size of asthma /COPD in China in 20 19 is about 24.5 billion. However, due to the high imitation barrier, the domestic market of asthma and COPD inhalation preparations has been monopolized by imported varieties for a long time, and the domestic substitution potential is huge.
After ten years of sharpening a sword, since the layout of respiratory preparations began on 20 13, Health Yuan has gradually emerged in the process of competing for respiratory preparations, becoming a blue ocean market. At present, its inhalation preparation sector is gradually entering the harvest period, and its income shows a rapid growth trend. In the first three quarters of 2022, the income of Health Yuan respiratory preparation products reached 862 million yuan, up by 265,438+05% year-on-year, with a rapid growth.
June 5438+October 2022 10, Health Yuan announced that its tobramycin inhalation solution (Class 2.4) and acetylcysteine solution for inhalation were approved for marketing. In addition, the pipeline layout of the research and development of health yuan respiratory preparation is perfect, and the varieties under research are rich. In the next few years, many heavy varieties such as formoterol fumarate inhalation solution and terbutaline sulfate atomized inhalation solution will be expected to be approved for listing. With the continuous enrichment of Health Yuan's inhalation product matrix, its leading position in inhalation preparation track will be consolidated, and it will continue to contribute to the performance of Health Yuan.
After years of development, Health Yuan has developed into an innovative comprehensive pharmaceutical group driven by scientific research and innovation, integrating research and development, production, sales and service of medical and health food. The company's business scope covers chemical preparations, chemical raw materials and intermediates, traditional Chinese medicine preparations, diagnostic reagents and equipment, health food and other fields, and has formed a strong competitive advantage in many therapeutic fields such as respiration, anti-infection, assisted reproduction, digestive tract, psychiatry and tumor immunity. Respiratory drugs are the key products of the company in recent years. In terms of inhalation preparations, regardless of product assembly line or R&D innovation ability, Health Yuan has always been in the leading position of domestic pharmaceutical companies. In September this year, Health Yuan successfully listed and issued Global Depositary Receipts (hereinafter referred to as GDR) on the Swiss Stock Exchange. Became the first biomedical enterprise in China to issue GDR in Switzerland. Significant progress has been made in the process of internationalization.
At present, Health Yuan is on a benign track of innovation-driven growth. Looking forward to the future, Yu Xiong, president of Health Yuan, once said: "Innovation and internationalization are the genes and development drivers of Health Yuan. We will focus on innovative drugs and high-end compound preparations, and constantly increase input and output." And such a healthy RMB may be worth looking forward to.
Disclaimer: This article is for reference only and does not constitute investment advice.