Formoterol Fumarate Inhalation Solution, the first product of its kind approved for marketing with clinical verification exemption with our assistance, is expected to become a major player among the inhaled drug products with a market value of more than 1 billion CNY.

     The Formoterol Fumarate Inhalation Solution, for which our company is responsible for registration, was launched in August 2022. This product is an originator drug developed by Mylan for the treatment of COPD (Chronic Obstructive Pulmonary Disease). It was initially marketed in the United States under the trade name PERFOROMIST^® on May 11, 2007, with Dey Pharma, L.P. as the original applicant. In March 2014, Mylan Specialty L.P. became the marketing authorization holder, and The Ritedose Corporation serves as the manufacturer. On September 17, 2019, multiple departments in China, including the National Health Commission, the National Medical Products Administration, the National Healthcare Security Administration, and the China National Intellectual Property Administration, organized a panel of experts who recognized the clinical supply shortage of this product and encouraged generic alternatives.

The List of the First Batch of Encouraged Generic Drug Catalog

Clinical respiratory specialists believe that currently, there are no long-acting β2 receptor agonists that can be nebulized in China. For elderly patients with COPD or those in critical condition, due to the decrease in tidal volume, the use of dry powder inhalers cannot effectively achieve the drug delivery dose and therapeutic effect.

Nebulized therapy is a method that uses the principle of gas jetting to convert the liquid medication into tiny aerosol droplets suspended in the gas, forming an aerosol that enters the respiratory tract. It has the advantages of rapid onset, high drug amount inhaled into the lungs, prolonged drug deposition in the lungs, and ease of use without the need for patient cooperation. Therefore, the introduction of this inhalation solution to the market can effectively meet the clinical needs of these patients.

According to available epidemiological data, the overall incidence rate of COPD in China (8.6%) is slightly lower than the global average (10.1%) estimated by GOLD, but higher than that of the United States and Europe. The prevalence of COPD in adults over 40 in China is significantly lower than that in Latin America and Africa, but significantly higher than in Europe, America, Japan, South Korea, and other countries.

China has nearly 100 million patients with COPD, with an incidence rate of over 8.6% in adults. Compared to survey results from a decade ago, the prevalence of COPD in China has increased by 67%.

On April 10, 2018, the results of a study among a large-scale population called the "Chinese Adult Pulmonary Health Study," conducted by a team led by Wang Chen, a member of Chinese Academy of Engineering, revealed that the prevalence of COPD in China significantly increases with age.

Among Chinese adults aged 20 and above, the COPD prevalence is 8.6%. Among those aged 40 and above, it rises to 13.7%, while in the population aged 60 and above, the prevalence exceeds 27%. Specifically, among individuals aged 60 to 69, the prevalence is 21.2%, and among those aged 70 and above, it reaches a staggering 35.5%. Furthermore, the prevalence is higher in males (11.9%) than in females (5.4%), with the number of male patients being 2.2 times that of females.

In 2019, the Expert Consensus on Anti-infective Therapy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease in China estimated that there were approximately 100 million COPD patients. COPD has become a common chronic disease, much like hypertension and diabetes.

Apart from its use in COPD treatment, this product can also be utilized for preoperative airway cleaning in clinical settings. Hence, it has the potential to become a promising product with a market value of more than one billion CNY, like Acetylcysteine Solution for Inhalation and Levosalbutamol Hydrochloride Nebuliser Solution.