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On February 9, Jiankangyuan announced that the National Medical Products Administration (NMPA) had recently accepted the application for the registration and listing of its inhaled powder for salmeterol and fluticasone propionate for domestic production. It was introduced that the original research product of salmeterol and fluticasone propionate inhaled powder is Seretide® from GlaxoSmithKline (GSK), a combination inhaled powder of salmeterol and fluticasone propionate. Salmeterol is a long-acting β2-receptor agonist that can lastingly dilate the bronchi; fluticasone propionate is a glucocorticoid that can control inflammation and reduce acute attacks. Salmeterol and fluticasone propionate inhaled powder is used for the regular treatment of reversible obstructive airway diseases, including asthma and chronic obstructive pulmonary disease.

The first domestic company to have its application for a Seretide® generic accepted

Seretide® is a dry powder inhaler, where the drug is stored in a reservoir in dry powder form, and the patient inhales a measured dose of the drug via the device. Seretide® was first approved for import into China in 2001 and is a Class B drug under the national medical insurance system. Data from Pharma智网 shows that the global sales of Seretide® in 2021 were approximately RMB 12.009 billion. According to IQVIA's sample statistics and estimated data, the domestic terminal sales of Seretide® in 2021 were approximately RMB 863 million. In recent years, although many pharmaceutical companies have begun to develop Seretide® generics, the domestic market is still dominated by the original research drug, indicating the difficulty of imitation. According to professionals, the difficulty of imitating Seretide® is far greater than that of improved new drugs. On the one hand, it is very difficult to achieve equivalence with the original research drug both in vivo and in vitro during the research and development process; on the other hand, the development of generic drugs requires not only research on the drug combination itself but also the appropriate delivery device, which greatly increases the difficulty of imitation.

The website of the Center for Drug Evaluation (CDE) of the NMPA shows that since the CDE issued the "Guidelines for Bioequivalence Studies of Oral Inhalation Formulations" in December 2020, Jiankangyuan has become the first domestic company to submit and have its application for the marketing authorization of this product accepted. The acceptance of this marketing application represents another major progress in Jiankangyuan's long-term layout of the respiratory drug sector and means that the launch of domestic salmeterol and fluticasone propionate inhaled powder is imminent.

The inhaled drug product matrix is becoming increasingly complete, and is expected to continue to contribute to incremental revenue.

Respiratory diseases are the third most common chronic disease in China, after cardiovascular diseases and diabetes. Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic respiratory diseases. Public information shows that there are about 30 million asthma patients in China, mainly children, with an overall prevalence of 3.02% in children aged 0-14, and it is rapidly increasing; the number of COPD patients exceeds 100 million, and the prevalence increases with age, reaching 35.5% in people over 70 years old.

Environmental problems, coupled with the impact of aging, will lead to an increase in the prevalence, and the increase in prevalence plus long-term medication 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 2019 was about 24.5 billion. Due to the high barriers to imitation, the domestic market for asthma and COPD inhaled drugs has long been monopolized by imported products, so the potential for domestic substitution is huge.

After ten years of hard work, since it began to develop respiratory drugs in 2013, Jiankangyuan has gradually emerged in the competition for this blue ocean market. Currently, its inhaled drug sector is gradually entering the harvest period, and its revenue is showing rapid growth. In the first three quarters of 2022, Jiankangyuan's respiratory drug products achieved revenue of RMB 862 million, a year-on-year increase of 215%, showing a rapid growth momentum.

In October 2022, Jiankangyuan announced that its tobramycin inhalation solution (Class 2.4) and acetylcysteine inhalation solution were approved for marketing. In addition, Jiankangyuan has a comprehensive R&D pipeline for respiratory drugs, with a rich variety of products under development. In the next few years, several blockbuster products such as formoterol fumarate inhalation solution and terbutaline sulfate nebulization inhalation solution are expected to be approved for marketing. As Jiankangyuan's inhaled drug product matrix continues to expand, its leading position in the inhaled drug sector will be further consolidated, and it will continue to contribute to Jiankangyuan's performance growth.

After years of development, Jiankangyuan has now become an innovative comprehensive pharmaceutical group that is driven by scientific research and innovation, and integrates the research, development, production, sales, and service of pharmaceutical and health food products. The company's business scope covers chemical preparations, chemical raw materials and intermediates, traditional Chinese medicine preparations, diagnostic reagents and equipment, health food products, and other fields, and has formed strong competitive advantages in multiple therapeutic areas such as respiratory, anti-infection, assisted reproduction, digestive tract, mental and tumor immunity. Respiratory drugs are the company's key products in recent years. In terms of inhaled preparations, Jiankangyuan is already in a leading position among domestic pharmaceutical companies, both in terms of product pipeline and R&D innovation capabilities. In September this year, Jiankangyuan successfully listed and issued Global Depositary Receipts (GDRs) on the SIX Swiss Exchange, becoming the first biopharmaceutical company in China to issue GDRs in Switzerland. Significant progress has been made in internationalization.

Currently, Jiankangyuan is on a virtuous path of innovation-driven growth. Looking to the future, Yu Xiong, president of Jiankangyuan, once said: "Innovation and internationalization are the genes and driving force of Jiankangyuan's development. We will continue to increase and accelerate investment and output in the fields of innovative drugs and high-end complex preparations." Such a Jiankangyuan may be worth more expectation.

Source: Red Weekly