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On October 11, 2022, after eight years of development, tobramycin inhalation solution was finally approved for marketing and given the brand name Jianketo®. Behind this achievement lies the arduous process of new drug research and development, the tireless efforts of countless researchers, and the long-awaited hopes of clinical patients.

In 2014, Zhong Nanshan, an academician of the Chinese Academy of Engineering, initiated a clinical research project on tobramycin inhalation solution. The reason for launching this project was the increasing prevalence of bronchiectasis in China, coupled with a lack of domestic clinical guidelines and antibacterial drugs with relevant indications. The fact that a leading figure in Chinese respiratory medicine placed such importance on tobramycin highlights the significance of this commonly used antibiotic.

In essence, this project represented a groundbreaking achievement. Tobramycin inhalation solution would not only be the first inhaled antibiotic in China but also the world's first nebulized inhalation formulation for bronchiectasis. Therefore, the research and development of tobramycin inhalation solution was included in the national "Major New Drug Creation" special support catalog and led by Professor Guan Weijie of the National Clinical Medical Research Center for Respiratory Diseases and Guangzhou Respiratory Research Institute, along with other top scholars.

The Significance of the First Breakthrough

How should we understand the significance of being the first inhaled antibiotic to be marketed domestically and the first globally for the treatment of bronchiectasis?

While bronchiectasis is a common chronic respiratory disease, clinical focus primarily lies on managing acute exacerbations, leaving a lack of effective management for stable-phase bronchiectasis, leading to frequent relapses. From a physician's perspective, many domestic clinical guidelines for bronchiectasis are based on foreign guidelines or consensus. A practical problem is the limited availability of accessible drugs for clinical treatment in China.

Returning to the development of Jianketo®, from the day the project was initiated, it was imbued with high expectations, not solely due to the involvement of prominent figures like Academician Zhong Nanshan. Previous clinical treatments for bronchiectasis often involved long-term oral or injectable medications, which had significant side effects and a high risk of developing drug resistance. Therefore, Jianketo® was one of the research options considered in addressing these issues.

In fact, previous clinical studies on bronchiectasis had largely ended in failure. At the beginning of Jianketo®'s development, HealthGen faced numerous uncertainties. Fortunately, after eight years of persistence, it finally received approval. Jianketo® represents a significant breakthrough in the field of respiratory diseases in China. Its status as the "first" in two aspects fills a gap in inhaled treatment for bronchiectasis patients in China, providing an accessible tool for the standardized clinical management of patients in the stable phase. The key to Jianketo® filling this gap lies in its altered method of drug administration for bronchiectasis.

As the first inhaled antibiotic, Jianketo® had to make effective changes. On one hand, the drug development involved adjusting the particle size of tobramycin to be more suitable for inhalation; on the other hand, it involved improving the inhalation device, specifically developing a new nebulizer with oscillating multi-hole technology, significantly improving the deposition of tobramycin in the lungs. As Dr. Jin Fang, Chief Scientist of HealthGen, stated, these two changes in Jianketo®, while seemingly simple, are actually very difficult to achieve without causing airway irritation or significant side effects, while ensuring the drug reaches the lungs.

Inhaled formulations are actually complex preparations with high technological content. In the international market, multinational pharmaceutical companies such as AstraZeneca, GlaxoSmithKline, and Boehringer Ingelheim have long held a technological monopoly. "In the past, for chronic airway diseases such as bronchiectasis, COPD, and asthma, the preferred route of administration was inhalation. However, these drugs were mainly imported. Now, we are proud to have achieved domestication in drug delivery technology, benefiting more patients at a more affordable price." Professor Chen Rongchang gave high praise to this achievement: This is a significant advancement in the local treatment of bronchiectasis in the past ten years.

Release The Value of the Breakthrough Benefits

For HealthGen (600380.SH), the creator of Jianketo®, this undoubtedly marks the beginning of a period of reaping commercial rewards. However, the more significant implication lies in HealthGen's efforts to establish a virtuous cycle through the synergy of industry, academia, research, and investment, systematically developing the inhaled formulation field. While striving to improve drug accessibility for the public, HealthGen is also pushing towards more world-class achievements.

The birth of every new drug and the creation of every new treatment represent a step forward in our understanding of disease. This process will further inspire the entire Chinese innovative drug industry and enterprises to strive for greater achievements. The realization of Jianketo®'s value also involves achieving commercial success and gaining recognition from the capital market. After all, HealthGen is a listed company, and its success is also related to the investment interests of 100,000 investors.

Returning to HealthGen, the company behind Jianketo®, this veteran listed company has always demonstrated a keen understanding of market trends and a forward-looking approach, allowing it to adapt during crucial stages and achieve sustainable growth. In fact, Jianketo® is a landmark innovative drug for HealthGen, solidifying its leading position in the domestic high-end inhaled formulation market.

More than a decade ago, Zhu Baoguo, chairman of HealthGen, made the strategic decision to focus on the inhaled formulation sector. Particularly after the introduction of Dr. Jin Fang's team in 2014, HealthGen's advantage in the domestic high-end inhaled formulation field has accelerated.

To date, HealthGen has seven varieties and eleven specifications of inhaled formulations on the market, with over 30 products under development. This extensive pipeline of products is the foundation of its position as a "leading player in the domestic inhaled formulation sector."

Last June, three drugs for obstructive airway diseases were included in the fifth batch of national centralized procurement. HealthGen's inhaled budesonide suspension, inhaled ipratropium bromide solution, and inhaled combined ipratropium bromide solution were all successfully bid. The effect of national centralized procurement was immediate. The growth rate of HealthGen's inhaled budesonide suspension in key provincial and municipal public hospitals in 2021 reached 13066%, and the growth rate in the first quarter of this year reached 2420%. In 2019, the domestic terminal sales scale of budesonide suspension was 8 billion yuan, and only four companies, including HealthGen, had this single product included in the centralized procurement. Therefore, HealthGen's budesonide suspension is still in the expansion phase. According to the company's financial reports, inhaled formulations contributed 577 million yuan to HealthGen's total revenue in 2021, a year-on-year increase of 658%, which is considered by securities research institutions as a signal of HealthGen's accelerating commercialization of respiratory formulations.

This year, on the same day that Tobramycin inhalation solution was approved, Health Yuan also obtained approval for another new drug for the treatment of respiratory diseases with excessive thick and viscous mucus secretion - Acetylcysteine inhalation solution. This is another market with terminal sales exceeding 20 billion RMB in China (IQVIA 2021 data: 23.53 billion RMB). While multinational pharmaceutical companies still dominate the market, Health Yuan has opened up another area for domestic substitution.

Having now secured Levalbuterol inhalation solution, Budesonide inhalation suspension, Tobramycin inhalation solution, and Acetylcysteine inhalation solution, Health Yuan now comprehensively covers six major categories of asthma and COPD treatment drugs.

Looking at Health Yuan's pipeline of respiratory disease drugs under development, a number of new products are expected to enter the late stages of clinical trials in the coming years, continuously strengthening the product lineup and its market breakthrough efforts. Health Yuan is only just beginning to unleash the value benefits of being a "leading domestic inhaler manufacturer".