Changfeng Pharma's Dual Breakthrough in Drug-Device Combination: A New Dimension in Tackling the Billion-Dollar Respiratory Market

CF PharmTech’s comprehensive layout in the field of respiratory disease treatment has surpassed the public’s original stereotypical perceptions of the company.

In the field of respiratory disease treatment, severe emphysema and idiopathic pulmonary fibrosis (IPF) are both conditions characterized by a high burden and unmet clinical needs. The former is marked by dynamic hyperinflation and activity limitation, with existing drugs showing limitations in long-term management; the latter, as a progressive and fatal fibrotic lung disease, has a median survival of only 3–5 years, with limited standard treatment options. CF PharmTech, by pursuing dual pathways through both medical devices and pharmaceuticals, is poised to create synergistic effects in these niche segments.

In fact, as an innovative enterprise dedicated to the R&D, manufacturing, and commercialization of inhalation drug delivery technologies and inhaled medications, CF PharmTech is one of the few domestic companies mastering the full-chain technology for inhalation formulations. It is breaking the long-standing monopoly of multinational pharmaceutical companies in this field. Notably, its core product, CF017 (Budesonide Suspension for Inhalation), was successfully included in the National Centralized Drug Procurement program, achieving a 16% market share in 2024 and becoming the best-selling inhaled medication in China.

Against the backdrop of a continuous rise in the incidence of respiratory diseases, this high-barrier sector featuring complex formulations that combine drugs with medical devices has become a scarce asset sought after by capital. This trend has been validated in the capital markets. On October 8, CF PharmTech officially listed on the Hong Kong Stock Exchange, with its stock price surging immediately upon opening. By the close of trading, the share price had soared by 161.02% from the issue price of HK$14.75. This enthusiasm was also evident during the earlier IPO subscription period: by noon on October 2, CF PharmTech had secured at least HK$339.6 billion in margin financing lent by brokers. Based on the initial public offering fundraising target of HK$60.77 million, the oversubscription ratio reached a staggering 5,587 times.

From the market’s perspective, this dual breakthrough—combining clinical progress with government-level recognition—has further reinforced the investment thesis of “scarcity + growth + certainty,” injecting new momentum into the release of the company’s mid-to-long-term value.

Recently, the minimally invasive interventional lung volume reduction device independently developed by CF PharmTech completed the enrollment of its first patient (FPI), marking the official entry of this product into the clinical validation phase. This study aims to expand a minimally invasive interventional treatment pathway for patients with emphysema and other chronic obstructive pulmonary disease (COPD)-related conditions.

Chronic obstructive pulmonary disease (COPD), a common chronic respiratory condition, is the third leading cause of death worldwide, with over 100 million patients in China. Meanwhile, there are approximately 45.7 million asthma patients aged 20 and above in China, and the prevalence rate is increasing year by year. Inhaled formulations have become the preferred route of administration recommended by clinical guidelines for the treatment of asthma and COPD.

It is understood that the human trial device for this interventional instrument relies on bronchoscopy-guided, branch-level airflow regulation and targeted lung volume reduction strategies. It aims to improve pulmonary function and exercise tolerance while reducing residual volume (RV), and to enhance reproducibility and postoperative management controllability based on individualized assessments. The study will proceed according to protocol with continuous enrollment, perioperative safety monitoring, and multidimensional assessments via imaging and pulmonary function tests. Primary endpoints cover device- and procedure-related safety and technical success rates, while observing trends in clinical outcomes such as FEV1, RV, 6-minute walk distance (6MWD), and St. George’s Respiratory Questionnaire (SGRQ) scores. The study data will form an auditable chain of evidence to support subsequent regulatory registration strategies and commercialization decisions.

Lung Volume Reduction (LVR) Therapy Addresses Significant Unmet Needs in Current Clinical PracticePatients with severe emphysema face long-term challenges, including dynamic hyperinflation, exercise limitation, and risk of acute exacerbations. Existing pharmacological therapies offer limited improvement in pulmonary hyperinflation and lung elastic recoil. Multiple randomized controlled trials and real-world studies have demonstrated that eligible patients undergoing endobronchial valve treatment achieve clinically meaningful improvements in FEV1, RV, 6MWD, SGRQ, and risk of acute exacerbations. Furthermore, as a minimally invasive approach, it offers the advantage of reversibility and removability.

During the same period, CF PharmTech’s global first-in-class inhaled innovative drug project for pulmonary fibrosis (including idiopathic pulmonary fibrosis, IPF) was successfully selected as a Suzhou 2025 “Key Core Technology Breakthrough” project.

Idiopathic Pulmonary Fibrosis (IPF) is a progressive and fatal fibrotic lung disease, with a median survival of only 3–5 years for typical patients. Clinically, it is commonly characterized by progressive decline in lung function and recurrent acute exacerbations, imposing sustained pressure on quality of life and care resources. The global burden of IPF is substantial, with prevalence generally higher in North America than in Europe and Asia.

Currently, only two drugs have been approved in the United States and China for the treatment of idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib, both of which are oral medications. Nintedanib achieved global sales of approximately €3.51 billion in 2023 and around €3.8 billion in 2024. With population aging, wider adoption of imaging technologies, and improved diagnostic rates, the market still holds significant growth potential.

Currently, there are no approved inhaled drugs for IPF worldwide.

Given the limited treatment options for pulmonary fibrosis and the ongoing need to improve long-term tolerability and adherence to medication, CF PharmTech’s project focuses on multi-dimensional modulation of key pathways, including inflammation, oxidative stress, and fibroblast activation. This approach holds potential value as a complement or additive to the current standard of care (SoC), while leaving strategic room for subsequent combination therapies. The project will steadily advance through key milestones, including finalization of formulation and manufacturing processes, optimization of the delivery system, non-clinical safety and efficacy evaluation, regulatory and patent positioning, and clinical preparation, thereby driving clinical translation and industrialization through a data-driven approach.

In response, the management of CF PharmTech stated that this project initiation serves not only as an endorsement but also as a call to action. Leveraging the advantages of inhalation delivery—namely, “direct targeting of lesions and precise drug delivery”—CF PharmTech will address the unmet global need in pulmonary fibrosis by consistently advancing the project through high-quality data and clear milestones, thereby delivering verifiable outcomes to patients, partners, and investors.

CF PharmTech Has Forged a Path of Breakthrough Innovation.

From a technical perspective, minimally invasive interventional volume reduction devices rely on bronchoscopy-based lobar airflow regulation and targeted lung volume reduction strategies, aiming to reduce residual volume and improve pulmonary function and exercise tolerance. In contrast, innovative inhaled drugs leverage the company’s integrated inhalation platform to achieve direct delivery to the lesion site with precision, thereby reducing systemic burden and demonstrating potential for complementarity or additive effects with current standard-of-care treatments. Both approaches reflect CF PharmTech’s technological expertise in minimally invasive interventions and inhalation delivery.

CF PharmTech’s simultaneous advancement in the dual fields of medical devices and innovative inhaled drugs demonstrates its integrated capability spanning “engineering iteration–clinical evaluation–quality systems.” While minimally invasive volume-reduction devices focus on interventional procedures and physical volume reduction, innovative inhaled drugs concentrate on drug delivery and modulation of molecular mechanisms. These two approaches form a technological complementarity in the management of severe respiratory diseases, jointly strengthening the company’s overall solution capabilities in the respiratory field.

This achievement is underpinned by the CF PharmTech core team’s long-standing accumulation of theoretical knowledge and manufacturing expertise in inhalation formulations. It is understood that all key members of CF PharmTech possess strong academic backgrounds and extensive industry experience. For instance, Dr. Liang Wenqing, Chairman and CEO, holds a Ph.D. in Molecular and Cellular Biology from the University of Massachusetts, completed postdoctoral research at Harvard Medical School, and has experience in venture capital and entrepreneurship. Dr. Li Li, Chief Scientist, earned his Ph.D. in Chemistry from the University of Michigan and brings over 20 years of R&D experience in inhalation formulations, having previously worked at multinational pharmaceutical companies such as GlaxoSmithKline and Schering-Plough. Dr. Li Qi, Chief Operating Officer and Dean of the Drug Research Institute, possesses extensive experience in drug development and management.

Meanwhile, national policies have also been vigorously encouraging the research and development (R&D) of inhalation preparations. With the release of the Guiding Principles for Bioequivalence Studies of Generic Orally Inhaled Preparations by the Center for Drug Evaluation of the National Medical Products Administration in 2020, the R&D of inhalation preparations has become further standardized. In 2022, nine departments, including the Ministry of Industry and Information Technology and the National Development and Reform Commission, jointly issued the 14th Five-Year Plan for the Development of the Pharmaceutical Industry, which also proposed prioritizing the development of complex formulation technologies, including inhalation drug delivery systems.

"Supported by national policies and driven by intensive R&D efforts, CF PharmTech is forging a new path to break the monopoly of multinational pharmaceutical companies."

According to Frost & Sullivan, the global market size for inhalation preparations is projected to grow to USD 29.3 billion in 2025 and reach USD 33.7 billion by 2030, while China’s market for inhalation preparations is expected to reach RMB 23.9 billion in 2025. However, for a long period, the inhalation preparations market has been dominated by multinational pharmaceutical companies. Previous reports citing data from the National Healthcare Security Administration indicated that foreign companies accounted for more than 80% of the inhalation preparations market.

CF PharmTech stands out in the industry, leveraging its deep technological expertise and large-scale manufacturing capabilities to establish multiple competitive moats in technology, production capacity, and brand.

It is reported that CF PharmTech’s currently marketed flagship products include CF017 and CF018. Among them, CF017 (Budesonide Suspension for Inhalation) was rapidly included in the National Centralized Drug Procurement program following its approval in 2021, successfully breaking the monopoly held by foreign pharmaceutical companies and becoming CF PharmTech’s first blockbuster product. By adopting a “price-for-volume” strategy, CF PharmTech’s winning bid price for budesonide in the centralized procurement was 43% lower than that of the originator drug, enabling its market share to surge from 3% in 2021 to 16% in 2024.

CF018 (azelastine hydrochloride and fluticasone propionate nasal spray), as the first combination hormonal-antihistamine nasal spray in China, has filled a clinical gap. Furthermore, in 2024, CF PharmTech’s GW006 (arformoterol nebulizer solution for the treatment of chronic obstructive pulmonary disease) received approval from the U.S. FDA, marking international recognition of its product quality.

CF PharmTech’s end-to-end respiratory platform is scarce and difficult to replicate. With the anticipated approval of subsequent new products and various innovative advancements, CF PharmTech’s globalization process is expected to further accelerate. The market is also looking forward with increased anticipation to the aforementioned drug-device combinations.