Changfeng Pharma Advances in Respiratory Therapeutics with Two Approved Inhalation Products and Comprehensive Pipeline

Inhalation formulations are a specialized dosage form administered via the lungs and represent the most ideal route of administration for the treatment of respiratory diseases. Compared with injectable formulations, inhalation formulations cause less mechanical trauma, are easier to administer, and improve patient compliance. Compared with oral formulations, inhalation formulations deliver drugs locally to the lungs, enabling rapid and direct onset of action, higher bioavailability, reduced dosing requirements, enhanced therapeutic efficacy, and minimal toxic side effects.

In the respiratory inhaled drug sector, long dominated by foreign pharmaceutical companies, Chinese enterprises are on the rise. Respiratory inhaled formulations have become a hot investment focus in China, with leading firms such as Longmen Capital placing significant bets on this track.

In China’s respiratory inhalation therapy sector, CF PharmTech holds a first-mover advantage.

In terms of product progress, CF PharmTech has transformed from a pure laboratory-based R&D enterprise into a company with comprehensive capabilities in R&D, manufacturing, and commercialization, entering a harvest period. In 2021, the company’s Budesonide Suspension for Inhalation and Albuterol Sulfate Solution for Inhalation, both developed in-house, received approval from the National Medical Products Administration (NMPA) in succession.

In terms of financing, CF PharmTech has completed multiple rounds of funding. In the first half of 2020 alone, the company closed its Series E and Series F financing rounds, bringing the cumulative amount raised to nearly RMB 1.5 billion.

Longmen Capital is an early institutional investor in CF PharmTech, having participated in the company’s Series D financing round as early as 2017. Wang Haining, Founding Partner of Longmen Capital, stated, “CF PharmTech was one of the projects invested in during the early stages of Longmen Capital’s establishment, and it has significantly influenced our fund’s subsequent investment logic. Since then, we have increasingly focused on R&D-driven enterprises, with an emphasis on early-stage investments.”

“The barriers to entry for inhaled formulations are exceptionally high, making it one of the few high-barrier segments within the generic drug industry; indeed, the complexity of developing generics for many such products is comparable to that of creating innovative drugs. CF PharmTech boasts a robust pipeline, with numerous products positioned for first-to-file generic approval, alongside a growing portfolio of innovative candidates that hold the potential to challenge the long-standing monopoly held by multinational corporations in this field.”

CF PharmTech was co-founded by Dr. Liang Wenqing and Dr. Li Li. Dr. Liang has a background in biology, while Dr. Li specializes in chemical engineering. Both founders studied and worked abroad for many years and have prior entrepreneurial experience.

In 2007, driven by a strong interest in China’s healthcare and medical industry, Dr. Liang Wenqing and Dr. Li Li, who were then based overseas, decided to return to China to co-found an enterprise. Their goal was to build a comprehensive, globally oriented pharmaceutical company focused on the independent development of drugs.

The two founders were exceptionally prudent in selecting their entrepreneurial track.

“First, taking into account the team’s professional expertise, we initially focused on the sector of inhaled formulations for respiratory diseases."Dr. Liang Wenqing specializes in biology and corporate development strategy. As most respiratory diseases are immune-mediated, Dr. Liang has in-depth knowledge of treatment regimens and drug development trends in this therapeutic area. Dr. Li Li brings over two decades of international experience in the development of combination products integrating pharmaceuticals and medical devices."

“Secondly, we hope that the selected track has a huge market demand, and the field of respiratory diseases also fits this point very well.“Respiratory diseases are the second most prevalent disease category in China, representing a vast market. The article ‘Prevalence, Risk Factors, and Management of Asthma in Chinese Adults,’ published in The Lancet in 2019, reported that the total number of adults with asthma in China reached 45.7 million, while the number of adults with COPD approached 100 million. Chronic respiratory diseases have become the third leading cause of death from chronic diseases among Chinese residents.”

“Finally, industry barriers must be high to prevent excessive competition.“If barriers to entry are too low, it is highly likely that hundreds of companies will flood the market in a short period, which is detrimental to the healthy development of the industry. Inhaled formulations represent a sector with extremely high barriers to entry.”Inhalation products are combination drug-device products; during development, considerations must include drug properties, device characteristics, and patient usage habits.This has significantly increased the complexity of R&D, resulting in prolonged development cycles and substantial investment. In particular, the development of complex inhalation formulations in particulate and suspension forms presents even greater challenges, involving multiple disciplines such as materials science, inhalation dynamics, and traditional pharmaceutics.

Moreover, the dosage of inhaled formulations is extremely low, making it challenging to achieve stable manufacturing processes and ensure precise pulmonary delivery of microgram-level doses. Furthermore, molecules administered via the pulmonary route are difficult to detect in the bloodstream, imposing stringent requirements on analytical techniques for inhaled formulations.

Inhalation formulations also face high regulatory barriers.. Regulations for inhalation products vary across countries and regions, particularly with regard to clinical requirements; therefore, companies developing inhalation products should pay close attention to the regulatory requirements in each country and region.

Given the stringent requirements that inhaled formulations impose on enterprises in terms of R&D, manufacturing, and regulatory compliance, China has long suffered from a weak foundation in high-end inhalation equipment, reliance on imported devices, insufficient talent reserves, and a shortage of active pharmaceutical ingredients (APIs). Consequently, Chinese companies with substantial technical expertise in developing complex respiratory inhaled formulations have been extremely rare. The establishment of CF PharmTech in 2007, along with its subsequent rapid growth, opened a new chapter for the vigorous development of China’s respiratory inhaled formulation industry.

“The transformation of the respiratory inhalation drug industry requires the concerted efforts of generations of researchers to gradually overcome key technical challenges. CF PharmTech has established an early presence in this field. We are confident that, by leveraging the strengths of CF PharmTech and collaborating with numerous industry peers, we can achieve widespread domestic substitution of inhalation drugs with Chinese-made alternatives and further drive disruptive innovation across the sector,” said Zhu Yuyu, Board Secretary of the company.

CF PharmTech aims to provide comprehensive inhalation formulation solutions for the field of respiratory diseases.

In terms of disease coverage, CF PharmTech focuses closely on respiratory diseases, with a product portfolio that encompasses a full range of respiratory products., covering multiple high-demand therapeutic areas such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis, with a robust pipeline in development.

CF PharmTech has established R&D and manufacturing platforms for four major types of inhalation formulations: aerosols, nasal sprays, nebulizer solutions, and dry powder inhalers.Zhu Yuyu stated, “Although the market shares of various technology platforms in the domestic market currently vary significantly, there are no obvious clinical disadvantages among them. Instead, each platform has its own unique characteristics and is suitable for different patient populations, serving as complementary alternatives. Only by comprehensively covering all four major technology platforms and continuously launching high-quality products can clinical needs be fully met.”

Currently, CF PharmTech has two approved inhaled formulations, further opening the door to domestic substitution of respiratory inhaled products.

In May 2021, the Budesonide Suspension for Inhalation developed by the Company was approved by the NMPA.Budesonide Suspension for Inhalation is the inhaled pharmaceutical product with the largest market share in China, achieving sales of billions of yuan in 2019. With the approval of the company’s product and its inclusion in the centralized volume-based procurement program, it is poised to generate substantial savings in national medical insurance funds in the future.

In October 2021, the company’s inhalation solution of salbutamol sulfate was approved by the NMPA.Inhaled salbutamol sulfate solution is indicated for the treatment of chronic bronchospasm unresponsive to conventional therapy and for the management of severe acute asthma exacerbations. In 2019, GSK’s global sales of salbutamol reached US$1.178 billion.

As its products are successively launched on the market, CF PharmTech has successfully transitioned from a pure R&D-focused enterprise into a comprehensive company with integrated capabilities in research and development, manufacturing, and commercialization, entering a new stage of development.The launch of multiple domestically produced products demonstrates that local companies are also capable of competing with multinational corporations in the high-end inhaled formulation market.In the future, domestic companies will play an increasingly important role in this market by launching more domestically produced alternative products and expanding globally.

“Broad Coverage, In-depth Layout” is the core strategy of CF PharmTech in its business layout. In the future, targeting clinical needs in the respiratory field, CF PharmTech will cover more diseases with urgent clinical demands and deeply develop ecological treatment solutions for respiratory diseases.

Zhu Yuyu stated, “CF PharmTech conducts product R&D with a focus on the global market. The company expects to launch several more products in China, the United States, Europe, and other countries and regions in the near future, maintaining a sustainable annual pace of product launches.”

The Wave of Innovative Drugs in China Is Coming,The domestic inhaled formulation sector is also showing a trend of transitioning from generic drugs to innovative drugs.“The core drug development technology platform built by CF PharmTech is highly conducive to our entry into the field of innovation. We are currently advancing innovations in dosage forms and strategic layouts for novel compounds, with the expectation that unique innovative drug products will enter clinical trials in the future.”