Luoxin Pharmaceutical Introduces Novel Budesolv Nasal Spray for Allergic Rhinitis Amid Expanding Market Opportunities

　　【Pharmaceutical Network Product News】 Recent reports indicate that Austrian biopharmaceutical company Marinomed stated in an announcement that, pursuant to a collaboration and licensing agreement, Luoxin Pharmaceutical Group Co., Ltd. will further develop and commercialize Budesolv (budesonide solution nasal spray), a formulation indicated for the treatment of allergic rhinitis, in mainland China, Hong Kong, Macau, and the Taiwan region of China.
 

This will bring good news to patients with allergic rhinitis. It is understood that allergic rhinitis, also known as allergic rhinitis (AR), is one of the most common allergic diseases. It is a chronic inflammatory disease of the nasal mucosa triggered by allergen exposure in atopic individuals, characterized by the IgE-mediated release of inflammatory mediators and the involvement of various immune cells and cytokines. Data indicates that the overall prevalence in China has currently reached 17.6%, with a patient population of approximately 240 million, and continues to exhibit an upward trend. The pharmaceutical market for the treatment of allergic diseases holds substantial growth potential.
 

However, data indicates that as of the end of 2020, only three desensitization therapy drugs were marketed in China: Wolwo Bio's "Dermatophagoides farinae Drops", Denmark's ALK's "House Dust Mite Allergen Preparation", and Germany's Allergopharma's "Mite Allergen Injection". Among them, Wolwo Bio's "Dermatophagoides farinae Drops" has been widely used in clinical desensitization therapy for allergic rhinitis and allergic asthma caused by dust mites since its approval in 2006.
 

The market for allergic rhinitis drugs holds substantial potential, and strengthening the introduction and R&D of therapeutics in this field represents a significant benefit for patients. According to the announcement, Budesolv, newly introduced by Luoxin Pharmaceutical, is a novel formulation of the glucocorticoid budesonide and belongs to the class of corticosteroid nasal sprays. Budesolv, as a novel budesonide glucocorticoid formulation, has not yet been marketed domestically or internationally. According to data from IQVIA and Menet, the global market size for corticosteroid nasal sprays in 2020 was USD 2.15 billion (calculated at ex-factory prices), while the combined market size in China for hospitals with over 100 beds and retail pharmacies reached RMB 1.305 billion.
 

Luoxin Pharma stated that the respiratory disease therapeutic area, including allergic rhinitis, is one of the core therapeutic areas the company has consistently focused on. The signing of the "License Agreement" with Marinomed regarding the budesonide solution nasal spray will further enrich the company's product portfolio, expand its product lineup in the respiratory therapeutic area, and strengthen its competitive advantage.
 

It is reported that currently, companies in China have not invested substantially in the R&D of medications for allergic rhinitis. Besides Luoxin Pharmaceutical’s recent introduction of Budesolv, what other enterprises have made progress in the field of allergic rhinitis therapeutics?
 

It has been reported that on March 18, the Class 1 new drug Benhuanquixiu'an Nasal Spray (trade name: Bilitin®), independently developed by Yingu Pharmaceutical, received approval from the National Medical Products Administration (NMPA). The approved indication is for the relief and improvement of symptoms associated with allergic rhinitis, including rhinorrhea, nasal congestion, nasal itching, and sneezing. Industry sources indicate that Bilitin® can modulate bronchoconstriction and mucus secretion. By selectively antagonizing M1 and M3 receptors without affecting M2 receptors, it demonstrates low toxicity and adverse effects, ensuring a high safety profile and broad applicability. It offers a new therapeutic option for a wide range of patients with allergic rhinitis and holds substantial market potential.
 

Additionally, CSPCHA115 from Zhongqi Pharmaceutical of CSPC Group, litapilun from Guangdong HEC Pharm, and Wolwo Biotech from Zhejiang Wolwo Bio-Engineering Co., Ltd. are currently in the clinical stage. Among these, the first two are domestic Class 1 chemical drugs, while Wolwo Biotech is a biological vaccine.