Core Viewpoint - Montelukast, once regarded as a "cough miracle drug," is now under scrutiny due to its potential psychiatric side effects, leading to a shift in its usage from a widely accepted treatment to one requiring careful evaluation and caution [1][3][9] Regulatory Changes - The National Medical Products Administration (NMPA) has revised the drug's labeling to include warnings about serious adverse reactions such as depression and suicidal tendencies, advising patients to seek medical attention if such symptoms occur [3][4] - The updated labeling emphasizes that adverse neuropsychiatric reactions have been reported across all age groups, and symptoms may persist if the drug is not discontinued [4] Usage Patterns - Despite the warnings, Montelukast is still widely used for common symptoms like cough and rhinitis, with the original drug "Singulair" selling over 2 million boxes on a single platform [1][7] - A study indicated that only 13.88% of prescriptions for Montelukast adhered to its approved indications, with off-label use reaching 86.12%, particularly for chronic obstructive pulmonary disease and bronchitis [5][6] Patient and Physician Perspectives - Many patients and their families face a dilemma between relying on Montelukast for its cough relief and the fear of its side effects, leading to increased anxiety about treatment options [3][8] - Some healthcare providers continue to recommend Montelukast despite known side effects, indicating a gap in awareness regarding its risks [6][9] Market Dynamics - There are over 60 approved Montelukast products in China, with a significant market presence, but the tightening of prescription practices is leading to a shift in how the drug is perceived and used [7][8] - The clinical application of Montelukast is becoming more cautious, with a focus on clear communication of potential risks to patients and their families [7][9] Alternative Treatments - Experts suggest that there are safer and effective alternatives for treating allergic conditions, including various non-prescription medications and nasal corticosteroids, but public perception of these alternatives remains a barrier [8][9] - The reluctance to use corticosteroids due to misconceptions about their safety may lead patients to continue using Montelukast, which poses higher risks [8]

Core Insights - Huadong Medicine has entered into an exclusive commercialization partnership with Hangzhou Changxi Pharmaceutical for the inhalation drug CXG87, aimed at addressing unmet medical needs in respiratory diseases in mainland China [1][7] Group 1: Product and Market Potential - CXG87 is a modified inhalation powder formulation of Budesonide/Formoterol, developed as a Class 2 new drug for treating asthma and other respiratory diseases, with Phase III clinical trials completed and a new drug application expected in mid-2026 [2] - The inhalation drug market in China is projected to reach approximately 23.9 billion RMB by 2025, with a potential market space of up to 60 billion RMB due to a large patient base, including around 50 million asthma patients and nearly 99 million with chronic obstructive pulmonary disease [4] Group 2: Competitive Landscape - The original drug for CXG87 is AstraZeneca's Symbicort, which has dominated the market since its launch in 2005, generating nearly 2.6 billion RMB in sales in 2023, indicating significant room for domestic alternatives with differentiated advantages [3] - The inhalation formulation sector is characterized by high technical barriers, with fewer than 20 domestic inhalation formulations approved in the past decade, making it a challenging field for many companies [3] Group 3: Commercialization Strategy - Huadong Medicine has a robust commercialization strategy, with a professional team focused on clinical value and academic promotion, utilizing a multi-channel marketing approach across over 30 provinces in China [5] - The company reported a 59% year-on-year increase in sales and agency service revenue for its innovative product segment, demonstrating its capability to successfully launch and scale new products [5] Group 4: Strategic Collaboration - The partnership between Huadong Medicine and Changxi Pharmaceutical signifies a shift in the domestic inhalation formulation sector from mere imitation to innovation, leveraging the strengths of both companies to tap into the respiratory medication market [7] - Both companies' leaders express confidence in the potential of CXG87, emphasizing the importance of this collaboration in maximizing the drug's commercial and clinical value [6][7]