Core Viewpoint - AstraZeneca's Breztri inhalation aerosol has been submitted for a new indication in China, likely for asthma treatment, following positive results from two Phase III trials [1][3]. Group 1: Product Information - Breztri inhalation aerosol is a fixed-dose combination therapy that includes budesonide (an inhaled corticosteroid), glycopyrrolate (a long-acting muscarinic antagonist), and formoterol (a long-acting beta-2 adrenergic agonist) [2]. - The product is classified as a chemical drug and is imported, with the application date recorded as September 17, 2025 [2]. Group 2: Clinical Trial Results - Two Phase III studies (KALOS and LOGOS) involving 4,461 poorly controlled asthma patients demonstrated that Breztri significantly improved forced expiratory volume in one second (FEV1) compared to the Symbicort group [3]. - The studies also indicated a significant reduction in the rate of severe asthma exacerbations for patients using Breztri [3]. Group 3: Market Context - Asthma affects up to 262 million people globally, with nearly half of those on dual therapy still experiencing poor control, which limits lung function and quality of life [3].

Core Insights - The asthma market in China is experiencing significant growth, with the respiratory drug market size projected to reach approximately $12.8 billion in 2024, up from $11.8 billion in 2023, driven by advancements in inhalation technology and increased patient demand [2][4] - The concept of "silent zone" in the lungs, referring to small airways that are often overlooked in asthma treatment, is gaining attention as a critical area for intervention [1][3] - The need for innovative drug delivery systems that can effectively target both large and small airways is essential for overcoming current treatment challenges in asthma management [4][6] Market Dynamics - The current diagnosis rate for asthma in China is about 28.5%, with a similar control rate, indicating that over 70% of asthma patients are not effectively managed [4] - The market for allergic asthma drugs is projected to reach 19.6 billion yuan in 2024, reflecting a steady increase due to rising patient numbers and pharmaceutical investments in research and development [4][5] - Inhalation therapies are becoming the mainstream treatment for respiratory diseases, with ultra-fine particle drugs showing a significant increase in lung deposition rates, reaching up to 56% [6][8] Competitive Landscape - Global leaders in the allergic asthma drug market include GlaxoSmithKline and AstraZeneca, while domestic companies like Zhengda Tianqing and Hengrui Medicine are emerging as significant players [5] - The inhalation drug market is dominated by a few key products, with Budesonide leading the market at 5.3 billion yuan, accounting for 23.7% of the inhalation drug market share in China [8] - The market is witnessing increased collaboration and strategic investments, as seen with Baiyang Pharmaceutical's investment in Jikun Pharmaceutical for innovative drug development [11][12] Regulatory and Policy Environment - The "Healthy China 2030" initiative emphasizes the prevention and treatment of respiratory diseases, aiming to reduce mortality rates and enhance healthcare services [7] - The government is expanding insurance coverage for respiratory diseases, which is expected to further stimulate market demand [7] Future Trends - There is a growing focus on targeted therapies for different asthma phenotypes, moving towards personalized treatment plans based on genetic and biomarker assessments [9][10] - The introduction of biologics as adjunct therapies is gaining traction, although they currently cannot replace existing treatment regimens [10][12] - Companies are increasingly looking to align their strategies with China's healthcare policies and demographic trends, particularly in the context of an aging population and rising chronic disease prevalence [13][14]

Core Viewpoint - The increasing frequency of thunderstorm asthma cases in northern China is linked to climate change and rising allergen concentrations, leading to a surge in asthma attacks during and after thunderstorms [1][3][4] Group 1: Thunderstorm Asthma Overview - Thunderstorm asthma is characterized by acute asthma attacks or exacerbations occurring during or shortly after thunderstorms [1] - Recent years have seen recorded cases of thunderstorm asthma in various regions of China, including Yulin in 2018, Ningxia in 2022, and Hohhot in 2023 [1] Group 2: Asthma Prevalence and Diagnosis - Approximately 45.7 million individuals aged 20 and above in China suffer from asthma, with a prevalence rate of 4.2%, which has been on the rise since 2010 [3] - The pediatric asthma population is significant, with over 15 million children under 18 exhibiting typical wheezing symptoms, indicating a larger undiagnosed group when including other respiratory symptoms [4] - The diagnosis and control rates for asthma in China are both below 30%, highlighting a gap in effective management [4] Group 3: Challenges in Asthma Management - Many asthma patients lack adequate knowledge about their condition, and there is a common issue of undiagnosed small airway disease among patients [5] - The small airways, which are crucial for gas exchange, are often overlooked in clinical practice, leading to challenges in asthma management [5][8] Group 4: Prevention and Screening - Thunderstorm asthma poses a challenge to healthcare resources, potentially endangering patient lives, thus emphasizing the need for preventive measures [6] - Asthma screening can be conducted through lung function tests or questionnaires, which can help identify early-stage asthma patients [7] - Patients often overlook symptoms such as prolonged coughing or shortness of breath, which may be related to asthma, necessitating increased awareness and proactive medical consultation [7] Group 5: Treatment Innovations - New asthma medications are being introduced to improve treatment convenience and adherence, such as the recently launched budesonide/formoterol inhalation powder by Kasey Group [9] - Effective delivery of inhaled medications to small airways is critical for asthma management, with advancements in drug formulation and inhalation techniques being essential for improving treatment outcomes [9]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Cryofocus Medtech (Shanghai) Co., Ltd. 哮喘冷凍消融系統獲得美國食品監督管理局授予的突破性醫療器械認證 本公告乃由康灃生物科技（上海）股份有限公司（「本公司」，連同其附屬公司統稱 為「本集團」）自願作出，以告知本公司股東及潛在投資者有關本集團業務的最新 進展。 本公司欣然宣佈，於2025年7月24日，本集團的哮喘冷凍消融系統（「哮喘冷凍消 融系統」），本集團的呼吸介入產品之一，由冷凍治療設備及氣道冷凍消融導管組 成，已獲得美國食品及藥物管理局授予的突破性醫療器械認證。 哮喘冷凍消融系統為用於治療中度及重度哮喘的自主研發冷凍消融系統。在手術 過程中，哮喘冷凍消融系統通過冷凍消融破壞肺部迷走神經，減少過度活化乙醯 膽鹼的釋放（其為哮喘病因），並減少黏液分泌，從而達到治療哮喘的效果。 本公司無法保證哮喘冷凍消融系統的未來前景。本公司股東及潛在投資者於買賣 本公司證券時務請審 ...

Group 1 - The core viewpoint of the articles emphasizes the chronic nature of asthma as an airway inflammatory disease that requires ongoing management and treatment to prevent acute attacks and long-term complications [2][4][6] - The importance of adhering to prescribed inhalation therapies, particularly the combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), is highlighted as essential for controlling inflammation and alleviating symptoms [3][4] - A significant portion of asthma patients in China, approximately 55%-70%, are not effectively managing their condition, indicating a substantial unmet medical need [3] Group 2 - Severe asthma patients, constituting about 5% of the asthma population in China, face higher risks of complications and economic burdens due to frequent acute episodes and hospitalizations [5] - Innovative therapies, particularly biologics, are emerging as effective treatments for severe asthma, targeting specific inflammatory pathways and reducing reliance on corticosteroids [5][6] - The recent update to the bronchial asthma prevention and treatment guidelines introduces the concept of "clinical cure," offering hope for better management and quality of life for severe asthma patients [6]

Group 1 - Asthma is a common chronic respiratory disease characterized by airway inflammation, which can occur at any age and leads to symptoms such as wheezing, chest tightness, shortness of breath, and coughing [2] - The inflammation associated with asthma causes long-term damage to the airways, resulting in structural changes such as airway smooth muscle contraction [2] - Misdiagnosis of asthma is common due to overlapping symptoms with other conditions, particularly chronic cough and chest tightness, which may require further examination for accurate diagnosis [2] Group 2 - Allergic rhinitis can increase the risk of developing asthma, as inflammation may spread from the upper airways to the bronchial tubes if not well-controlled [3] - Individuals with allergic conditions should monitor their respiratory symptoms closely and seek medical evaluation for early diagnosis and treatment [3] Group 3 - Although asthma cannot be cured, most patients can manage their condition effectively through proper medication and treatment protocols, allowing them to breathe freely [4] - Treatment options include both pharmacological and non-pharmacological approaches, with inhaled corticosteroids being the first-line maintenance therapy [4] - New targeted biological therapies are emerging, offering improved treatment options by addressing immune abnormalities associated with asthma [4] Group 4 - Standardized management and long-term care are crucial for asthma patients to control their condition and improve their quality of life [5] - Public awareness of standardized diagnosis and treatment can facilitate early detection and intervention, potentially preventing the progression to chronic obstructive pulmonary disease [5] - Enhanced communication between patients and healthcare providers is essential for improving treatment adherence and patient confidence in managing their condition [5]

Group 1 - The global asthma patient population exceeds 358 million, with projections to surpass 400 million this year; in China, the number of patients exceeds 45 million, including 15 million children [1] - Common triggers for asthma in children include dust mites, pet dander, certain foods, vigorous exercise, and emotional factors such as crying or laughing [1] - Asthma is characterized by bronchial spasms leading to breathing difficulties, with an increasing number of cases attributed to allergies and viral respiratory infections [1] Group 2 - Inhalation therapy is a classic treatment method for asthma, tailored to the patient's age and condition, with a gradual reduction in medication [2] - Other treatment options include traditional Chinese medicine, dietary adjustments, and acupuncture, which can help improve symptoms and reduce asthma attack risks [2] - Parents are advised to seek medical attention promptly during acute asthma attacks, as prolonged hypoxia can damage vital organs [2]