葛兰素史克公司周二表示，美国卫生监管机构已批准该公司用于治疗重症哮喘的附加药物，这为患者选 择一种用药频率较低的治疗方案进入市场铺平了道路。 责任编辑：王永生 葛兰素史克公司周二表示，美国卫生监管机构已批准该公司用于治疗重症哮喘的附加药物，这为患者选 择一种用药频率较低的治疗方案进入市场铺平了道路。 责任编辑：王永生 ...

Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Date**: November 13, 2025 - **Key Speakers**: Michael Henderson (CEO), Carl Dambkowski (CMO), Jeff Hartness (CCO), Jane Pritchett Henderson (CFO) Key Industry and Company Insights Asthma Data and APG777 - **APG777 Phase 1 Readout**: Expected in Q1 2026, focusing on asthma data [2][4] - **Comparison with Ebglyss**: Ebglyss failed due to underdosing (20% of effective dose) and lack of targeting type 2 disease [2][3] - **Targeting Type 2 Disease**: Apogee aims to enroll high FeNO patients, expecting a change in FeNO similar to Dupixent (15-20 parts per billion) [3][4] - **Loading Dose**: APG777 will use a loading dose of 720 mg, compared to Ebglyss's 500 mg [5][7] Future Plans in Asthma - **Expansion Plans**: If successful, Apogee plans to initiate Phase 2B studies in asthma and EoE, contingent on atopic dermatitis data [8][9] - **Overlap with Atopic Dermatitis**: Approximately 30% overlap between atopic dermatitis and asthma patients [9] Atopic Dermatitis Phase 2 Program - **Part A Results**: Positive results reported, with 52-week maintenance data expected in Q1 2026 [10][11] - **Success Metrics**: Aiming for maintenance of EC75 response at week 52, with a benchmark of 72% for Dupixent [11][12] - **Dosing Strategy**: Plans for every three-month and six-month dosing regimens, with data expected to inform Phase 3 studies [12][13] Mechanistic Insights - **Differentiation from Competitors**: APG777 targets IL-13 and IL-4 receptors, potentially leading to better durability of response compared to competitors [16][17] Part B Study Design - **Dose Optimization**: Part B will explore three doses versus placebo, aiming to fully understand the dose-response curve [19][20] - **Market Research**: Positive feedback from physicians, with 60% preferring APG777 over competitors [37][38] Market Positioning - **Market Disruption Potential**: Ebglyss and Nemluvio are currently strong competitors, but Apogee believes it can capture significant market share [38][39] - **Combination Therapy**: Plans to explore combinations with APG990, aiming for additive efficacy [32][33] Financial Position - **Cash Reserves**: Apogee has $913 million in cash, providing a runway into the second half of 2028 [30] Timeline for Future Trials - **Phase 3 Trials**: Expected to start next year, with a potential market launch in 2029 [27] Additional Insights - **Conjunctivitis Rates**: Lower rates observed in higher exposure groups, aligning with Dupixent's data [26] - **Combination with TSLP**: Future plans to explore combinations with TSLP based on upcoming data [41][44] Conclusion Apogee Therapeutics is positioned to make significant advancements in the treatment of asthma and atopic dermatitis with its APG777 product. The company is focused on differentiating its therapies through targeted dosing and mechanistic advantages, while also preparing for future market competition and expansion into additional indications.

Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Focus**: Development of potentially best-in-class antibodies for atopic dermatitis and asthma, with a busy pipeline ahead [1][2] Key Points on Atopic Dermatitis - **Market Potential**: The atopic dermatitis market is large, with Dupixent continuing to grow despite new entrants like Ebglyss and Nemluvio, which are annualizing at approximately $650 million and $500 million respectively [3][4] - **Biologic Penetration**: Current biologic penetration in the atopic dermatitis space is around 10%, indicating significant growth potential [4] - **Triple 7 and Combination Approach**: Apogee aims to position its drug, Triple 7, and its combination approach (279) as frontline treatments for atopic dermatitis, with phase three trials expected to start by the end of next year [2][6] Clinical Data Highlights - **Phase 2 Trial Results**: The phase 2 trial showed promising results with a placebo-adjusted EASI-75 of 42.5%, indicating strong efficacy compared to existing treatments [7][8] - **Rapid Itch Relief**: Significant itch relief was observed as early as 48 hours post-treatment, comparable to Nemluvio [8][10] - **Safety Profile**: Conjunctivitis rates were similar to those seen with Dupixent, but no discontinuations due to this side effect were reported [11][12] Future Developments - **Upcoming Data**: Maintenance data for dosing every three and six months is expected in Q1 of next year, which will be crucial for regulatory discussions [14][15] - **Combination Studies**: A study combining Triple 7 with OX40 ligands (279) is currently enrolling, aiming to replicate JAK-like efficacy without associated safety issues [22][24] Asthma Pipeline - **Asthma Focus**: Apogee is prioritizing asthma due to the overlap with atopic dermatitis patients, with proof of concept studies expected in Q1 [28][30] - **Dosing Strategy**: A single dose of 720 mg is planned to evaluate efficacy against Dupixent, particularly in reducing FeNO levels [29][30] Financial Position - **Cash Reserves**: Apogee has over $900 million in cash, providing a runway into the second half of 2028, covering phase three top-line data [33] Conclusion - Apogee Therapeutics is positioned to make significant strides in the atopic dermatitis and asthma markets with a robust pipeline and promising clinical data. The company is focused on establishing its products as frontline therapies while maintaining a strong financial position to support ongoing and future clinical trials.

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]