2025.11. 24 本文字数：1255，阅读时长大约2.5分钟 作者 | 第一财经 马晓华 当"一抹就退"的激素药膏成为无数家庭的首选，特应性皮炎的治疗也陷入了一场恶性循环：瘙痒、 用药、缓解、复发、加重……再用药。如今，一款国产创新药，试图为这场漫长的斗争画上休止符。 "我的病人里，特应性皮炎约占三分之二，其中激素滥用的情况触目惊心。"11月22日，北京大学人 民医院皮肤科张建中教授在"首届湿疹之友健康管理论坛"上表示，"他们自行购药，随意涂抹，后果 很严重——不可逆的膨胀纹、激素依赖性皮炎，这些都已成为皮肤科门诊的常见'后遗症'。" 监管灰色地带与患者的自救困局 特应性皮炎（AD），这种被俗称为"过敏性湿疹"的疾病，远非简单的皮肤问题。它是一种慢性、复 发性、炎症性皮肤病，常与过敏性鼻炎、哮喘等结伴而行，被视为一种系统性疾病。全球范围内， AD的发病率持续攀升，中国形势尤为严峻：1-7岁儿童患病率已达12.94%，而1-12月龄婴儿的患 病率更是高达30.48%。 在皮肤科药物唾手可得的今天，混乱的自我药疗成为了疾病管理的"放大器"。"在药店柜台与网络平 台上，各类'皮肤神膏'唾手可得。"一位业内专家 ...

在皮肤科药物唾手可得的今天，混乱的自我药疗成为了疾病管理的"放大器"。"在药店柜台与网络平台 上，各类'皮肤神膏'唾手可得。"一位业内专家评论道，"监管的灰色地带与商业的过度营销，共同构筑 了激素滥用的温床。"与此同时，"谈激素色变"的恐慌又让部分患者拒绝一切必要治疗，导致病情失 控。 监管的灰色地带与商业的过度营销，共同构筑了激素滥用的温床 当"一抹就退"的激素药膏成为无数家庭的首选，特应性皮炎的治疗也陷入了一场恶性循环：瘙痒、用 药、缓解、复发、加重……再用药。如今，一款国产创新药，试图为这场漫长的斗争画上休止符。 "我的病人里，特应性皮炎约占三分之二，其中激素滥用的情况触目惊心。"11月22日，北京大学人民医 院皮肤科张建中教授在"首届湿疹之友健康管理论坛"上表示，"他们自行购药，随意涂抹，后果很严重 ——不可逆的膨胀纹、激素依赖性皮炎，这些都已成为皮肤科门诊的常见'后遗症'。" 监管灰色地带与患者的自救困局 特应性皮炎（AD），这种被俗称为"过敏性湿疹"的疾病，远非简单的皮肤问题。它是一种慢性、复发 性、炎症性皮肤病，常与过敏性鼻炎、哮喘等结伴而行，被视为一种系统性疾病。全球范围内，AD的 发病率持续 ...

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 Insights - The "Expert Consensus on the Treatment and Management of Atopic Dermatitis (2025 Edition)" has been published, providing standardized clinical application guidance for the innovative drug, Zeli Mei Ben Wei Mo De Ointment [1][2] - Atopic dermatitis (AD) has a prevalence rate of 10%-15% among children in China, making it the leading non-fatal skin disease burden [1] - The consensus emphasizes the importance of Zeli Mei Ben Wei Mo De Ointment as a treatment option for the two-thirds of patients with mild to moderate AD, based on research data from the Chinese population [1][2] Treatment Mechanism - Zeli Mei Ben Wei Mo De Ointment works by inhibiting type 2 inflammatory cytokines and repairing the skin barrier, specifically targeting IL-4/IL-13 induced tight junction damage [2] - Clinical trials indicate that the ointment can reduce and eliminate skin lesions while alleviating itching, with most adverse reactions being mild to moderate [2] Treatment Guidelines - The consensus provides clear guidelines for treating special areas and populations, recommending the use of moderately potent topical medications in sensitive areas to avoid the risk of skin atrophy from long-term corticosteroid use [2] - The dual mechanism of Zeli Mei Ben Wei Mo De Ointment offers unique advantages in addressing the inflammatory responses and barrier defects commonly seen in AD patients in China, particularly for children and those contraindicated for steroids [2] - The publication of the consensus aims to guide medical institutions in standardizing the selection of topical medications for AD, promoting the standardization of AD diagnosis and treatment in China [2]

Core Viewpoint - Company subsidiary Guangdong Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SHR-1905 injection, targeting atopic dermatitis [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-1905 injection was accepted on July 17, 2025, and meets the requirements for drug registration [1] - The approval allows the company to conduct clinical trials for atopic dermatitis [1] Group 2: Product Information - SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The product aims to improve inflammatory conditions and control disease progression [1] Group 3: Market Context - A similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), has been approved and is projected to generate global sales of approximately $1.22 billion in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Insights - The market potential for Atopic Dermatitis (AD) is significant, with a large patient population and unmet medical needs, particularly for effective and safe treatments [1][2] - The development of small molecules and biologics is entering a new phase, with several new therapies gradually being approved for AD treatment [2][3] - JAK inhibitors show excellent efficacy but have safety concerns, while TYK2 is emerging as a promising new option with potentially higher safety [3][4] - Biologics such as IL-4Rα and IL-31 demonstrate strong efficacy in improving skin lesions and alleviating itching, but there is still room for improvement compared to JAK inhibitors [4][5] - Dual and multi-target antibodies may offer a new approach by combining the advantages of different targets, with several companies already exploring this strategy [5] Group 1: Market Overview - Atopic Dermatitis (AD) is a chronic, recurrent inflammatory skin disease characterized by severe itching, affecting approximately 600-700 million patients globally, with around 67 million in China [1] - The demand for effective and safe medications is high due to the significant burden of the disease on patients' daily lives [1] Group 2: Treatment Landscape - Traditional therapies have poor safety profiles, leading to the emergence of biologics and small molecule targeted therapies over the past decade, with about a dozen products approved globally [2] - Current approved small molecule JAK inhibitors include Upadacitinib and Abrocitinib, but they carry safety warnings from the FDA [3] Group 3: Biologics Efficacy - Among the biologics, IL-4Rα and IL-13 show confirmed efficacy, while IL-31 is particularly effective in alleviating itching [4] - There is a notable difference in efficacy between biologics and JAK inhibitors, with Upadacitinib showing superior results in head-to-head studies [4] Group 4: Future Directions - The exploration of dual/multi-target antibodies aims to enhance treatment efficacy and extend dosing intervals, with several companies already developing such therapies [5] - Ongoing research into various targets may lead to improved outcomes for AD patients [5]

Group 1 - The ADP employment number in the US increased by 54,000 in August, which is below market expectations, leading traders to maintain their interest rate cut bets unchanged [1] - The US stock market opened with mixed results, with the Nasdaq up 0.15%, the S&P 500 up 0.11%, and the Dow Jones down 0.06% [1] Group 2 - Salesforce, a customer relationship management software giant, saw its stock drop over 7% as it expects a slowdown in revenue growth for Q3, which is below expectations [1] - Sanofi's stock fell by 8.6% despite its Amlitelimab treatment for atopic dermatitis meeting all primary and secondary endpoints in Phase III studies, as the results did not meet market expectations [1] - Figma, a UI design software developer, experienced a drop of over 19% after its first earnings report post-IPO fell short of expectations, with guidance only slightly exceeding forecasts [1] - American Eagle, a US apparel retailer, surged over 33% after reporting Q2 results that exceeded expectations and reissuing its full-year guidance [1]

Core Viewpoint - Sanofi's experimental drug for atopic dermatitis, amlitelimab, has underperformed in late-stage trials, disappointing investors and leading to a pre-market stock drop of up to 9.3% [1]. Group 1: Drug Performance and Market Impact - Amlitelimab showed improvement in skin clearance and disease severity compared to placebo, but the efficacy was still lower than Sanofi's best-selling drug, Dupixent [1]. - The stock has declined by 18% over the past 12 months, reflecting investor concerns about the drug's potential [1]. - Analysts believe the results of the amlitelimab trial are crucial for Sanofi, especially given the uncertain future of another key drug, itepekimab [1]. Group 2: Future Prospects and Comparisons - Sanofi is seeking alternatives to Dupixent, which is projected to generate over €21 billion annually at peak sales [3]. - Amlitelimab is expected to generate approximately €1.5 billion (around $1.75 billion) in annual revenue by 2031 [3]. - Amlitelimab has a dosing advantage, requiring administration only once every three months compared to Dupixent's more frequent dosing schedule [3]. Group 3: Other Drug Developments - The efficacy results of itepekimab have been mixed in recent late-stage trials, as it is being tested for chronic obstructive pulmonary disease in former smokers [4].

Core Viewpoint - The Chinese innovative drug sector is gaining global competitiveness, highlighted by significant business development (BD) deals and the promising clinical data of the drug SM17, which is expected to attract attention from major pharmaceutical companies [1][2][12]. Group 1: Market Dynamics - The market is actively seeking the next major BD deal, especially after the significant $6 billion BD deal between 3SBio and Pfizer, indicating a trend of increasing interest in Chinese innovative drugs [1]. - The total amount of outbound transactions for Chinese innovative drugs is projected to reach a record high by 2025, with $45.5 billion already achieved in 2025 alone [5][7]. - The frequency of BD transactions is driven by multinational pharmaceutical companies facing "patent cliffs," necessitating the acquisition of innovative drug pipelines to replenish their product lines [7][8]. Group 2: SM17 Drug Overview - SM17 is a first-in-class monoclonal antibody targeting the IL-25 receptor, showing promising results in clinical trials for moderate to severe atopic dermatitis (AD) [2][3]. - The drug demonstrated a 91.7% response rate in itch control and a 75% response rate in skin lesion improvement during phase 1b trials, significantly outperforming existing treatments [4]. - SM17's unique dual mechanism of action allows for rapid itch relief and effective inflammation reduction, setting it apart from current therapies [3][4]. Group 3: Clinical and Commercial Potential - The global AD patient population is substantial, with at least 230 million affected worldwide, including over 70 million in China, indicating a significant market opportunity for SM17 [2][4]. - SM17's safety profile is favorable, with no serious adverse events reported during the clinical trials, further enhancing its attractiveness for potential licensing deals [4][9]. - The drug has potential applications beyond AD, including asthma and other autoimmune diseases, which could broaden its commercial prospects [9][11]. Group 4: Company Strategy and Future Outlook - The company has established a robust pipeline of innovative drugs, focusing on monoclonal antibodies for various immune-related diseases, positioning itself for sustainable growth [11][12]. - The strategic emphasis on self-research and innovation, coupled with promising clinical data for SM17, is expected to attract significant investment and partnership opportunities [12].