目前，该实验状态为进行中（尚未招募），目标入组人数160人。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现 的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不 构成个人投资建议。受限于第三方数据库质量等问题，我们无法对数据的真实性及完整性进行分辨或核 验，因此本文内容可能出现不准确、不完整、误导性的内容或信息，具体以公司公告为准。如有疑问， 请联系biz@staff.sina.com.cn。 责任编辑：小浪快报 该药物剂型为注射剂，有预充式安全注射针和预充式自动注射笔两种，规格均为2mL: 0.3g，用法为皮 下注射，单次用药。本次试验主要目的为比较使用预充式安全注射针（PFS）和预充式自动注射笔 （AI）的SHR - 1819注射液的生物利用度；次要目的为比较其安全性和免疫原性。 SHR - 1819注射液为生物制品，适应症为特应性皮炎。特应性皮炎是一种慢性、复发性、炎症性皮肤 病，表现为皮肤瘙痒、红斑、丘疹等。诊断主要依据典型临床表现，治疗包括外用药物、口服药物等。 本次试验主要终点指标包括比较使用不同注射装置的SHR ...

Core Viewpoint - The article discusses the challenges and advancements in the treatment of atopic dermatitis (AD), highlighting the issues of steroid misuse and the introduction of a new non-steroidal innovative drug that aims to break the cycle of treatment and relapse [3][4][5]. Group 1: Atopic Dermatitis Overview - Atopic dermatitis is a chronic, recurrent inflammatory skin disease often associated with other allergic conditions, with a rising incidence globally, particularly severe in China where the prevalence in children aged 1-7 years is 12.94% and in infants aged 1-12 months is 30.48% [4]. - The misuse of steroid creams has become a significant issue, leading to severe side effects such as irreversible skin changes and dependency, as patients often self-medicate without proper guidance [3][5]. Group 2: Treatment Challenges - The current treatment landscape is characterized by a dichotomy of steroid overuse and fear of steroid use, complicating effective management of the disease [6]. - Traditional treatments involve a trade-off between the rapid relief provided by steroids and the long-term damage they can cause to the skin, while non-steroidal options are perceived as slower and less effective [6]. Group 3: Innovative Solutions - The introduction of the innovative drug, Zeli Mei® (bimekizumab), represents a significant advancement, being the first aromatic hydrocarbon receptor (AhR) modulator approved for treating AD in patients over 2 years old [8]. - Clinical trials have shown promising results, with nearly 60% of patients achieving deep itch relief after 8 weeks of treatment, and 70% of patients remaining relapse-free for 10 months after stopping the medication [8]. - The Chinese market for eczema topical agents is projected to reach approximately 5.28 billion yuan in 2024, with steroid-based medications currently dominating the market, exemplified by "Pian Yan Ping" achieving sales of 1.04 billion yuan in 2023 [8].

Core Insights - The article discusses the challenges of managing atopic dermatitis (AD) in China, highlighting the issues of hormone abuse and the need for innovative treatments [1][2][3] - A new non-steroidal drug, Zeli Mei® (bimekizumab), has been approved for the treatment of AD, offering a potential solution to the ongoing cycle of flare-ups and treatment failures [2][3] Regulatory and Market Context - The current regulatory gray area and excessive marketing contribute to the widespread abuse of steroid medications for AD [2] - The prevalence of AD is increasing, with a reported incidence of 12.94% among children aged 1-7 years and 30.48% among infants aged 1-12 months in China [1] Treatment Challenges - Patients often resort to self-medication due to the availability of various topical treatments, leading to a dual challenge of overuse and fear of necessary steroid treatments [2] - Traditional steroid treatments are effective but can cause long-term skin damage, while non-steroidal options are safer but take longer to show results [2] Innovative Solutions - The introduction of Zeli Mei® represents a significant advancement, being the first aromatic hydrocarbon receptor (AhR) modulator approved for AD treatment in children over 2 years old and adults [3] - Clinical trials indicate that nearly 60% of patients experienced significant itch relief after 8 weeks of treatment, and 70% of patients remained relapse-free for 10 months after stopping the medication [3] Market Potential - China has approximately 70 million AD patients, with over 90% requiring topical treatments, indicating a substantial market opportunity for new therapies [3] - The market for eczema topical agents in China is projected to reach approximately 5.28 billion yuan in 2024, with steroid medications currently holding a significant market share [3]

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].