康诺亚 20251209 Q&A 康诺亚公司在自免领域的核心产品有哪些？其市场前景如何？ 康诺亚公司是一家专注于自免领域的领先企业，其核心产品包括 CM310（思 普曲帕单抗）和下一代自免双抗 CM512。CM310 今年（2025 年）纳入了医 保目录，预计将快速放量。该产品对标赛诺菲的达必妥，后者在全球销售额排 名第四，在国内销售额超过 25 亿元人民币。CM310 目前已获批三个适应症： 成人中重度特应性皮炎、慢性鼻息肉和季节过敏性鼻炎，并计划拓展至青少年 和儿童中重度皮炎。 康诺亚的另一大看点是其自主研发的下一代自免双抗 CM512，该药物最近公布的一期数据非常积极，优于现有疗法。估值方面，我 康诺亚自主研发的下一代自免双抗 CM512 同时靶向 TSLP 和白介 13， 半衰期长达 70 天，有望实现超过 3 个月一次给药，优于赛诺菲同靶点 药物，具有显著的市场竞争力。 CM512 的一期数据显示，300 毫克剂量组在 12 周时 EASI 75 和 EASI 90 应答率分别为 58.3%和 41.7%，优于现有靶向白介素阿尔法生物制 剂，且安全性良好，为后续临床试验奠定基础。 康诺亚的 Clau ...

太平洋证券发布研报称，首次覆盖，给予康诺亚-B(02162)"买入"评级，目标股价82.07港元，中国特应 性皮炎药物市场正迎来高速增长期，以度普利尤单抗和司普奇拜单抗为代表的核心产品加速放量。同 时，康诺亚核心产品快速放量，重点管线进度领先，以及自免双抗CM512初步数据积极。 太平洋证券主要观点如下： 中国特应性皮炎药物市场将迅速增长 赛诺菲的度普利尤单抗(达必妥)已在美国、欧盟、日本及中国获批准上市，用于治疗儿童、青少年和成 人特应性皮炎，哮喘和慢性阻塞性肺疾病等，2024年全球销售额已达到141.4亿美元，为全球销售额第 四大药品。根据米内网数据显示，近年来该产品在中国市场迅速放量，2022年其销售额突破10亿元， 2023年以约48%的增速增长至超19亿元，2024年以约33%的增速增长至超25亿元。 (2)康悦达处于快速放量阶段，有望成为重磅大单品 根据康诺亚财报数据，司普奇拜单抗(康悦达)2024年实现销售收入约0.36亿元，2025年上半年实现销售 收入约1.70亿元，目前正处于快速放量阶段。随着过敏性疾病的医疗需求不断增长，司普奇拜单抗治疗 成人特应性皮炎、慢性鼻窦炎伴鼻息肉和季节性过敏性鼻 ...

太平洋证券发布研报称，首次覆盖，给予康诺亚-B(02162)"买入"评级，目标股价82.07港元，中国特应 性皮炎药物市场正迎来高速增长期，以度普利尤单抗和司普奇拜单抗为代表的核心产品加速放量。同 时，康诺亚核心产品快速放量，重点管线进度领先，以及自免双抗CM512初步数据积极。 太平洋证券主要观点如下： (2)康悦达处于快速放量阶段，有望成为重磅大单品 根据康诺亚财报数据，司普奇拜单抗(康悦达)2024年实现销售收入约0.36亿元，2025年上半年实现销售 收入约1.70亿元，目前正处于快速放量阶段。随着过敏性疾病的医疗需求不断增长，司普奇拜单抗治疗 成人特应性皮炎、慢性鼻窦炎伴鼻息肉和季节性过敏性鼻炎等适应症未来纳入医保后有望加速放量。此 外，司普奇拜单抗治疗青少年中重度特应性皮炎、结节性痒疹、哮喘、慢性阻塞性肺病等适应症的不断 扩展，有望促进其未来将保持强劲增长。 (3)全球首款长效TSLP x IL-13双抗初步展现BIC潜力 CM512是康诺亚自主研发的全球首款IgG-like长效型TSLP x IL-13双阻断剂，可同时靶向TSLP和IL-13， 能够早期抑制炎症级联反应的启动，有效减少Th2细胞 ...

Core Viewpoint - 康诺亚-B's CM512, the world's first long-acting TSLP x IL-13 dual blocker for treating moderate to severe atopic dermatitis (AD), has successfully met all endpoints in its Phase I clinical study, indicating strong potential in the market [1] Group 1: Company Developments - 康诺亚-B's stock rose by 4.08% to HKD 59.95, with a trading volume of HKD 31.28 million [1] - The company has reported that CM512's early clinical data shows a significantly better EASI-90 response compared to APOGEE's core asset APG777, while maintaining excellent safety and similar dosing frequency [1] Group 2: Market Context - The long-acting autoimmune treatment sector is currently experiencing significant growth, with APOGEE's market capitalization increasing by over 75% in the last two months, reaching USD 4.3 billion [1] - The commercial sales team for 康诺亚-B is expected to expand to around 400 people by the end of the year, focusing on hospital access and coverage, particularly in key hospitals for AD [1] Group 3: Future Outlook - Sales of 康诺亚-B's drug,司普奇拜单抗, are anticipated to see rapid growth by 2026, as the company prioritizes breakthrough scenarios in core hospitals [1] - The company is also considering the potential for limited price reductions for 司普奇拜单抗 due to high negotiation reductions last year and cost pressures [1]

Group 1: Market Overview - The overall market experienced a pullback last week, but funding pressure is expected to improve marginally due to a rebound in private equity registrations and public fund launches, with private fund registrations rising to 337, exceeding 300 for two consecutive weeks [2][3] - The peak of A-share unlock market value has passed, and the net reduction in industrial capital has shown a marginal decline, indicating a reduction in funding supply pressure [2] Group 2: Fixed Income Analysis - In the construction industry, the supply and demand remain weak, with new home transactions showing a decline while second-hand home transactions have slightly increased [2] - The industrial sector shows strong freight volume performance, but production rates are mixed, with some sectors like coking and independent refineries seeing an increase, while the chemical and automotive sectors remain weak [2] Group 3: Energy Sector Insights - In the global gas turbine market, new orders increased by 95% year-on-year to 24GW in Q3 2025, driven by various factors including energy policy shifts and AI power demand [5] - The high demand for gas turbines is expected to boost exports for domestic component manufacturers, with companies like Yingliu and Haomai Technology positioned to benefit [5] Group 4: Fiscal Policy Outlook - The fiscal policy in 2026 is expected to be more proactive, with a projected fiscal deficit rate of around 4% and an increase in special bond quotas to approximately 5 trillion yuan to support debt resolution and other initiatives [6][7] - The upcoming Central Economic Work Conference will serve as a key observation point for policy reserves and future deployments [6] Group 5: Company-Specific Analysis - Kangnuo Ya-B (2162 HK) is highlighted for its potential in the global autoimmune pipeline, with a market cap increase of over 75% recently, and promising early clinical data for its CM512 product [9] - Black Sesame Intelligence (2533 HK) is recognized for its advancements in the robotics sector with the launch of the SesameX multi-dimensional intelligent computing platform, indicating strong growth potential [10]

Industry Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [1] Core Viewpoints - The report highlights significant clinical advancements in the dual-antibody sector, particularly focusing on the TSLP/IL-13 dual antibody Lunsekimig by Sanofi, which has entered Phase III clinical trials for COPD, with the first patient dosed on September 24 [4][5] - The report emphasizes the potential of dual antibodies in autoimmune diseases, particularly in respiratory conditions like asthma and COPD, indicating a substantial market opportunity [7] Summary by Relevant Sections Industry Basic Situation - The closing index level is 8665.0, with a 52-week high of 9323.49 and a low of 6764.34 [1] Clinical Progress Updates - Sanofi's Lunsekimig is in Phase II/III trials for COPD, aiming to enroll 1884 patients to evaluate its efficacy and safety compared to a placebo [4] - The CM512 dual antibody by Connoa shows promising results in atopic dermatitis, with EASI-75 and EASI-90 response rates of 58.3% and 41.7% respectively, compared to 21.4% and 0% in the placebo group [5] Market Activity and Collaborations - The report notes ongoing collaborations, such as the agreement between Qianxin Biotech and Roche for QX031N, which targets both TSLP and IL-33, with an upfront payment of $75 million and potential milestone payments up to $995 million [6] - The report also mentions the presentation of the CS2015 dual-specific antibody by Basestone Pharmaceuticals at the ACAAI conference, showcasing its therapeutic potential [6] Investment Recommendations - The report suggests focusing on companies like Connoa, Innovent Biologics, Qianxin Biotech, and Basestone Pharmaceuticals, as dual antibodies are expected to reshape treatment paradigms in autoimmune diseases [7][9]

Core Insights - The report from China Post Securities highlights the potential of dual antibodies in the field of autoimmune diseases, particularly in respiratory conditions like asthma and COPD, indicating significant room for improvement in existing therapies. The market potential for TSLP class dual antibodies is viewed positively [1]. Group 1: Clinical Progress of Dual Antibodies - Sanofi's lunsekimig (TSLP/IL-13 dual antibody) has entered Phase III clinical trials, with the first patient dosed on September 24. The trials aim to enroll 1,884 patients to evaluate the efficacy and safety of lunsekimig compared to placebo in adults with eosinophilic phenotype COPD [1]. - The primary endpoint of the studies is the annualized rate of moderate to severe COPD exacerbations from baseline to week 48. The company confirmed the completion of the first patient dosing during the Q3 earnings call on October 24 [1]. Group 2: Efficacy Data and Advantages - The first-phase data for Connoa's CM512 (TSLP x IL-13 dual antibody) in atopic dermatitis (AD) showed promising results, with EASI-75 and EASI-90 response rates of 58.3% and 41.7% respectively at the 300mg dose after 12 weeks, compared to 21.4% and 0% in the placebo group. This indicates a strong potential for deep relief and sustained stability [2]. - CM512's long half-life advantage suggests that it can effectively reduce dosing frequency in clinical use, thereby improving patient compliance [2]. Group 3: Ongoing Transactions and Research Activity - On October 28, Qianxin Biotech entered a global exclusive collaboration and licensing agreement with Roche for QX031N, a long-acting dual antibody targeting TSLP and IL-33, with an upfront payment of $75 million and potential milestone payments up to $995 million. This product is expected to be developed as a new treatment option for COPD and asthma [3]. - BGI Pharma showcased the OX40L/TSLP bispecific antibody CS2015 at the 2025 ACAAI, which demonstrated therapeutic potential in preclinical trials [3].

Keymed Bioscience Conference Call Summary Company Overview - **Company**: Keymed Bioscience (2162.HK) - **Industry**: Immunology Biotech in China Core Insights and Arguments - **Pipeline Potential**: Keymed is recognized for its well-established immunology pipeline, with significant upside potential driven by its product candidates, particularly Stapokibart and CM512 [4][10] - **Stapokibart Validation**: The approval of Stapokibart serves as a validation of the company's R&D and regulatory capabilities, enhancing investor confidence [4][10] - **CM512 Breakthrough Potential**: CM512, a TSLP/IL-13 bispecific antibody, is highlighted for its breakthrough potential, with projected peak sales of approximately US$3.3 billion globally by 2035 [5][10] - **Market Forecasts**: The company anticipates peak sales of Rmb5.2 billion in the Chinese market by 2035, contributing to 50% of its total equity valuation [10] Development Strategy - **Diversified Pipeline**: Keymed is focusing on enriching its immunology pipeline with various modalities, including early-stage development assets [6][10] - **Global Oncology Potential**: The company aims to unlock the global potential of its oncology pipeline through strategic partnerships [6] Financial Projections - **Target Price**: The 12-month forward target price for Keymed is set at HK$92.67, based on a DCF valuation with a discount rate of 12% [11] - **Growth Rate**: A terminal growth rate of 3% is projected, reflecting growth potential from the early-stage pipeline [12] Probability of Success (PoS) - **Success Rates**: The probability of success for Stapokibart is 100%, while CM512 has a PoS of 32% for asthma and 9% for COPD [13] Key Risks - **R&D Risks**: The company faces R&D risks associated with its key pipeline assets, including uncertainties in commercial execution and potential pricing pressures from rising competition [17] - **Development Uncertainties**: There are uncertainties regarding the development of CM512, which could impact its market entry and success [17] Upcoming Catalysts - **Regulatory and Clinical Milestones**: Key upcoming catalysts include regulatory negotiations for CM310 and clinical data releases for CM512 and CMG901, with timelines extending into 2026 [15][16] Conclusion Keymed Bioscience is positioned as a significant player in the immunology sector in China, with a robust pipeline and strategic growth initiatives. However, investors should remain cautious of the inherent risks associated with R&D and market competition.

Core Insights - The article discusses the promising Phase I clinical results of CM512, a dual-target antibody for treating atopic dermatitis (AD), showing significant efficacy compared to placebo [1][2]. Group 1: Clinical Results - After three doses in the first month, the 300mg dose group achieved EAS-75 and EAS-90 rates of 58.3% and 41.7% respectively at 12 weeks, significantly outperforming the placebo group which had rates of 21.4% and 0% [1]. - The drug demonstrated a long half-life of 70 days, indicating potential for extended dosing intervals [1]. - The safety profile was comparable between the treatment and control groups, with similar rates of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) [1]. Group 2: Competitive Advantage - CM512 shows potential as a best-in-class (BIC) treatment, particularly in deep remission metrics, with an adjusted EASI-90 of 41.7% [2]. - Compared to standard therapies, CM512 outperformed Dupilumab and other IL-13 monoclonal antibodies in clinical trials, indicating a competitive edge [2]. - The drug also competes favorably against small molecule drugs like JAK1 inhibitors, demonstrating higher efficacy in achieving EASI-90 [2]. Group 3: Future Development and Valuation - The company is expanding CM512's indications, with ongoing Phase I trials for asthma and Phase II trials for multiple conditions including COPD and chronic spontaneous urticaria [3]. - The long half-life of CM512 (70 days) compared to competitors (10 days for Lunsekimig) enhances its market potential [3]. - The company adjusted its profit forecasts for 2025-2027, reflecting a more optimistic outlook based on CM512's early data, raising the target price to 91.08 HKD [3].

Key Insights - The report discusses the potential bubble in AI investments, indicating that the AI sector may be transitioning from the acceleration phase to the frenzy phase, with signs of irrational valuations and performance under expectations [2][4][5] - The report highlights the resilience of Chinese exports, which grew by 6% year-on-year in Q2 despite tariffs reaching 145%, and anticipates continued strong growth in exports through 2026 [4] - The report emphasizes the strong performance of large brokerage firms, with a 62% year-on-year increase in net profit for the first nine months of 2025, driven by asset expansion and increased investment activity [8] - The report notes the positive outlook for the airline industry, particularly for China National Aviation, as it benefits from improving supply-demand dynamics [11] - The report indicates that Spotify's revenue for Q3 2025 reached €4.272 billion, a 7% year-on-year increase, with a strong performance in user growth and profitability [12] - The report mentions that YUM China achieved a revenue of $3.2 billion in Q3 2025, reflecting a 4% year-on-year growth, supported by strong same-store sales [19] Group 1: AI Sector - The report outlines concerns regarding the AI bubble, suggesting that the sector is moving towards a potential frenzy phase characterized by irrational valuations [2][5] - It notes that AI-related investments contributed approximately 1 percentage point to U.S. economic growth in the first half of 2025, indicating significant economic impact [5] Group 2: Chinese Exports - The report highlights the resilience of Chinese exports, which grew by 6% year-on-year in Q2 2025, despite high tariffs [4] - It anticipates that the structural improvements in the export sector will continue to support growth through 2026 [4] Group 3: Brokerage Firms - The report indicates that large brokerage firms experienced a 62% increase in net profit year-on-year for the first nine months of 2025, driven by asset growth and increased investment activity [8] - It suggests that the operating environment for brokerages is improving, with enhanced performance elasticity and sustainability [8] Group 4: Airline Industry - The report discusses the positive outlook for China National Aviation, which is expected to benefit from improving industry supply-demand dynamics [11] - It highlights the company's recent engagement with investors regarding operational performance and future growth strategies [11] Group 5: Spotify - The report states that Spotify's Q3 2025 revenue reached €4.272 billion, a 7% year-on-year increase, with strong user growth and profitability [12] - It emphasizes the company's ongoing innovation in content and product features, which are expected to drive future growth [12] Group 6: YUM China - The report notes that YUM China achieved a revenue of $3.2 billion in Q3 2025, reflecting a 4% year-on-year growth, supported by strong same-store sales [19] - It highlights the company's effective cost management and expansion strategies as key drivers of its performance [19]