格隆汇12月7日｜康诺亚宣布，公司自主研发的国家1类新药康悦达®（司普奇拜单抗注射液）纳入《国 家基本医疗保险、生育保险和工伤保险药品目录（2025年）》，该目录将自2026年1月1日起正式实施。 此次纳入新版国家基本医疗保险药品目录，康悦达®（司普奇拜单抗）在多个适应症上填补了治疗领域 空白和医保目录空白：它是国产首个治疗中重度特应性皮炎的生物制剂，带来更高治疗获益，打破了长 期以来进口药物的垄断, 为外用药控制不佳的患者带来靶向治疗新选择；同时，它也是国内首个治疗慢 性鼻窦炎伴鼻息肉的生物制剂、全球唯一治疗季节性过敏性鼻炎的IL-4Rα抗体药物，为传统治疗手段效 果不佳、存在未满足临床需求的患者提供了革新性的治疗方案。 ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02162 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 第 1 頁 共 10 頁 v 1.1.1 FF301 公司名稱: ...

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]

每经AI快讯，康诺亚-B(02162.HK)涨超4%，截至发稿，涨4.08%，报59.95港元，成交额3128.21万港 元。 ...

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].

Group 1 - The core viewpoint of the articles highlights the strong performance of innovative drug stocks in the market, with notable increases in share prices for companies such as Gilead Sciences-B (up 8.82%) and Kintor Pharmaceutical (up 4.60%) [1] - The report from CICC emphasizes the importance of innovative drugs and medical devices in China's "14th Five-Year Plan," indicating a shift from "follow-up innovation" to "quality transformation" in domestic innovative drugs [1] - The collaboration between Hansoh Pharmaceutical and Roche for the global exclusive license of the antibody-drug conjugate HS-20110 is seen as a significant advancement, with expectations for smooth development due to Roche's expertise [2] Group 2 - The partnership between Innovent Biologics and Takeda Pharmaceutical aims to advance the development of next-generation tumor immunotherapy and antibody-drug conjugates, leveraging Takeda's strong sales network in Japan and the West [2] - Valiant Pharmaceuticals' agreement with the U.S. company Dianthus for the development and commercialization of its autoimmune drug LBL-047 outside Greater China is viewed as beneficial for product development [2] - The overall sentiment in the pharmaceutical industry is optimistic regarding the international expansion of innovative drugs, with multiple companies securing significant partnerships to enhance their research and commercialization efforts [2]

Core Insights - The eczema formulation market is projected to grow from 4.03 billion to 5.28 billion yuan from 2019 to 2024, with a compound annual growth rate (CAGR) of 5.5% [1][11] - The primary patient demographic for eczema is adults aged 18 to 60, accounting for 51.6% of cases, while children aged 2 to 12 represent 20.7% of the patient population [1][9] - The industry is characterized by a clear supply chain, with upstream raw materials, midstream production, and downstream sales channels including hospitals and online platforms [6][7] Market Overview - Eczema formulations are designed to prevent, alleviate, or treat eczema through mechanisms such as anti-inflammatory effects, itch relief, skin barrier repair, and immune regulation [1][5] - The market is influenced by increasing eczema incidence due to environmental degradation and rising stress levels, alongside heightened consumer awareness regarding skin health [1][11] Industry Structure - Major players in the eczema formulation industry include both foreign and domestic pharmaceutical companies, with foreign firms dominating the high-end market and domestic companies competing effectively in the mid to low-end segments [1] - Key companies in the industry include Heng Rui Medicine, Innovent Biologics, Connoa, and Xianju Pharmaceutical [1] Research and Analysis - The research team utilized various analytical models such as SCP, SWOT, PEST, and regression analysis to assess the market environment, industry policies, competitive landscape, and technological innovations within the eczema formulation sector [2][20] - A comprehensive report titled "2026-2032 China Eczema Formulation Industry Development Outlook and Investment Strategy Research Report" has been compiled to provide insights for enterprises, research institutions, and investment organizations [2][20]

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.