机构：中邮证券 研究员：盛丽华/徐智敏 事件 公司发布25 年中期业绩公告，25H1 公司收入74.34 亿元，同比+14.3%，溢利31.35 亿元，同比 +15.0%。 投资要点 创新药及合作收入维持高增，总收入占比提升至83%。 2025 年上半年创新药与合作产品收入约61.5 亿元，占比提升至82.7%。按治疗领域来看，抗肿瘤收入 45.3 亿元占比60.9%；抗感染收入7.4 亿元，占比9.9%；中枢神经系统收入7.7 亿元，占比10.4%；代谢 及其他领域收入14.0 亿元，占比18.8%。 阿美替尼新适应症获批贡献增量，多项创新管线稳健推进。 研发进展角度来看，阿美替尼在2025 年新获批两项适应症：辅助治疗NSCLC 和不可切除NSCLC 患者 根治性放化疗后的维持治疗。同时2025 年6 月在英国获批上市单药的一线治疗，有望持续抬升阿美替尼 的收入天花板。同时公司新增多个3 期关键注册临床：B7H3 ADC（骨与软组织肉瘤）、B7H4 ADC （卵巢癌）、IL-23p19(中重度板块状银屑病，荃信生物合作)，推进稳健为公司未来成长提供动力。 BD 合作收入持续增厚业绩。 2025H1 公司已 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [1][8]. Core Insights - The company reported a revenue of 7.434 billion yuan for the first half of 2025, reflecting a year-on-year increase of 14.3%, with a profit of 3.135 billion yuan, up 15.0% year-on-year [4]. - The revenue from innovative drugs and collaborations continues to grow, with total revenue contribution rising to 83%, and innovative drug and collaboration product revenue reaching approximately 6.15 billion yuan, accounting for 82.7% of total revenue [5]. - The company has received approvals for new indications for its drug Amatinib, which is expected to enhance revenue potential, alongside multiple ongoing Phase III clinical trials [6]. - The company has secured significant collaboration income, including a 112 million USD upfront payment from Merck and an 80 million USD upfront payment from Regeneron [7]. - The company is positioned as a leading domestic pharmaceutical enterprise, transitioning from traditional generics to innovative business, with expected revenues of 14.432 billion yuan, 16.590 billion yuan, and 19.164 billion yuan for 2025, 2026, and 2027 respectively [8]. Financial Summary - The latest closing price is 36.36 HKD, with a total market capitalization of 225.4 billion HKD [3]. - The company has a debt-to-asset ratio of 11.33% and a price-to-earnings ratio of 42.3 [3]. - Forecasted revenues for 2025-2027 are 14.432 billion yuan, 16.590 billion yuan, and 19.164 billion yuan, with net profits projected at 4.986 billion yuan, 5.664 billion yuan, and 6.391 billion yuan respectively [12][13].

Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) experienced a decline of 3.38% on September 4, with a trading volume of 1.427 billion yuan. The fund has shown significant growth in both share volume and total assets since its inception in January 2024 [1][2]. Group 1: Fund Performance - The Hong Kong Innovative Drug ETF (159567) was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1]. - As of September 3, 2024, the fund's latest share volume was 6.668 billion shares, and its total assets reached 6.724 billion yuan. This represents an increase of 1586.48% in share volume and 1679.83% in total assets compared to December 31, 2023, when the share volume was 395 million shares and total assets were 378 million yuan [1]. Group 2: Trading Activity - Over the past 20 trading days, the cumulative trading amount for the Hong Kong Innovative Drug ETF (159567) was 33.138 billion yuan, with an average daily trading amount of 1.657 billion yuan. Since the beginning of the year, the cumulative trading amount over 165 trading days was 185.061 billion yuan, averaging 1.122 billion yuan per day [1]. Group 3: Fund Holdings - The current fund manager of the Hong Kong Innovative Drug ETF (159567) is Ma Jun, who has managed the fund since its inception, achieving a return of 99.52% during this period [2]. - Key holdings in the fund include: - Innovent Biologics (9.52% holding, 2.60 billion yuan market value) - WuXi Biologics (9.47% holding, 2.58 billion yuan market value) - BeiGene (8.73% holding, 2.38 billion yuan market value) - CanSino Biologics (7.62% holding, 2.08 billion yuan market value) - China National Pharmaceutical Group (7.17% holding, 1.96 billion yuan market value) - CSPC Pharmaceutical Group (6.34% holding, 1.73 billion yuan market value) - 3SBio (5.83% holding, 1.59 billion yuan market value) - Hansoh Pharmaceutical (4.54% holding, 1.24 billion yuan market value) - Zai Lab (2.86% holding, 781.055 million yuan market value) [2].

Group 1 - FTSE Russell announced changes to the FTSE China 50 Index and FTSE China A50 Index, effective after market close on September 19, 2025 [1] - The FTSE China A50 Index will include companies such as BeiGene Ltd (688235.SH), Xinyisheng (300502.SZ), WuXi AppTec (603259.SH), and Zhongji Xuchuang (300308.SZ) [1] - Companies removed from the FTSE China A50 Index include China National Nuclear Power (601985.SH), China Unicom (600050.SH), Guodian Nanjing Automation (600406.SH), and Wanhua Chemical (600309.SH) [1] Group 2 - The FTSE China A50 Index serves as an important reference for overseas investors, and historical adjustments to the index typically attract significant passive capital from abroad [1] - The FTSE China 50 Index remains unchanged, with only the list of candidate stocks updated to include China Hongqiao Group (01378), Hansoh Pharmaceutical (03692), Huatai Securities (06886), JD Health (06618), and New China Life Insurance (01336) [1]

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8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 翰森製藥集團有限公司 呈交日期: 2025年9月2日 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) | 03692 | 說明 | - | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 20,000,000,000 | HKD | | 0.00001 | HKD | | 200,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 20,000,000,000 | HKD | | 0.00001 | HKD | | 200,000 | 本月底法定/ ...

经济观察网9月1日，翰森制药(03692)发布公告，宣布其创新药昕越(伊奈利珠单抗注射液)于2025年8月 26日获得中国国家药品监督管理局签发的药品注册证书，批准增加适应症：适用于免疫球蛋白G4相关 性疾病(IgG4-RD)成人患者。这是该产品获得的第二项适应症，此适应症曾于2025年2月8日被纳入优先 审评审批程序。 伊奈利珠单抗是靶向CD19B细胞消耗性抗体。该产品于2019年与VielaBio签订许可协议，获得在中国内 地、香港、澳门开发及商业化的独家许可。2022年3月，该产品获得NMPA批准在中国上市，适用于抗 水通道蛋白4(AQP4)抗体阳性的视神经脊髓炎谱系疾病(NMOSD)成人患者的治疗，并于2023年1月首次 被纳入国家基本医疗保险药品目录。 ...

Core Viewpoint - Hansoh Pharmaceutical (03692) announced that its innovative drug, XinYue (Inalizumab injection), received a drug registration certificate from the National Medical Products Administration (NMPA) of China on August 26, 2025, approving an additional indication for adult patients with Immunoglobulin G4-related disease (IgG4-RD) [1] Group 1 - The drug XinYue has now been approved for a second indication, expanding its therapeutic applications [1] - The new indication was included in the NMPA's priority review and approval process on February 8, 2025 [1]

Core Viewpoint - Hansoh Pharmaceutical (03692) announced that its innovative drug, XinYue® (Inalizumab Injection), received a drug registration certificate from the National Medical Products Administration (NMPA) of China on August 26, 2025, for an additional indication: treatment of adult patients with Immunoglobulin G4-related disease (IgG4-RD) [1] Summary by Categories Product Approval - XinYue® has been approved for a second indication, expanding its therapeutic use [1] - The new indication was included in the NMPA's priority review and approval process on February 8, 2025 [1]

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，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Hansoh Pharmaceutical Group Company Limited 翰森製藥集團有限公司 （於開曼群島註冊成立的有限公司） （股份代號：3692） 於本公告日期，董事會成員包括主席兼執行董事鍾慧娟女士、執行董事孫遠女士 及呂愛鋒博士；及獨立非執行董事林國強先生、陳尚偉先生及楊東濤女士。 昕越® （伊奈利珠單抗注射液）第二項適應症 獲國家藥品監督管理局簽發藥品註冊證書 翰森製藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董 事會」）欣然宣佈，於二零二五年八月二十六日，創新藥昕越® （伊奈利珠單抗注射 液）（「該產品」）獲中國國家藥品監督管理局（「NMPA」）簽發的藥品註冊證書，批 准增加適應症：適用於免疫球蛋白G4相關性疾病(IgG4-RD)成人患者。此為昕越® 獲批的第二項適應症，該適應症曾於二零二五年二月八日獲NMPA納入優先審評 審批程序。 關於該產品 伊奈 ...

Group 1 - The National Medical Products Administration (NMPA) has approved a new indication for Hansoh Pharmaceutical's (03692.HK) Inalizumab injection for the treatment of Immunoglobulin G4-related disease (IgG4-RD), which was previously prioritized for review by the Center for Drug Evaluation (CDE) [1] - Inalizumab is a targeted CD19B cell-depleting antibody, and it was first approved by the NMPA in March 2022, making this the second indication for the drug [1] - The approval is based on positive results from the global pivotal Phase III trial MITIGATE, which was conducted in 22 countries, including China, and is the first randomized, double-blind, placebo-controlled study in IgG4-related disease [1] Group 2 - In the 52-week placebo-controlled period, the risk of relapse for IgG4-RD patients treated with Inalizumab was significantly reduced by 87% compared to the placebo group [2] - Among 68 patients treated with Inalizumab, only 7 experienced a relapse, while 40 out of 67 patients in the placebo group relapsed [2] - 57.4% of patients treated with Inalizumab achieved complete remission without relapse or treatment by week 52, compared to 22.4% in the placebo group [2] Group 3 - Inalizumab is currently the only approved CD19 monoclonal antibody for IgG4-RD globally, highlighting its unique position in the market [3]