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/ ...

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] Group 1 - XinYue is a targeted CD19B cell-depleting antibody [1] - The product was licensed in 2019 through an agreement with VielaBio for exclusive development and commercialization rights in mainland China, Hong Kong, and Macau [1] - In March 2022, XinYue was approved by NMPA for marketing in China for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) [1] Group 2 - In January 2023, XinYue was included in the National Basic Medical Insurance Drug List for the first time [1] - The additional indication for IgG4-RD was prioritized for review and approval 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, 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]

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 2.67% on September 1, with a trading volume of 1.985 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1] - As of August 29, 2024, the fund's latest share count was 6.686 billion, with a total size of 6.403 billion yuan, reflecting a year-to-date increase of 1591.03% in shares and 1594.74% in size compared to the end of 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 91.54% during the tenure [2] - The top holdings of the fund include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant weightings in the portfolio [2] - The fund's liquidity is strong, with a cumulative trading amount of 34.181 billion yuan over the last 20 trading days, averaging 1.709 billion yuan per day [1]

Group 1 - Pharmaceutical stocks in Hong Kong have shown strong performance, with notable gains in companies such as 加科思-B (up 23.18%), 三叶草生物-B (up 22.09%), and others [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with 恒瑞医药 achieving record high revenue and profit, and 翰森制药 exceeding revenue expectations [1] - Upcoming major conferences, including the World Lung Cancer Conference (WCLC) and the European Society for Medical Oncology (ESMO), will showcase research results from innovative domestic drugs [1] Group 2 - 海通国际 maintains a positive outlook on Hong Kong pharmaceutical companies due to their stable cash flow, rich R&D pipelines, and normalizing external licensing revenues [2] - The recent slight pullback in the Hong Kong pharmaceutical sector is attributed to rapid fund rotation, with expectations of short-term fluctuations [2] - The long-term value reassessment logic in the pharmaceutical industry remains unchanged, supported by the engineer dividend and a rich catalyst environment in the innovative drug industry [2]