Core Viewpoint - The Hong Kong innovative drug sector is experiencing significant growth, with the Hong Kong Innovative Drug 50 ETF (513780) leading the market with a year-to-date increase of over 112% [2] Group 1: Market Performance - The Hong Kong Innovative Drug 50 ETF (513780) has seen a net inflow of 800 million yuan in the last 20 days, with a total net inflow exceeding 2 billion yuan this year, bringing its latest scale to 2.712 billion yuan [2] - The ETF is noted for having the largest scale and best liquidity among its peers, allowing for T+0 trading [2] Group 2: Composition and Holdings - The index tracked by the Hong Kong Innovative Drug 50 ETF consists solely of innovative drug companies, with major holdings including industry leaders such as CanSino Biologics, Innovent Biologics, WuXi Biologics, BeiGene, China National Pharmaceutical Group, CSPC Pharmaceutical Group, Hansoh Pharmaceutical, WuXi AppTec, and 3SBio [2] Group 3: Future Outlook - CITIC Securities anticipates an increase in innovative drug catalyst events in September, suggesting that the recent technology switch has cleared out short-term speculative money from the sector, which may allow innovative drugs to continue their upward trend after recent adjustments [2]

Group 1 - Pharmaceutical stocks continue to rise, with notable increases in companies such as BeiGene (up 7.87%), Clover Biopharma (up 6.03%), and Tigermed (up 5.03%) [1] - BlackRock increased its stake in 3SBio by acquiring approximately 47.6 million shares at a price of HKD 30.1096 per share, totaling around HKD 14.33 billion, raising its ownership to 5.1% [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with companies like Hengrui Medicine and Hansoh Pharmaceutical reporting record high revenues and profits [1] Group 2 - The pharmaceutical sector has shown strong stock performance in the first half of the year, driven by continuous business development (BD) overseas, excellent clinical data, and supportive policies [2] - The innovative drug sector is experiencing rapid sales growth, with several key products being approved and included in medical insurance, leading to increased domestic sales [2] - Companies like BeiGene and Hutchison China MediTech have successfully commercialized their products overseas, contributing significantly to revenue growth [2]

Group 1 - Pharmaceutical stocks continued to rise, with notable increases in companies such as BeiGene (up 7.87% to HKD 209.8), Clover Biopharmaceuticals (up 6.03% to HKD 1.23), and Tigermed (up 5.03% to HKD 50.5) [1] - BlackRock increased its stake in 3SBio by acquiring approximately 47.6 million shares at a price of HKD 30.1096 per share, totaling around HKD 14.33 billion, raising its ownership to about 124 million shares or 5.1% [1] - The overall performance of Hong Kong pharmaceutical companies was robust in the first half of the year, with companies like Heng Rui Medicine achieving record revenue and profit, and Hansoh Pharmaceutical exceeding revenue expectations [1] Group 2 - The pharmaceutical sector performed well in the first half of the year, driven by continuous business development overseas, strong clinical data, and supportive policies, with the innovative drug sector leading the gains [2] - The innovative drug sector is experiencing rapid sales growth as several key products have been approved and included in medical insurance, leading to increased domestic sales [2] - Companies like BeiGene and Hutchison China MediTech have successfully commercialized their products overseas, contributing significantly to revenue growth [2]

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 Insights - The pharmaceutical and biotechnology sectors are experiencing fluctuations, with the innovative drug index showing a slight increase of 0.65% while the Hang Seng Healthcare Index decreased by 3.36%, marking the largest weekly decline for Hong Kong's innovative drugs in nearly two months [5][6]. Company Developments - Fukan Biotech submitted its listing application to the Hong Kong Stock Exchange, achieving a post-financing valuation of 3.188 billion yuan after its C2 round of financing. The company focuses on breakthrough therapies for cancer-related diseases and has a diverse product pipeline, including one commercialized product and several candidates in development [7]. - Tianxing Medical also submitted its application to the Hong Kong Stock Exchange, positioning itself as China's largest domestic sports medicine company. The company reported revenues of 327 million yuan and 111 million yuan for 2024 and the first five months of 2025, respectively, with corresponding pre-tax profits of 108 million yuan and 36.83 million yuan [9]. Clinical Trials and Approvals - The National Medical Products Administration disclosed 80 clinical trial registrations from August 24 to August 29, with 24 trials in Phase II or above [10]. - The first oral HER2 inhibitor, Zongertinib, developed by Boehringer Ingelheim, received conditional approval in China for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations [14]. - Pfizer initiated the first Phase III clinical trial for its PD-L1 ADC drug, PF-08046054, targeting previously treated PD-L1 positive NSCLC patients, with a total enrollment of 680 participants [18]. Market Trends - The STEER real-world study presented at the European Society of Cardiology Congress indicated that Wegovy (semaglutide) significantly reduced the risk of major adverse cardiovascular events by 57% compared to Tirzepatide in overweight or obese patients with cardiovascular disease [16].

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]