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 或任何部分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。 Simcere Pharmaceutical Group Limited 自願公告 SIM0237於2026年歐洲泌尿外科學會年會公佈非肌層浸潤性膀胱癌的I/II期 臨床研究數據 本公告由先聲藥業集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，以告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團自主研發的創新融合蛋白 SIM0237（PD-L1/IL15v雙特異性抗體）於2026年歐洲泌尿外科學會年會（EAU 2026） 公佈用於治療卡介苗（「BCG」）無應答高危非肌層浸潤性膀胱癌（「NMIBC」）的I/II 期臨床研究數據。 截至數據截止日（2025年11月28日），共有49名患者接受SIM0237單藥膀胱灌注治 療。在伴原位癌（CIS）且至少完成一次基線後腫瘤評估的患者中，80%的患者達到 完全緩解（CR）。在僅伴乳頭狀病變的患 ...

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Investment Rating - The investment rating for the company is maintained at "Buy" with a target price of HKD 19.82 [1][5][11] Core Insights - The company has successfully licensed its SIM0613 (LRRC15 ADC) to France's Ipsen for an upfront payment of USD 45 million and a total deal value of USD 1.06 billion, marking the third licensing deal in 2025 and indicating the company's innovative drug pipeline is entering a monetization phase [1][2] - The SIM0613 ADC platform shows significant potential, with advantages demonstrated in preclinical models and no direct competitors in clinical stages, positioning it as a potential first-in-class (FIC) product globally [2][3] - The company is accelerating its global pipeline expansion, with multiple products and technology platforms poised for overseas exploration, including promising candidates in autoimmune and oncology fields [3][4] Financial Projections - The adjusted net profit forecasts for 2025, 2026, and 2027 are projected at RMB 1.18 billion, RMB 1.40 billion, and RMB 1.52 billion respectively, reflecting a compound annual growth rate (CAGR) of 14% from 2025 to 2027 [5][11] - The expected earnings per share (EPS) for the same years are RMB 0.45, RMB 0.54, and RMB 0.59, with a price-to-earnings (PE) ratio projected to be 33.19x for 2026 [5][11][12]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative price increase of over 15% within the next 6 to 12 months compared to the benchmark index [11]. Core Insights - The company has demonstrated significant growth in its innovative drug business, with total revenue reaching 3.585 billion yuan in the first half of 2025, a year-on-year increase of 15.1%. Innovative drug revenue accounted for 77.4% of total revenue, reflecting a consistent upward trend over the past five years [7]. - The adjusted net profit for the first half of 2025 was 651 million yuan, up 21.1% year-on-year, with a research and development investment rate of 28.7%, an increase of 9 percentage points [7]. - The company has launched 10 innovative drugs and is focusing on three main areas: neuroscience, oncology, and autoimmune diseases, with notable revenue growth in these sectors [7]. Financial Forecast and Valuation - The company is projected to achieve revenues of 7.69 billion yuan, 9.01 billion yuan, and 10.43 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 16%, 17%, and 16% [5][8]. - The forecasted net profit for the same years is expected to be 1.193 billion yuan, 1.389 billion yuan, and 1.609 billion yuan, reflecting significant growth of 63% in 2025 and steady growth of 16% in the following years [5][8]. - The report highlights a projected P/E ratio decreasing from 40.5 in 2024 to 18.5 in 2027, indicating an improving valuation as earnings grow [5]. Product Pipeline and Innovation - The company is advancing its innovative product pipeline, with several products in various stages of development, including two products in NDA review and three in Phase III clinical trials [7][8]. - Key products include the unique sublingual stroke treatment and a novel insomnia drug, both of which are expected to capture significant market share due to their differentiated mechanisms and clinical evidence [7]. - The company is also actively pursuing international collaborations and licensing agreements to enhance its technological platform and expand its market reach [7][8].