Summary of the Conference Call for Xiansheng Pharmaceutical Industry Overview - Xiansheng Pharmaceutical operates in the field of neuro-specialty pharmaceuticals and is recognized as a leading enterprise in this sector [3][4]. Core Products and Market Performance - Key products include: - **Xianbixin Injection**: Launched in 2020, it has experienced rapid sales growth with a compound annual growth rate (CAGR) of nearly 750% from 2020 to 2024 [3][4]. - **Idaravone R-enantioform Sublingual Tablets**: Approved in December 2024, it completes a comprehensive vascular therapy for stroke treatment, expected to be a significant drug following Idaravone [3][4]. - A new generation of non-controlled insomnia medication is set to be launched in Hong Kong in May 2024 and anticipated for domestic release in 2025, showing optimistic market prospects [3][4]. Innovations in Oncology - Major oncology products include: - **Koserra** and **Anlitai**: Both have been included in the national medical insurance directory and are expected to be promoted for hospital use this year [5][6]. - A business development (BD) agreement with Aibowei, with a total contract value of up to 1.055 billion yuan, indicates strong R&D capabilities and future project potential [5][6]. R&D Investment and Financial Impact - R&D investments have significantly increased, totaling 6.42 billion yuan from 2020 to mid-2023. The proportion of innovative revenue rose from 21.4% in 2017 to 72% last year, leading to substantial overall performance improvement [7][8]. Clinical Efficacy and Market Outlook - **Idaravone R-enantioform** shows superior clinical efficacy compared to standard Idaravone, with significant improvements in the ROCK scale scores. It has received Breakthrough Therapy Designation (BTD) in the U.S., indicating potential for international market expansion [8][9]. - **Aideqing**: An anti-inflammatory and anti-rheumatic biological agent, ranked second in hospital use, with sales exceeding 900 million yuan last year, expected to maintain rapid growth [9]. Emerging Therapies in Oncology - The company is focusing on **Sanze Su**, a new generation recombinant humanized VEGF monoclonal antibody, which may provide breakthroughs in cancer treatment. Continuous efforts are being made to expand the oncology treatment portfolio through additional BD projects [10]. Clinical Trials and New Drug Development - A phase III clinical trial achieved its primary endpoint in January 2024, showing a significant progression-free survival (PFS) of 5.49 months. A New Drug Application (NDA) was submitted in March 2024, with approval expected in 2025 [11][12]. Pipeline Products of Interest - The pipeline includes several noteworthy products, such as **Enzeshushu** and a self-developed monoclonal antibody in collaboration with Aibowei, currently undergoing phase I trials in the U.S. and China [12]. Focus on Neurology - A new generation insomnia drug is a key focus for the company, expected to be approved in 2025. The market for such drugs is promising, with significant sales growth observed in similar products [13][14]. Future Development Plans - The company plans to continue advancing clinical R&D and explore new collaboration opportunities while closely monitoring upcoming product approvals to ensure market entry and rapid growth [15].

Core Viewpoint - The announcement highlights the acceptance of the new drug application for Madaxanovir tablets by the National Medical Products Administration (NMPA) in China, indicating a significant step forward in the treatment of influenza for adults and adolescents without complications [1][2]. Group 1: Drug Development - The collaboration between the company and Jiaxing Antikang Biotechnology Co., Ltd. focuses on the development of Madaxanovir, an antiviral drug aimed at treating influenza [1]. - Madaxanovir is characterized as an inhibitor of the polymerase acidic protein (PA) endonuclease activity, which is crucial for the replication of the influenza virus [2]. Group 2: Drug Advantages - Madaxanovir presents several advantages, including no central nervous system side effects, oral absorption unaffected by food, and a higher safety dosage compared to existing treatments [2]. - The drug requires only a single oral dose to effectively block the replication of the influenza virus within 24 hours, potentially offering significant convenience for patients, including children [2].

Investment Rating - The report assigns a "Buy" rating for the company for the first time [1][5]. Core Insights - The company has a diversified product matrix focusing on neurology, oncology, and autoimmune diseases, with a significant increase in the proportion of revenue from new drugs, which is expected to continue growing [2][3]. - The company has achieved important milestones in its innovative drug pipeline, including several approvals and negotiations for inclusion in national insurance [2][3]. - The launch of the sublingual formulation of a key drug is anticipated to meet the growing demand for outpatient treatment of ischemic stroke, enhancing the company's market position [2][3][4]. Summary by Sections Company Overview - The company, established in 1995 and listed in 2020, focuses on innovative drug development in neurology, oncology, and autoimmune diseases, with a solid commercial foundation and ongoing product innovation [10][15]. Financial Performance - Revenue projections for 2024-2026 are estimated at 66.36 billion, 76.90 billion, and 86.54 billion CNY, with expected growth rates of 0%, 16%, and 13% respectively [5][18]. - The net profit forecast for the same period is 10.37 billion, 11.93 billion, and 13.36 billion CNY, with growth rates of 45%, 15%, and 12% respectively [5][18]. Product Pipeline and Market Strategy - The company has successfully increased the proportion of revenue from innovative drugs, reaching 72% in 2023, and is expected to further enhance this with upcoming product approvals [2][15]. - The approval of the sublingual formulation of a key drug is expected to create synergies with existing products and address outpatient treatment needs [2][34]. - The company has established a strong commercial system with a wide reach across various medical institutions in China, supporting its product distribution and market penetration [26][30]. Research and Development - The company has a robust pipeline of innovative drugs, including several in late-stage clinical trials, and has successfully licensed out its research products internationally, indicating strong innovation capabilities [3][4][30]. - The company is actively pursuing international clinical research for its innovative drugs, reflecting its strategic intent to expand globally [2][3].

医药 先声药业：创新药密集兑现，未来持续增长可期 走势比较 (10%) 2% 14% 26% 38% 50% 24/2/14 24/4/26 24/7/7 24/9/17 24/11/28 25/2/8 先声药业 恒生指数 股票数据 总股本/流通(亿股) 24.86/24.86 总市值/流通(亿港元) 169.32/169.32 12 个月内最高/最低价 (港元) 7.70/4.98 2025 年 02 月 12 日 公司深度研究 买入/维持 先声药业(02096) 昨收盘:6.81 相关研究报告 <<穿越风雪，奔赴山海—2025 年医药 行业投资策略>>--2025-01-06 <<全链条支持医药创新顶层文件获 批，全国多地支持政策先后落地>>-- 2024-08-04 证券分析师：谭紫媚 电话：0755-83688830 E-MAIL：tanzm@tpyzq.com 分析师登记编号：S1190520090001 证券分析师：张懿 电话：021-58502206 E-MAIL：zhangyi@tpyzq.com 分析师登记编号：S1190523100002 报告摘要 神经专科制药龙头地位稳固 （1）先必新舌 ...

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company is positioned for sustained growth due to a concentrated pipeline of innovative drugs that are set to be launched [1][10] - The company has established itself as a leader in specialized pharmaceuticals, particularly in neurology, oncology, and autoimmune diseases [15][23] Summary by Sections Innovative Drug Pipeline - The company has successfully launched 8 innovative drugs, with several included in the national medical insurance directory, which is expected to drive future growth [16][20] - The innovative drug revenue has significantly increased, with a CAGR of 33.8% from 2017 to 2023, rising from 21.4% of total revenue in 2017 to 72.0% in 2023 [20][21] Neurology Products - The newly approved sublingual formulation of Xianbixin is expected to improve adherence among acute ischemic stroke patients, complementing the existing injectable formulation [4][29] - Xianbixin has shown a CAGR of 749.9% from 2020 to 2023, indicating strong market potential [31] Oncology Products - Multiple oncology drugs have been approved, including Envidah and Koseira, which have been included in the national medical insurance directory, suggesting potential for significant market uptake [8][44] - Envidah is recommended in various clinical guidelines for the treatment of advanced non-small cell lung cancer (NSCLC) [41][42] Autoimmune Products - Aidesin, a key product for rheumatoid arthritis, has shown a CAGR of 39.9% from 2016 to 2023, establishing itself as a leading treatment option [36][40] Financial Projections - Revenue projections for 2024-2026 are estimated at 67.76 billion, 76.54 billion, and 87.11 billion CNY, with corresponding net profits of 9.73 billion, 12.07 billion, and 15.04 billion CNY [10][12] - The company is expected to maintain a low valuation compared to peers, with a projected PE ratio decreasing from 16 to 10 over the same period [10][12]

Investment Rating - The report assigns a **Buy** rating to Simcere Pharmaceutical (2096 HK) with a target price of HK$10.00, representing a potential upside of 53.2% from the current price of HK$6.53 [5] Core Views - Simcere Pharmaceutical has entered into a licensing agreement with AbbVie for SIM0500, a BCMA x GPRC5D x CD3 trispecific antibody, with a total potential deal value exceeding $1.055 billion [1] - SIM0500 is currently in Phase I clinical trials for relapsed/refractory multiple myeloma (MM), a market with significant potential as the global MM treatment market is projected to reach $26.7 billion by 2024 [1] - The deal represents the second and largest out-licensing transaction in Simcere's history, following the 2022 licensing of SIM0278 to Almirall [1] - SIM0500 also shows potential in autoimmune diseases due to its ability to target B cells expressing BCMA and GPRC5D, with other BCMA-targeting drugs already demonstrating efficacy in conditions like Sjögren's syndrome and rheumatoid arthritis [1] - The TCE platform has been validated through this deal, with three additional molecules targeting AML, CLL/DLBCL, and solid tumors expected to enter clinical trials soon [1] Market Potential - The global MM market is substantial, with 188,000 new cases and 121,000 deaths annually, making it the largest single subtype in the hematologic oncology market [1] - SIM0500 has shown superior tumor suppression in preclinical models compared to competing BCMA x CD3 bispecific antibodies and GPRC5D x CD3 bispecific antibodies [1] - The low-affinity targeting of CD3 and subcutaneous injection formulation may reduce CRS risk and improve administration convenience [1]

Investment Rating - The report does not provide a specific investment rating for Simcere Pharmaceutical (2096 HK) [1] Core Views - Simcere Pharmaceutical's new drug Xianbixin sublingual tablets have been approved for market, which is expected to synergize with the injectable form to improve stroke treatment accessibility [2] - Two other drugs, Celsera and Enlituo, have been included in the National Reimbursement Drug List (NRDL), significantly enhancing their market accessibility [3] - The company's innovative drug revenue accounted for over 70% of total revenue in H1 2024, with a noticeable increase in gross margin [4] Financial Performance - In H1 2024, Simcere Pharmaceutical's revenue from innovative drugs reached 2 2 billion yuan, accounting for 70 7% of total revenue [4] - The company's gross margin in H1 2024 was 79 1%, an increase of 3 4 percentage points compared to the same period in 2023 [4] - Revenue is projected to grow from 6 64 billion yuan in 2024 to 9 36 billion yuan in 2026, with net profit expected to increase from 714 76 million yuan to 1 78 billion yuan over the same period [6][10] Product Pipeline - Xianbixin sublingual tablets showed a 64 4% functional recovery rate in clinical trials, significantly higher than the placebo group's 54 7% [2] - Celsera, a drug that protects bone marrow during chemotherapy, was successfully included in the NRDL and achieved localization in Hainan Province, potentially improving product gross margin [3] - Enlituo, a domestically developed EGFR monoclonal antibody, was approved in China in June 2024 and also included in the NRDL [3] Market Expectations - Xianbixin sublingual tablets are expected to achieve penetration rates of 0 9% and 3 9% in 2025 and 2026, respectively, with corresponding revenues of 250 million yuan and 650 million yuan [9] - Celsera is projected to reach penetration rates of 4%, 12%, and 16% in 2024, 2025, and 2026, respectively, with revenues of 220 million yuan, 420 million yuan, and 560 million yuan [9] - The company's overall revenue is expected to grow at a compound annual growth rate (CAGR) of 18 8% from 2024 to 2026 [10]

先聲藥業集團有限公司 | --- | --- | --- | --- | --- | --- | |---------------------------------------------------------|-------|-------|----------------|-------|-------| | | | | | | | | （ 於 香 港 註 冊 成 立 的 有 限 公 司 ） 股 份 代 號 : | | | | | | | 2024 中期報告 | | | | | | | | | | | | | | | | | | | | | | | | 讓患者早日用上 | | | | | | | | 藥物 | | 目錄 公司資料 2 財務概要 4 公司概覽 5 管理層討論及分析 7 31 企業管治及其他資料 獨立核數師審閱報告 43 44 合併損益表 合併損益及其他全面收益表 45 合併財務狀況表 46 合併權益變動表 48 51 簡明合併現金流量表 未經審核中期財務報告附註 52 公司資料 獨立非執行董事 宋瑞霖先生 汪建國先生 王新華先生 宋嘉桓先生 審計委員會 王新華先生（主席） 宋瑞霖先生 汪 ...

Investment Rating - The report maintains a "Buy" rating for Simcere Pharmaceutical Group (02096) [4] Core Views - Simcere Pharmaceutical's adjusted net profit grew rapidly in H1 2024, driven by the commercialization of innovative drugs [1] - The company's innovative drug revenue accounted for over 70% of total revenue, with a strong trend of increasing proportion [1] - Multiple blockbuster innovative drugs have made progress, with one new drug approved and two new drug NDAs accepted [1] - The report is optimistic about the company's performance growth from 2024 to 2026, driven by both existing and new innovative drug products [1][2] Financial Performance - H1 2024 revenue was approximately RMB 3.114 billion (YoY -7.9%), mainly due to declines in promotion service revenue and Simceres sales [1] - Innovative drug revenue was approximately RMB 2.203 billion (YoY -8.7%), accounting for 70.7% of total revenue [1] - Net profit attributable to shareholders was RMB 457 million (YoY -79.9%), while adjusted net profit was RMB 538 million (YoY +36.5%) [1] Innovation Progress - One new innovative drug, Enlituo, was approved for marketing [1] - Two new innovative drugs, Enzeshu and Keweike, had their NDAs accepted [1] - Leduquimab (IL-4Rα) completed FPI for two indications: atopic dermatitis and asthma [1] Financial Forecasts - 2024-2026 EPS is projected to be RMB 0.38, 0.48, and 0.59 per share respectively [2] - 2024E revenue is forecasted at RMB 7.459 billion (+13% YoY), with net profit of RMB 960 million (+34% YoY) [3][7] - 2025E revenue is projected at RMB 8.666 billion (+16% YoY), with net profit of RMB 1.225 billion (+28% YoY) [3][7] - 2026E revenue is expected to reach RMB 9.802 billion (+13% YoY), with net profit of RMB 1.489 billion (+22% YoY) [3][7] Valuation - As of September 4, 2024, the stock's closing price corresponds to a 2024 PE of 15x [2] - The report maintains a positive outlook on the company's growth potential driven by its innovative drug portfolio [2] Key Financial Ratios - Gross margin is expected to increase from 75.43% in 2023 to 81.25% in 2026 [9] - Net profit margin is projected to grow from 10.82% in 2023 to 15.19% in 2026 [9] - ROE is forecasted to improve from 9.90% in 2023 to 15.84% in 2026 [9] - Debt-to-asset ratio is expected to decrease from 33.45% in 2023 to 29.69% in 2026 [9]

Investment Rating - Maintains a **Buy** rating for Simcere Pharmaceutical (2096 HK) with a target price of HKD 10.00, implying a potential upside of 90.9% [1] Core Views - **1H24 Performance**: Adjusted net profit grew by 36% YoY, driven by gross margin recovery (+3.3ppts) and reduced R&D expense ratio (-4.8ppts) [1] - **Revenue Recovery**: Expected 2024-26 revenue CAGR of 14%, supported by stable sales of Xianbixin and rapid market penetration of new products [1] - **New Product Launches**: Key products like Xianbixin (sublingual tablet), Cosela, and Suvaximab are expected to drive growth, with combined peak sales potential exceeding RMB 8.5 billion [1] Financial Performance - **1H24 Revenue**: Declined by 7.9% YoY, with innovative drug revenue down 8.7%, accounting for 70.7% of total revenue [1] - **Gross Margin**: Improved to 78.8% in 2024E, up 0.3ppts from previous forecasts, with further improvement expected to 79.8% by 2026E [4] - **Adjusted Net Profit**: Forecasted to grow at a CAGR of 21% from 2024-26, reaching RMB 1.37 billion by 2026E [1][4] Product Pipeline and Market Potential - **Xianbixin**: Sales expected to stabilize, with sublingual tablet launch expanding treatment scenarios and maintaining a peak sales target of RMB 5.5 billion [1] - **Cosela**: Potential inclusion in NRDL by end of 2024 could drive annual sales to exceed RMB 500 million [1] - **New Launches**: Suvaximab and Daliresib expected to contribute over RMB 3 billion in peak sales within the next 18 months [1] Valuation and Forecasts - **DCF Valuation**: Target price revised to HKD 10.00 based on updated financial forecasts, reflecting a 91% upside potential [1] - **Free Cash Flow**: Expected to grow from RMB 750 million in 2025E to RMB 1.83 billion by 2033E, driven by operational leverage and cost efficiency [5] Industry Comparison - **Biotech Sector**: Simcere Pharmaceutical is part of a broader biotech sector with strong growth potential, as evidenced by similar buy ratings for peers like Legend Biotech (LEGN US) and BeiGene (6160 HK) [6]