Summary of Key Points from the Conference Call of Xiansheng Pharmaceutical Company Overview - **Company**: Xiansheng Pharmaceutical - **Industry**: Pharmaceutical, specifically focusing on innovative drugs and oncology Core Insights and Arguments - **Innovative Drug Launches**: In 2024, Xiansheng Pharmaceutical launched eight innovative drugs, with six entering the national medical insurance system. The main growth drivers for 2025 are two oncology drugs, Kexaila and Anlotinib, with market sales of approximately 1 billion RMB and 1.5 billion RMB respectively [3][4][19] - **Revenue Growth**: The revenue from innovative drugs increased significantly from 33% in 2019 to 74.3% in 2024. However, the revenue from generic drugs dropped from 3.4 billion RMB to 1.7 billion RMB due to centralized procurement impacts [3][6][19] - **Future Drug Approvals**: The company anticipates three innovative drugs, including Suvisumab, Daliweisheng, and Madanosawei, to be approved within the next 12 months, with peak sales expected to reach 6-8 billion RMB [3][4][19] - **International Collaborations**: Xiansheng has established partnerships with Allergan and AbbVie, enhancing team confidence and expecting further progress in self-developed project licensing in 2025 and 2026 [5][19] - **Financial Performance**: In 2024, the gross margin reached 80.2%, with adjusted net profit exceeding 1 billion RMB, marking a new high since the company went public. The company expects over 15% growth in both revenue and adjusted operating profit for 2025 [6][19][22] - **Clinical Trial Success**: The drug Enzhu Suvisumab showed significant efficacy in a Phase III trial for platinum-resistant ovarian cancer, achieving dual benefits in progression-free survival (PFS) and overall survival (OS) with a lower incidence of severe side effects [3][19][26] - **Breakthrough Therapy Designation**: The FDA granted breakthrough therapy designation to Xiansheng's innovative drug for stroke, expediting its overseas development process and potentially shortening the approval timeline [3][31] Additional Important Content - **R&D Pipeline**: The company is focusing on enhancing its R&D pipeline with new products targeting various therapeutic areas, including oncology and autoimmune diseases. The introduction of new technologies, such as brain-targeted delivery systems, is expected to improve drug efficacy [3][15][18] - **Market Strategy**: Xiansheng plans to strengthen its marketing capabilities and expand into county-level markets, where many products are already included in medical insurance [21][22] - **Shareholder Returns**: The company has a robust shareholder return plan, expecting to distribute 0.16 RMB per share for the 2024 profits and has initiated a share buyback program [20][22] - **Response to Industry Challenges**: Despite challenges such as tight medical insurance funding and centralized procurement, the company remains optimistic about the pharmaceutical industry's growth in China, with a focus on high-quality development [21][29] This summary encapsulates the key points discussed in the conference call, highlighting the company's strategic direction, financial performance, and future growth prospects.

Financial Performance - The group's total revenue for the year ending December 31, 2024, was RMB 6.635 billion, an increase of 0.4% compared to RMB 6.608 billion in 2023[4]. - The profit attributable to equity shareholders was RMB 733 million, an increase of 2.6% from RMB 715 million in 2023[4]. - Adjusted profit attributable to equity shareholders was RMB 1.018 billion, up 41.6% from RMB 719 million in 2023[4]. - Revenue from innovative pharmaceuticals reached RMB 4.928 billion, accounting for 74.3% of total revenue, up 3.6% from RMB 4.756 billion in 2023[4]. - Revenue from the neuroscience segment was RMB 2.174 billion, representing 32.8% of total revenue, a growth of 10.4% from RMB 1.969 billion in 2023[4]. - Revenue from the autoimmune segment was RMB 1.811 billion, making up 27.3% of total revenue, with a significant increase of 28.0% from RMB 1.415 billion in 2023[107]. - Revenue from the oncology segment decreased by 17.6% to RMB 1.298 billion, which accounted for 19.6% of total revenue, down from RMB 1.576 billion in 2023[107]. - Total R&D investment for the year was RMB 1.523 billion, a decrease of 22.3% from RMB 1.960 billion in 2023, representing 23.0% of revenue, down from 29.7% in 2023[109]. - The company achieved a revenue of RMB 6.635 billion for the year ending December 31, 2024, representing a growth of 0.4% compared to RMB 6.608 billion in 2023[107]. - Gross profit for 2024 was RMB 5,324,579 thousand, up from RMB 4,984,153 thousand in 2023, indicating a growth of approximately 6.8%[154]. - Net profit for the year was RMB 733,165 thousand, slightly up from RMB 713,950 thousand in 2023, showing a growth of about 2.0%[156]. Research and Development - The R&D pipeline has three new drug molecules in Phase III clinical trials, with multiple products entering critical POC data phases[6]. - The company has established over 60 innovative drug varieties in its pipeline, with 16 innovative drugs undergoing registration clinical trials[16]. - The company is developing five innovative drugs simultaneously in China and the US, including SIM0501, SIM0500, SIM0508, and SIM0505[9]. - The company has approximately 40 preclinical candidate drugs, providing a strong and diversified product pipeline for sustainable long-term growth[101]. - The IND for SIM0506 is expected to commence clinical trials in April 2024 for advanced solid tumors with KRAS mutations[103]. - The IND for SIM0686 was formally accepted by CDE in January 2025, targeting advanced malignancies such as gastric and lung cancer[105]. - The company has made significant progress in production capacity and efficiency, with a new production base completed in just 12 months[13]. - The company has approximately 974 R&D personnel, including about 174 PhDs and 525 Master's degree holders, supporting its innovative drug development capabilities[17]. Product Development and Commercialization - The group has entered the commercialization phase with eight innovative drugs, including two newly approved products in China[5]. - The company achieved a 45% year-on-year increase in overseas licensing transactions for innovative drugs, surpassing $15 billion in 2024[14]. - The company has eight innovative drugs approved for sale, with over 45 products included in the National Reimbursement Drug List (NRDL)[17]. - The company has entered into exclusive commercialization agreements for several products, including TGRX-326 and SIM0500, enhancing its product layout in the oncology field[10]. - The product Xianbixin® (Idaravone and Right-angled Alcohol Injection) holds approximately 28% market share in the stroke injection market, covering about 1.31 million new patients and over 5,500 medical institutions as of December 31, 2024[24]. - Xianbixin® sublingual tablets received FDA "Breakthrough Therapy" designation in August 2024, marking it as the first innovative drug in the global stroke treatment field to achieve this status[29]. - The product Endu® (Recombinant Human Vascular Endothelial Inhibitor Injection) has been included in multiple clinical practice guidelines for advanced NSCLC since 2017 and is currently being explored for new indications in malignant pleural effusion[33]. - Envida® (Envafolimab Injection) is the world's first subcutaneously administered PD-(L)1 antibody, offering advantages such as shorter administration time and good safety profile[38]. Financial Position and Investments - As of December 31, 2024, the net cash generated from operating activities was RMB 1.391 billion, a significant increase from RMB 0.151 billion in the previous year[116]. - The group had cash and cash equivalents of RMB 1.943 billion as of December 31, 2024, compared to RMB 2.007 billion on December 31, 2023[116]. - The current ratio was 200.4% as of December 31, 2024, down from 209.9% a year earlier, while the debt-to-asset ratio increased to 38.6% from 33.5%[117]. - The group completed the acquisition of Nanjing Baijiahui Innovative Medical Technology Co., Ltd. for RMB 42.31 million on January 31, 2024[125]. - The group plans to raise RMB 970 million through a capital increase, which will result in approximately 11.45% of the enlarged issued share capital being allocated to investors[126]. - The company has a net amount of HKD 3,513.09 million from its initial public offering and over-allotment, with 60% allocated to strategic development in key therapeutic areas[149]. - As of December 31, 2024, HKD 2,107.85 million (60%) of the net proceeds has been allocated to ongoing research and development of selected products, with an expected full utilization by 2027[150]. Corporate Governance and Compliance - The company has complied with the Corporate Governance Code during the reporting period[138]. - The audit committee, consisting of three independent non-executive directors, has reviewed the financial reporting process and internal control systems[142]. - The company’s financial reports for the year ending December 31, 2024, have been prepared in accordance with applicable accounting standards and regulations[143]. - The chairman and CEO positions are held by the same individual, which the board believes ensures consistent leadership and timely decision-making[139]. - The annual general meeting of shareholders is scheduled for June 13, 2025[145]. Market and Competitive Position - The company received an A rating in the latest ESG assessment by MSCI, indicating a leading position in the Chinese pharmaceutical industry[12]. - The company is focused on therapeutic areas such as neuroscience, oncology, autoimmune diseases, and anti-infection, aiming for high-quality development[16]. - The group aims to enhance its global layout focusing on high-value, differentiated pipelines and accelerate the conversion of key clinical stage products[20]. - The company’s share repurchase reflects confidence in its business outlook and aims to create value for shareholders[135]. - The company’s financial resources are deemed sufficient to maintain a healthy financial position while conducting share repurchases[135].

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 ...