[Table_IndustryInfo] 2025 年 05 月 11 日 强于大市(维持) 证券研究报告•行业研究•医药生物 医药行业创新药周报（5.5-5.9） 2025 年 5 月第二周创新药周报 A 股和港股创新药板块及 XBI 指数本周走势 西南证券研究院 [Table_Summary] 2025 年 5月第二周，陆港两地创新药板块共计 39个股上涨，67个股下跌。其中 涨幅前三为海创药业-U（22.76%）、长春高新（8.99%)、众生药业（8.98%）。 跌幅前三为复宏汉霖（-12.64%）、康诺亚-B（-12.40%）、博安生物（-11.77%）。 本周 A 股创新药板块上涨 2.33%，跑赢沪深 300 指数 0.33pp，生物医药上涨 0.75%。近 6 个月 A 股创新药累计上涨 5.43%，跑赢沪深 300 指数 9.13pp， 生物医药累计下跌 10.55%。 本周港股创新药板块下跌 2.14%，跑输恒生指数 3.75pp，恒生医疗保健下跌 3.75%。近 6 个月港股创新药累计上涨 22.08%，跑赢恒生指数 4.47pp，恒生医 疗保健累计上涨 18.10%。 本周 XBI 指数 ...

Core Viewpoint - Northeast Pharmaceutical has demonstrated a notable performance in quality transformation through structural adjustments in the first quarter of 2025, despite a slight revenue increase of only 0.36% [1] Group 1: Financial Performance - The company achieved a 20.5% year-on-year reduction in sales expenses and a simultaneous decrease in management expenses, while strategically increasing R&D expenses to 32 million yuan, an 88% year-on-year surge [2] - As of the end of the first quarter, the company's debt-to-asset ratio decreased to 58.82%, down 2.63 percentage points from the beginning of the year, indicating improved financial health and reduced short-term repayment risks [2] Group 2: Innovation and R&D - Northeast Pharmaceutical is implementing a dual-driven strategy of "innovative drugs + generic drugs," covering multiple therapeutic areas including the nervous system, digestive system, and oncology, which highlights its long-term growth potential [3] - The company has accelerated its strategic layout in cutting-edge fields of innovative drugs, with a significant increase in R&D funding aimed at tumor immunotherapy, a key trend in the global pharmaceutical industry [3] - The company has developed over 10 targeted cell immunotherapy products for various cancers, with DCTY1102 injection expected to be the first TCR-T cell drug targeting KRAS G12D to enter Phase I clinical trials in China [3] Group 3: Competitive Strategy - The company has consolidated its competitive advantage through a "combination of innovation and imitation" strategy, with 243 product specifications included in the national medical insurance catalog and 120 in the national essential drug list, providing a stable foundation for performance growth [4] - This dual-driven model of "innovative drugs leading and generic drugs supporting" ensures short-term performance certainty while opening up long-term growth opportunities [4] Group 4: Global Strategy - The company is leveraging its international gene advantage to enhance its global sales network, with its leading products exported to over 100 countries and regions, thereby diversifying market risks and creating sustainable revenue streams [5] - Despite short-term profit fluctuations, the company's strategic transformation is showing initial results, with management reforms and future-oriented R&D investments leading to significant improvements in operational quality [5] - As the innovative drug pipeline matures and the global strategy deepens, Northeast Pharmaceutical is transitioning from a traditional pharmaceutical company to a leader in biotechnology, with the commercialization of cell therapies expected to initiate a new growth cycle [5]

Core Viewpoint - The chairman and general manager of Maiwei Biotech, Liu Datao, is under investigation by the China Securities Regulatory Commission (CSRC) for suspected short-term trading, which may impact the company's operations and market confidence [1][2][10]. Company Overview - Maiwei Biotech was founded in May 2017 and went public on the Shanghai Stock Exchange's Sci-Tech Innovation Board on January 18, 2022, focusing on innovative biopharmaceuticals across various therapeutic areas [6]. - The company has experienced significant revenue growth but has faced substantial net losses since its listing [7]. Financial Performance - In 2022, Maiwei Biotech reported revenue of 27.73 million yuan, a year-on-year increase of 70.88%, but incurred a net loss of 955 million yuan [7]. - Revenue rose to 128 million yuan in 2023, a 361.03% increase, yet the net loss expanded to 1.053 billion yuan [7]. - For 2024, revenue further increased to 200 million yuan, a 56.28% growth, but the net loss remained high at 1.044 billion yuan [7]. Cost and Investment - The company attributes revenue growth to successful market expansion and increased sales of its core products, but rising operating costs and high R&D expenses have compressed profit margins [8]. - R&D expenses were reported at 759 million yuan in 2022, 836 million yuan in 2023, and 783 million yuan in 2024, indicating sustained high investment levels [8]. Market Sentiment - Maiwei Biotech's stock price has been declining, with a cumulative drop of over 12% from April 25 to May 9 [5]. - The ongoing investigation into the chairman may further dampen market confidence and complicate the company's plans for an H-share listing in Hong Kong [10].

Core Viewpoint - The investigation into Liu Datao, the chairman and general manager of Maiwei Biotech, by the China Securities Regulatory Commission (CSRC) for suspected short-term trading does not significantly impact the company's daily operations [1][2] Company Overview - Maiwei Biotech was established in 2017, focusing on the research, production, and sales of innovative drugs and biosimilars, primarily targeting oncology and age-related diseases [1][2] - The company has three products on the market: Junmaikang, Mailishu, and Maiweijian, but remains unprofitable with cumulative losses [3] Financial Performance - For 2024, Maiwei Biotech reported revenue of 200 million yuan, with 145 million yuan from drug sales and 55.03 million yuan from technical services [3] - The company experienced a 33.7% year-on-year decline in revenue for Q1 2025, with net losses increasing from 206 million yuan to 292 million yuan [4] - R&D expenses remain high, with 783 million yuan spent in the previous year, despite a 6.33% decrease compared to the prior year [3] Shareholding and Management - Liu Datao holds a 3.78% stake in the company, amounting to 15.1 million shares, all of which are subject to lock-up agreements [2] - The actual controllers of Maiwei Biotech are Tang Chunshan and Chen Shanna, with Tang being one of the founders and currently serving as an executive director [2] Debt and Financing Strategy - The company's debt ratio increased significantly from 42.24% at the end of 2023 to 63.61% at the end of 2024 [4] - To address funding issues, Maiwei Biotech has applied for a listing on the Hong Kong Stock Exchange and plans to issue up to 500 million yuan in targeted debt financing tools [4]

Core Viewpoint - Recently, Paig BioPharma (Hangzhou) Co., Ltd. has disclosed its post-hearing information set on the Hong Kong Stock Exchange, following previous attempts to list on the Shanghai Stock Exchange's Sci-Tech Innovation Board [1][3]. Group 1: Company Overview - Paig BioPharma was established in May 2008 and was previously known as Paig BioPharma (Suzhou) Co., Ltd. The company currently has a registered capital of approximately RMB 367 million [3]. - The major shareholders include Michael Min Xu, Yunfeng Fund, Yingke Capital, and Tigermed [3]. Group 2: Listing Attempts - In August 2021, the company submitted its prospectus to apply for listing on the Sci-Tech Innovation Board, aiming to raise RMB 2.538 billion for innovative drug R&D, production base construction, and R&D center establishment. However, the application was withdrawn in April 2022 after two rounds of inquiries [3]. - In February 2024, Paig BioPharma submitted an application for listing on the main board of the Hong Kong Stock Exchange, with the raised funds intended for the commercialization and indication expansion of its core product PB-119, further development of PB-718, and ongoing R&D for other pipeline candidates [3]. Group 3: Financial Performance - As of the end of 2023 and 2024, Paig BioPharma reported net income of approximately RMB 14.635 million and RMB 7.007 million, respectively, with annual losses of approximately RMB 279.181 million and RMB 283.351 million [15][16]. - The company's R&D expenses were RMB 236.731 million in 2023 and RMB 95.427 million in 2024, indicating a significant focus on R&D activities [16]. Group 4: Corporate Changes - In February 2025, the company changed its name and registered address from Suzhou to Hangzhou, which is not a common practice during the listing application phase [5][12]. - The company has also established a subsidiary, Paig Xinyi BioPharma Technology (Suzhou) Co., Ltd., in January 2025, which has seen a capital increase from RMB 1 million to RMB 5 million [5].

Core Points - The company is holding a shareholder meeting on May 20, 2025, to discuss various agenda items including the independent director's report for 2024 and voting on resolutions [1][2] - The company reported a revenue of 1.585 billion yuan for 2024, a slight decrease of 0.27% compared to the previous year, with a net profit of 100 million yuan, down 5.73% [10][11] - The company has made significant progress in stem cell drug development, with multiple clinical trials approved and ongoing for new treatments [12][22] - The company is focusing on enhancing its governance structure and compliance, having received various quality management certifications [17][18] Company Operations - The board of directors has operated in compliance with relevant laws and regulations, approving 32 resolutions with a 100% approval rate [5][6] - The company has established a governance structure involving the shareholder meeting, board of directors, and supervisory board, ensuring clear responsibilities and effective operation [10] - The company has implemented a comprehensive quality management system, achieving ISO certifications in quality, environmental management, and occupational health and safety [17][18] Financial Performance - The company reported a total asset value of 5.249 billion yuan as of December 31, 2024, a decrease of 3% from the previous year [30] - The company’s cash flow from operating activities was negative 64 million yuan, indicating challenges in cash generation [30] - The company has initiated a share buyback program, repurchasing shares worth 200 million yuan, which is 199.32% of its net profit for the year [31] Future Plans - The company aims to deepen its research and development in stem cell therapies and expand its market presence both domestically and internationally [22][24] - The company plans to enhance its automated production capabilities and improve the efficiency of its cell therapy products [23] - The company is committed to building a comprehensive health management ecosystem for families, integrating various health services and insurance collaborations [25]

Meeting Overview - The annual general meeting of Aurite Pharmaceutical Co., Ltd. is scheduled for May 16, 2025, at 14:30 [1] - The meeting will be held at the company's administrative building in Taizhou, Zhejiang Province [1] - Shareholders can participate through both on-site and online voting [1][4] Agenda Items - The meeting will discuss the remuneration plans for the board of directors and senior management for 2025, as well as confirm the execution of 2024 remuneration [2][3] - The meeting will also address the remuneration plan for the supervisors for 2025 and confirm the execution of 2024 remuneration [2] Company Performance - In 2024, the company achieved a net profit of 355 million yuan, a year-on-year increase of 22.59% [9] - The net profit attributable to the parent company, after deducting non-recurring gains and losses, was 351 million yuan, reflecting a growth of 34.25% compared to the previous year [9] - The total assets of the company reached 3.877 billion yuan, an increase of 50.60% from the beginning of the year [10] - The total liabilities amounted to 1.546 billion yuan, up 154.67% from the beginning of the year [10] Business Development - The company continues to focus on the research, production, and sales of specialty complex APIs and pharmaceutical intermediates, maintaining a competitive edge in the market [10] - Revenue from the API and intermediate business grew by 7.73% year-on-year, with improved gross margins [10] - The company has made significant progress in expanding its online sales channels, with notable growth in sales of its products [10][11] Research and Development - The company invested 146 million yuan in R&D during the reporting period, a 6.91% increase year-on-year [11] - A total of 45 projects are currently under research, covering small molecule APIs, peptides, and oligonucleotides [11] - The company has submitted 29 invention patent applications and received 13 new patent grants during the reporting period [12][13] Financial Management - The company successfully issued convertible bonds, which will support its development projects and enhance its product matrix [14] - The total planned investment for the projects funded by the convertible bonds is approximately 1.020 billion yuan [14] Governance and Compliance - The board of directors held seven meetings during the year, ensuring compliance with legal and regulatory requirements [16][21] - The supervisory board conducted six meetings, focusing on financial oversight and compliance with corporate governance standards [25][29] Future Plans - The company aims to enhance its product offerings and expand its market presence, particularly in the fields of oligonucleotide and peptide drugs [24] - Plans include the construction of new production lines and the continuous improvement of its governance and management systems [24][25]

Core Viewpoint - The stock price of Yuan Da Pharmaceutical (00512) has experienced a strong upward trend, achieving a four-day consecutive rise and over 20% increase within the week, driven by significant innovations in various fields [1]. Group 1: Innovations and Clinical Trials - The company has reached clinical endpoints in the Phase II trial of its innovative drug STC3141 for treating sepsis and has received acceptance for the Phase III clinical trial application of its radiopharmaceutical TLX591 for oncology [1][7]. - Yuan Da Pharmaceutical has a robust pipeline with 15 innovative products in the registration phase, covering multiple cancer types and offering integrated diagnostic and therapeutic solutions [3][5]. Group 2: Financial Performance - The nuclear medicine oncology segment is projected to generate approximately HKD 589 million in revenue for 2024, reflecting a year-on-year growth of nearly 177%, with the core product contributing nearly HKD 500 million [3]. - The company has seen its core product, Yttrium-90 microsphere injection, achieve over 140% year-on-year sales growth for two consecutive years [3]. Group 3: Strategic Developments - Yuan Da Pharmaceutical has established a comprehensive industrial layout, including R&D, production, sales, and regulatory qualifications, with a new radioactive drug R&D and production base in Chengdu expected to commence operations soon [6]. - The company is investing approximately HKD 3 billion in this facility, which aims to become a global hub for innovative nuclear medicine [6]. Group 4: Market Potential - The global market for sepsis treatment drugs is expected to grow from USD 12.54 billion in 2024 to USD 19.37 billion by 2032, with a compound annual growth rate of 5.58% [7]. - Yuan Da Pharmaceutical is positioned to fill a significant clinical gap in sepsis treatment with STC3141, which is anticipated to be a groundbreaking therapy [7]. Group 5: Eye Care Sector - The company has developed a comprehensive product system in the ophthalmology field, focusing on various eye diseases and has several innovative products in the pipeline [10][13]. - Yuan Da Pharmaceutical is recognized as a leader in the eye care sector, with a strong marketing network and a commitment to addressing unmet clinical needs [10][13].

证券代码：002422 证券简称：科伦药业 四川科伦药业股份有限公司投资者关系活动记录表 编号：0074 | | □分析师会议 □特定对象调研 | | --- | --- | | 投资者关系活 | □媒体采访 √业绩说明会 | | | □新闻发布会 □路演活动 | | 动类别 | □现场参观 | | | □其他：电话调研 | | 参与单位名称 | 本 次 业 绩 说 明 会 以 文 字 问 答 方 式 在 进 门 财 经 召 开 （ 网 址 ： | | 及人员姓名 | https://s.comein.cn/syfe7cqa）。 | | 时间 | 2025 年 5 月 6 日 15：00-17：00 | | 地点 | 线上 | | | 董事长刘革新先生；独立董事任世驰先生；副总经理兼财务总监赖德贵先 | | 上市公司接待 | 生；副总经理兼董事会秘书冯昊先生；销售负责人戈韬先生；科伦博泰首席 | | 人员姓名 | 财务官兼董事会秘书周泽剑先生；川宁生物副总经理兼董事会秘书顾祥先 | | | 生。 | | | 公司就投资者对经营现状、发展战略、研发进展等方面所提的问题进行了回复，主要内 | | | 容如下： | ...

Core Viewpoint - BeiGene has shown significant improvement in reducing losses, with a notable increase in revenue driven by the sales of its self-developed products [1][2][3] Financial Performance - In Q1 2025, BeiGene reported revenue of 8.048 billion yuan, a year-on-year increase of 50.2%, marking the second consecutive quarter with revenue exceeding 8 billion yuan [1][2] - The net profit attributable to shareholders was -94.503 million yuan, a substantial reduction from -1.908 billion yuan in the same period last year, achieving a loss reduction rate of 95.05% [1][2] - For the full year 2024, the company reported revenue of 27.21 billion yuan, up 56.2% year-on-year, with a net profit loss reduced to 4.98 billion yuan [2] Product Performance - BeiGene has three major self-developed products: BTK inhibitor Zebrutinib (brand name "百悦泽"), PD-1 monoclonal antibody Tislelizumab (brand name "百泽安"), and PARP inhibitor Pamiparib (brand name "百汇泽") [3][4] - In Q1 2025, Zebrutinib generated global sales of 5.692 billion yuan, a 63.7% increase, accounting for 70.73% of total revenue [4] - Tislelizumab's sales reached 1.245 billion yuan in Q1 2025, a 19.3% increase, primarily due to new indications being included in the national medical insurance catalog in China [4] Research and Development Investment - BeiGene has invested heavily in R&D, with cumulative expenditures reaching approximately 69.788 billion yuan over the past eight years [5] - R&D expenses have consistently increased from 2.017 billion yuan in 2017 to 14.14 billion yuan in 2024, reflecting the company's commitment to innovation [5]