（文章来源：证券日报） 证券日报网讯 1月13日，海思科发布公告称，控股股东王俊民将所持700万股公司股份质押展期至2027 年1月12日，占其持股1.75%，占公司总股本0.63%，质权人为招商证券股份有限公司，用于自身生产经 营。 ...

证券代码：002653 证券简称：海思科 公告编号：2026-009 海思科医药集团股份有限公司 关于控股股东部分股份质押展期的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 下： | | 持股 | | 本次质押前 | 本次质押后 | 占其所 | 占公司 | 已质押股份情况 | | 未质押股份情况 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | | 持股 | | | | | | | | | | | 数量 | | 质押股份数 | 质押股份数 | 持股份 | 总股本 | 已质押股 | 占已 | 未质押股 | 占未 | | 名称 | （万股） | 比例 | 量（万股） | 量（万股） | 比例 | 比例 | 份限售和 | 质押 | 份限售和 | 质押 | | | | | | | | | 冻结数量 | 股份 | 冻结数量 | 股份 | 1 股东 名称 是否为控 股股东或 第一大股 东及其一 致行动人 本次质押 数量 (万股) 占其 所持 股份 比例 占公 ...

Investment Rating - The report indicates a positive investment outlook for the pharmaceutical sector, with the overall performance of the Shenwan Pharmaceutical and Biological Index increasing by 7.8% during the week, outperforming the Shanghai Composite Index which rose by 3.82% [2][3]. Core Insights - The pharmaceutical sector's overall valuation stands at 30.6 times earnings, ranking 10th among 31 Shenwan primary industries [5]. - The report highlights significant developments in the long-term care insurance system transitioning from pilot programs to full establishment during the 14th Five-Year Plan, with coverage reaching nearly 300 million people and fund expenditures exceeding 100 billion yuan by the end of 2025 [11]. - Notable advancements in drug commercialization include the launch of Novo Nordisk's oral GLP-1 weight loss drug Wegovy in the U.S., with monthly costs ranging from $149 to $299 for self-paying patients [13][14]. - Moderna has submitted a New Drug Application (NDA) for its seasonal flu vaccine mRNA-1010, showing promising efficacy results in clinical trials [15]. - Arrowhead has reported positive mid-stage results for its RNAi therapies ARO-INHBE and ARO-ALK7, demonstrating significant reductions in visceral and liver fat [16][17]. - GSK's hepatitis B drug Bepirovirsen has shown statistically significant functional cure rates in its Phase III trials [18]. - Recent approvals for innovative drugs in China include BeiGene's BCL-2 inhibitor and Sanofi's APOC3 siRNA drug, which addresses familial chylomicronemia syndrome [19][21]. Summary by Sections Market Performance - The Shenwan Pharmaceutical and Biological Index increased by 7.8%, ranking 6th among 31 Shenwan primary industries [2][3]. - Various sub-sectors showed positive growth, with medical devices and medical outsourcing leading with increases of 10.8% and 11.1%, respectively [5]. Industry Dynamics - The long-term care insurance system is set to expand significantly, with a focus on providing care for the elderly and disabled [11][12]. - The report emphasizes the importance of innovation in drug development, particularly in RNAi therapies and small nucleic acid drugs, which are gaining traction in clinical settings [16][18]. Company Developments - Significant partnerships and collaborations are highlighted, such as the $8.88 billion research collaboration between Insilico Medicine and Servier focusing on oncology [20]. - The report notes the successful commercialization of several new drugs, including BeiGene's and Sanofi's recent approvals, which are expected to impact market dynamics positively [19][21]. - The establishment of new companies and subsidiaries, such as the brain-computer interface subsidiary by Xinwei Medical, indicates a strategic shift towards innovative technologies in healthcare [22].

21智讯01月12日电，海思科在投资者关系活动中表示，HSK39004在差异化方面具有优势，公司同步推 进吸入混悬液和干粉吸入制剂，其中干粉吸入制剂在全球范围内进度领先。该制剂使用更便捷，无需雾 化装置，且更易实现联用。国内关键II期数据将于2026年Q1读出，计划2026年Q2启动COPDIII期研究， 有望于2027年底或2028年Q1提交NDA申请。 ...

Core Viewpoint - Northeast Securities research report indicates that Haisco's core pipeline selection for NEWCO's overseas expansion highlights product confidence [1] Group 1: Partnership and Financials - The company signed an exclusive licensing agreement with AirNexis, granting AirNexis exclusive rights to develop, produce, and commercialize HSK39004 globally, excluding mainland China, Hong Kong, Macau, and Taiwan [1] - AirNexis will pay Haisco an upfront payment of $108 million, which includes $40 million in cash and approximately $68 million worth of 19.9% equity in AirNexis, along with potential milestone payments of up to $955 million and royalties [1] Group 2: Product and Market Potential - HSK39004 is a dual inhibitor of PDE3/4 and represents a new therapeutic option in the COPD field, addressing unmet clinical needs [1] - The company is focusing on multiple fields including analgesia/anesthesia, autoimmune diseases, metabolism, and oncology, continuously enriching its product matrix [1] - The innovative drug pipeline and simultaneous domestic and international expansion are expected to sustain long-term steady growth [1]

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, indicating a "Buy" rating based on recent market performance and emerging opportunities in innovative drug development [2][3]. Core Insights - The pharmaceutical sector saw a significant increase, with the Shenwan Pharmaceutical and Biological Index rising by 7.8%, outperforming the Shanghai Composite Index, which increased by 3.82% [2][3]. - The report highlights the ongoing commercialization of innovative drugs, including the oral GLP-1 medication Wegovy by Novo Nordisk, and the successful clinical trials of various RNAi therapies [11][13][18]. - The establishment of a comprehensive long-term care insurance system in China is expected to enhance the healthcare landscape, potentially benefiting the pharmaceutical sector [11][12]. Market Performance - The Shenwan Pharmaceutical and Biological Index ranked 6th among 31 Shenwan first-level sub-industries, with various sub-sectors showing positive growth, such as medical devices (+10.8%) and medical research outsourcing (+11.1%) [2][5]. - The overall valuation of the pharmaceutical sector stands at 30.6 times earnings, ranking 10th among 31 Shenwan first-level industries [5][10]. Recent Key Events - The report notes the successful approval and commercialization of several new drugs, including BeiGene's BCL-2 inhibitor and Sanofi's APOC3 siRNA drug, which address significant medical needs [20][22]. - Collaborations in drug development are highlighted, such as the $8.88 billion partnership between Insilico Medicine and Servier focusing on oncology [21]. - The report emphasizes the potential of the brain-computer interface industry, with companies like Mindray Medical and Lepu Medical making strides in this area [24]. Investment Opportunities - The report suggests focusing on domestic innovative drug companies and CROs, particularly those involved in the development of small nucleic acid drugs and brain-computer interface technologies [2][11]. - Specific companies to watch include Tigermed, WuXi AppTec, and Innovent Biologics, which are positioned to benefit from the recovery of the innovative drug sector [2][11].

Group 1: Overview of Collaboration - HaiSiKe's PDE3/4 overseas authorization aims to achieve a win-win model by retaining Chinese rights while sharing overseas profits, accelerating the molecule's international deployment [2] - The company anticipates a period of international harvest and business development explosion in 2026, with ongoing expansion into oncology and large molecules [2] - The TYK2 project (FTP637) successfully entered overseas markets through a NEWCO model, completing phases 1-3 of clinical trials in about five years [3] Group 2: Key Collaboration Details - Transaction partner: AirNexis, led by Frazier Fund, with a transaction amount exceeding $1 billion, including an upfront payment of over $100 million and milestone payments of $955 million, along with double-digit sales sharing [3] - AirNexis is responsible for overseas clinical development and commercialization, while HaiSiKe retains rights for HSK39004 in China and global exclusive rights for combination formulations [3] - HaiSiKe's focus is on long-term benefits and overseas development efficiency while ensuring the protection of Chinese rights [4] Group 3: Clinical Progress and Differentiation - HaiSiKe is advancing both inhalation suspension and dry powder inhalation formulations, with the latter being globally leading [5] - The key phase 2 data in China is expected to be released in Q1 2026, with plans to initiate phase 3 studies for COPD in Q2 2026, aiming for NDA submission by late 2027 or Q1 2028 [5] - AirNexis plans to conduct population pharmacokinetics studies, with an NDA submission in the U.S. anticipated by Q4 2028 and potential approval by Q1 2030 [5] Group 4: Future Development and Opportunities - HaiSiKe is actively pursuing multiple projects in CNS and oncology, with hopes to initiate 1-2 key clinical trials in oncology by 2026 [7] - The company aims to independently conduct clinical research in the U.S. to generate proof-of-concept data before seeking external authorization partnerships, which could lead to larger transaction amounts [7] - Future collaborations may also involve platform-based R&D capabilities with leading multinational pharmaceutical companies or top-tier overseas investment funds [7] Group 5: Research and Development Focus - The R&D direction will focus on perioperative, respiratory, autoimmune, and oncology fields, expanding into biologics, ADCs, and cyclic peptides [8] - Short-term goals include advancing the approval of环泊酚 in the U.S., while mid-term goals involve achieving overseas market entries for DPP1 and PDE3/4 projects [8] - Long-term objectives include learning international market regulations and building a scalable overseas team [8]

Summary of Haizhi Science Conference Call Company Overview - **Company**: Haizhi Science (海思科) - **Key Focus**: Development and commercialization of innovative pharmaceuticals, particularly in the respiratory system and oncology sectors Key Industry Insights - **Collaboration with Frasier**: Haizhi Science is collaborating with Frasier to advance the clinical development and commercialization of PD34 in the U.S. Frasier has raised $220 million to support Phase I and II clinical trials, aiming for FDA approval by 2030 [2][4] - **Market Strategy**: The partnership with Frasier allows Haizhi Science to retain rights in the Chinese market while leveraging Frasier's expertise in respiratory drug development and funding capabilities [2][5] - **International Business Development (BD)**: Previous licensing agreements for TYK2 and DTP1 with Alumis and Casey demonstrate Haizhi Science's BD strength and lay the groundwork for future international collaborations [2][6] Core Product Development - **PD34 Potential**: PD34 is projected to have peak sales in the billions if successfully commercialized. The collaboration with Frasier is expected to accelerate its entry into the U.S. market [2][7] - **Clinical Trials**: Key Phase II data for PD34 is expected to be disclosed in early 2026, with plans for Phase III trials to follow. The company anticipates submitting a New Drug Application (NDA) in China by late 2027 or early 2028 [2][9] - **DPI Product 39,004**: This product is designed to meet various usage scenarios and has shown promising initial efficacy in clinical trials. It combines mixed rotation and DPI (dry powder inhaler) technologies [2][9] Financial Aspects - **Revenue Sharing**: Haizhi Science will receive a double-digit percentage of revenue from licensing agreements based on the development stage of assets in the U.S. [2][8] - **Future Licensing Opportunities**: The company plans to pursue additional licensing agreements and aims to report a new product by the end of 2026, with two to three more expected in 2026 [3][21] Competitive Landscape - **Differentiation**: 39,004 offers advantages over competitors by addressing various treatment backgrounds and demonstrating effective results in complex patient populations [2][9] - **Market Positioning**: Haizhi Science is strategically avoiding highly competitive areas in the domestic market while focusing on therapeutic areas like anesthesia, metabolism, and respiratory diseases [19] Future Directions - **Long-term Vision**: The company aims to transform into an innovative drug company over the next decade, focusing on unique and challenging products rather than generic competition [17][22] - **International Expansion**: Haizhi Science is committed to expanding its international presence and learning from global market leaders to enhance its competitive edge [16][19] Recent Achievements - **Product Pipeline**: Haizhi Science has four key molecules in development, with significant progress in clinical trials and regulatory submissions expected in the coming years [3][13][23] - **Market Recognition**: The company has successfully integrated several products into the healthcare system and is actively pursuing international collaborations [23] Conclusion - **Commitment to Innovation**: Haizhi Science is focused on advancing its product pipeline and expanding its market reach through strategic partnerships and innovative drug development, positioning itself for significant growth in the pharmaceutical industry [21][22]

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry as of January 11, 2026 [3] Core Insights - 2025 marked a significant year for Chinese innovative drugs going overseas, with total transaction amounts reaching $135.655 billion, including $7 billion in upfront payments and 157 deals, setting historical highs [4] - The innovative drug index saw a 35.31% increase in 2025, outperforming the CSI 300 index by 17.65% [4] - The trend of Chinese innovative drugs going global is expected to strengthen in 2026, with significant deals such as the one between Yilian Biotech and Roche for the YL201 project, which includes a $570 million upfront payment [4] - The small nucleic acid drug sector is experiencing breakthroughs, with GSK's Bepirovirsen showing positive results in Phase III trials for chronic hepatitis B, potentially becoming the first drug to achieve functional cure [5] - The report highlights the importance of oral autoimmune drugs, with Takeda's TYK2 inhibitor showing promising results in treating moderate to severe plaque psoriasis [6] - The brain-computer interface technology is entering a critical industrialization phase, with companies like Neuralink set to produce devices in 2026, supported by favorable policies and clinical trials in China [8] - The ZAP-X radiotherapy device is expected to capture a significant market opportunity in China, with the non-invasive tumor radiotherapy market projected to grow from RMB 27.2 billion in 2018 to RMB 59.4 billion by 2024 [10] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry index underperformed the CSI 300 index by 2.13% over the past week, ranking 25th among 31 industry indices [28] - Over the past month, the pharmaceutical industry index also lagged behind the CSI 300 by 5.42%, ranking 27th [29] 2. Pharmaceutical Sector Trends and Valuation - The current PE (TTM) for the pharmaceutical industry index is 36.95, above the five-year historical average of 31.12 [52] 3. Recent Research Achievements - The report includes various deep-dive studies on topics such as the growth of biological agents and oral drugs, and the impact of policy support on the inhalation drug industry [55] 4. Important Industry Policies and News - Recent policies include the issuance of the fourth batch of encouraged generic drug directories by the National Medical Products Administration [57] - Significant news includes GSK's announcement of positive Phase III results for Bepirovirsen and Yilian Biotech's licensing agreement with Roche [58][59]

Core Viewpoint - The company has signed an exclusive licensing agreement with AirNexis Therapeutics, granting AirNexis global rights (excluding China) to develop, produce, and commercialize HSK39004, a drug for chronic obstructive pulmonary disease (COPD) [2][3] Group 1: Licensing Agreement Details - AirNexis will pay an upfront fee of $108 million, which includes $40 million in cash and approximately $68 million worth of 19.9% equity in AirNexis, along with potential milestone payments of up to $955 million and royalties [2][3] - The transaction is classified as a related party transaction and requires shareholder approval [2] Group 2: Drug Information - HSK39004 is a dual inhibitor of PDE3/4, designed to expand airways and reduce inflammation, currently undergoing Phase II clinical trials in China [3] - The drug is available in two formulations: inhalation suspension and inhalation powder [3] Group 3: Financial Performance - For the first three quarters of 2025, the company reported revenue of 3.3 billion yuan, a year-on-year increase of 19.95%, while net profit attributable to shareholders decreased by 22.66% to 295 million yuan [4] Group 4: Investment and Strategic Implications - The agreement aligns with the company's strategy of internationalization and innovation, aiming to enhance global development and commercialization of HSK39004 [3] - The NewCo model used for this licensing agreement allows the company to retain partial ownership and control while attracting investment for clinical development [6][8]