证券简称：华海药业 证券代码：600521 公告编号：临 2025-083 号 债券简称：华海转债 债券代码：110076 浙江华海药业股份有限公司 第九届董事会第二次临时会议决议公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 具体内容详见公司于 2025 年 7 月 25 日刊登在中国证券报、上海证券报、证 券时报、证券日报及上海证券交易所网站（www.sse.com.cn）上的《浙江华海药 业股份有限公司关于部分募集资金投资项目延期的公告》。 2、审议通过了《关于募投项目结项并将节余募集资金永久补充流动资金的 议案》 表决情况：同意 9 票；反对 0 票；弃权 0 票。 会议决议：董事会同意募投项目"浙江华海生物科技有限公司 ADC 产业化 技改项目"结项并将节余募集资金永久补充流动资金。 1 / 2 该议案已经公司第九届董事会审计委员会第二次会议、第九届董事会独立董 事专门会议 2025 年第一次会议审议通过，且已经公司本次董事会审议通过。 浙江华海药业股份有限公司（以下称"公司"）第九届董事会第二次临时会 ...

浙江华海药业股份有限公司 独立董事专门会议 浙江华海药业股份有限公司 第九届董事会独立董事专门会议 2025 年第一次会议决议 浙江华海药业股份有限公司（以下简称"公司"）第九届董事会独立董事专门 会议 2025 年第一次会议于二零二五年七月十八日下午十五点在公司会议室以通 讯方式召开。会议应到会独立董事三人，实际到会独立董事三名，会议由公司独 立董事邓川先生主持，会议程序符合《中华人民共和国公司法》《上市公司独立董 事管理办法》及《公司章程》《公司独立董事工作制度》等相关规定，会议合法有 效。会议审议并通过了如下决议： 会议决议：公司募集资金投资项目"制剂数字化智能制造建设项目"延期事 项是根据项目实施的客观实际和经营需要作出的审慎决定，仅涉及项目进度的调 整，不涉及募投项目的投资内容、投资用途、投资总额、实施主体的变更，不存 在变相改变募集资金投向和损害公司股东利益的情形。因此，公司独立董事专门 会议同意本次部分募集资金投资项目延期事项。 二、审议通过了《关于募投项目结项并将节余募集资金永久补充流动资金的 议案》 表决情况：同意：3 票；反对：0 票；弃权：0 票。 会议决议：公司募投项目"浙江华海生物科 ...

Core Insights - Despite holding promising drug candidates like HB0034 and HB0025, Huahai Pharmaceutical's subsidiary Huatai has struggled to gain market traction, with its stock price dropping over 12% from a month ago [1][3] - Huatai's research pipeline includes leading candidates in the IL-36 and PD-1/VEGF dual antibody fields, yet it has failed to convert this potential into actual partnerships or product launches [2][3] - The company's innovative drug segment has become a financial burden, with significant losses projected for 2024 and a negative net asset position, raising concerns about its long-term viability [3][4] Group 1 - Huatai's HB0034 is the leading global candidate in the IL-36 space, with indications expanding from GPP to lupus and ulcerative colitis [2] - The PD-1/VEGF dual antibody HB0025 is targeting endometrial cancer and is nearing Phase III clinical trials [2] - Despite these advancements, Huatai has not secured any business development (BD) deals or product launches in over a decade [3] Group 2 - Huahai's core business remains strong, with over 30% market share in certain APIs and an 80% gross margin in its formulation business [3] - The innovative drug division's lack of product launches has led to a projected net loss of 330 million yuan in 2024, significantly impacting the parent company's profitability [3] - A performance guarantee agreement signed with investors requires Huahai to buy back shares if no products are launched within three years or if two products are not launched within five years [3][4] Group 3 - The current situation highlights a broader challenge within the Chinese biotech sector, where traditional revenue streams are dwindling while innovative pipelines struggle to realize value [4] - The company faces a critical decision on whether to wait for product approvals, accelerate business development efforts, or pivot its strategic focus [4]

Core Viewpoint - The Chinese innovative drug industry is experiencing significant growth in the first half of 2025, driven by policy benefits and international breakthroughs, with leading companies achieving explosive growth due to technological barriers and commercialization capabilities [1]. Company Performance Summaries - **Shuanglu Pharmaceutical**: Expected net profit for H1 2025 is between 100 million and 135 million RMB, a year-on-year increase of 237.95% to 356.24% from 29.59 million RMB in the same period last year, primarily benefiting from financial asset returns and breakthroughs in innovative drug pipelines [3][4]. - **Sino Biopharmaceutical**: Anticipated net profit ranges from 77.03 million to 94.14 million RMB, reflecting a year-on-year increase of 253.54% to 332.10%, driven by strong performance in peptide raw material exports [5][7]. - **Microchip Biotech**: Expected net profit of approximately 30.06 million RMB, representing a 173% increase, attributed to the inclusion of its core product (Sida Benamine) in medical insurance and optimized sales strategies [8][10]. - **Buchang Pharmaceutical**: Projected net profit between 488 million and 708 million RMB, a year-on-year increase of 110.88% to 205.94%, due to increased sales scale and reduced production costs [11][13]. - **Ganli Pharmaceutical**: Expected net profit of 600 million to 640 million RMB, a year-on-year increase of 100.73% to 114.12%, driven by significant revenue growth and refined expense management [15][16]. - **Shanghai Pharmaceuticals**: Anticipated net profit of 4.45 billion RMB, an increase of approximately 52% from the previous year, following the acquisition of a 10% stake in Shanghai Hengrui Medicine [17][18]. - **Liaoning Chengda**: Expected net profit between 689 million and 735 million RMB, a year-on-year increase of 50% to 60%, supported by a dual-driven strategy of healthcare and financial investment [19][21]. - **WuXi AppTec**: Projected net profit of approximately 6.3 billion RMB, a year-on-year increase of about 44.43%, driven by optimized CRDMO business models and significant non-operating gains from stock sales [23][25]. - **Notai Biopharmaceutical**: Expected net profit between 300 million and 330 million RMB, a year-on-year increase of 32.06% to 45.27%, attributed to sales growth in peptide raw materials [27][29]. - **I-Wu Biotech**: Anticipated net profit between 170 million and 180 million RMB, reflecting a year-on-year increase of 13.92% to 23.97%, focusing on allergy disease treatment products [30][31]. Industry Trends - The performance divergence in the innovative drug industry in 2025 indicates a shift from "scale competition" to "technological competition," with companies possessing genuine innovation capabilities and international layouts expected to lead, while those relying on capital operations or policy arbitrage face growth challenges [32].

Group 1 - The Alzheimer's concept sector increased by 2.28%, ranking fifth among concept sectors, with 27 stocks rising, including Wanbangde, Lisheng Pharmaceutical, and Zhejiang Zhenyuan reaching the daily limit [1] - Notable gainers in the sector included Jihua Group, Xinhua Pharmaceutical, and Boji Pharmaceutical, which rose by 5.85%, 4.98%, and 4.93% respectively [1] - The sector experienced a net inflow of 498 million yuan from main funds, with 21 stocks receiving net inflows, and six stocks seeing inflows exceeding 50 million yuan [2] Group 2 - The top stock in terms of net inflow was Huahai Pharmaceutical, with a net inflow of 87.51 million yuan, followed by Boji Pharmaceutical, Jihua Group, and Haizheng Pharmaceutical with inflows of 55.18 million yuan, 54.13 million yuan, and 53.91 million yuan respectively [2][3] - Zhejiang Zhenyuan and Boji Pharmaceutical had the highest net inflow ratios at 29.25% and 16.16% respectively [3] - The overall performance of the Alzheimer's concept sector was supported by significant trading volumes, with stocks like Lisheng Pharmaceutical and Wanbangde showing substantial price increases of 10% [4]

Policy Developments - The National Healthcare Security Administration reported that the basic medical insurance coverage rate in China remains stable at over 95%, with 1.32662 billion people insured by the end of 2024 [2] - The total income of the national basic medical insurance fund for 2024 is projected to be CNY 34,913.37 billion, while total expenditures are expected to be CNY 29,764.03 billion, resulting in a current balance of CNY 4,639.17 billion [2] - Since the establishment of the National Healthcare Security Administration in 2018, 835 new drugs have been added to the medical insurance drug list, with over 5,400 million CNY in sales from newly negotiated drugs between 2018 and 2024 [2] Drug and Device Approvals - Bayer's non-hormonal drug elinzanetant has been approved by the UK Medicines and Healthcare products Regulatory Agency for treating moderate to severe vasomotor symptoms related to menopause [5] - Innovent Biologics' new BCL2 inhibitor mesutoclax has received FDA approval to commence clinical trials for treating myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes [6] - Tianyu Co., Ltd.'s subsidiary has passed the review for ezetimibe raw materials by the National Medical Products Administration, pending GMP compliance inspection results for market launch [7] Capital Market Activities - Innostellar Biotherapeutics has signed a ten-year exclusive promotion agreement with Golden Age Health for the commercialization of its gene therapy candidate LX101 in mainland China [9] Earnings Disclosures - Da'an Gene anticipates a net loss of CNY 140 million to 200 million for the first half of 2025 [11] - Huahai Pharmaceutical expects a net profit decline of 40% to 50% year-on-year, projecting a profit range of CNY 374 million to 449 million [12] - KingMed Diagnostics forecasts a net loss of CNY 95 million to 65 million for the first half of 2025, representing a significant year-on-year decline [13] - Xinmai Medical projects a net profit of CNY 304 million to 361 million for the first half of 2025, a decrease of 10.52% to 24.78% compared to the previous year [14] - Wantai Biological Pharmacy anticipates a net loss of CNY 130 million to 160 million for the first half of 2025 due to market pressures and policy adjustments [15] Industry Events - *ST Suwu has received a notice of administrative penalty from the China Securities Regulatory Commission for falsifying financial reports, which may lead to forced delisting [17] - This incident serves as a warning for the pharmaceutical industry to focus on genuine innovation and establish effective internal controls to mitigate risks associated with management [17] Shareholder Movements - Qihe Venture, a shareholder holding over 5% of Xuantai Pharmaceutical, plans to reduce its stake by up to 7 million shares, representing no more than 1.5441% of the company's total shares [19]

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. is expected to report a significant decline in net profit for the first half of 2025, with estimates ranging from 374 million to 449 million yuan, representing a year-on-year decrease of approximately 40% to 50% [1][2] Financial Performance Summary - The estimated net profit attributable to shareholders for the first half of 2025 is projected to be between 374 million and 449 million yuan, a decrease of approximately 29.957 million to 37.457 million yuan compared to the same period last year [1][2] - The estimated net profit after deducting non-recurring gains and losses is expected to be between 0 and 420.85 million yuan, reflecting a year-on-year decline of approximately 45% to 55% [2] Previous Year Performance Comparison - In the same period last year, the net profit attributable to shareholders was 748.566 million yuan, and the net profit after deducting non-recurring gains and losses was 764.8527 million yuan [2] - The earnings per share for the previous year was 0.52 yuan [2] Reasons for Performance Change - The decline in net profit is primarily attributed to several factors: 1. Intensified competition in the raw material drug industry and the impact of domestic centralized procurement policies, leading to a decrease in sales revenue despite an increase in market share [2] 2. Increased investment in the research and development of innovative biological drugs, resulting in significantly higher R&D expenses [2] 3. Reduced foreign exchange gains due to currency fluctuations [2] - Non-operating gains and losses increased by approximately 50 million to 70 million yuan, mainly due to the increase in fair value changes of financial assets measured at fair value [2]

Zhejiang Huahai Pharmaceutical Co., Ltd. 2025 Semi-Annual Performance Pre-announcement of Decline [Current Period Performance Forecast](index=1&type=section&id=Current%20Period%20Performance%20Forecast) The company expects a significant decline in its 2025 first-half performance, with net profit attributable to shareholders projected to decrease by approximately 40% to 50% year-on-year, while net profit after deducting non-recurring gains and losses is expected to decline by about 45% to 55% year-on-year 2025 Semi-Annual Performance Forecast (RMB) | Performance Indicator | 2025 Semi-Annual Estimated Amount (RMB) | Year-on-Year Change | | :--- | :--- | :--- | | Net Profit Attributable to Shareholders | 374 million to 449 million yuan | Decrease of approximately 40% to 50% | | Net Profit After Deducting Non-Recurring Gains and Losses | 344 million to 421 million yuan | Decrease of approximately 45% to 55% | [Prior Period Performance Overview](index=1&type=section&id=Prior%20Period%20Performance%20Overview) The report provides 2024 prior period performance data as a benchmark, with net profit attributable to shareholders at 748.566 million yuan, net profit after deducting non-recurring gains and losses at 764.8527 million yuan, and earnings per share at 0.52 yuan 2024 Semi-Annual Performance (RMB) | Performance Indicator | 2024 Semi-Annual Amount (RMB) | | :--- | :--- | | Net Profit Attributable to Shareholders | 748.566 million yuan | | Net Profit After Deducting Non-Recurring Gains and Losses | 764.8527 million yuan | | Earnings Per Share | 0.52 yuan | [Key Reasons for Current Period Performance Change](index=2&type=section&id=Key%20Reasons%20for%20Current%20Period%20Performance%20Change) The year-on-year decline in current period performance is primarily influenced by three factors: product price decreases due to domestic centralized procurement, industry competition, and tariff issues impacting sales revenue; a significant year-on-year increase in R&D investment to accelerate biological innovative drug projects; and reduced exchange gains due to foreign currency exchange rate fluctuations, while non-operating gains and losses increased year-on-year due to fair value changes in financial assets - Due to deepening domestic centralized procurement policies, intensified competition in the API industry, and the impact of China-US tariffs, the company's product prices continued to fall, leading to a year-on-year decrease in current period sales revenue[6](index=6&type=chunk) - The company accelerated the advancement of biological innovative drug R&D projects, resulting in a significant year-on-year increase in R&D investment[6](index=6&type=chunk) - Foreign currency exchange rate fluctuations led to a year-on-year decrease in exchange gains[6](index=6&type=chunk) - During the reporting period, non-operating gains and losses increased by approximately **50 million to 70 million yuan** year-on-year, primarily due to increased gains from fair value changes in financial assets[6](index=6&type=chunk) [Risk Warning](index=2&type=section&id=Risk%20Warning) The company confirms that there are currently no significant uncertainties affecting the accuracy of this performance forecast - The company states that there are no significant uncertainties affecting the accuracy of this performance forecast[7](index=7&type=chunk) [Other Explanatory Notes](index=2&type=section&id=Other%20Explanatory%20Notes) The company explicitly states that the performance forecast data released this time is only a preliminary calculation result, unaudited, and the final accurate financial data will be subject to the company's officially disclosed 2025 semi-annual report, reminding investors to be aware of investment risks - This performance forecast data is preliminary and unaudited by an accounting firm; the final data will be subject to the company's officially disclosed 2025 semi-annual report[8](index=8&type=chunk)

华海药业（600521）公告，经财务部门初步测算，公司2025年半年度实现归属于上市公司股东的净利润 预计在3.74亿元至4.49亿元之间，与上年同期相比，将减少约3亿元到3.75亿元，同比下降约40%到 50%。公司2025年半年度归属于上市公司股东的扣除非经常性损益的净利润预计在3.44亿元至4.21亿元 之间，与上年同期相比，将减少约3.44亿元到4.21亿元，同比下降约45%到55%。 ...

Market Review - The CITIC Pharmaceutical Index increased by 1.80%, outperforming the CSI 300 Index by 0.98 percentage points, ranking 16th among 30 CITIC first-level industry indices [5] - The top ten stocks by increase this week include Frontier Biologics-U, Medici, Lianhuan Pharmaceutical, Kangchen Pharmaceutical, and others, with Frontier Biologics-U leading at 41.43% [4][5] - The bottom ten stocks by decrease include ST Weiming, Shenzhou Cell, and Shuotai Shen, with ST Weiming dropping by 18.51% [4][5] Overall Viewpoint and Investment Themes - The current valuation of the pharmaceutical sector is at a low point, with public funds (excluding pharmaceutical funds) having low allocation to the sector. The company remains optimistic about the growth of the pharmaceutical industry by 2025, driven by macroeconomic factors and the demand from major categories [9] - In the innovative drug sector, there is a shift from quantity logic to quality logic, focusing on differentiated domestic and international pipelines. The company suggests paying more attention to products and companies that can ultimately realize profits [9] - In the medical device sector, there is a noticeable recovery in bidding volumes for imaging equipment, and the home medical device market is expected to benefit from subsidy policies. The company highlights the potential for import substitution and growth in the orthopedic sector post-collection [9] - The innovation chain (CXO + life sciences services) is expected to see a rebound in overseas investment and a bottoming out in domestic investment, with a potential return to high growth by 2025 [9] - The pharmaceutical industry is anticipated to enter a new growth cycle, with a focus on specialty raw materials and the expiration of patents leading to new growth opportunities [9] Industry and Company Events - The company highlights the innovative layout of traditional Chinese medicine enterprises, with several products in clinical II and III phases, including those targeting chronic insomnia and primary acute gouty arthritis [29][30] - Yunnan Baiyao has several drugs in various clinical stages, including those for prostate cancer and other conditions, indicating a robust pipeline [16][19] - The company emphasizes the importance of the blood products sector, which is expected to see significant growth due to relaxed approval processes and increased production capacity [14] - The innovative drug pipeline of Yiling Pharmaceutical focuses on cardiovascular, respiratory, and endocrine diseases, with multiple drugs in clinical trials [20][21]