Core Insights - Saito Bio (300583.SZ) released its Q3 2025 report on October 29, 2025, indicating a total institutional holding of 43.2974 million shares, representing 22.82% of the company's total equity [1] Institutional Holdings - As of October 28, 2025, there is one institutional investor holding shares in Saito Bio, which is Shandong Runxin Investment Co., Ltd. [1] - The total institutional holding percentage decreased by 0.45 percentage points compared to the previous quarter [1] Public Fund Information - In this reporting period, 32 public funds were not disclosed compared to the previous quarter, including funds such as Guojin Quantitative Multi-Factor A, Guojin Quantitative Selected A, and others [1]

Group 1 - The core point of the news is that He Yuan Bio experienced a significant stock price increase of 213.49% on October 28, with a trading volume of 2.782 billion yuan [1] - On the same day, He Yuan Bio had a financing buy amount of 369 million yuan, with a net financing purchase of 269 million yuan, indicating strong investor interest [1] - The company's total financing and securities balance reached 269 million yuan, accounting for 7.21% of its circulating market value [1] Group 2 - As of October 28, the number of shareholders for He Yuan Bio increased to 47,100, a rise of 84,075% compared to the previous period [2] - The average circulating shares per person decreased to 869 shares, a drop of 99.85% from the previous period [2] - For the period from January to September 2025, He Yuan Bio reported an operating income of 19.6608 million yuan, a year-on-year decrease of 8.51%, and a net profit attributable to the parent company of -121 million yuan, also a decrease of 8.44% year-on-year [2]

Core Insights - The Chinese artificial bioactive bone industry is experiencing rapid growth, with a market size projected to reach approximately 1.528 billion yuan in 2024, reflecting a year-on-year increase of 6.26% [1][4] - This growth is primarily driven by an aging population, rising incidence of orthopedic diseases, and advancements in medical technology [1][4] - Domestic companies have made significant progress in the research and production of artificial bioactive bones, with products like "Yougou Sheng®" from Asia Bio covering thousands of hospitals across 31 provinces in China by 2024 [1][4] Industry Overview - Artificial bioactive bone is a type of bone-like material created through bioengineering or materials science, characterized by its ability to chemically bond with surrounding living bone tissue, promoting bone regeneration and defect repair [2] - The industry has evolved from traditional artificial bones, which lack bioactivity, to bioactive materials that significantly enhance bone repair efficiency and integration [2] Industry Development History - The Chinese artificial bioactive bone industry began in 2009 and has gone through three development phases, with significant milestones including the establishment of GMP production lines and the introduction of 3D printing technology [3][4] - By 2021, Asia Bio's "Yougou Sheng" received NMPA registration, becoming the first active multi-level structure artificial bone in China, and was included in the medical insurance catalog of 23 provinces [3][4] Market Size - The market for artificial bioactive bones in China is expected to grow to approximately 1.528 billion yuan in 2024, driven by demographic changes and advancements in medical technology [1][4] Key Companies - Major players in the industry include Aojing Medical, Zhenghai Bio, and Asia Bio, which are rapidly emerging through technological innovations and competitive pricing strategies [5][6] - Zhenghai Bio's "Haiyu" product has achieved a clinical fusion rate of 100% and is included in the medical insurance catalog of 23 provinces [5][6] - Aojing Medical has expanded its production capacity and is advancing into the dental implant sector through acquisitions [8][9] Industry Development Trends 1. Continuous technological innovation is expected to drive product upgrades, with advancements in 3D printing and nanotechnology enhancing the performance of bioactive bones [10] 2. Policy and market dynamics are anticipated to accelerate industry growth, with government initiatives promoting the adoption of cost-effective domestic products [11] 3. The industry is shifting towards a global presence, with companies expanding through international collaborations and acquisitions, aiming to establish a robust global market footprint [12][13]

Core Viewpoint - Kangtai Biological's operating performance continues to be under pressure, with a significant decline in net profit despite a slight increase in revenue [1][3][4]. Financial Performance - For the first three quarters of 2025, Kangtai Biological reported revenue of 2.063 billion yuan, a year-on-year increase of 2.24%, while net profit attributable to shareholders was 49.16 million yuan, representing an 86% decline [1][3]. - The company's net profit has been on a downward trend, with a 90.82% decrease in non-recurring net profit, amounting to 27.88 million yuan [3]. - The operating income for the first three quarters was 6.45 billion yuan, 7.47 billion yuan, and 6.71 billion yuan for Q1, Q2, and Q3 respectively, with year-on-year changes of 42.85%, -0.47%, and -17.74% [5]. Cost and Profitability Issues - The increase in operating costs, which reached 540 million yuan (up 61.74% year-on-year), has significantly outpaced revenue growth, contributing to the profit decline [9]. - The company recorded asset impairment losses totaling 163 million yuan [8]. Market Dynamics - The decline in performance is attributed to intensified market competition and a slowdown in market demand, alongside the normalization of the market post-pandemic [6][7]. - Despite a threefold increase in overseas market revenue, which reached 41.90 million yuan, it remains insufficient to offset the overall decline in performance due to its small base [12]. Strategic Initiatives - Kangtai Biological is actively pursuing international expansion, with successful entries into markets such as Turkey, Indonesia, Nicaragua, and Pakistan for its 13-valent pneumococcal polysaccharide conjugate vaccine [11]. - The company has increased its R&D investment to 420 million yuan, a 34.74% increase year-on-year, indicating a focus on innovation [13]. Future Outlook - The ability of Kangtai Biological to overcome current challenges through R&D and international expansion remains to be seen [14].

Core Viewpoint - The company has decided to terminate the development of prothrombin complex concentrate and shift focus to the more advantageous development of human coagulation factor IX, due to market demand, competitive landscape, and cost-effectiveness considerations [1][2]. Market Demand and Competitive Landscape - The domestic market for prothrombin complex concentrate has seen stable issuance volumes with limited new market space, while the market for human factor IX has fewer competitors and significant growth potential [1]. - Human factor IX is considered a better option for treating hemophilia B due to its lower risk of thrombotic side effects compared to prothrombin complex concentrate [1][2]. Product Comparison Analysis - Prothrombin complex concentrate contains various vitamin K-dependent factors and may pose risks of thrombosis with repeated high-dose use, while human factor IX is purer and has a higher specific activity, making it a safer treatment option [1][2]. Cost-Effectiveness Analysis - The clinical trial approval for prothrombin complex concentrate was obtained in 2008, but the regulatory requirements for production site changes and the need for extensive research have made it less economically viable compared to human factor IX, which has a higher sales price and greater market growth potential [2][4]. Project Background and Investment Plan - The genomic DNA length of human factor IX is approximately 34,000 bp, and the project is expected to complete development and obtain production approval by the end of 2030 [2][4]. - The estimated investment for the development of human factor IX is 60 million yuan, with funding sourced from both raised capital and the company's own funds [4]. Project Benefits and Feasibility - The human factor IX product is aimed at treating patients with factor IX deficiency (hemophilia B), and the limited number of competitors in this market suggests significant future growth opportunities [5]. - The project aligns with market trends and the company's operational needs, enhancing resource allocation and economic benefits, thereby improving profitability and market competitiveness [5][7]. Implementation Timeline - The implementation timeline for the new product development is expected to be completed by the end of 2030, with the associated production line construction already finished [6][4]. Impact of Changes on the Company - The termination of the prothrombin complex concentrate project will reduce the current year's net profit but is expected to enhance the company's future product development and sales capabilities [7]. - The board and supervisory committee have approved the change in fundraising purposes, emphasizing the alignment with the company's operational needs and long-term interests [8][10].

10月27日，基因编辑领域发生了一场"地震"。 明星公司Intellia Therapeutics股价单日暴跌42.23%，市值蒸发近半。暴跌的导火索，是一名接受其核心 管线NEX-z治疗的罕见心脏病患者，出现了严重肝损伤，导致两项三期临床被紧急暂停。 这已是该药物年内报告的第二起4级肝毒性事件。与5月底那起无症状且自行恢复的肝酶升高不同，这次 患者因肝酶和胆红素同时飙升而住院，触发了临床试验暂停机制。 安全性问题始终是基因编辑疗法头顶高悬的摩克利斯之剑。Intellia的安全事件甚至引发了基因编辑药物 肝脏安全性长期以来的担忧，"带崩"了整个基因编辑板块，包括Beam Therapeutics、Prime Medicine等 均出现不同程度的下跌。 接下来几周，对Intellia来说将异常漫长，对基因编辑领域或许又将是一次关于风险认知的集体教育。 01 考虑到这些升高是无症状的且发生率较低，nex-z ATTR 淀粉样变性中的风险/收益平衡仍然有利。分析 师继续认为 nex-z的TTR敲低效果令人印象深刻，能降低临床结果不佳的风险。这也使得当时公司股价 虽暴跌22%，但随后成功收复失地，并不断创下年内新高。 ...

Core Viewpoint - The company has announced changes regarding its financial reporting and the use of raised funds, including the appointment of new auditors and the reallocation of surplus funds to enhance operational efficiency [6][34][46]. Financial Reporting - The board and management have confirmed the accuracy and completeness of the quarterly report, which has not been audited [2][3]. - The company has not made any retrospective adjustments or restatements to previous accounting data [3]. Auditor Changes - The company has appointed new signing auditors from KPMG Huazhen due to internal adjustments, with the new auditors being Wang Pu and Li Bingman [6][7]. Shareholder Meeting - The company will hold its third extraordinary general meeting on November 13, 2025, to discuss various proposals, including the reallocation of surplus funds [12][13][14]. Fund Utilization - The company plans to permanently supplement its working capital with surplus funds from completed projects, totaling approximately 27.62 million yuan [34][39]. - The surplus funds are primarily due to lower-than-expected transaction costs and effective cash management [37][38]. Project Changes - The company has revised the use of raised funds for new product development, shifting focus from the development of prothrombin complex to factor IX, while maintaining the overall budget for the project at 340.5 million yuan [46][47].

Group 1 - The adjustment of the value-added tax rate will not affect the company's performance in 2024 and prior years, but it is expected to have an indirect impact on the company's total profit starting in 2025 [1] - The company has implemented measures to mitigate the impact of the tax rate adjustment, including optimizing product pricing and structure, strengthening tax management and cost control, aligning with market demand, and enhancing customer loyalty [1] - The specific financial impact of the tax rate adjustment will be determined by the audit report issued by the accounting firm [1] Group 2 - The company will hold its first extraordinary general meeting of shareholders in 2025 on November 13 at 14:30, located at the Vland Innovation Park in Qingdao [4][5] - Voting for the meeting will be conducted through a combination of on-site and online methods, with specific time slots for online voting [5][6] - Shareholders must register to attend the meeting, with detailed registration methods provided for different types of shareholders [11][12][13]

Financial Data and Key Metrics Changes - Neurocrine Biosciences reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [6][10] - CRENESSITY's sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption and persistency rates [6][7] - INGREZZA achieved net sales of $687 million in Q3, marking the third consecutive quarter of record new patient additions [7][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base that has expanded by 30% over the past two years, reflecting the strong clinical profile and unmet need for tardive dyskinesia treatment [10][11] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since its launch [13][15] - The company anticipates continued growth for both products, with plans for further sales force expansion to maximize patient share [8][16] Market Data and Key Metrics Changes - The tardive dyskinesia market is expected to grow significantly, with only about 10% of diagnosed patients currently treated with a VMAT2 inhibitor, indicating substantial growth potential for INGREZZA [10][11] - The congenital adrenal hyperplasia (CAH) community has shown favorable feedback towards CRENESSITY, with 80% of dispensed prescriptions now being reimbursed [6][15] Company Strategy and Development Direction - Neurocrine Biosciences is focused on expanding its sales force for both INGREZZA and CRENESSITY to accelerate growth into 2026 and beyond [4][8] - The company aims to drive revenue growth, advance R&D programs, enable business development, and return capital to shareholders, with a strong financial profile of over $2.1 billion in cash [9][80] - The strategic expansion of the sales force is intended to maximize patient share and prepare for anticipated launches of investigational psychiatric medicines [8][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both products and the potential for sustained long-term growth driven by their science and commitment to patients [5][9] - The company remains on track for its clinical programs, with anticipated top-line results for key studies in the near future [18][19] - Management acknowledged the potential impacts of the Inflation Reduction Act (IRA) on the market and emphasized the importance of maximizing patient share before 2027 [8][30] Other Important Information - The company is fully cooperating with a Department of Justice investigation related to the sales and marketing of INGREZZA, maintaining a robust compliance program [40][41] - The sales force expansion is expected to result in an increase in SG&A expenses of around $150 million in 2026 [9][79] Q&A Session Summary Question: Insights on patient dynamics and starts for CRENESSITY - Management noted that the adoption of CRENESSITY has been strong, with 540 new treatment forms in Q3, and they do not believe there are significant seasonal dynamics affecting enrollment [22][23] Question: Implications of the IRA on pricing and reimbursement - Management is monitoring the upcoming Oscado pricing and its potential effects on INGREZZA, emphasizing the importance of maximizing patient numbers before the IRA impacts [28][30] Question: Status of reimbursement requirements for CRENESSITY - Management indicated that reimbursement has been smooth, with no specific requirements for steroid tapering to continue coverage [34] Question: Sales force expansion details - The expansion is characterized as a 30% increase in overall sales footprint, primarily targeting psychiatry and neurology for INGREZZA, while also expanding the team for CRENESSITY [46][48] Question: Update on the Department of Justice investigation - Management confirmed they are cooperating with the DOJ regarding a civil investigative demand related to INGREZZA's sales and marketing practices [40][41] Question: Progress with CRENESSITY at centers of excellence - All centers of excellence have started adopting CRENESSITY, with varying rates of adoption, and there is optimism about community endocrinologists' engagement [43][44]

2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明：保证季度报告中财务信息 的真实、准确、完整。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 重要内容提示： 1.董事会及董事、高级管理人员保证季度报告的真实、准确、完整，不存在虚假记载、误导性陈述或重 大遗漏，并承担个别和连带的法律责任。 3.第三季度财务会计报告是否经过审计 □是 √否 一、主要财务数据 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：301080 证券简称：百普赛斯 公告编号：2025-067 （一） 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是 √否 ■ 公司2025年1-9月因股份支付影响当期损益的金额为8,321,702.80元，扣除股份支付影响后归属于母公司 上市股东的净利润为140,748,079.80元。 公司报告期末至季度报告披露日股本是否因发行新股、增发、配股、股权激励行权、回购等原因发生变 化且影响所有者权益金额 √是 □否 ■ （二） 非经常性损益项目和金额 √适用 □不适用 单位：元 公司不存在其他符合非经常 ...