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 ...

Core Viewpoint - The company, Bai'ao Tai Biopharmaceutical Co., Ltd., has released its quarterly report, ensuring the accuracy and completeness of the financial information presented, with no significant omissions or misleading statements [2][3]. Financial Data Summary - The financial statements for the third quarter are unaudited, covering the period from the beginning to the end of the quarter [3][6]. - The report includes major accounting data and financial indicators, although specific figures are not detailed in the provided text [3][4]. - The company confirms that there were no significant changes in the financial indicators compared to previous periods [5][6]. Shareholder Information - The report includes details about the total number of ordinary shareholders and the top ten shareholders, although specific numbers are not provided [5][6]. - There are no changes reported regarding the participation of major shareholders in securities lending activities [5][6]. Other Important Information - The company has not identified any additional significant information regarding its operational performance during the reporting period [5][6]. - The financial statements include the consolidated balance sheet, profit and cash flow statements for the period from January to September 2025, all of which are unaudited [6][7].

Core Insights - Junshi Bioscience (688180.SH) reported a significant increase in revenue and a reduction in net loss for the first three quarters of 2025, with total revenue reaching 1.806 billion yuan, a year-on-year growth of 42.06%, and a narrowed net loss of 596 million yuan, a decrease of 35.72% [1] - The company's core product, Toripalimab, has shown continuous growth in sales, achieving 1.495 billion yuan in revenue for the first three quarters, a 40% increase year-on-year, and has maintained a sequential growth for six consecutive quarters since 2024 [1][2] Financial Performance - For Q3 2025, Junshi Bioscience reported revenue of 637 million yuan, reflecting a year-on-year increase of 31.40% [1] - The company had a strong cash position with a total of 3.270 billion yuan in cash and financial assets as of the end of Q3 2025 [1] Product Development and Clinical Recognition - Toripalimab's clinical value has been recognized internationally, particularly highlighted at the 2025 ESMO annual meeting, where its combination therapy with ADC drug was presented, showing significant improvements in overall survival and progression-free survival compared to traditional chemotherapy [2] - The new indication for Toripalimab has been accepted for review by the NMPA in China, marking the 13th indication application for the drug [2] Global Commercialization and Market Expansion - Toripalimab has been approved in over 40 countries and regions across four continents, including major markets like the US and EU, with recent approvals in Pakistan and Canada [3] - The company has established a global commercialization network covering over 80 countries through partnerships with various pharmaceutical companies [3] R&D Pipeline and Future Prospects - Junshi Bioscience has developed over 50 drug candidates, with a focus on accelerating R&D in innovative pipelines, including next-generation therapies [3][4] - The company is preparing to submit a marketing application for its anti-IL-17A monoclonal antibody, JS005, which has shown positive results in a Phase III study for psoriasis [4] - A new equity incentive plan was introduced, indicating the company's confidence in achieving revenue targets of at least 2.4 billion yuan in 2025 [4]

Group 1 - Company Jiukang Bio reported Q3 performance, with revenue of approximately 1.012 billion yuan for the first three quarters of 2025, a year-on-year decrease of 18.24% [1] - The net profit attributable to shareholders was about 272 million yuan, down 27.03% year-on-year [1] - Basic earnings per share were 0.46 yuan, reflecting a decrease of 26.98% compared to the previous year [1] Group 2 - As of the report, Jiukang Bio's market capitalization stands at 8 billion yuan [2]

Summary of Arcutis Biotherapeutics Q3 2025 Earnings Call Company Overview - **Company**: Arcutis Biotherapeutics (NasdaqGS:ARQT) - **Date of Call**: October 28, 2025 - **Key Products**: ZORYVE (Cream and Foam) Industry Context - **Focus**: Dermatology, specifically treatments for immune-mediated dermatological diseases - **Market Dynamics**: Shift away from topical corticosteroids towards innovative non-steroidal treatments Key Financial Highlights - **Net Product Revenues**: $99.2 million in Q3 2025, a 122% increase from Q3 2024 and a 22% increase from Q2 2025 [8][12] - **Prescription Growth**: Total prescriptions for ZORYVE increased by 13% compared to Q2 2025 and by 92% compared to Q3 2024 [9] - **Net Income**: $7.4 million in Q3 2025, compared to a net loss of $41.5 million in Q3 2024 [13] - **Cash and Marketable Securities**: $191 million as of September 30, 2025 [15] Product Performance - **ZORYVE**: A topical agent for chronic inflammatory skin diseases, showing strong adoption among patients and clinicians [5] - **ZORYVE Foam 0.3%**: Launched in June 2025, contributed significantly to revenue growth with over 25% increase in product revenue from the previous quarter [10] - **Pipeline Development**: Introduction of ARQ-234, a novel biologic targeting atopic dermatitis [5][19] Strategic Growth Initiatives - **Core Business Expansion**: Focus on establishing ZORYVE as a foundational therapy for various dermatological conditions [18] - **Lifecycle Management**: Exploring new indications for ZORYVE based on clinician feedback and case reports [19] - **Pipeline Building**: Advancing innovative medicines and sourcing external innovations [20] Market Opportunity - **Addressable Market**: Approximately 30 million patients in the U.S. with plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, with 19 million currently receiving topical treatments [26] - **Market Share Goals**: Targeting to capture 15% to 20% of topical steroid prescriptions [26] Treatment Landscape Shift - **Corticosteroid Concerns**: Growing recognition of the adverse effects associated with long-term corticosteroid use, leading to a demand for safer alternatives [31][36] - **Professional Societies' Stance**: Recent statements from dermatology societies advocating for reduced reliance on topical corticosteroids [35][36] Clinical Insights - **Adverse Effects of Corticosteroids**: Local and systemic effects, including skin barrier damage and increased risk of diabetes and osteoporosis [32][33] - **Patient Awareness**: Increasing patient inquiries about non-steroidal options, reflecting a shift in treatment preferences [60] Conclusion - **Future Outlook**: Anticipation of achieving cash flow breakeven in Q4 2025, driven by ZORYVE's growth and strategic investments [15][16] - **Commitment to Innovation**: Arcutis aims to address unmet needs in dermatology through innovative treatments and a robust pipeline [5][19]

Core Viewpoint - ST Unimed (未名医药) reported a significant decline in profitability despite a revenue increase in Q3 2025, primarily due to the suspension of its core subsidiary, Tianjin Unimed, affecting its operations and stock status [1][3]. Financial Performance - In Q3 2025, ST Unimed achieved a revenue of 141 million yuan, marking a 35.94% year-on-year increase, but the cumulative revenue for the first three quarters fell by 32.62% to 212 million yuan [2][3]. - The net profit attributable to shareholders for the first three quarters was a loss of 68.81 million yuan, a drastic decline of 570.46% compared to a profit of 14.63 million yuan in the same period last year [2][3]. - The basic and diluted earnings per share were both -0.1043 yuan, reflecting a year-on-year decrease of 569.82% [2]. Operational Challenges - The operational difficulties stem from the suspension of Tianjin Unimed's production and sales since April 2025 due to regulatory compliance issues, which has severely impacted the company's revenue [3][5]. - Tianjin Unimed accounted for 60.09% of the company's total revenue in 2024, highlighting its critical role in ST Unimed's financial health [3]. Strategic Actions - ST Unimed has resolved historical equity issues with its wholly-owned subsidiary, Xiamen Unimed, by regaining 34% of its shares from Hangzhou Qiangxin Biotechnology Co., Ltd. through a settlement agreement [4]. - The company is actively seeking new growth opportunities, including a 45 million yuan investment in Sichuan Gukang Pharmaceutical Co., Ltd., acquiring a 51% stake and providing financial support of up to 55 million yuan [5].