与此同时，诺诚健华持续提高毛利水平，2025年第一季度毛利率比上年同期提高5.1个百分点，达到 90.5%。公司2025年第一季度净利润达到0.14亿元，当季度实现盈利。 截至2025年3月31日，诺诚健华持有现金及相关账户结余约77.8亿元。强劲的现金流将有助于公司加速 推进多项Ⅲ期注册临床试验开发和投资于差异化的ADC及其他管线，致力于为全球患者提供更多更好 的治疗选择。 诺诚健华联合创始人、董事长兼首席执行官崔霁松博士说："2025年将迎来公司发展进程的10周年。很 高兴我们在第一季度业绩取得开门红，国际化取得突破，商业化增长持续，多项管线获得重大进展，更 加丰富的商业化产品将为公司长期可持续增长奠定坚实的基础。我们将继续秉持'科学驱动创新患者所 需为本'的发展理念，持续提升创新、商业化和国际化水平，在中国及全球加速推进多个Ⅲ期注册临床 研究，造福更多全球患者。" 5月14日，诺诚健华医药有限公司(以下简称"诺诚健华")发布了截至2025年3月31日的2025年第一季度业 绩报告和近期公司进展。 诺诚健华2025年第一季度总收入同比增长129.9%，达到3.8亿元，主要归功于核心产品奥布替尼(商品 名： ...

Core Viewpoint - The innovative drug companies have turned losses into profits in the first quarter of 2025, driven by supportive policies, accelerated international expansion, and business development (BD) licensing agreements [1][2]. Financial Performance - In Q1 2025, Innovent Biologics reported a total revenue of 380 million yuan, a year-on-year increase of 129.9%, primarily due to the strong sales of its core product, Orelabrutinib, which grew by 89.2% to 310 million yuan [1][2]. - The gross profit margin for Q1 2025 increased by 5.1 percentage points year-on-year to 90.5%, with a net profit of 14 million yuan, marking the company's first profitable quarter [1][2]. Product Development and Market Strategy - Orelabrutinib, a selective BTK inhibitor, has been pivotal for the company's financial success, with its inclusion in the national medical insurance contributing to its sales growth [4]. - The company has entered into a licensing agreement with Prolium Bioscience, which could yield up to $520 million in total payments, enhancing its revenue stream [3]. Market Trends and Challenges - The BTK inhibitor market is projected to grow significantly, with estimates suggesting it will reach $20 billion by 2025 and $26 billion in China, driven by increasing patient numbers and new indications [6][7]. - Despite the promising market outlook, the industry faces challenges such as intense competition and the need for sustainable business models, particularly regarding the "selling seedlings" strategy for profitability [8][9]. Industry Outlook - The biopharmaceutical industry in China is experiencing robust growth, with a market size of 1.87 trillion yuan and new product sales increasing by over 250% [10]. - Long-term success will depend on balancing R&D investments with commercialization efficiency, as companies navigate clinical failures, policy fluctuations, and international competition [10].

Group 1: 华峰化学 - Company decided to terminate the acquisition of 100% equity in Zhejiang Huafeng Synthetic Resin Co., Ltd. and Zhejiang Huafeng Thermoplastic Polyurethane Co., Ltd. due to insufficient shareholder approval [1] - The decision was made based on prudence, as the proposal did not receive more than two-thirds of the valid voting rights at the shareholders' meeting [1] - Company will continue to promote related equity injection work and strictly fulfill asset injection commitments [1] Group 2: 中荣股份 - Actual controller and chairman Huang Huanran has been placed under residential surveillance by the police [2] - Other board members and senior management are performing their duties normally, and the board of directors is operating as usual [2] - Company specializes in the research, design, production, and sales of paper printing and packaging products [2] Group 3: 密尔克卫 - Three shareholders plan to reduce their holdings by a total of up to 2% of the company's shares through block trading [3] - The reduction includes 143.63 million shares, 97.65 million shares, and 75.03 million shares, representing 0.91%, 0.62%, and 0.47% of the total share capital respectively [3] - The reduction period is from June 6, 2025, to September 5, 2025, due to personal funding needs [3] Group 4: 舒泰神 - Subsidiary Jiangsu Beijietai Biotechnology Co., Ltd. has obtained a drug production license from the Jiangsu Provincial Drug Administration [4] - The license allows for the production of therapeutic biological products, specifically for registered declaration use [4] - The license is valid until May 7, 2030, and is not expected to have a significant impact on the company's current performance [4] Group 5: 捷顺科技 - Company won the bid for the "Chongqing Beautiful Sunshine Home and other public rental housing supporting parking space operation project" [5] - The project includes four public rental housing supporting parking lots with a total of 13,335 parking spaces [5] - The minimum guaranteed revenue for the project is quoted at 40.43 million yuan per year, with a total contract amount expected to exceed 100 million yuan [5] Group 6: 综艺股份 - Company signed an investment cooperation intention agreement to acquire control of Jiangsu Jilai Microelectronics Co., Ltd. through cash capital increase or share transfer [6] - Jilai Micro primarily engages in the research, production, and sales of power semiconductor chips and devices [6] - The transaction is expected to constitute a major asset restructuring [6] Group 7: 东山精密 - Subsidiary DSBJ PTE. LTD. plans to acquire 100% equity of French GMD Group for approximately 100 million euros (about 814 million yuan) [7] - The acquisition aims to advance the company's globalization strategy and enhance its market share in the automotive parts sector [7] - The company specializes in the research, production, and sales of electronic circuit products and precision components [7] Group 8: 诺诚健华 - Company reported a net profit of 17.97 million yuan for the first quarter of 2025, a significant turnaround from a loss of 142 million yuan in the same period last year [8] - The first quarter revenue reached 381 million yuan, representing a year-on-year growth of 129.92% [8] - The company focuses on the research, production, and commercialization of innovative drugs [8] Group 9: 凯美特气 - Shareholders plan to reduce their holdings by up to 3% of the company's shares through centralized bidding and/or block trading [9] - The total number of shares to be reduced is 20.86 million [9] - The reduction is due to personal funding needs [9] Group 10: 海创药业 - Controlling shareholder plans to reduce holdings by up to 2% of the company's shares through centralized bidding and block trading [10] - The total number of shares to be reduced is 1.98 million [10] - The reduction is due to personal funding needs [10] Group 11: 高争民爆 - Controlling shareholder plans to reduce holdings by up to 3% of the company's shares through centralized bidding and block trading [11] - The total number of shares to be reduced is 828,000 [11] - The reduction is due to the company's funding needs [11] Group 12: 金埔园林 - Two shareholders plan to reduce their holdings by a total of up to 1.91% of the company's shares [12] - The reductions include 183.93 million shares and 167.73 million shares [12] - The reasons for the reductions are asset optimization and personal funding needs [12] Group 13: 掌趣科技 - The largest shareholder plans to reduce holdings by up to 1% of the company's shares through centralized bidding or block trading [13] - The total number of shares to be reduced is 27.2 million [13] - The reduction is due to personal funding needs [13] Group 14: 美凯龙 - Company announced that its director and general manager has been placed under investigation and detention by the local supervisory committee [14] - Other board members and senior management are performing their duties normally, and daily operations are unaffected [14] - The company specializes in managing and operating self-operated and franchised shopping malls [14] Group 15: 新强联 - Major shareholder plans to reduce holdings by up to 1.89% of the company's shares through centralized bidding and block trading [15] - The total number of shares to be reduced is 717,490 [15] - The reduction is due to operational needs [15] Group 16: 日月明 - Shareholder plans to reduce holdings by up to 1% of the company's shares through centralized bidding [16] - The total number of shares to be reduced is 80,000 [16] - The reduction is due to personal funding needs [16] Group 17: 同有科技 - Major shareholder and vice president plan to reduce their holdings by up to 1.53% of the company's shares [17] - The total number of shares to be reduced is 730,850 [17] - The reduction is due to personal funding needs [17] Group 18: 爱尔眼科 - Subsidiary successfully acquired 60% equity and specific debt of Shenzhen Guangsheng Digital Technology Co., Ltd. for 650 million yuan [18] - The transaction constitutes a related party transaction [18] - The acquired asset will serve as long-term medical premises for the subsidiary [18]

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：688428 证券简称：诺诚健华 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、准确性和完整性依法承担法律责任。 重要内容提示 管理层业绩评述 诺诚健华医药有限公司（以下简称"诺诚健华"或"公司"）管理层评论说："公司是一家以卓越的自主研 发能力为核心驱动力的高科技创新生物医药企业，拥有全面的研发、生产和商业化能力，专注于肿瘤和 自身免疫性疾病等存在巨大未满足临床需求的领域，在全球市场内开发具有突破性潜力的同类首创或同 类最佳药物。 2025年1-3月公司实现总营业收入3.81亿元，比上年同期增长129.92%，毛利率为90.5%,比上年同期的 85.4%提高了5.1个百分点。营业收入与毛利率的高速增长主要为核心产品奥布替尼（宜诺凯?）销售收 入持续增长以及公司与Prolium Bioscience Inc.（以下简称"Prolium"）达成授权许可的首付款所致。公司 2025年1-3月的净利润为0.14亿元，与上年同期相比实现盈利。 2025年1-3月公司核心产品奥布替尼（宜诺凯?）销售收入持 ...

Core Insights - Nuo Cheng Jian Hua achieved profitability for the first time since its establishment, reporting a net profit of 0.18 billion yuan in Q1, with total revenue reaching 3.81 billion yuan, a year-on-year increase of 129.92% [1] - The growth in revenue is primarily attributed to the strong sales performance of its core product, Oubutini (brand name: Yinuokai), which saw a sales revenue increase of 89.2% to 3.1 billion yuan, driven by its inclusion in medical insurance and enhanced commercialization efforts [1] Financial Performance - In Q1, Nuo Cheng Jian Hua's total revenue was 3.81 billion yuan, marking a 129.92% increase year-on-year [1] - The company reported a net profit of 0.18 billion yuan, indicating its first profitable quarter since inception [1] Product Development and Market Strategy - Oubutini is positioned as a BTK inhibitor, with plans to expand its application from hematological malignancies to autoimmune diseases, which represent the second-largest pharmaceutical market globally [4] - The company is initiating global Phase III clinical trials for Oubutini in treating primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), with an NDA submission expected in mid-2026 for immune thrombocytopenic purpura (ITP) [4] Strategic Partnerships - In January, Nuo Cheng Jian Hua entered a licensing agreement with Prolium Bioscience for the development and commercialization of the CD20×CD3 bispecific antibody ICP-B02, with potential total payments of up to 520 million USD [2] - The agreement allows Prolium to develop and commercialize ICP-B02 in non-oncological fields globally and in oncology outside Asia, while Nuo Cheng Jian Hua will receive tiered royalties on future product sales [2] Cash Position - As of March 31, 2025, Nuo Cheng Jian Hua held approximately 77.8 billion yuan in cash and cash equivalents, providing a strong financial foundation for ongoing and future projects [4] Future Outlook - The company plans to strengthen its global R&D pipeline and actively explore international collaborations and licensing opportunities to expand its business beyond the Chinese market [5]

中国国际金融股份有限公司 关于诺诚健华医药有限公司 与西湖大学签订战略合作框架协议 二、关联人基本情况 1 （一）关联关系说明 公司非执行董事施一公博士为西湖大学校长，根据《上海证券交易所科创板 股票上市规则》的规定，认定西湖大学为公司关联人。 与科研合作协议暨关联交易的核查意见 中国国际金融股份有限公司作为诺诚健华医药有限公司（以下简称"诺诚健 华"或"公司"）首次公开发行人民币普通股（A 股）股票并在科创板上市的保 荐机构，根据《证券发行上市保荐业务管理办法》《上海证券交易所科创板股票 上市规则》和《上海证券交易所上市公司自律监管指引第 11 号——持续督导》 等法律、行政法规、部门规章及业务规则，对诺诚健华医药有限公司与西湖大学 签订战略合作框架协议与科研合作协议暨关联交易的事项进行了认真、审慎核查， 具体情况如下： 一、关联交易概述 2025 年 5 月 13 日，诺诚健华的全资子公司北京诺诚健华医药科技有限公司 （以下简称"北京诺诚健华"）与西湖大学签订《战略合作框架协议》与《科研 合作协议》，双方将就创新药物研发、平台共建、人才培养及成果转化等方面建 立合作。 公司非执行董事施一公博士为西湖大学校 ...

| A | 股代码：688428 | 股简称：诺诚健华 A | 公告编号：2025-016 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于与西湖大学签订战略合作框架协议 与科研合作协议暨关联交易的公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 诺诚健华医药有限公司（以下简称"公司"或"诺诚健华"）的全资子 公司北京诺诚健华医药科技有限公司（以下简称"北京诺诚健华"）与西湖大学 于 2025 年 5 月 13 日签订《战略合作框架协议》与《科研合作协议》，双方将就 创新药物研发、平台共建、人才培养及成果转化等方面建立合作（以下简称"本 事项"或"本次关联交易"）。 本事项构成关联交易，根据协议，北京诺诚健华对共同开展的创新药物 研发项目提供前期资金支持，并基于项目进展支付里程碑付款，合计不超过 5,400 万元人民币，未构成《上市公司重大资产重组管理办法》中规定的重大资产重组， 交易实施不存在重大法律障碍。 ...

Financial Performance - In Q1 2025, the company achieved total revenue of CNY 381.26 million, a year-on-year increase of 129.92%, with a gross margin of 90.5%, up from 85.4% in the same period last year[4] - Sales revenue from the core product, Acalabrutinib (Ibrutinib®), reached CNY 311.67 million, representing a year-on-year growth of 89.22%[5] - The company reported a net profit of CNY 14 million in Q1 2025, compared to a net loss of CNY 142.40 million in the same period last year[7] - Total revenue for Q1 2025 reached RMB 381.26 million, a significant increase of 130.0% compared to RMB 165.82 million in Q1 2024[20] - Net profit for Q1 2025 was RMB 14.48 million, compared to a net loss of RMB 145.66 million in Q1 2024, marking a turnaround in profitability[21] - The company reported a basic earnings per share of RMB 0.01 for Q1 2025, recovering from a loss of RMB -0.08 per share in Q1 2024[21] Cash and Assets - Cash and cash equivalents, including financial assets, totaled approximately CNY 7.78 billion as of March 31, 2025, enabling the company to accelerate the development of its pipeline projects[6] - Total current assets as of March 31, 2025, amount to ¥7,897,451,169.58, an increase from ¥7,820,188,584.21 as of December 31, 2024[17] - Cash and cash equivalents are reported at ¥6,326,896,740.80, up from ¥6,240,825,867.22[17] - Total assets as of the end of the reporting period were CNY 9.41 billion, a slight increase of 0.07% from the previous year[7] - Total assets amount to ¥9,413,626,277.76, compared to ¥9,407,493,740.91 at the end of 2024[18] - The company has a total equity of ¥6,766,115,758.89 as of March 31, 2025[18] Research and Development - Research and development expenses amounted to CNY 207.60 million, accounting for 54.45% of total revenue, a decrease of 52.73 percentage points compared to the previous year[7] - Research and development expenses increased to RMB 207.60 million in Q1 2025, up from RMB 177.73 million in Q1 2024, reflecting the company's commitment to innovation[20] Shareholder Information - Total number of common shareholders at the end of the reporting period is 13,343[14] - HKSCC NOMINEES LIMITED holds 48.57% of shares, totaling 856,006,175 shares[14] - The company has not reported any significant changes in shareholder relationships or actions during the reporting period[16] Operational Metrics - Operating cash flow for Q1 2025 was RMB 56.52 million, a recovery from a negative cash flow of RMB -84.04 million in Q1 2024[24] - Total operating costs for Q1 2025 were RMB 383.94 million, up from RMB 303.02 million in Q1 2024, indicating increased operational expenses[20] - Investment activities generated a net cash inflow of RMB 78.22 million in Q1 2025, compared to RMB 502.67 million in Q1 2024[24] - The company received RMB 1.40 billion in cash from investment recoveries in Q1 2025, compared to RMB 1.02 billion in Q1 2024[24] Strategic Developments - Acalabrutinib received approval for a new indication for first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in April 2025[5] - The company entered into a licensing agreement with Prolium Bioscience Inc., contributing to the increase in revenue from licensing fees[4] - The company plans to continue expanding its market presence and investing in new technologies to drive future growth[26]

诺诚健华公告，2025年第一季度实现总营业收入3.81亿元，同比增长129.92%；其中药品销售收入 311,666,494.52元，同比增长89.11%。第一季度净利润为1796.76万元，上年同期为-1.42亿元，实现扭亏 为盈。截至2025年3月31日，公司持有现金及相关账户结余约77.78亿元。 ...

Mesutoclax是一款新型口服高选择性BCL2抑制剂，旨在单药或与BTK抑制剂等其他药物联合治疗慢性 淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)、套细胞淋巴瘤(MCL)和其他非霍奇金淋巴瘤(NHL)、以 及急性髓系白血病(AML)。BCL2是细胞凋亡通路的重要调控蛋白，其表达异常与多种恶性血液肿瘤的 发生发展相关。Mesutoclax通过选择性抑制BCL2蛋白，恢复肿瘤细胞凋亡，从而抑制肿瘤生长和扩 散。 诺诚健华联合创始人、董事长兼CEO崔霁松博士说："很高兴mesutoclax被授予突破性疗法认定，这将有 助于我们全速推进mesutoclax在中国和全球多中心、多适应症的临床试验，以早日造福患者。" 目前，mesutoclax正在中国和全球开展一系列临床试验，包括联合奥布替尼一线治疗CLL/SLL的注册性 III期临床试验，以及治疗AML的临床试验等。 CDE的突破性疗法认定(BTD)旨在加快具有显著临床优势的新药临床开发。纳入突破性疗法认定的新药 往往针对严重危及生命或者严重影响生存质量的疾病，且在临床试验中显示效果或安全性具有明显优 势。 关于诺诚健华 诺诚健华(上交所代码：688428； ...