| 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 - InnoCare Pharma achieved total revenue of RMB 381.26 million in Q1 2025, representing a year-on-year increase of 129.92%[10] - The sales revenue of the core product, Orelabrutinib (宜诺凯®), reached RMB 311.67 million, a year-on-year growth of 89.22%[11] - The net profit attributable to shareholders was RMB 17.97 million, a significant turnaround from a net loss of RMB 142.40 million in the previous year[10] - The company's operating revenue increased significantly by 129.92%, primarily due to the continuous increase in sales volume of Acalabrutinib and revenue recognition from the upfront payment related to the licensing agreement with Prolium[16] - The net profit attributable to shareholders of the listed company showed a significant increase, driven by the substantial rise in operating revenue[16] - Net profit for Q1 2025 was ¥14,475,474.83, compared to a net loss of ¥145,660,375.68 in Q1 2024, indicating a turnaround in profitability[29] Profitability and Margins - The gross profit margin for Q1 2025 was 90.5%, up from 85.4% in the same period last year, an increase of 5.1 percentage points[10] - The net profit excluding non-recurring gains and losses also increased, reflecting the same underlying factors as the net profit[16] - The weighted average return on equity was 0.27%, recovering from a negative 2.01% in the same period last year[10] Research and Development - Research and development expenses totaled RMB 207.60 million, accounting for 54.45% of total revenue, a decrease of 52.73 percentage points compared to the previous year[10] - Research and development expenses as a percentage of operating revenue decreased by 52.73 percentage points, indicating a more efficient allocation of resources in relation to revenue growth[16] - Research and development expenses for Q1 2025 amounted to ¥207,599,189.43, an increase from ¥177,728,720.87 in Q1 2024, representing a 17% rise[28] Cash Flow and Financial Position - Cash and cash equivalents as of March 31, 2025, amounted to approximately RMB 7.78 billion, providing a solid financial foundation for ongoing project development[11] - The company reported a net cash flow from operating activities of RMB 56.52 million, compared to a negative cash flow of RMB 84.04 million in the same period last year[10] - The net cash flow from operating activities saw a significant increase compared to the same period last year, primarily due to higher cash receipts from sales[16][17] - Cash inflows from operating activities amounting to RMB 447,604,700.75, a 55.2% increase compared to RMB 288,822,501.34 in Q1 2024[30] - The net cash flow from operating activities for Q1 2025 was RMB 56,524,292.65, recovering from a net outflow of RMB -84,043,543.78 in Q1 2024[30] Shareholder Information - As of the end of the reporting period, the total number of issued shares was 1,762,567,202, with 84.89% listed in Hong Kong and 15.11% on the Shanghai Stock Exchange[18] - The top ten shareholders held a significant portion of the shares, with HKSCC NOMINEES LIMITED holding approximately 48.57%[21] - The company has a diverse shareholder base, with various foreign and domestic institutional investors among the top shareholders[22] Assets and Liabilities - Total assets as of the end of Q1 2025 were RMB 9.41 billion, a slight increase of 0.07% from the end of the previous year[10] - Total liabilities decreased to ¥2,647,510,518.87 from ¥2,661,558,105.85, showing a reduction of approximately 0.5%[26] - The total equity attributable to shareholders increased to ¥6,748,973,642.92 from ¥6,725,301,365.03, indicating a growth of approximately 0.4%[26] Market Developments - Orelabrutinib received approval for a new indication for first-line treatment of chronic lymphocytic leukemia (CLL) in April 2025, expanding its market potential[11]

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]

Core Insights - The company reported a total revenue of 381 million yuan in Q1 2025, representing a year-on-year increase of 129.92% [1] - Pharmaceutical sales revenue reached approximately 311.67 million yuan, showing a growth of 89.11% compared to the previous year [1] - The net profit for Q1 2025 was 17.97 million yuan, a significant turnaround from a net loss of 142 million yuan in the same period last year [1] - As of March 31, 2025, the company held cash and cash equivalents of about 7.78 billion yuan [1]

简历显示：赵伟先生:中国,硕士研究生。历任葛兰素史克(上海)医药研发有限公司药物化学部助理研究 员、广发证券股份有限公司投资自营部医药研究员、招商基金管理有限公司研究部医药组组长及招商基 金管理有限公司国际业务部基金经理助理。现任农银汇理基金管理有限公司基金经理。2019年11月8日 至2021年3月5日担任农银汇理中小盘混合型证券投资基金基金经理。2020年1月13日至2021年3月5日担 任农银汇理行业成长混合型证券投资基金基金经理。2020年1月21日至2021年3月5日任职农银汇理创新 医疗混合型证券投资基金基金经理。2017年6月20日至2021年3月5日担任农银汇理医疗保健主题股票型 证券投资基金基金经理。曾任农银汇理中国优势灵活配置混合型证券投资基金基金经理。2021年03月加 入富国基金管理有限公司,2021年7月6日起担任富国精准医疗灵活配置混合型证券投资基金基金经理。 2024年04月23日起担任富国科创板两年定期开放混合型证券投资基金基金经理。 金融界2025年5月12日消息，富国精准医疗混合A(005176) 最新净值2.6542元，下跌3.50%。该基金近1个 月收益率-2.01%， ...

Core Viewpoint - The biopharmaceutical company, Innovent Biologics, announced that its BCL2 inhibitor, mesutoclax (ICP-248), has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL) patients who are resistant to BTK inhibitors, marking it as the first BCL2 inhibitor in China to receive this designation [1][2]. Group 1: Product and Clinical Development - Mesutoclax is a novel oral, highly selective BCL2 inhibitor designed for monotherapy or in combination with other drugs like BTK inhibitors to treat chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL), other non-Hodgkin lymphomas (NHL), and acute myeloid leukemia (AML) [1]. - The mechanism of action of mesutoclax involves selective inhibition of the BCL2 protein, which is crucial in regulating apoptosis, thereby restoring tumor cell apoptosis and inhibiting tumor growth and spread [1]. - Currently, mesutoclax is undergoing a series of clinical trials in China and globally, including a pivotal Phase III trial for the first-line treatment of CLL/SLL in combination with obinutuzumab, as well as trials for AML [2]. Group 2: Company Overview - Innovent Biologics is a commercial-stage biopharmaceutical company focused on the development of innovative drugs for malignant tumors and autoimmune diseases, with multiple products in commercialization, clinical, and preclinical stages [3]. - The company has established branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3].

A股创新药概念集体回调，迈威生物跌超10%，百济神州、信立泰双双跌超8%，益方生物、舒泰神、热 景生物、百利天恒、诺诚健华等跌幅靠前。 ...

早盘 创新药概念集体回调， 迈威生物跌超10%， 百济神州、 信立泰双双跌超8%， 益方生物、 舒泰 神、 热景生物、 百利天恒、 诺诚健华等跌幅靠前。 ...

Group 1 - The core viewpoint of the news is the performance and holdings of the Industrial and Commercial Bank of China Medical Healthcare Stock Fund, which has shown positive returns in recent months and has a diversified portfolio in the healthcare sector [1][3] - As of May 9, 2025, the latest net value of the fund is 2.5040 yuan, with a growth of 0.72%. The fund's return over the past month is 5.17%, ranking 504 out of 783 in its category; over the past three months, the return is 9.06%, ranking 88 out of 778; and year-to-date, the return is 9.87%, ranking 103 out of 773 [1] - The top ten holdings of the fund account for a total of 39.79%, with significant investments in companies such as Heng Rui Pharmaceutical (8.90%), WuXi AppTec (5.12%), and Mindray Medical (2.80%) [1] Group 2 - The fund was established on November 18, 2014, and as of March 31, 2025, it has a total scale of 2.724 billion yuan. The fund managers are Zhao Bei and Ding Yang [1] - Zhao Bei has extensive experience in the healthcare sector, having served as the fund manager for various healthcare-related funds since 2014, while Ding Yang joined the company in 2017 and currently serves as a fund manager [2]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年4月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 諾誠健華醫藥有限公司（於開曼群島註冊成立的有限公司） 呈交日期: 2025年5月7日 I. 法定/註冊股本變動 FF301 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 ...