Core Insights - Nuo Cheng Jian Hua reported a significant revenue growth of 129.9% year-on-year for Q1 2025, reaching 380 million yuan, driven by the strong performance of its core product, Oubutini, and a licensing agreement with Prolium [1] - The revenue from Oubutini increased by 89.2% year-on-year to 310 million yuan, primarily due to the inclusion of three major indications in medical insurance and enhanced execution by the commercialization team [1] - The gross profit margin improved by 5.1 percentage points year-on-year to 90.5%, with a net profit of 14 million yuan for Q1 2025, marking a profitable quarter [1] - As of March 31, 2025, the company held approximately 7.78 billion yuan in cash and cash equivalents, which will support the acceleration of multiple Phase III clinical trials and investments in differentiated ADCs and other pipelines [1] Company Developments - The CEO, Dr. Cui Jisong, highlighted that 2025 marks the 10th anniversary of the company's development, celebrating a strong start in Q1 with breakthroughs in internationalization and sustained commercialization growth [2] - The company aims to enhance its innovation, commercialization, and internationalization efforts, accelerating multiple Phase III clinical studies in China and globally to benefit more patients [2]

Core Viewpoint - The company, Nuo Cheng Jian Hua, reported significant growth in Q1 2025, with a revenue increase of 129.92% year-on-year, driven primarily by the sales of its core product, Acalabrutinib (brand name: Ibrutinib) [1][4][5]. Financial Performance - Q1 2025 revenue reached 381 million yuan, up from 165.82 million yuan in the same period last year, marking a 129.92% increase [3]. - The net profit attributable to shareholders was 17.97 million yuan, a turnaround from a loss of 142.4 million yuan in the previous year [3]. - Gross margin improved to 90.5%, an increase of 5.1 percentage points year-on-year [1][3]. Product Performance - Acalabrutinib sales reached 311.67 million yuan in Q1 2025, reflecting a year-on-year growth of 89.22% [5]. - The product has received approval for its first-line treatment indication for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in adults, expected to enter medical insurance this year, which is anticipated to be a new growth driver for the company [4][6][7]. Research and Development - The company invested approximately 207.6 million yuan in R&D, which accounted for 54.45% of its revenue, a decrease of 52.73 percentage points compared to the previous year [3]. - Nuo Cheng Jian Hua aims to develop five to six innovative drugs over the next three to five years, with ongoing clinical trials for various indications [8][9]. Strategic Partnerships - The company signed a strategic cooperation framework agreement with Westlake University to enhance drug development and talent cultivation, with funding support not exceeding 54 million yuan [9]. - Nuo Cheng Jian Hua is actively exploring international collaborations and licensing agreements to expand its business beyond the Chinese market [9]. Financial Position - As of March 31, 2025, the company had cash and cash equivalents totaling approximately 4.84 billion yuan, with total liquid assets around 7.78 billion yuan [10].

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]

Core Viewpoint - The company, Nuo Cheng Jian Hua, reported significant growth in revenue and profit for the first quarter of 2025, driven by the sales of its core product, Abrucept, and a licensing agreement with Prolium Bioscience Inc [3][4]. Financial Performance - For Q1 2025, the company achieved total revenue of 381 million RMB, 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 [3]. - The net profit for Q1 2025 was 14 million RMB, marking a return to profitability compared to the same period last year [3]. Product Sales - Sales revenue from Abrucept reached 311 million RMB in Q1 2025, representing a year-on-year growth of 89.22% [4]. - In April 2025, Abrucept received approval for a new indication for first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in adult patients [4]. Strategic Partnerships - On May 13, 2025, the company's subsidiary signed a strategic cooperation framework agreement with West Lake University to collaborate on innovative drug research and development, platform construction, talent cultivation, and achievement transformation [11][13]. - The total funding support for the collaborative projects is capped at 54 million RMB, which will be paid based on project milestones [11][17]. Shareholder Information - As of March 31, 2025, the company had approximately 7.778 billion RMB in cash and cash equivalents, indicating a strong liquidity position to support ongoing project development [5]. - The total number of shares issued by the company is 1,762,567,202, with 84.89% listed in Hong Kong and 15.11% on the Shanghai Stock Exchange [6]. Governance and Compliance - The board of directors confirmed that the quarterly report is accurate and complete, with no false statements or significant omissions [2][10]. - The strategic cooperation agreement with West Lake University was approved by the board and does not require shareholder meeting approval, as it falls within the board's decision-making authority [12][22].

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]

Core Viewpoint - 诺诚健华 reported a strong performance in Q1 2025, driven by significant growth in its core product, 奥布替尼, and strategic partnerships, indicating a robust trajectory for future growth [2][3]. Financial Performance - Total revenue for Q1 2025 increased by 129.9% year-on-year, reaching 380 million yuan, primarily due to 奥布替尼's sales and a licensing agreement with Prolium [2]. - 奥布替尼 sales grew by 89.2% year-on-year, amounting to 310 million yuan, supported by its inclusion in insurance coverage for three major indications [2]. - Gross margin improved by 5.1 percentage points year-on-year to 90.5%, with net profit for the quarter at 14 million yuan [2]. Product Development and Pipeline Progress - 奥布替尼 received approval for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China, enhancing its market position [3]. - 明诺凯's application for innovative treatment has been accepted for priority review in mainland China, with approvals in Hong Kong, Macau, and Taiwan [3]. - The new generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review status, with its NDA accepted in China [4]. - BCL2 inhibitor mesutoclax (ICP-248) has been approved for a Phase II trial in China, with ongoing patient enrollment for a Phase III trial [4]. Clinical Trials and Market Expansion - 奥布替尼 is entering Phase III trials for multiple sclerosis and immune thrombocytopenic purpura (ITP), with NDA submission expected in mid-2026 [6]. - The company is advancing two TYK2 inhibitors, soficitinib (ICP-332) and ICP-488, into clinical trials for atopic dermatitis and psoriasis, respectively [7]. - The global market for autoimmune diseases is projected to reach $185 billion by 2029, indicating significant growth potential for the company's products [6]. International Collaboration and Strategy - 诺诚健华 has entered a licensing agreement with Prolium for the development and commercialization of CD20×CD3 bispecific antibody ICP-B02, with potential payments totaling up to $520 million [8]. - The company is actively exploring international collaborations and licensing opportunities to expand its business beyond the Chinese market [8].

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 - 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]