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].

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 ...

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]

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。 ...