Core Insights - The article highlights the profitability achievements of Beijing-based innovative pharmaceutical companies, particularly Baijiahong and Nocare, marking a significant milestone in their development journey [1][2]. Group 1: Company Performance - Baijiahong reported a net profit of 450 million yuan in the first half of the year, achieving profitability for the first time [1][3]. - Nocare achieved a net profit of 18 million yuan in the first quarter, marking its first quarterly profit, with a significant reduction in net loss to 36 million yuan in the first half of the year [4]. Group 2: Product Sales and Market Expansion - Baijiahong's innovative drug, Zebutinib, generated global sales of 12.527 billion yuan in the first half, a year-on-year increase of 56.2%, with notable growth in the U.S. (51.7%) and Europe (81.4%) [3]. - The sales of another cancer drug, Trelatuzumab, reached 2.643 billion yuan, reflecting a 20.6% increase, driven by new indications approved in China [3][4]. Group 3: R&D and Future Prospects - Baijiahong has established a new R&D center in Changping, covering over 47,000 square meters and equipped with advanced laboratories, supporting the development of over 40 products in clinical and commercialization stages [2][3]. - Nocare is expanding its pipeline with its core product, Obutinib, which is also being tested for autoimmune diseases, potentially unlocking new market opportunities [4].

Core Insights - Nocera Healthcare reported a 74.3% year-on-year revenue growth in the first half of 2025, reaching 730 million yuan, driven by the strong performance of its core product, Oubatinib (brand name: Yinuokai®), and an upfront payment from a licensing agreement with Prolium [2][3] - The company's drug revenue increased by 53.5% year-on-year to 640 million yuan, primarily due to Oubatinib's inclusion in the national medical insurance, which has expanded its patient base, particularly in the marginal zone lymphoma indication [2] - Nocera's losses decreased by 86.7% year-on-year to 36 million yuan, attributed to increased operating income and improved cost efficiency [2] Financial Performance - Research and development expenses rose by 6.9% year-on-year to 450 million yuan, mainly for building a differentiated R&D platform and advancing more Phase III clinical projects [2] - As of June 30, 2025, the company held approximately 7.68 billion yuan in cash and cash equivalents, which will support the acceleration of multiple Phase III registration clinical trials and investments in differentiated ADC and other pipelines [2] Strategic Developments - 2025 marks the 10th anniversary of the company, which is entering a new phase of rapid development [3] - Significant progress has been made in advancing the product pipeline, achieving multiple key milestones that lay a solid foundation for long-term growth [3] - The company has formed strategic partnerships to expand its global footprint, including a licensing collaboration with Connoa and Prolium Bioscience to develop and commercialize the CD20×CD3 bispecific antibody ICP-B02 (CM355) [3] - Nocera continues to enhance its commercialization team's capabilities, leading to increased market penetration and revenue growth for Oubatinib, demonstrating the company's ability to translate scientific innovation into sustained business performance [3]

Group 1 - The company reported a revenue of 731 million yuan in the first half of 2025, a 74.76% increase compared to 420 million yuan in the same period last year [1] - Pharmaceutical sales revenue reached 641 million yuan, up 53.47% from 418 million yuan year-on-year [1] - The company achieved a net profit attributable to shareholders of -30 million yuan, narrowing the loss by 88.51% compared to -262 million yuan in the same period last year [1] Group 2 - The flagship product, Obinutuzumab, generated sales of 637 million yuan in the first half of 2025, reflecting a year-on-year growth of 52.84% [1] - The company received breakthrough therapy designation for ICP-248, which targets MCL (after BTK inhibitor treatment failure), with plans for clinical trials in four indications [1] - The first domestic CD19 monoclonal antibody, Tafasitamab, has been approved for use in combination with Lenalidomide for r/r DLBCL, with sales expected to start between late Q3 and early Q4 [1] Group 3 - Obinutuzumab's international phase III clinical trial for SPMS and PPMS has received FDA approval, with subject recruitment expected to begin in the second half of 2025 [2] - The company is exploring international collaboration potential for ICP-332 and ICP-488, two TYK2 inhibitors, across multiple indications [2] - Revenue projections for the company are estimated at 1.413 billion yuan, 1.787 billion yuan, and 2.385 billion yuan for 2025, 2026, and 2027 respectively [2]

Group 1 - The complexity of hematological tumors presents numerous investment opportunities in various subtypes of treatment [1] - The market for hematological tumors is expanding due to innovative therapies, with significant product launches expected [1] - The number of long-term patients is increasing, with approximately 4 million patients globally having survived five years or more as of 2022, which is three times the number of new patients [1] Group 2 - Future development directions for hematological tumor treatment include improving efficacy, reducing recurrence, and optimizing administration [2] - Acute leukemias like AML and ALL primarily use chemotherapy or targeted combination therapies to enhance survival rates [2] - CAR-T therapy shows high remission rates for aggressive lymphomas and multiple myeloma, providing more treatment options for patients [2] Group 3 - The competition in the targeted drug market for hematological tumors has entered a new phase, with a focus on technological iterations and exploration of new targets [3] - In the BTK field, new products are emerging to compete in the post-resistance market, with Zebutinib outperforming Ibrutinib [3] - The BCL-2 domain is seeing advancements with differentiated designs and optimized dosing strategies to gain competitive advantages [3]

| 证券代码：688428 | 证券简称：诺诚健华 | | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | | 上海荣正企业咨询服务（集团）股份有限公司 | | | | 关于 | | | | 诺诚健华医药有限公司 | | | | 之 | | | | 独立财务顾问报告 | | | | | | 目 录 | | 一、释义 | | | | 本公司、公司、上市公 InnoCare | Pharma | Limited，中文名称：诺诚健华医药有限公 | | 指 | | | | 司 司 | | | | 独立财务顾问 指 | 上海荣正企业咨询服务（集团）股份有限公司 | | | 上海荣正企业咨询服务（集团）股份有限公司关于诺诚健华 | | | | 独立财务顾问报告 指 医药有限公司 | 2024 | 年科创板限制性股票激励计划预留授予 | | 事项之独立财务顾问报告 | | | | 本激励计划、本计划 指 | 诺诚健华医药有限公司 2024 | 年科创板限制性股票激励计划 | | 限制性股票、第二类限 | | 符合本激励计划授予条件的激励对象，在满足相应归属条件 | | 指 ...

FANGDA PARTNERS http://www.fangdalaw.com 中国上海市石门一路 288 号 电子邮件 E-mail: email@fangdalaw.com 兴业太古汇香港兴业中心二座 24 楼 电 话 Tel.: +86-21- 2208 1166 邮政编码：200041 传 真 Fax.: +86-21-5298 5599 HKRI Taikoo Hui Shanghai, PRC 上海市方达律师事务所 关于诺诚健华医药有限公司（InnoCare Pharma Limited） 法律意见书 致：诺诚健华医药有限公司（InnoCare Pharma Limited） 上海市方达律师事务所（以下简称"本所"）是具有中华人民共和国境内法律 执业资格的律师事务所。根据诺诚健华医药有限公司（InnoCare Pharma Limited） （以下简称"诺诚健华"、"公司"或"上市公司"）的委托，本所担任诺诚健华 2024 年科创板限制性股票激励计划项目（以下简称"本激励计划"）的特聘专项法律顾 问，就本激励计划项下向激励对象授予预留限制性股票（以下简称"本次授予"或 "预留授予"）的有关事项出 ...

Core Viewpoint - The company announced the completion of the first patient dosing in a registration clinical trial for its novel BCL2 inhibitor, mesutoclax (ICP-248), aimed at treating BTK inhibitor-treated mantle cell lymphoma (MCL) [1][2] Group 1: Product Development - Mesutoclax is a new oral, highly selective BCL2 inhibitor that targets the BCL2 protein, which is crucial in the apoptosis pathway and is linked to various malignant hematological tumors [1] - The unique mechanism of action of mesutoclax allows it to restore programmed cell death in tumor cells, demonstrating potential efficacy in treating MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS) [1] - The registration clinical trial aims to evaluate the safety and efficacy of mesutoclax in patients with MCL who have previously been treated with BTK inhibitors, addressing a significant unmet need in this aggressive form of B-cell non-Hodgkin lymphoma [1] Group 2: Company Strategy - The co-founder, chairman, and CEO of the company expressed optimism that mesutoclax could provide new treatment hope for lymphoma patients and emphasized the commitment to accelerate its clinical development for both Chinese and global markets [2]

Core Viewpoint - The report from China Galaxy recommends the pharmaceutical industry, highlighting the significant growth potential in the hematological oncology market driven by innovative therapies and the increasing number of long-term patients [1] Group 1: Market Dynamics - The hematological oncology market is expanding due to advancements in precision diagnostics, prognostic stratification, immunotherapy, and targeted therapies, leading to improved survival rates and quality of life for patients [1] - According to WHO, the number of long-term patients with hematological malignancies reached approximately 4 million in 2022, which is three times the number of new patients, indicating a growing market for treatments [1] - The market is expected to see blockbuster products, with global sales of Daratumumab exceeding $10 billion in 2024, and both Ibrutinib and Lenalidomide surpassing $5 billion in sales [1] Group 2: Treatment Trends - Future treatment directions for hematological malignancies focus on improving efficacy, reducing relapse rates, and optimizing administration methods, particularly in acute leukemias and chronic leukemias [2] - In chronic myeloid leukemia (CML), the use of BCR-ABL TKI therapy is being explored to overcome resistance through technological iterations and new targets [2] - CAR-T therapy is providing more treatment options for patients with high relapse rates, particularly in aggressive lymphoma and multiple myeloma [2] Group 3: Competitive Landscape - The targeted drug market for hematological malignancies is entering a new competitive phase, with innovations in BTK inhibitors and BCL-2 inhibitors leading the way [3] - Zebutinib has outperformed Ibrutinib, establishing itself as a leading product in the BTK space, while the market for post-resistance treatments is becoming increasingly competitive [3] - In the BCL-2 space, advancements in dosing and differentiated designs are giving products like Lisocabtagene Maraleucel a competitive edge [3] Group 4: Investment Opportunities - The complexity of hematological malignancies presents numerous investment opportunities, particularly as treatment approaches evolve towards chronic disease management [4] - Companies to watch include BeiGene, which is covering the CLL/SLL indications with a comprehensive product matrix, and Innovent Biologics, which is building a diversified product portfolio centered around Orelabrutinib [4] - Ascentage Pharma is focusing on third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create differentiated competitive advantages [4]

Investment Rating - The report maintains a "Buy" rating for the blood cancer drug industry [3][6]. Core Insights - The blood cancer market is expanding due to innovative therapies, with significant advancements in precision diagnosis, prognosis stratification, and targeted therapies such as CAR-T and TCE, leading to improved patient survival and quality of life [5][8]. - The number of patients with blood cancer who have survived for five years or more is approximately 4 million globally, which is three times the number of new patients, indicating a growing market for long-term treatments [5][13]. - The high cost of blood cancer drugs and the emergence of blockbuster products are driving market growth, with several drugs expected to exceed $10 billion in sales by 2024 [5][17]. Summary by Sections 1. Blood Cancer Market Expansion - The proportion of new blood cancer patients is less than 10% of all new cancer cases, with a steady increase in incidence rates [8]. - Blood cancer patients have a long survival period, resulting in a large population of existing patients [13]. - The high cost of blood cancer treatments contributes to the frequent emergence of blockbuster drugs [17]. 2. Clinical Diagnosis and Treatment of Blood Cancer - Blood cancers are classified based on cell origin, differentiation, and affected sites, including leukemia, lymphoma, and multiple myeloma [19][20]. - Treatment for acute leukemia primarily involves chemotherapy or targeted combination therapies to improve survival rates [24]. - Lymphoma treatment varies by subtype, with Rituximab being a cornerstone therapy [23]. - Multiple myeloma treatment focuses on CD38 monoclonal antibodies, with ongoing exploration of solutions for relapsed and refractory cases [23]. 3. Analysis of Popular Targets and Therapies - The BTK field is seeing intense competition, with new products emerging to address resistance issues [5]. - The BCL-2 area is advancing with differentiated designs and optimized dosing strategies [5]. - The BCR-ABL TKI domain is witnessing the introduction of third-generation inhibitors that show superior efficacy [5]. 4. Company Profiles - BeiGene is focusing on a comprehensive product matrix to cover CLL/SLL indications [5]. - Innovent Biologics is building a diversified product portfolio centered around Oubreti [5]. - Ascentage Pharma is developing third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create competitive advantages [5]. - Diligent Pharma is innovating with a globally first high-selectivity JAK1 inhibitor and a dual-target LYN/BTK inhibitor [5]. 5. Investment Recommendations - The blood cancer sector presents numerous investment opportunities due to its complexity and the variety of treatment subfields [5]. - The long survival cycle of blood cancer patients and the high costs of drug treatments indicate a significant market potential [5].

登录新浪财经APP 搜索【信披】查看更多考评等级 A股代码：688428 A股简称：诺诚健华 公告编号：2025-034 港股代码：09969 港股简称：诺诚健华 诺诚健华医药有限公司 董事会决议公告 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。 一、董事会会议召开情况 诺诚健华医药有限公司（以下简称"诺诚健华"或"公司"）于2025年8月20日在公司会议室以现场会议结 合通讯方式召开董事会。会议应出席董事7人，实际出席董事7人，董事会主席Jisong Cui（崔霁松）博 士担任会议主席。会议的召集、召开、表决程序符合有关法律、行政法规、部门规章、规范性文件和公 司章程的规定。 二、董事会会议审议情况 （一）审议通过《根据2024年科创板限制性股票激励计划向激励对象授予预留限制性股票》的议案 根据《上市公司股权激励管理办法》《2024年科创板限制性股票激励计划（草案）》及其摘要的相关规 定和公司2024年第一次临时股东大会（股东特别大会）的审议批准及授权，董事会认为公司2024年科创 板限制性股票激励计划规定的预留授予条 ...