Core Viewpoint - The company, Innovent Biologics, has announced that its oncology pipeline candidates ICP-248, ICP-723, and ICP-B05 will present their latest research findings at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the advancements in their clinical trials and potential therapeutic applications [1][2][3][4]. Group 1: Project Details - **ICP-248 (Mesutoclax)**: A novel oral BCL2 inhibitor aimed at treating non-Hodgkin lymphoma (NHL) and acute myeloid leukemia (AML). The company will present preliminary safety and efficacy data for this drug at ASCO [2]. - **ICP-723 (Zurletrectinib)**: A second-generation pan-TRK inhibitor designed for patients with advanced or metastatic solid tumors carrying NTRK gene fusions. The company has submitted a new drug application for this candidate in China and will present data on its efficacy and safety in pediatric patients at ASCO [3]. - **ICP-B05 (CM369)**: An anti-CCR8 monoclonal antibody developed in collaboration with Connoa Biopharmaceuticals, targeting regulatory T cells in the tumor microenvironment. The company is conducting Phase I clinical trials and will present initial results at ASCO [4].

| 股代码：688428 A | 股简称：诺诚健华 A | 公告编号：2025-012 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 自愿披露关于多项肿瘤管线最新研究成果入选 2025 年美国临床肿瘤学会（ASCO）年会的公告 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。 诺诚健华医药有限公司（以下简称"公司"或"诺诚健华"）肿瘤管线 ICP-248 （Mesutoclax）、ICP-723（Zurletrectinib）和 ICP-B05（CM369）最新研究成果入 选 2025 年美国临床肿瘤学会（ASCO）大会，并将在大会上公布一系列在研管线 最新数据。 2025 年 ASCO 年会将于 2025 年 5 月 30 日到 6 月 3 日在芝加哥举办。ASCO 年会是全球肿瘤领域权威的学术交流盛会，将展示当前国际前沿的临床肿瘤学科 研成果和肿瘤治疗技术。 一、入选项目情况 1 抑制剂治疗，以及对第一代 TRK 抑制剂产生耐药的携带 NTRK ...

Trading Information Summary - As of April 3, 2025, the stock price of Nocera Health (688428) closed at 18.48 CNY, down by 2.69% with a turnover rate of 2.14% and a trading volume of 56,900 shares, amounting to a total transaction value of 106 million CNY [1] - On the same day, the net outflow of main funds was 2.36 million CNY, accounting for 2.22% of the total transaction value; net inflow from retail investors was 1.92 million CNY, representing 1.8% of the total transaction value [1][3] Company Announcements Summary - Nocera Health submitted a securities change monthly report as of March 31, 2025, indicating that the total issued shares remained unchanged, with 1,496,284,235 shares listed on the Hong Kong Stock Exchange and 266,282,967 shares listed on the Shanghai Stock Exchange [1][3] - The company has initiated a stock incentive plan for 2023, granting 7,209,000 shares at a price of 6.95 CNY per share, with 522,500 shares becoming invalid by the end of March 2025. For 2024, 9,870,200 shares were granted at a price of 6.65 CNY per share, with 40,000 shares invalidated by the same date [2]

Financial Data and Key Metrics Changes - In 2024, the company achieved drug sales growth of 49.7%, primarily driven by core product Aureloproteinib, which reached RMB1 billion in sales, reflecting a 49.1% increase compared to 2023 [11][12] - The net loss for the year decreased by 29.9%, from RMB646 million in 2023 to RMB453 million in 2024, indicating improved operational efficiency [11][12] - Gross margin ratio increased from 82.6% in 2023 to 86.3% in 2024, demonstrating enhanced manufacturing efficiency and revenue growth [12] Business Line Data and Key Metrics Changes - The commercialization of Aureloproteinib was a significant driver, achieving over RMB1 billion in sales, marking a milestone for the company [10][14] - The launch of the AMZAL indication for Aureloproteinib contributed to its rapid growth, establishing the company as the first mover in this market [13][14] Market Data and Key Metrics Changes - The company is focusing on expanding its market reach in China, particularly in low-tier cities, to enhance hospital coverage and sales for its hematology products [77] - The company anticipates that the MZL contribution to sales will grow to around 50% by the end of 2025, indicating strong market potential [76] Company Strategy and Development Direction - The company aims to accelerate its pipeline development, with expectations of three to four large asset approvals in the next three years [16] - Strategic collaborations, such as the partnership with Voluum for the development of CD2063 antibody, are key to expanding the company's global reach [15] - The company is prioritizing business development and aims to secure first-line approvals for its products in both China and globally [64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a growth rate of at least 30% in 2025, driven by the continued success of MZL and expansion into new markets [76][78] - The company is optimistic about the approval timelines for its key products, including tafacitumab, which is expected to receive approval in the second quarter of 2025 [80] Other Important Information - The company has made significant advancements in its innovative pipeline, with 50 drugs in various stages of development, including pre-IND, Phase I, II, and III trials [16] - The ADC platform is a new focus area for the company, with the first candidate B7 ADC expected to enter clinical trials soon, showcasing the company's commitment to expanding its therapeutic offerings [45][50] Q&A Session Summary Question: Can you elaborate on the ADC platform and its differentiation? - Management highlighted the strengths of the ADC platform, emphasizing the innovative linker and payload design that enhances efficacy and safety compared to existing therapies [45][50] Question: What is the strategy for ICP-248 and its positioning in the market? - Management acknowledged the competitive landscape but expressed confidence in securing first-line approval for their BCL2 inhibitor in China, while also pursuing global opportunities [64][66] Question: What is the timeline for the Phase III trial of orilabrutinib in SLE? - Management indicated that the Phase IIb data would be available in the fourth quarter, with a high possibility of initiating the Phase III trial within the same year [72] Question: What are the expectations for tafacitumab's approval timeline? - Management anticipates approval for tafacitumab around the second quarter of 2025, with preparations for commercial launch already underway [80] Question: How does the company view competition in the hematology space? - Management acknowledged the competitive data presented by peers but remains focused on improving their own efficacy and securing market share through strategic positioning [60][84]

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3月31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4月3日 I. 法定/註冊股本變動 | 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 | ...

Market Overview - After the Spring Festival and during the Two Sessions, the TMT sector led by Deepseek has initiated a "revaluation of Chinese assets" trend, supported by a relatively stable RMB exchange rate and positive policy expectations[1] - The A-share and Hong Kong technology sectors currently exhibit a high risk appetite, although adjustments have been observed since mid-March due to uncertainties surrounding the new round of "reciprocal tariffs" from the US and concerns over AI "computing power bubbles"[1] - In March, the Shanghai Composite Index, CSI 300 Index, and ChiNext Index recorded gains of +0.45%, -0.07%, and -3.07%, respectively[1] Policy and Economic Outlook - The 2025 Two Sessions emphasized expanding domestic demand and promoting consumption as primary objectives, with a focus on addressing low domestic inflation and external uncertainties[2] - The "Consumption Promotion Action Plan" issued on March 16 aims to enhance consumer capacity and stabilize the stock market, with expectations for new capital market policies to accelerate implementation[2] - The central bank reiterated the need for a moderately loose monetary policy, with potential for reserve requirement ratio (RRR) and interest rate cuts based on economic conditions[2] Investment Recommendations - Focus on large consumption and cyclical industries in Q2, particularly those showing signs of recovery or strong performance[3] - Continue to monitor defensive sectors such as banking and dividend stocks due to external uncertainties[4] - The long-term trend for AI remains positive, with significant investment from major domestic companies, presenting potential short-term investment opportunities during market corrections[5] Selected Stock Portfolio - The recommended portfolio includes stocks from various sectors: China Mobile, Hongri Da, Lu Wei Optoelectronics, Sinovac Biotech, and others, covering telecommunications, pharmaceuticals, machinery, and non-bank financials[5]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [2][3] Core Insights - The company achieved a revenue of 1.009 billion yuan in 2024, representing a year-on-year growth of 36.68%, with drug sales revenue reaching 1.006 billion yuan, up 49.74% [3] - The net profit attributable to shareholders was a loss of 440 million yuan, narrowing by 30% [3] - The first commercialized product, the BTK inhibitor Obutinib, saw sales exceed 1 billion yuan in 2024, growing by 49.14% year-on-year, driven by multiple factors including its inclusion in the national medical insurance catalog [4] - The company is advancing its self-developed ADC platform, with the first IND submission expected within the year [2][4] Financial Performance and Forecast - Revenue forecasts for 2025, 2026, and 2027 are projected at 1.411 billion yuan, 1.702 billion yuan, and 2.058 billion yuan respectively, with net profits expected to be losses of 427 million yuan, 355 million yuan, and 235 million yuan [9][11] - The company is expected to continue benefiting from the growth of Obutinib and the anticipated approval of Tafasitamab, which is expected to contribute to revenue in 2025 [9][11] Clinical Development - The company has initiated a registration Phase III clinical trial for ICP-248 in combination with Obutinib for the treatment of 1L CLL/SLL, with promising clinical data reported [5] - The company is also exploring multiple indications in the autoimmune field, with ongoing clinical trials for Obutinib in treating PPMS, SPMS, and ITP [6] - The second-generation TRK inhibitor ICP-723 has shown a high overall response rate of 85.5% in clinical trials and is expected to submit an NDA soon [8] Market Position and Future Prospects - The company is positioned to expand its market presence with the anticipated approval of Tafasitamab and the ongoing development of its ADC platform targeting difficult-to-treat solid tumors [4][9] - The strong commercial capabilities and the positive clinical outcomes of its products are expected to drive future growth [4][9]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [2][3]. Core Insights - The company achieved a revenue of 1.009 billion yuan in 2024, representing a year-on-year growth of 36.68%, with drug sales revenue reaching 1.006 billion yuan, up 49.74% [3]. - The net profit attributable to shareholders was a loss of 444 million yuan, narrowing by 30% [3]. - The company’s first commercialized product, the BTK inhibitor Acalabrutinib, saw sales exceed 1 billion yuan in 2024, with a growth rate of 49.14% [4]. - The company is advancing its ADC platform and plans to submit its first IND application within the year [4][8]. Financial Performance - The company forecasts revenues of 1.411 billion yuan, 1.702 billion yuan, and 2.058 billion yuan for 2025, 2026, and 2027 respectively, with net profits expected to be losses of 427 million yuan, 355 million yuan, and 235 million yuan [9][11]. - The company’s R&D expenses for 2024 were 815 million yuan, reflecting a year-on-year increase of 7.57% [3]. Product Pipeline and Clinical Trials - The company is progressing with multiple clinical trials, including a Phase III trial for ICP-248 in combination with Acalabrutinib for 1L CLL/SLL, which has shown promising clinical data [5]. - Tafasitamab is expected to be approved in the first half of 2025, contributing to the company's growth trajectory [4]. - The company is also exploring Acalabrutinib's potential in autoimmune diseases, with several clinical trials underway [6]. Market Position and Future Outlook - The company is well-positioned with its core product Acalabrutinib and the anticipated approval of Tafasitamab, which is expected to enhance its revenue streams [9]. - The ADC platform is expected to target hard-to-treat solid tumors, indicating a strategic expansion into new therapeutic areas [8].

自免管线陆续兑现，挖掘未满足临床需求。奥布替尼治疗PPMS和SPMS的全球IⅡI期临床正在启动，有 望在2025年内实现FPI。同时已实现治疗ITF的POC，计划2025年底前完成Ⅲ期注册临床，并于2026年上 半年递交NDA；SLE适应症IIb期试验已完成患者招募，预计2025年四季度数据读出。另外两款差异化 TYK2抑制剂，ICP-332特应性皮炎Ⅲ期临床已入组超过110例惠者，自激风其/Ⅲ期临床已启动，结节性 择疹全球其期临床计划开展；ICP488正加速推进银屑病Ⅲ期临床，首例患者完成入组。公司持续布局 自身免疫性疾病口服疗法，进一步挖掘未满足临床需求。 持续拓展实体瘤领域，首主开发ADC平台值得期待。第二代泛TRK抑制剂ICP-723针对NTRK融合阳性 晚期实体瘤已完成I期注册临床，计划2025年4月初递交NDA，儿童适应症计划2025年下半年递交 NDA。公司自主研发的ADC平台采用不可逆生物偶联技术、亲水链接子及创新型载荷，具备强大的肿 瘤杀伤效应和充足的安全窗口，首款ADC产品ICP-B794（B7-H3ADC)计划于2025年上半年递交IND申 请。 事件：2025年3月28日，诺诚健华发布 ...

Core Viewpoint - The company Nocare Biopharma showcases its commitment to innovation and high-quality development at the 2025 Zhongguancun Forum, emphasizing its contributions to global patient accessibility and technological advancements in the biopharmaceutical sector [1][2]. Group 1: Recognition and Awards - Nocare Biopharma received two significant recognitions at the Zhongguancun Forum, including being the only biopharmaceutical company selected for the Beijing Municipal Government Quality Management Award and having its novel oral BCL2 inhibitor Mesutoclax (ICP-248) included in the "Top 100 New Technologies and Products List" [1][2]. - The company was nominated for the Beijing Municipal Government Quality Management Award, standing out among over 300 applicants, with only 10 companies receiving awards [1]. Group 2: Innovative Products and Pipeline - Nocare Biopharma's new oral high-selectivity BCL2 inhibitor ICP-248 was highlighted at the forum, marking the third innovative product from the company to be recognized in the "Top 100 New Technologies and Products List" [2]. - The company showcased its innovative pipeline in hematological malignancies and autoimmune diseases, including new BTK inhibitors and TYK2 inhibitors [2]. Group 3: Market Potential and Research Focus - The global market for autoimmune diseases is projected to reach $185 billion by 2029, prompting Nocare Biopharma to enhance its drug discovery platform and accelerate clinical research for its high-potential TYK2 inhibitors targeting unmet clinical needs [3]. - The company is focused on addressing various autoimmune diseases such as atopic dermatitis and psoriasis through its innovative drug development efforts [3]. Group 4: Integration of AI in Drug Development - Nocare Biopharma is actively exploring the integration of artificial intelligence (AI) in its drug development processes, aiming to enhance molecular screening and clinical trial efficiency [4][5]. - The company has established a dedicated R&D team to develop and upgrade its computational chemistry platform, which includes modules for predicting physicochemical properties and drug design [4].