Summary of the Conference Call Company Overview - The conference call discusses the developments and future outlook of **Nocera Biopharma** (诺诚健华), particularly focusing on its lead drug **Obinutuzumab** (奥布替尼) and its various indications [2][4]. Key Points Industry and Market Potential - **Obinutuzumab** has been approved for three indications, with **marginal zone lymphoma** being an exclusive indication. It is expected to be included in medical insurance in 2024, with a market potential of at least **1.5 billion RMB** [2]. - The company anticipates peak domestic sales for **Obinutuzumab** to reach **6-7 billion RMB**, with contributions from hematological malignancies estimated at **2.5-3 billion RMB**, **ITP** at **1 billion RMB**, and **SLE** potentially reaching **3 billion RMB** if approved [2][13]. Clinical Development - The **BCL-2 inhibitor** combined with **BTK inhibitor** has completed patient enrollment for phase II clinical trials, with phase III trials expected to start in the first half of 2025 and an NDA submission targeted for 2027 [2][5]. - In the **multiple sclerosis (MS)** field, **Obinutuzumab** has received FDA approval to conduct international phase III trials for **PPMS** and **SPMS**, with patient enrollment planned for 2025 [2][7]. - The **NTRK inhibitor ICP723** is expected to submit an NDA by the end of March 2025, with promising efficacy and safety data to be disclosed at the EHA [2][9]. Financial Outlook - The company aims to achieve breakeven by 2027, with potential for earlier achievement if business development progresses favorably [2][12]. - The R&D budget for 2025 is projected to be between **900 million to 1 billion RMB**, with management expenses remaining stable [2][28][29]. - The company reported a cash balance exceeding **7 billion RMB** at the end of 2024, with a loss of approximately **400 million RMB** [2][30]. Business Development and Partnerships - The company has signed a **CD3CD20** agreement and is in discussions for 8-9 other assets, with varying stages of negotiation [2][10][21]. - The switch from **Mei Pharma** to a new partner for the **BCL-2 inhibitor** was made for safety and efficacy reasons, aiming to enhance treatment compliance [2][22]. Regulatory and Competitive Landscape - The patent for **Ibrutinib** will expire in December 2026, but the impact on **Obinutuzumab** sales is expected to be limited due to its unique advantages and upcoming approvals in autoimmune indications [2][3][26]. - The patent for **Obinutuzumab** is set to expire in **2034**, with potential extensions until **2040** for specific indications [2][27]. Additional Insights - The company plans to disclose 1-2 new oral autoimmune drugs in 2025, aiming to strengthen its position in the oral product market [2][8]. - The **SLE** clinical trial is focused on improving the **Systemic Lupus Erythematosus Disease Activity Index (SIG)**, with data expected in late 2025 [2][18]. Conclusion - Nocera Biopharma is positioned for significant growth with its innovative pipeline and strategic market positioning, particularly with **Obinutuzumab**. The company is actively pursuing clinical trials and business development opportunities to enhance its market presence and financial stability [2][4][12].

Investment Rating - The industry investment rating is maintained as "Add" for the pharmaceutical and biotechnology sector [5]. Core Viewpoints - The competitive landscape of the BTK inhibitor market is continuously changing, with BeiGene's Zanubrutinib rapidly approaching a leading market share position in the U.S. market. In 2024, the company's product revenue reached 26.994 billion yuan, a significant increase from 15.504 billion yuan in the previous year, primarily driven by sales growth of Zanubrutinib and other licensed products [2][12]. - Zanubrutinib's global sales in 2024 amounted to 18.859 billion yuan, reflecting a growth of 106.4%. U.S. sales were 13.890 billion yuan, up 107.5%, largely due to expanded use in CLL indications. European sales reached 2.564 billion yuan, a 195.4% increase, while sales in China were 1.856 billion yuan, growing by 35.2% [2][12]. - The company expects revenue for 2025 to be between 35.2 billion and 38.1 billion yuan, driven by Zanubrutinib's leading position in the U.S. and ongoing expansion in Europe and other key global markets [2][12]. Summary by Sections Market Review - During the week of February 24 to February 28, 2025, the A-share pharmaceutical and biotechnology sector fell by 2.72%, underperforming the CSI 300 index by 0.49 percentage points, while outperforming the ChiNext index by 1.74 percentage points. The sector ranked 23rd among 31 first-level sub-industries [1][17]. Company Dynamics - BeiGene's Zanubrutinib ranked first in prescription volume among new CLL patients in the U.S. market, achieving a 97% year-on-year revenue growth in Q4 2024, surpassing competitors like Ibrutinib and Acalabrutinib [3][13]. - Another domestic BTK inhibitor, Orelabrutinib from Innovent Biologics, received approval for a Phase III clinical trial in combination with a BCL-2 inhibitor for first-line CLL/SLL treatment [15]. Investment Recommendations - BTK inhibitors show significant advantages in treating B-cell malignancies and certain B-cell immune disorders, making them a hot target for blood malignancies and autoimmune diseases. The report suggests focusing on BeiGene and Innovent Biologics [4][16].

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2月28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3月5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 | | 50,000 | 本月底法 ...

证券研究报告 | 行业周报 2025 年 03 月 02 日 医药 本周医药板块下跌 2.72%，礼来加强 IBD 赛道布局 | 股票 | 股票 | 投资 | EPS （元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2024E | 2025E | 2024E | 2025E | | 002755.SZ | 奥赛康 | 买入 | 0.13 | 0.2 | 110.38 | 71.75 | | 01952.HK | 云顶新耀-B | 买入 | -2.93 | -0.12 | - | - | | 02105.HK | 来凯医药-B | 买入 | -0.9 | -1 | - | - | | 600079.SH | 人福医药 | 增持 | 1.33 | 1.59 | 14.95 | 12.51 | | 688192.SH | 迪哲医药 | 增持 | -2.01 | -1.33 | -23.91 | -36.13 | | 688315.SH | 诺禾致源 | 买入 | 0.47 | 0.53 | 36.68 | 32. ...

Summary of Conference Call Company and Industry Involved - **Company**: 诺诚建华 (Nuo Cheng Jian Hua) - **Industry**: Biopharmaceuticals, specifically focusing on hematology and autoimmune diseases Core Points and Arguments 1. **Company's Growth Potential**: The company is characterized by both certainty and growth potential, particularly through its product 奥布提尼 (Obutini) in the hematology sector [2][15][40] 2. **Product Pipeline**: The company has a robust pipeline with multiple indications for 奥布提尼, including: - **MZL (Marginal Zone Lymphoma)**: Expected to contribute significantly to revenue growth due to its unique market position [3][4] - **CL (Chronic Lymphocytic Leukemia) and SL (Small Lymphocytic Lymphoma)**: Anticipated to reach a peak sales of approximately 800 million RMB by 2025 [4][5] - **MCL (Mantle Cell Lymphoma)**: Expected to launch in 2026 with a peak sales forecast of around 700 million RMB [5] - **DRBCL (Diffuse Large B-Cell Lymphoma)**: Smaller market size but part of a comprehensive strategy [6] 3. **Market Dynamics**: The hematology market is projected to grow significantly, with a current market size of approximately 67 billion USD and a CAGR of 10.5% to 13.5% expected over the next five years [20][22] 4. **Competitive Landscape**: The company’s 奥布提尼 is positioned favorably against other BTK inhibitors, with a focus on affordability and efficacy [25][26] 5. **Expansion into Autoimmune Diseases**: The company is also expanding into autoimmune diseases, with significant market potential, particularly in the treatment of PPMS (Primary Progressive Multiple Sclerosis) and ITP (Immune Thrombocytopenic Purpura) [8][10][28] 6. **Financial Health**: The company has a strong financial position with over 7 billion RMB in cash reserves, supporting ongoing R&D efforts [18] 7. **R&D Capability**: The company has demonstrated strong R&D capabilities, with a focus on both small and large molecules, and a commitment to innovation [14][17] 8. **Sales Efficiency**: The company has seen a continuous improvement in gross margins due to an increasing proportion of high-margin products and operational efficiencies [16] Other Important but Possibly Overlooked Content 1. **Regulatory Milestones**: Key regulatory submissions are expected in the coming years, including for 奥布提尼 in various indications, which could significantly impact revenue [13][39] 2. **Strategic Partnerships**: The company has engaged in partnerships to enhance its product offerings and market reach, particularly in the context of its dual strategy in hematology and autoimmune diseases [10][19] 3. **Market Trends**: The shift towards targeted therapies in hematology is expected to drive market growth, with a focus on improving patient outcomes and reducing treatment costs [22][23] 4. **Long-term Vision**: The company aims to maintain a balanced portfolio across different therapeutic areas, ensuring sustained growth and innovation [14][41] This summary encapsulates the key insights from the conference call, highlighting the company's strategic positioning, product pipeline, market dynamics, and financial health.

诺诚健华医药有限公司 自愿披露关于在 2025 年第 10 届美洲多发性硬化症 治疗与研究委员会（ACTRIMS）年度论坛发布 奥布替尼治疗复发缓解型多发性硬化症 临床 II 期数据的公告 | A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-005 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 在第 12 周时，服用奥布替尼的所有三个剂量组与安慰剂组相比，Gd+T1 脑 部累计新发病灶和 T2 脑部累计新发/扩大病灶的数量均显著减少（p<0.05），并 且每天一次 80 毫克剂量组和每天两次 50 毫克剂量组在第 24 周时与安慰剂组相 比，上述病灶的累计数量也显著减少（p<0.05）。每天一次 80 毫克剂量组的 Gd+T1 脑部累计新发病灶的数量在第 12 周时与安慰剂组相比减少了 90.4%，在第 24 周 时减少了 92.3%。每个奥布替尼剂量组在最早的评估时间点第 4 周时即达到对新 发病灶的控制，并且疗效持续至第 24 周。 二、奥布替尼研发进展情况 当前，公司已与美国食品药品监督管理局（以下简称"FDA"）就启动 ...

| A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-004 | | --- | --- | --- | | 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 BCL2 抑制剂 ICP-248 (Mesutoclax) 联合奥布替尼用于一线 CLL/SLL 治疗的注册性 Ⅲ期临床试验获得 CDE 批准的公告 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"）于近日获悉，公司 自主研发的 BCL2 抑制剂 ICP-248 (Mesutoclax) 联合 BTK 抑制剂奥布替尼治疗 一线慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（以下简称"CLL/SLL"）获国家药 品监督管理局（NMPA）药品审评中心（CDE）批准开展注册性 III 期临床试验。 目前公司已启动该临床研究，现将主要情况公告如下： 申请人：北京诺诚健华医药科技有限公司 二、ICP-248 (Mesutoclax) 的其他相关情况 ICP-248 (M ...

Summary of Conference Call Company and Industry Overview - The conference call primarily focused on a pharmaceutical company, specifically discussing its product, Obutini, and its positioning in the hematology and autoimmune disease treatment markets [1][10]. Core Points and Arguments 1. **Core Recommendation Logic**: The company believes that Obutini has both short-term performance certainty and long-term growth potential, driven by its sales growth in the hematology sector [1][12]. 2. **Sales Guidance Adjustments**: Over the past year, the company has consistently raised its global sales guidance for Obutini, from an initial estimate of 30% growth to a final projection of 49% to 50%, with absolute sales expected to reach 1 billion [2][12]. 3. **Market Potential in Hematology**: The company anticipates significant growth in Obutini's sales, particularly in the marginal zone 08 lymphoma indication, which is expected to maintain its competitive advantage [2][5]. 4. **Sales Projections for Clinical Trials**: The sales for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are projected to grow from approximately 300 million to 350 million, with a notable increase expected in 2026 due to new trial launches [3][4]. 5. **MCL Sales Forecast**: The company estimates that the sales peak for MCL (Mantle Cell Lymphoma) could reach around 720 million, with future sales potential of 1 billion [4][5]. 6. **Overall Market Size**: The company projects that the total sales potential for Obutini in hematology could reach between 2.5 billion to 3 billion, indicating a significant market opportunity [5][12]. 7. **Expansion Beyond Hematology**: The company is also exploring opportunities in the autoimmune disease sector, which has a larger patient population compared to hematology, thus extending Obutini's product lifecycle and sales ceiling [6][7][10]. 8. **International Market Strategy**: The company is actively pursuing international market opportunities, which could further enhance Obutini's sales potential [7][9]. 9. **Product Pipeline**: The company has a diverse product pipeline beyond Obutini, including several candidates in various stages of clinical trials, which supports its long-term growth strategy [10][11][34]. 10. **Financial Projections**: The company forecasts sales revenues of 1 billion, 1.39 billion, and 1.92 billion for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 35%, 46%, and 32% [13][35]. 11. **Improving Profitability**: The company has shown continuous improvement in gross margins and operational efficiency, with expectations of turning losses into profits in the near future [14][15][16]. 12. **Market Trends in Hematology**: The hematology market is projected to grow at a CAGR of 10.5% to 13.5% from 2024 to 2028, driven by advancements in treatment modalities [18][20]. Other Important Insights - **Differentiated Positioning**: Obutini's unique molecular structure enhances its selectivity, safety, and efficacy compared to other treatments, positioning it favorably in the market [23][25]. - **Regulatory Milestones**: The company is anticipating several key regulatory milestones in the coming years, which could significantly impact its market position and sales trajectory [12][34]. - **Collaborative Opportunities**: The company is exploring business development opportunities to enhance its product offerings and market reach [17][32]. This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic focus, market potential, and financial outlook.

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1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2月6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 | | 50,000 | 本月底法 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [4]. Core Views - The company is a leading player in the hematological malignancies sector, with its core product, Obutinib, demonstrating solid advantages in efficacy, safety, and patient affordability compared to other BTK inhibitors [1][2]. - Obutinib has received approval for the treatment of relapsed/refractory marginal zone lymphoma (MZL), making it the only BTK inhibitor with this indication in China, which is expected to accelerate its sales growth [1]. - The company forecasts Obutinib's sales to reach 1.001 billion RMB in 2024, representing a 49% year-on-year increase, while the net loss is projected to decrease by 30% to 443 million RMB [1][4]. Summary by Sections Investment Logic - The company has established a leadership position in the domestic hematological malignancies market, with Obutinib as a second-generation BTK inhibitor showing superior efficacy and safety [1]. - The approval of Obutinib for MZL is expected to significantly boost its sales [1]. - The company anticipates substantial improvement in operational performance, with a projected sales revenue of 1.001 billion RMB for 2024, a 49% increase year-on-year, and a reduction in net loss to 443 million RMB [1]. Pipeline and Expansion - Obutinib is expected to receive approval for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) in 2025/2026, which will inject new growth momentum into its sales [2]. - The company is also advancing Obutinib's clinical trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), where treatment options are currently limited [2]. - The company has a robust pipeline with multiple products in various stages of clinical development, including therapies for autoimmune diseases and solid tumors [3][30]. Financial Projections - The company projects sales revenues of approximately 1.001 billion RMB, 1.457 billion RMB, and 1.919 billion RMB for 2024, 2025, and 2026, respectively, with year-on-year growth rates of 35%, 46%, and 32% [4][7]. - The net loss is expected to decrease from 443 million RMB in 2024 to 301 million RMB in 2025 and further to 187 million RMB in 2026 [4][7]. - The target price based on DCF valuation is set at 14.77 RMB per share, indicating significant upside potential [4].