Transformational Global Collaboration With InnoCare Pharma Conference Call October 8, 2025 1 Disclaimer FORWARD-LOOKING STATEMENTS: This presentation contains "forward-looking statements" which involve risks, uncertainties and contingencies, many of which are beyond the control of Zenas BioPharma, Inc. (the "Company" or "Zenas"), which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of hi ...

智通财经APP讯，诺诚健华(09969)发布公告，本公司于美国注册成立的全资附属公司InnoCare Pharma Inc.(InnoCare)已就奥布替尼及另外两项临床前资产(统称"许可产品")的开发、生产及商业化与Zenas BioPharma, Inc.(Zenas;纳斯达克代码：ZBIO)订立独占许可协议及认购协议。 奥布替尼(宜诺凯®)为一款处于后期临床阶段、具有潜在同类最佳优势的高中枢神经系统渗透性、选择 性、不可逆口服小分子BTK抑制剂。在多发性硬化症(MS)领域，InnoCare已于2025年第三季度启动针对 原发进展型多发性硬化症(PPMS)的III期临床试验，并预计于2026年第一季度启动继发进展型多发性硬 化症(SPMS)的III期临床试验。上述III期PPMS及SPMS临床试验方案已获得美国FDA及欧洲EMA的指导 意见并达成共识。在其他自身免疫疾病领域，其在中国针对免疫性血小板减少症(ITP)的III期注册性试 验已完成患者入组，计划于2026年上半年提交新药上市申请;针对系统性红斑狼疮(SLE)的IIb期试验正在 进行中，预计于2025年第四季度获得顶线数据。 Zenas是一家处于 ...

Core Viewpoint - The approval of Ibrutinib (Yinokai) for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) in Singapore marks a significant step in the international expansion of the company [1] Group 1: Product Approval and Development - Ibrutinib has received approval from the Health Sciences Authority (HSA) in Singapore for treating adult patients with R/R MZL, representing the second indication approved for the drug in Singapore [1] - The company is advancing Ibrutinib's global development in the field of autoimmune diseases, in addition to its application in lymphoma treatment [1] Group 2: Market Context and Patient Needs - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with an increasing incidence rate globally [1] - There is a lack of effective treatment options for MZL patients who experience disease progression or relapse after first-line therapy [1] Group 3: Previous Approvals - Earlier in April, Ibrutinib was approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - The drug has also been approved in China for treating R/R CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R MZL, with all three indications included in the national medical insurance [2]

Group 1 - The core point of the article is that Innovent Biologics has received approval from the Health Sciences Authority of Singapore for its drug Ibrutinib (宜诺凯®) to treat relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking a significant step in the company's international expansion [2] - Ibrutinib is a highly selective BTK inhibitor developed by Innovent, which aims to improve safety and efficacy by avoiding off-target adverse events, and is being advanced for the treatment of hematological malignancies and autoimmune diseases [2] - The approval in Singapore is the second indication for Ibrutinib, following its earlier approval for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China [3] Group 2 - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with a rising incidence globally, and patients with disease progression/relapse after first-line treatment currently lack effective treatment options [2]

Core Insights - The company Innovent Biologics has received approval from the Health Sciences Authority of Singapore for its drug Ibrutinib (Yinokai) to treat relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking a significant step in its international expansion [1] - Ibrutinib is a highly selective BTK inhibitor that has demonstrated good efficacy and safety in treating R/R MZL, providing new treatment options for lymphoma patients in Singapore [1] - The company is also advancing the global development of Ibrutinib for autoimmune diseases, in addition to its applications in hematologic malignancies [1] Company Developments - In April of this year, Ibrutinib was approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - Prior approvals in China include treatments for previously treated CLL/SLL, relapsed/refractory mantle cell lymphoma (R/R MCL), and R/R MZL, all of which are covered by the national health insurance [2] Industry Context - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with a rising incidence rate globally [1] - Patients with MZL who progress or relapse after first-line treatment currently lack effective therapeutic options [1]

Core Viewpoint - BeiGene (ONC.US) experienced a significant increase of over 9%, closing at $334.20, following the release of its financial report indicating a strong revenue growth and a return to profitability in the first half of 2025 [1] Financial Performance - In the first half of 2025, the company achieved total revenue of 17.518 billion yuan, representing a year-on-year growth of 46.03% [1] - Product revenue reached 17.36 billion yuan, with a year-on-year increase of 45.8% [1] - The company reported a net profit of 450 million yuan, marking its first return to profitability this year [1] Product Performance - The growth in product revenue was driven by sales increases of self-developed products, namely Brukinsa® (Zebutinib capsules) and Tislelizumab, as well as increased sales from Amgen licensed products [1] - Zebutinib demonstrated outstanding performance, becoming the leading BTK inhibitor in both the U.S. and global markets [1] Sales Data - Global sales of Zebutinib reached 12.527 billion yuan, reflecting a year-on-year growth of 56.2% [1] - In the U.S. market, sales of Zebutinib amounted to 8.958 billion yuan, with a year-on-year increase of 51.7% [1] - Zebutinib has rapidly gained adoption among patients and physicians in the U.S. due to its best-in-class clinical characteristics, making it the largest and fastest-growing product in the market [1]

Core Viewpoint - BeiGene reported a significant financial turnaround in the first half of 2025, achieving a total revenue of 17.518 billion yuan, a year-on-year increase of 46.03%, and a net profit of 450 million yuan, marking its first profit of the year [2][3]. Financial Performance - Total revenue for the first half of 2025 reached 17.518 billion yuan, up 46.03% year-on-year [2]. - Product revenue was 17.36 billion yuan, reflecting a growth of 45.8% [2]. - The company achieved a net profit of 450 million yuan, indicating a turnaround from previous losses [2]. Product Performance - The growth in product revenue was driven by sales of self-developed products, namely Brukinsa® (Zebutinib) and Tislelizumab, as well as increased sales from licensed products [2]. - Zebutinib's global sales reached 12.527 billion yuan, a 56.2% increase year-on-year, making it the leading BTK inhibitor in both the U.S. and global markets [2][3]. - In the U.S. market, Zebutinib sales amounted to 8.958 billion yuan, up 51.7% [3]. - In Europe, Zebutinib sales were 1.918 billion yuan, growing by 81.4% [3]. - In China, Zebutinib sales reached 1.192 billion yuan, an increase of 36.5% [3]. - Tislelizumab generated sales of 2.643 billion yuan, reflecting a 20.6% growth, primarily due to new indications being covered by insurance [3]. Research and Development - The company anticipates over 20 milestone advancements in blood cancers and solid tumors within the next 18 months [4]. - In the blood cancer sector, two products, BGB-16673 and Sotorasib, are in Phase 3 clinical trials [4]. - BGB-16673 is noted for its rapid clinical progress as a BTK degrader, showing potential for treating relapsed or refractory B-cell malignancies [4]. - Sotorasib has submitted applications for two indications in China and is expected to file for global accelerated approval in the second half of 2025 [4]. - The company is also developing multiple potential best-in-class products and combination therapies for key cancers, including breast, lung, and gastrointestinal cancers [4]. Stock Performance - As of August 29, BeiGene's A-share price closed at 278 yuan, marking a 12.55% increase and reaching a historical high [5].

Core Viewpoint - Nocera Biopharma (09969) shares rose over 3%, currently up 3.5% at HKD 18.63, with a trading volume of HKD 133 million, ahead of the board meeting scheduled for August 19 to approve mid-term results [1] Group 1: Financial Performance - Nocera Biopharma's first-quarter revenue increased by 130% year-on-year, with net profit turning positive at HKD 1.8 billion, exceeding expectations due to strong growth of its core product, Oubreti, and confirmation of upfront payment from Prolium [1] - CICC has revised its profit forecasts for Nocera Biopharma, narrowing expected losses for the next two years from HKD 436 million and HKD 256 million to HKD 415 million and HKD 225 million, respectively [1] Group 2: Product Insights - Oubreti, a BTK inhibitor developed by Nocera Biopharma, is primarily used for treating chronic lymphocytic leukemia and is gaining market share, holding a significant position in the domestic BTK inhibitor market [1] - In 2024, Oubreti's sales revenue is projected to exceed HKD 1 billion, representing a year-on-year growth of 49.14%, capturing a 30% market share in the domestic BTK inhibitor market [1]

Core Viewpoint - Nocera Health (09969) has seen a stock increase of over 3%, currently at 18.63 HKD, with a trading volume of 133 million HKD, ahead of its board meeting scheduled for August 19 to approve mid-term results [1] Financial Performance - Nocera Health's first-quarter revenue increased by 130% year-on-year, with net profit turning positive at 1.8 billion HKD, exceeding expectations due to strong growth of its core product, Oubreti [1] - CICC has revised its profit forecasts for Nocera Health, narrowing expected losses for the next two years from 436 million HKD and 256 million HKD to 415 million HKD and 225 million HKD respectively [1] Product Insights - Oubreti, a BTK inhibitor developed by Nocera Health, is primarily used for treating chronic lymphocytic leukemia and has been gaining market share, holding a significant position in the domestic BTK inhibitor market [1] - In 2024, Oubreti's sales revenue is projected to exceed 1 billion HKD, representing a year-on-year growth of 49.14%, capturing a 30% market share in the domestic BTK inhibitor market [1]

Core Insights - The global pharmaceutical sales ranking for the first half of 2025 has been released, highlighting the dominance of GLP-1 drugs, with the top three drugs surpassing $10 billion in sales, marking them as key growth drivers in the industry [1][2][3] - The competition among global pharmaceutical giants is intensifying, particularly in the metabolic drug sector, with companies like Novo Nordisk and Eli Lilly expected to further strengthen their market positions [2][3] GLP-1 Drug Market Dynamics - Novo Nordisk's GLP-1 family, particularly semaglutide, achieved sales of $16.632 billion, securing the top position, while Eli Lilly's tirzepatide followed closely with $14.734 billion, reflecting a year-on-year growth of 121.3% [3][4] - The sales of GLP-1 drugs are reshaping the "king of drugs" competition, with semaglutide and tirzepatide leading the market, and the latter's rapid growth could potentially position it as the top-selling drug for the year [3][4] Emerging Drug Categories - New therapeutic modalities, including bispecific antibodies, antibody-drug conjugates (ADC), and fusion proteins, are gaining traction, accounting for over 15% of the top-selling drugs, with ADC drug Enhertu entering the list with $3.9 billion in sales [1][8] - The mRNA vaccine category also contributed significantly, with three vaccines generating a total of $9.4 billion in sales [1] CDK4/6 Inhibitor Market - The CDK4/6 inhibitor market is experiencing a reshuffle, with Eli Lilly's Abemaciclib leading at $2.648 billion, followed by Novartis' Ribociclib, which saw a remarkable growth rate of 58.7% [6] - Pfizer's Palbociclib, once a market leader, has seen a decline, with sales dropping to $2.026 billion, marking a significant shift in market dynamics [6] BTK Inhibitor Landscape - The global BTK inhibitor market is projected to reach approximately $12.5 billion by 2024, with Ibrutinib, Acalabrutinib, and Zanubrutinib dominating over 97% of the market share [7] - Chinese innovation is making strides, with BeiGene's Zanubrutinib entering the global top 50 list for the first time, achieving sales of $1.742 billion [7][8] Future Outlook - The GLP-1 market is expected to maintain high growth, potentially securing two of the top three positions in the overall sales ranking for 2025, indicating a significant shift in the weight loss drug market [8] - The rise of new molecular entities such as bispecific antibodies and ADCs suggests that the next wave of major innovations will stem from modality innovations, further transforming the pharmaceutical landscape [8]