Summary of Conference Call Notes Company and Industry Overview - **Company**: 赛领医药 (Sailin Pharmaceuticals) - **Industry**: Biopharmaceuticals, focusing on autoimmune diseases and oncology treatments Key Points and Arguments Product Developments - **艾佳莫德 (Eijamode)**: - Currently has a penetration rate of only 10% in the Chinese market for Myasthenia Gravis (MG) treatment, with significant growth potential due to new guidelines recommending its use for early and diverse patient populations [2][17] - Achieved a cumulative target rate of 73% and a first-cycle target rate of 40% in clinical settings, indicating strong efficacy [3][17] - Plans to enhance market education and increase hospital coverage to boost penetration [4][17] - **ZL1,310**: - Demonstrated a high overall response rate (ORR) of 67% in second-line small cell lung cancer patients, with a 79% ORR in the 1.6 mg dosage group [2][7] - Received FDA fast track designation and is expected to initiate global registration clinical trials in the second half of the year [7][12] - **Z21,503**: - A bispecific antibody for atopic dermatitis showing promising preclinical data for itch and inflammation relief, with plans to submit a global IND application in the second half of the year [2][8] - **Bemarituzumab**: - Positive results in a global Phase III study for first-line gastric cancer, with plans to submit for market approval within six months [2][9] Financial Performance - **Q2 2025 Financials**: - Total revenue reached $110 million, a 9% year-over-year increase, with Eijamode revenue growing by 46% quarter-over-quarter [3][12] - Cash reserves exceeded $830 million, supporting business expansion and R&D investments [4][12] Market Dynamics - **Competition**: - Zele's sales revenue decreased in Q2 due to changes in competitive landscape but is expected to stabilize in the second half of the year [4][6] - New product **顶优乐 (Dingyoule)** received positive feedback but faced supply constraints, which the company is actively addressing [6][23] Future Outlook - **Growth Projections**: - Eijamode is projected to become a blockbuster product with peak sales potential of 7 billion RMB, driven by increasing market acceptance and new indications [18][19] - Zele is expected to recover and grow in market share, particularly in the ovarian cancer treatment segment [21][22] - **Clinical Trials and Approvals**: - Plans to submit multiple IND applications and initiate key clinical trials for various products, including those targeting autoimmune diseases and cancers [12][10][11] Strategic Initiatives - **AI Integration**: - The company plans to utilize AI platforms for patient management and to enhance treatment adherence [5][17] - **Market Education**: - A focus on educating healthcare providers and patients about new treatment guidelines and product benefits to increase adoption rates [4][17] Additional Important Information - The company is actively expanding its product pipeline and exploring collaborations to enhance its market position [15][34] - The competitive landscape for small cell lung cancer treatments is intensifying, with multiple products entering late-stage trials [26][27] - The company is preparing for the commercialization of new therapies, including those for IGA nephropathy and thyroid eye disease, with significant market potential [32][33]

Financial Data and Key Metrics Changes - The company reported base business sales of $6.9 billion, growing 4% year over year, driven by strong performance in HIV products [6][41] - Total product sales reached $7.1 billion, reflecting a 2% year-over-year increase, partially offset by a 44% decline in Vecluri sales due to fewer COVID-19 related hospitalizations [6][41] - Non-GAAP diluted EPS for the quarter was $2.01, with a product gross margin of 87% [42][41] Business Line Data and Key Metrics Changes - HIV sales amounted to $5.1 billion, representing a 7% year-over-year growth, with Biktarvy and Descovy contributing significantly [14][41] - Biktarvy sales grew 9% year over year to $3.5 billion, while Descovy saw a remarkable 35% increase to $653 million [14][16] - Trodelvy sales reached $364 million, up 14% year over year, reflecting strong demand in metastatic breast cancer [24][41] Market Data and Key Metrics Changes - The U.S. PrEP market has expanded to over 5 million active users, growing in the mid-teens year over year [17][20] - Descovy's market share for PrEP grew to over 40% in the U.S., with unrestricted access covering 88% of total lives [17][66] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue [20][21] Company Strategy and Development Direction - The company is focused on expanding its HIV product portfolio, with plans for up to eight additional product launches by 2033 [32] - The recent FDA approval of lenacapavir (YES2Go) is seen as a transformative step in HIV prevention, with a strong commercial launch strategy in place [5][18] - The company aims to enhance its oncology pipeline, particularly with Trodelvy, which is expected to advance into first-line treatment settings [10][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the HIV portfolio and the potential of lenacapavir to significantly impact the HIV epidemic [8][20] - The company is closely monitoring the macroeconomic landscape and is prepared to adapt its strategies as needed [47] - Management highlighted the importance of maintaining operational discipline while pursuing growth opportunities [48] Other Important Information - The company returned $1.5 billion to shareholders in the second quarter, including $527 million in share repurchases [48] - A new $6 billion share repurchase program has been approved to support continued buybacks [48] Q&A Session Summary Question: Can you elaborate on the early uptake with YES2Go? - Management reported strong early uptake with over 25,000 customer calls executed, indicating high awareness and readiness for the launch [51][56] Question: How durable is the growth rate for Descovy? - Management noted that the PrEP market is growing at about 15% year over year, with Descovy's performance driven by favorable access and reduced co-pays [63][66] Question: What is the potential impact of the MFN proposal on Gilead's business? - Management acknowledged ongoing discussions regarding the MFN proposal and emphasized the importance of maintaining patient access to medications [71][72] Question: How would changes in the USPSTF guidelines affect commercialization? - Management expressed confidence that even if guidelines change, the company could still ensure access to HIV prevention through strong payer relationships [80][82] Question: What updates should be expected regarding the WONDERS program? - Management indicated that updates on the WONDERS program would be forthcoming, particularly following the resolution of the clinical hold [85]

CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 智通财经APP讯，中国生物制药(01177)发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的创新药LM-24C5 "CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临 床试验批准，同意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试 验。 ...

Financial Data and Key Metrics Changes - For the first half of 2025, the company generated $192 million in ChemTrak revenue, representing a 32% year-over-year growth, marking a significant milestone four years post-launch [4][8] - In Q2 2025, net sales reached $98 million, a 30% increase compared to Q2 2024, and a 4% sequential increase over Q1 2025 [26][28] - The net loss decreased from $36 million to $5 million year-over-year, indicating improved financial performance as revenue growth outpaced operating expenses [29] Business Line Data and Key Metrics Changes - ChemTrak's performance in the U.S. saw net revenue of $64 million in Q2 2025, a 15% increase year-over-year, with a therapy duration of 13 months and a market penetration of approximately 68% [9][26] - In Europe, Q2 2025 net revenue was $33 million, reflecting an exceptional 115% year-over-year growth, driven by successful launches in the UK, Poland, and the Netherlands [10][26] Market Data and Key Metrics Changes - The company has launched ChemTrak in 28 countries and is approved in 39 globally, with ongoing expansion into Turkey and MENA regions through a partnership with Air Chem [6][7] - The company anticipates incremental growth from Europe as new launches mature, with expectations for continued growth in established markets [10][28] Company Strategy and Development Direction - The company's strategy focuses on three core pillars: maximizing ChemTrak's value, advancing the clinical portfolio, and innovating for sustainable growth [3][5] - The company is on track to file the CTA for its autoimmune candidates in type one diabetes by the end of 2025 and plans to start phase one trials in 2026 [5][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of ChemTrak and the diversified pipeline, emphasizing the commitment to advancing clinical programs efficiently [5][31] - The company remains focused on delivering progress in lifecycle management plans for ChemTrak and enrolling patients across multiple ongoing clinical trials [31] Other Important Information - The company has a strong balance sheet with $883 million in cash and marketable securities, allowing for continued investment in innovation while maintaining financial discipline [29][30] - The company expects to pay approximately $65 million related to European rebate accruals from prior periods in 2025 [29] Q&A Session Summary Question: What happens to patients whose dose is being discontinued in the study? - Patients on the discontinued dose will continue on that dose, although the IDMC may recommend switching to the go-forward dose, but they will not be included in the ITT analysis [34][35] Question: Should the company start thinking about a breakeven point? - It is too early to consider profitability as the company continues to invest in three phase three trials and expects R&D expenses to increase [37][38] Question: Can you provide details on the growth in the U.S. and the timeline for the phase three ADAM trial? - Growth in the U.S. is driven by deeper penetration into the community, with expectations for moderate growth moving forward. The ADAM trial is in early stages of site activation, typically taking up to three years for accrual [54][59] Question: How is the duration of therapy trending in Europe compared to the U.S.? - The duration of therapy in Europe is expected to be consistent with the U.S., with mature markets showing excellent duration similar to the U.S. [79][80] Question: What is the company's confidence regarding U.S. trial centers and patient demographics? - The company is confident that the site footprint will meet FDA requirements, with sufficient U.S. sites for both trials [108] Question: What are the expectations around the HIV program's dose escalation and expansion? - The company aims to see viral control beyond twelve weeks to trigger expansion, with ongoing dose escalation to find the right dose [88][90]

Core Viewpoint - BeiGene has reported its first half-year profitability since its listing, driven by significant product revenue growth and improved cost management [1][3]. Financial Performance - Total revenue for the first half of 2025 reached RMB 17.518 billion, a year-on-year increase of 46.0% [1]. - Operating profit was RMB 799 million, and net profit attributable to shareholders was RMB 450 million, marking a turnaround from losses in the previous year [1]. - Product revenue amounted to RMB 17.36 billion, up 45.8% year-on-year [1]. Key Products and Sales - The sales of the BTK inhibitor, Zebrutinib, reached RMB 12.527 billion in the first half, a 56.2% increase [2]. - In the U.S. market, Zebrutinib sales were RMB 8.958 billion, growing by 51.7% [1][2]. - The PD-1 inhibitor, Tislelizumab, generated sales of RMB 2.643 billion, reflecting a 20.6% increase [2]. Market Position - Zebrutinib has maintained the top position in the BTK inhibitor market in the U.S. for two consecutive quarters, with Q2 sales of USD 684 million, a 43% increase [2]. - In Europe, Zebrutinib sales reached RMB 1.918 billion, up 81.4% [2]. - In China, Zebrutinib sales were RMB 1.192 billion, a 36.5% increase [2]. R&D Pipeline - The company anticipates over 20 milestone developments in its blood cancer and solid tumor pipelines within the next 18 months [1]. - BeiGene has established three proprietary products in blood cancer treatment, including Zebrutinib and two products in Phase 3 clinical trials [3]. - The company is expanding its pipeline in solid tumors, focusing on various cancers and utilizing diverse technology platforms [3]. Future Guidance - BeiGene has updated its full-year revenue guidance for 2025 to a range of RMB 35.8 billion to RMB 38.1 billion [3]. - The gross margin guidance has been adjusted to a mid-high range of 80% to 90% [3]. - Positive cash flow from operating activities is expected for the year, excluding capital expenditures [3].

百济神州联合创始人、董事长兼首席执行官欧雷强（John V. Oyler）表示，第二季度强劲的表现，进一 步巩固了公司在全球肿瘤治疗领域的领先地位，并充分证明了公司实现可持续、长期增长的能力。"我 们目标明确，正在不断朝着使命前进，致力于为全球更多患者带来突破性药物。百悦泽作为公司血液肿 瘤领域的核心产品，确立了同类最佳BTK抑制剂的标杆地位，获批适应症最广泛，并在美国市场继续保 持领先优势，这得益于其在五个适应症中展现出的优异疗效、良好的安全性以及积极的患者获益。另外 两款处于3期临床研究阶段的血液肿瘤产品——BCL2抑制剂索托克拉和BTK嵌合式降解激活化合物 （CDAC）BGB-16673——将在近期公布关键性数据并启动新临床试验，进一步加强我们的领先地位。 在近期的投资者研发日活动上，我们展示了清晰的增长路径，预计未来18个月内将迎来超过20项研发里 程碑事件。这也包括在广泛的实体瘤管线中取得众多潜在积极进展。我们正针对一系列高发癌症打造全 球产品管线。" 其中，BTK抑制剂泽布替尼再次突破市场预期，上半年全球销售额达125.27亿元，同比增长56.2%。在 美国市场，泽布替尼销售额达89.58亿元，同 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 內幕消息 百濟神州有限公司 截至2025年6月30日止三個月及六個月未經審核業績以及 業務進展最新情況 本公告乃根據香港聯合交易所有限公司證券上市規則（「上市規則」）第13.09條及 根據證券及期貨條例（香港法例第571章）第XIVA部而刊發。 百濟神州有限公司（「本公司」或「百濟神州」）欣然公佈其截至2025年6月30日止 三個月及六個月的未經審核簡要合併財務業績以及業務進展最新情況。 本公司欣然公佈本公司及其附屬公司截至2025年6月30日止三個月及六個月未經 審核簡要合併財務業績（「第二季度業績」）以及2025年第二季度關鍵業務亮點和更 新2025年年度財務指引（「業務進展」）。第二季度業績乃根據美國證券交易委員會 的適用規則刊發。 第二季度業績乃根據美國公認會計準則編製（「美國公認 ...

8月6日，百济神州(纳斯达克代码：ONC；香港联交所代码：06160.HK；上交所代码：688235.SH)公布 2025年第二季度美股业绩报告，以及A股半年度主要财务数据公告。2025年上半年，百济神州实现营业 总收入175.18亿元，同比增长46.0%。产品收入达173.60亿元，同比增长45.8%。 基于此，百济神州更新收入指引，预计2025年全年营收将从人民币352亿元至381亿元之间，调整为人民 币358亿元至381亿元之间。此外，毛利率更新为80%至90%的中高位区间。现金流方面，经营活动产生 的现金流量扣除购建固定资产等资本性支出后的净额预计全年为正。 百济神州联合创始人、董事长兼首席执行官欧雷强(John V. Oyler)表示："第二季度强劲的表现，进一步 巩固了公司在全球肿瘤治疗领域的领先地位，并充分证明了我们实现可持续、长期增长的能力。我们目 标明确，正在不断朝着使命前进，致力于为全球更多患者带来突破性药物。百悦泽 作为公司血液肿瘤 领域的核心产品，确立了同类最佳BTK抑制剂的标杆地位，获批适应症最广泛，并在美国市场继续保持 领先优势，这得益于其在五个适应症中展现出的优异疗效、良好的安全 ...

Core Viewpoint - BeiGene reported strong financial performance for the first half of 2025, achieving significant revenue growth and profitability, driven by product sales and effective cost management [1][2][3] Financial Performance - Total revenue for the first half of 2025 reached RMB 17.518 billion, a year-on-year increase of 46.0% [1] - Product revenue amounted to RMB 17.360 billion, reflecting a growth of 45.8% compared to the previous year [1] - Operating profit was RMB 799 million, and net profit attributable to shareholders was RMB 450 million, marking a turnaround from losses in the same period last year [1] - The company updated its revenue guidance for 2025, now expecting total revenue between RMB 35.8 billion and RMB 38.1 billion, with a gross margin forecast of 80% to 90% [1] Product Performance - The BTK inhibitor, Zanubrutinib (Brukinsa), achieved global sales of RMB 12.527 billion in the first half of 2025, a 56.2% increase year-on-year [3] - In the U.S. market, Zanubrutinib sales reached RMB 8.958 billion, up 51.7%, driven by strong demand across all indications [3] - The PD-1 inhibitor, Tislelizumab, generated sales of RMB 2.643 billion, a 20.6% increase, benefiting from new indications and increased hospital access in China [4] R&D Pipeline - The company is at a critical juncture in its R&D pipeline, expecting over 20 milestone events in the next 18 months across hematological and solid tumor indications [6] - BeiGene has advanced 15 new molecular entities into clinical trials from 2019 to 2023, with over 10 new entities entering trials in 2024 alone [6] - The company has established a robust global clinical development platform, conducting over 170 trials across 40 countries with more than 25,000 patients enrolled [6] Future Developments - In hematological oncology, BeiGene has three fully owned products, including Zanubrutinib and two candidates in Phase 3 trials, which are expected to meet unmet needs in chronic lymphocytic leukemia (CLL) [7] - In solid tumors, the company is advancing multiple products, including a CDK4 inhibitor for breast cancer and a PRMT5 inhibitor, with clinical trials expected to commence in the near future [8][9]

智通财经APP讯，百济神州(06160)发布截至2025年6月30日止三个月及六个月未经审核业绩，2025年第 二季度总收入为13.15亿美元，同比增加41.56%;净利润9432万美元，上年同期净亏损1.2亿美元;每股基 本收益0.07美元。 于2025年上半年，实现总收入24.33亿美元，同比增加44.73%;净利润9559万美元，上年同期净亏损3.72 亿美元;每股基本收益0.07美元。 公告称，第二季度总收入增长主要得益于百悦泽® (泽布替尼)在美国和欧洲的销售额增长。 2025年第二 季度，产品收入为13亿美元，上年同期为9.21亿美元。产品收入增长主要得益于百悦泽®销售额增长。 美国仍是公司最大的市场，产品收入达6.85亿美元，上年同期为4.79亿美元。从安进公司获得授权许可 的产品和百泽安® (替雷利珠单抗)的销售也对产品收入增长做出贡献。 "第二季度强劲的表现，进一步巩固了公司在全球肿瘤治疗领域的领先地位，并充分证明了我们实现可 持续、长期增长的能力。"百济神州联合创始人、董事长兼首席执行官欧雷强先生表示，"我们目标明 确，正在不断朝着使命前进，致力于为全球更多患者带来突破性药物。百悦泽®作为 ...