Core Insights - The company reported a revenue of 17.518 billion yuan for the first half of the year, representing a year-on-year growth of 46.03%, and achieved a net profit of 450 million yuan, compared to a loss of 2.877 billion yuan in the same period last year [1] - The revenue growth was primarily driven by the global sales performance of core products, particularly the BTK inhibitor, Brukinsa (Zebutinib), which generated global sales of 12.527 billion yuan, a 56.2% increase year-on-year [1] - The company continues to invest heavily in R&D, with R&D expenses reaching 7.278 billion yuan, a 9.80% increase, accounting for 41.54% of total revenue [1] Revenue Breakdown - Brukinsa sales in the U.S. reached 8.958 billion yuan, a year-on-year increase of 51.7% - Sales in Europe amounted to 1.918 billion yuan, growing by 81.4% - Sales in China were 1.192 billion yuan, reflecting a 36.5% increase [1] - The other core product, PD-1 monoclonal antibody, Baiyuean (Tislelizumab), achieved sales of 2.643 billion yuan, a 20.6% increase, supported by new indications being included in medical insurance in China [1] R&D and Pipeline Developments - The company has one of the largest oncology research teams in the industry and is strong in the translational discovery of small molecules and antibody drugs, with three proprietary platform technologies: ADC, bispecific antibodies, and CDAC [2] - Over the next 18 months, the company anticipates more than 20 milestone advancements in its hematologic and solid tumor pipelines [3] - The global Phase III trial for the BCL2 inhibitor, Sonrotoclax, in combination with Brukinsa for first-line treatment of CLL has completed patient enrollment [3] Collaborations and Commercialization - In August 2025, the company entered into an agreement with Royalty Pharma to sell the royalty rights for the global sales of Tarlatamab outside of China, with a transaction value of up to 950 million USD, optimizing cash flow structure [4] - The company has established a competitive global commercialization team in major markets such as the U.S., EU, and China, and is accelerating business expansion in Asia-Pacific, Latin America, and the Middle East to diversify revenue sources [4]

Core Viewpoint - The company is actively implementing its "Quality Improvement and Efficiency Enhancement" action plan for 2025, focusing on accelerating drug development, enhancing financial management, and improving corporate governance to increase shareholder value and maintain compliance with regulatory requirements [1][12]. Group 1: Drug Development and Commercialization - The company has made significant progress in its core drug pipeline, with multiple candidates in various clinical development stages targeting key oncogenic drivers such as ALK, RET, and KRAS (G12C) [2][3]. - The key Phase III clinical study of SY-5007 for RET fusion-positive NSCLC has met its primary endpoint, demonstrating significant anti-tumor activity [3]. - The company is advancing the development of SY-3505, a third-generation ALK inhibitor, with key Phase II and III studies completed, and patient follow-ups are ongoing [3][4]. - SY-5933 has shown promising pharmacokinetic properties and anti-tumor activity in patients with KRAS (G12C) mutations, with good tolerability observed [4][5]. - The company is exploring combination therapies with SY-5933 and SY-707, showing enhanced anti-tumor effects in preclinical models [6]. Group 2: Early Pipeline and International Collaboration - The company is committed to early-stage research, presenting key data on four projects at the 2025 AACR annual meeting, including a fourth-generation ALK inhibitor and various other targeted therapies [7]. - Plans are in place to present data on SY-5007 at the 2025 ESMO annual meeting, highlighting the company's ongoing commitment to international academic exchange [7]. Group 3: Infrastructure Development - The company has signed an economic development cooperation agreement to invest up to 787 million yuan in a new drug research and industrialization base at Bio Park, enhancing its R&D and production capabilities [8]. Group 4: Financial Management - As of mid-2025, the company reported total assets of 819.45 million yuan and equity attributable to shareholders of 704.64 million yuan, with no interest-bearing debt, indicating a strong financial position [9]. - The company achieved cash management income of 9.44 million yuan through prudent investment strategies while ensuring liquidity and safety [10]. Group 5: Corporate Governance - The company has strengthened its governance structure, holding multiple board meetings and enhancing communication with key personnel to ensure compliance and effective oversight [11]. - Amendments to the company's governance documents are underway to align with new regulations, aiming to clarify responsibilities and improve governance efficiency [12]. Group 6: Investor Relations and Information Disclosure - The company emphasizes investor communication, participating in nearly 60 investor engagement activities and ensuring transparent information disclosure [12][13]. - A total of 2 regular reports and 17 temporary announcements were disclosed in the first half of 2025, maintaining high standards of transparency and compliance [13][14].

Core Viewpoint - The company has reported significant revenue growth and profitability improvements in its interim results, driven by successful commercialization of its product pipeline and strategic partnerships in the oncology sector [1][2][3] Financial Performance - The company achieved revenue of RMB 466 million, a year-on-year increase of 249.59% [1] - Profit attributable to owners was RMB 41.75 million, compared to a loss of RMB 192 million in the same period last year [1] - Basic earnings per share were RMB 0.02 [1] - Revenue from MRG007 licensing was RMB 309 million, up from RMB 20.7 million in the same period last year [1] - Sales of Puyuheng (Petrilizumab injection) generated RMB 151 million, a significant increase of 58.8% compared to RMB 94.8 million in the previous year [1] - Revenue from CDMO services was RMB 6.3 million, down from RMB 17.8 million in the same period last year [1] Product Pipeline and Development - The company has strategically developed multiple oncology product pipelines, including one candidate drug in the clinical/commercialization stage and nine in clinical stages [2] - Among the nine clinical candidates, seven are targeted therapies and two are immunotherapies [2] - MRG003 has received FDA designations including BTD, ODD, and FTD for treating NPC [2] - MRG002 and CMG901 have also received FDA designations for their respective indications [2] - The company is focused on building and developing new technology platforms as part of its innovation strategy [2] Commercialization Strategy - The company aims to commercialize its product pipeline in China through a professional sales and marketing team while expanding into international markets via strategic partnerships [3] - Puyuheng has completed the commercialization process and is experiencing rapid sales growth [3] - CMG901's global rights have been licensed to AstraZeneca, and MRG007's rights outside Greater China have been licensed to ArriVent [3] - The company has established end-to-end commercialization capabilities in the domestic market and is positioning itself as a global biotech company [3]

Core Viewpoint - Colun Biotechnology reported a 31.3% year-on-year decline in revenue for the first half of the year, with a net loss of 145 million yuan, both figures better than market expectations [1] Group 1: Financial Performance - The company's product sales amounted to 310 million yuan, primarily driven by sac-TMT, with an expansion into second-line non-small cell lung cancer (NSCLC) expected to accelerate sales growth in the second half of the year [1] - The sales forecasts for Colun Biotechnology for 2025 to 2027 have been adjusted upwards by 5.3%, 2.7%, and 2.3% respectively, while net profit forecasts have been adjusted downwards by 20.2% and then upwards by 34.2% and 21.9% for the same period [1] Group 2: Clinical Developments - Colun Biotechnology is set to present third-phase clinical data for sac-TMT in second-line NSCLC and second-line HR+ HER2- breast cancer at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] - Multiple third-phase trials covering first-line NSCLC and triple-negative breast cancer (TNBC) are expected to yield results next year [1] Group 3: Analyst Ratings - The target price for Colun Biotechnology has been raised from 328.4 HKD to 500.6 HKD, with a reaffirmation of the "outperform" rating [1]

投资要点 事件： 8 月 18 日，百利天恒美国子公司SysImmune 与百时美施贵宝（BMS）共同宣布，FDA 授予伦康 依隆妥单抗（Iza-Bren，BL-B01D1）突破性疗法资格，用于治疗携带 EGFR 外显子 19 缺失或外显子21 L858R 替换突变且既往接受过EGFR-TKI 和含铂化疗治疗的局部晚期或转移性 NSCLC 患者。 风险提示：研发进度不及预期，临床结果具备不确定性，市场竞争恶化等。 点评：本次突破性疗法资格的获得主要是基于 BL-B01D1-101（中国）、BL-B01D1-203（中国）和 BL- B01D1-LUNG-101（美国 / 欧盟）研究数据，这些试验表明，在经第三代 EGFR TKI和含铂化疗后进展 的 EGFRmt NSCLC 患者中，Iza-Bren 展现出疗效改善的证据且安全性可控。FDA 突破性疗法认定旨在 加速那些可能显著优于现有标准疗法的药物开发和审评进程。 近五年目标成为一家具有全球能力和规模的MNC：公司目前已具备跨国药企四大核心能力中的三项关 键支柱——全球早期研发能力、全球临床开发能力与全球生产供应能力。随着BL-B01D1 的成功商业 化，公 ...

Investment Rating - The report maintains a "Buy" rating for the company, with target prices adjusted to $18 for US shares and HK$28 for Hong Kong shares, reflecting a potential upside of 10% and 19% respectively [8][20]. Core Insights - The company's revenue from three core products significantly underperformed expectations in the first half of 2025, primarily due to intensified competition in the Chinese market. Consequently, the annual revenue guidance for the oncology segment has been revised downward [1][5]. - The report highlights that the overall oncology revenue for 1H25 was $143 million, down 14.9% year-over-year and 26.3% quarter-over-quarter, which was below both the report's and market expectations [5][8]. - The company is expected to achieve a revenue range of $127 million to $207 million in the second half of 2025, with management expressing confidence in potential sales growth due to new approvals and market penetration [5][8]. Financial Performance Summary - The company reported a net profit of $455 million in 1H25, which was slightly better than expectations, primarily due to cost savings in R&D and administrative expenses [5][8]. - Revenue projections for 2025, 2026, and 2027 have been adjusted to $575 million, $657 million, and $794 million respectively, reflecting a year-over-year decline of 8.8% in 2025, followed by growth in subsequent years [9][11]. - The report indicates that the company is considering introducing external oncology assets to enhance its pipeline, leveraging its strong cash reserves [7][8]. Market Expectations - The report outlines optimistic and pessimistic scenarios for the company's future performance, with target prices of $25 and $10 under different market conditions [24][30]. - The potential catalysts for the next 12 months include new drug approvals and submissions, which could significantly impact revenue growth [7][8].

A 股代码：688235 A 股简称：百济神州 公告编号：2025-028 港股代码：06160 港股简称：百济神州 美股代码：ONC 百济神州有限公司 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。 特别提示： ? 本公告所载的百济神州有限公司（以下简称"百济神州"或"公司"）2025 年半年度主要财务数据为初步核算数据，未经会计师事务所审计，具体数据以公司 ? 本公告财务数据按中国企业会计准则编制并呈列。 ? 本公司已于 2025 年 8 月 6 日同步发布了根据美国公认会计原则及美国证券交 易委员会适用规则编制的截至 2025 年 6 月 30 日止三个月及六个月未经审计财务业 绩，提请投资者注意与本公告区别。 一、2025 年半年度主要财务数据和指标 单位：人民币千元 项目 本报告期 上年同期 增减变动幅度（％） 营业总收入 17,518,269 11,996,406 46.0 其中：产品收入 17,360,163 11,907,783 45.8 营业利润 798,940 -2,698,571 不适用 利润总额 7 ...

Financial Data and Key Metrics Changes - Revenue reached $1.3 billion in Q2 2025, representing a 42% year-on-year growth [5][17] - GAAP earnings per ADS grew by $2 compared to Q2 of the previous year [5] - Free cash flow generated in Q2 was $220 million, an increase of over $400 million year-on-year [5] - Gross margin improved to approximately 87% from 85% in the prior quarter [21] - Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year [23] Business Line Data and Key Metrics Changes - Brukinza global revenues were $950 million, growing 49% year-on-year, driven by strong performance across all geographies [17] - Tovembra reported a 22% increase in revenue, reflecting continued market leadership in China [19] - In-licensed products showed continued strength, growing 27% year-on-year [19] Market Data and Key Metrics Changes - The US market generated $685 million with a year-on-year growth of 43% [20] - China revenue totaled $429 million, a 23% increase [20] - Europe contributed $152 million with 87% year-on-year growth [20] - Rest of world markets grew by 168% driven by market expansions and new launches [20] Company Strategy and Development Direction - The company aims to maintain leadership in the hematology franchise and expand its solid tumor pipeline [6][15] - Plans to combine assets in multiple phase three trials to improve outcomes for CLL patients [15] - The company is focused on serial innovation in CLL and aims to build a deep pipeline across various disease areas [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in long-term market leadership for Brukinza despite competitive pricing pressures [18] - The company anticipates stable pricing for the remainder of the year [46] - Future impacts from potential US tariffs are expected to be manageable within the context of the P&L [73] Other Important Information - The company is preparing for the initial global approval of Sonro and anticipates pivotal data for its BTK CDAC by 2026 [15] - The tablet formulation of Brukinza is expected to achieve a lower cost of goods and improve patient convenience [24] Q&A Session Summary Question: Update on Brukinza's US net pricing and inventory changes - Management anticipates stable pricing for the remainder of the year and has no significant inventory levels to comment on [46][47] Question: Reaction to Bruin CLL 314 data for PERTO versus IMBRUVICA - Management noted that the OR superiority was not formally tested and emphasized the importance of PFS data [48][49] Question: Delay in starting the second line phase three trial for CDK4 - Management stated that the delay is modest and aims to let data mature for better dose level selection [53] Question: Impact of US tariffs on gross margin - Management indicated that current guidance contemplates known tariffs and that impacts have been mitigated through supply chain strategies [73] Question: Specifics on access to Brukinza and revenue mix - Management confirmed that Brukinza continues to be listed on all Medicare Part D formularies and access is strong [99][100]

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，概不對因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 希維奧®是世界首款獲批准的核輸出蛋白口服選擇性XPO1抑制劑。其具有新穎的 作用機制，在聯合治療中具有協同作用，快速起效，且反應持久。 （股份代號：6996） 自願公告 希維奧®在中國獲批用於多發性骨髓瘤的二線治療 本公告由德琪醫藥有限公司（「本公司」，連同其附屬公司統稱為「本集團」）自願 作出，以向本公司股東及有意投資者提供有關本集團的最新業務發展資料。本 公司董事（「董事」）會（「董事會」）欣然宣佈，中國國家藥品監督管理局(NMPA) 已批准希維奧® （塞利尼索）（與硼替佐米和地塞米松(XVd)聯用）用於治療既往接 受過至少一種治療的多發性骨髓瘤(MM)成年患者，這是希維奧®的一種新適應症。 承董事會命 德琪醫藥有限公司 董事長 梅建明博士 香港，2025年7月28日 於本公告日期，董事會包括執行董事梅建明博士及龍振國先生；及獨立非執行董 ...

Core Viewpoint - The company will present the latest research results of its self-developed products DZD8586 and DZD6008 at the 2025 American Society of Clinical Oncology (ASCO) conference [1] Group 1: Product DZD8586 - DZD8586 is aimed at treating B-cell non-Hodgkin lymphoma, with a focus on chronic lymphocytic leukemia/small lymphocytic lymphoma [1] - The efficacy and safety of DZD8586 will be showcased, particularly through a summary analysis included in an oral presentation [1] Group 2: Product DZD6008 - DZD6008 is a novel, highly selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor [1] - The product targets EGFR-mutant non-small cell lung cancer patients who have undergone multiple lines of treatment, including third-generation EGFR TKIs [1] - Positive research results for DZD6008 will be presented for the first time [1]