Core Viewpoint - The voluntary withdrawal of the lawsuit by both parties marks a significant victory for BeiGene and represents a shift for Chinese innovative pharmaceutical companies from "defensive outbound" to "rule-based outbound" strategies [1][16]. Summary by Sections Patent Dispute Conclusion - The two-year patent battle concluded with BeiGene successfully defending its position as AbbVie decided not to appeal the final decision of the U.S. Patent and Trademark Office [2][3]. - The resolution clears the patent obstacles for Zanubrutinib in the U.S. market, which is the first innovative drug approved in the U.S. from China and has generated over $6.4 billion in revenue for BeiGene [3][4]. Strategic Importance of Zanubrutinib - Zanubrutinib is crucial for BeiGene, contributing over 70% of its sales, and serves as a key product for entering the U.S. and global markets [12]. - The drug has achieved significant market share, surpassing its competitor Ibrutinib in the BTK inhibitor field by mid-2025 [3][13]. Legal Strategy and Tactics - A pivotal moment in the patent battle was BeiGene's proactive approach in initiating a Post Grant Review (PGR) process, leading to the invalidation of AbbVie's patent [6][8]. - This strategy shifted the focus from infringement to the validity of the patent itself, allowing BeiGene to take the initiative rather than merely defending against claims [9][10]. Implications for Chinese Pharmaceutical Companies - The outcome is viewed as a landmark victory for Chinese innovative pharmaceutical companies in navigating the U.S. intellectual property landscape [4][16]. - The case serves as a reference model for other Chinese companies facing complex patent disputes abroad, emphasizing the importance of understanding U.S. patent law and utilizing various procedural tools [17][18]. Future Considerations - Despite the victory, the competitive landscape remains challenging, and Chinese pharmaceutical companies must continue to innovate and comply with international regulations [14][16]. - Establishing a robust global intellectual property strategy is essential for both defensive and offensive maneuvers in future patent disputes [18].

一场持续两年多的专利保卫战告终了，百济神州（688235.SH/06160.HK/ONC.US）守住了城池。 10月8日，百济神州公告，艾伯维决定不对美国专利商标局最终决定提起上诉，双方已提交共同协议。 至此，泽布替尼在美国市场的专利障碍得以清除。 这场专利战始于2023年6月，当时，艾伯维子公司以泽布替尼侵犯其伊布替尼专利权益为由，起诉了百 济神州。 百济神州是中国创新药"一哥"，也是国际化成绩最好的药企。对百济神州来说，这是一场不能输的战 役。 泽布替尼是中国第一款在美获批的创新药，也是中国第一款国产重磅炸弹药物（年销售额超10亿美 元）。上市以来为百济神州贡献营收合计超64亿美元。近几年，泽布替尼在美国市场更是风生水起， 2025年上半年，在BTK抑制剂领域，泽布替尼市场占有率已超过对手伊布替尼，提升至全球第一。可以 说，百济神州造就了泽布替尼，泽布替尼也成就了百济神州。 专注生命科学领域业务的汉坤律师事务所合伙人顾泱告诉经济观察报，百济神州与艾伯维自愿撤回全部 诉讼，标志着双方在本次专利争议中取得了程序性和实质性进展，也为中国创新药出海解决专利纠纷提 供了思路。 这场诉讼的落幕，被业内视为中国创新药企 ...

百济神州作为中国创新药企的标杆，随着产品全球销售的推进，2025年将实现盈利，标志着公司从研发 投入期迈向商业化收获期。同时，随着新一代技术平台的产品兑现，ADC，PROTAC等众多新管线将进 入验证阶段，百济也将由血液瘤龙头向实体瘤和免疫领域拓展。我们认为，百济神州已进入到新的阶 段，正在向全球MNC进化。 免疫与炎症领域，IRAK4 CDAC在特应性皮炎和结节性痒疹的2期临床入组中，预计2025H2读出poc数 据。 公司进入稳定盈利阶段：25Q2公司的GAAP毛利率为87.4%，同比提升2.4个百分点。25Q2公司GAAP持 续盈利达0.94亿美金，经调整净利润为2.53亿美金，盈利能力显著增强。 盈利预测和投资建议：随着公司自研产品，如百悦泽和百泽安的新适应症持续获批，我们预计2025- 2027年公司的百悦泽的收入分别为279.6、356.0、416.8亿元，同比分别增长49%、27%、17%。百泽安 的收入分别为7.5、8.8、10.2亿美元（53.0、62.6、72.6亿元），同比分别增长20%、18%、16%。2026年 我们预计BCL2抑制剂获批上市。公司未来合作收入存在不确定性，我们假设该 ...

10月8日晚间，百济神州发布公告，披露旗下核心BTK抑制剂泽布替尼（商品名"百悦泽"）在美国市场 被诉专利侵权的最新进展：百济神州及艾伯维旗下公司Pharmacyclics公司已向法院提交一份共同协议， 自愿撤回案件，案件已做出终局处理。这意味着，这场历时两年多的跨国专利侵权诉讼案，百济神州获 胜。 尽管双方就上述专利侵权案已经终结，但艾伯维针对百济神州BGB-16673的专利诉讼仍在进行中。2024 年9月，艾伯维提起诉讼，声称百济神州在BTK降解剂研发过程中窃取了艾伯维的商业机密，该诉讼主 要围绕百济神州在研药物BGB-16673。百济神州认为，该诉讼意在阻碍BGB-16673的开发进程。BGB- 16673是一款口服、靶向BTK的在研嵌合式降解激活化合物（CDAC），也是百济神州管线中进展最快 的BTK降解剂，2024年8月27日被FDA授予快速通道认定。 对于这一起诉讼，百济神州表示，无论结果是否对公司有利，对此类申诉进行辩护可能会导致高额成 本，并分散管理层的注意力。如果公司未能抗辩成功，可能导致需要支付经济赔偿以及失去重要的知识 产权并遭受声誉损失。 畅销药的专利保护战 泽布替尼被诉专利侵权，百济 ...

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） 授出受限制股份單位及業績股份單位 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。於2025年9月30 日，董事會薪酬委員會根據2016期權及激勵計劃的條款向二百三十七名承授人授 出涉及合共36,234股美國存託股份的受限制股份單位，並向一名承授人授出涉及 合共2,935股美國存託股份的業績股份單位。 2016期權及激勵計劃項下的受限制股份單位及業績股份單位 於2025年9月30日，董事會薪酬委員會根據2016期權及激勵計劃的條款授予二百 三十七名承授人合共36,234股美國存託股份受限制股份單位，並向一名承授人授 出合共2,935股美國存託股份業績股份單位。該等受限制股份單位及業績股份單位 相當於509,197股股份，約佔本公告之日公司發行股份總數的0.03%。 ...

截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 百濟神州有限公司 (根據瑞士法律註冊成立的公司) 呈交日期: 2025年10月8日 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 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) | 06160 | 說明 | 請見備注 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,311,463,847 | USD | | 0.0001 USD | | 231,146.38 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 2,311,463,847 | USD | | 0.0001 USD | | 231,146.38 | ...

Core Viewpoint - The majority of Chinese concept stocks in the US pre-market are experiencing declines, with notable exceptions such as Bilibili which is up by 6% [1] Company Performance - Bilibili is showing a positive performance with a 6% increase [1] - JD.com is slightly down by 0.2% [1] - NIO has decreased by 0.5% [1] - Li Auto and Alibaba both fell by 1% [1] - Xpeng Motors is down by 3% [1] - BeiGene has seen a decline of 4% [1]

Core Viewpoint - The Hong Kong biopharmaceutical sector experienced a significant decline, with major companies reporting substantial drops in stock prices, indicating a bearish trend in the market [1]. Group 1: Stock Performance - Innovent Biologics (099660) saw a decline of 11.54%, with a latest price of 16.640 and a market capitalization of 293.36 billion, despite a year-to-date increase of 171.90% [2]. - Rongchang Biologics (09995) dropped by 9.20%, priced at 108.600, with a total market value of 612.08 billion, and a remarkable year-to-date increase of 654.17% [2]. - Kelun-Biotech (06990) fell by 7.71%, with a latest price of 533.000 and a market cap of 1,242.88 billion, while still showing a year-to-date increase of 226.39% [2]. - Tigermed (03347) decreased by 6.86%, priced at 43.960, with a market capitalization of 378.51 billion and a year-to-date increase of 44.25% [2]. - WuXi AppTec (02268) experienced a decline of 6.22%, with a latest price of 77.650 and a market cap of 954.09 billion, maintaining a year-to-date increase of 153.34% [2]. - CanSino Biologics (09926) dropped by 5.15%, priced at 134.500, with a market capitalization of 1,238.94 billion, and a year-to-date increase of 121.58% [2]. - Other companies like Junshi Biosciences (01877) and BeiGene (06160) also reported declines, with respective decreases of 3.16% and 2.48% [2].

Group 1 - Norin Pharma and Zenas BioPharma have reached a licensing agreement for the global development and commercialization rights of Obinutuzumab in multiple sclerosis and other non-oncology indications [1] - Zenas also acquired rights to two preclinical molecules, a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor [1] - This strategic collaboration aims to accelerate the clinical development of Obinutuzumab and maximize its clinical and commercial value globally, particularly in the field of multiple sclerosis [1] Group 2 - The board of *ST Sailong has received resignation letters from Chairman Chen Ke, Vice President and Secretary Zhang Xu, and Vice President Duan Daifeng [2] - Chen Ke and Zhang Xu will retain their positions as President and Secretary, respectively, while Duan Daifeng's resignation reflects a personal career development decision [2] - This "name resignation but actual retention" adjustment is common but may indicate potential strategic disagreements within the company [2] Group 3 - BeiGene announced that Pharmacyclics LLC has decided not to appeal the final written decision of the U.S. Patent and Trademark Office, leading to the voluntary withdrawal of the lawsuit [3] - The lawsuit was resolved without adverse effects on BeiGene, and the development and sales of Baiyueze® in the U.S. remain unaffected [3] - The resolution of this litigation does not pose significant negative impacts on the company's operations [3] Group 4 - BaiLi Tianheng's first antibody-drug conjugate (ARC) has received clinical trial approval from the National Medical Products Administration [4] - The drug, Lutetium [177Lu]-BL-ARC001 injection, is intended for patients with locally advanced or metastatic solid tumors who have failed standard treatments [4] - This therapy offers new hope for advanced solid tumor patients by precisely targeting and destroying tumor cells, showcasing a differentiated innovation path in the current ADC drug development landscape [4]

Core Viewpoint - The lawsuit involving BeiGene and Pharmacyclics has been voluntarily withdrawn, resulting in no negative impact on the company's operations or product development in the U.S. market [2][5][4]. Group 1: Lawsuit Details - On June 13, 2023, Pharmacyclics LLC filed a lawsuit against BeiGene and its subsidiary BeOne Medicines USA, claiming patent infringement related to the product 百悦泽? [3]. - The patent in question is U.S. Patent No. 11,672,803, which was granted to Pharmacyclics on the same day the lawsuit was filed [3]. - The court has agreed to pause the infringement lawsuit pending the outcome of a Patent Trial and Appeal Board (PTAB) review, which is expected to conclude by November 1, 2023 [3]. Group 2: Impact on the Company - The lawsuit has not adversely affected the research and sales of 百悦泽? in the U.S. market, nor has it significantly impacted the company's overall operations [5]. - The company maintains confidence in its intellectual property related to 百悦泽? and plans to continue developing innovative cancer treatment solutions [2][5].