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].

Core Viewpoint - The patent dispute between BeiGene and AbbVie has concluded, allowing BeiGene to maintain its market position for the drug Zebrutinib in the U.S. market, marking a significant victory for Chinese innovative pharmaceutical companies in the U.S. intellectual property landscape [2][3][10]. Summary by Sections Patent Dispute Resolution - On October 8, BeiGene announced that AbbVie would not appeal the final decision from the U.S. Patent and Trademark Office, leading to the removal of patent barriers for Zebrutinib in the U.S. market [2]. - The patent battle began in June 2023 when AbbVie accused BeiGene of infringing its patent rights related to Ibrutinib [2][4]. - Zebrutinib is the first innovative drug approved in the U.S. from China, contributing over $6.4 billion in revenue since its launch [2][8]. Strategic Victory - The turning point in the patent battle was BeiGene's proactive approach in filing for a Post Grant Review (PGR) to challenge the validity of AbbVie's patent, which ultimately led to the patent being declared invalid [4][6]. - AbbVie had been preparing for this legal action since obtaining a new patent just days before filing the lawsuit against BeiGene [5][6]. Market Impact - Zebrutinib has become a leading product for BeiGene, accounting for over 70% of its sales, and has established a strong market presence in the U.S. and globally [8][9]. - In 2024, Zebrutinib achieved $2.6 billion in annual sales, ranking among the top 20 global oncology drugs [9]. Industry Implications - The resolution of this patent dispute is seen as a landmark victory for Chinese innovative pharmaceutical companies, shifting their role from defensive to proactive in international markets [10][12]. - The case serves as a reference for other Chinese pharmaceutical companies on how to navigate complex patent disputes in the U.S. [12]. Future Considerations - Despite the victory, the competitive landscape remains challenging, and Chinese pharmaceutical companies must continue to innovate and adapt to international regulations [9][11]. - Establishing robust global intellectual property strategies is essential for Chinese companies to effectively compete and protect their innovations [12].

Group 1 - Six stocks received buy ratings from institutions today, with Baijia Shenzhou-U, Gongchuang Turf, and Yujing Co. being newly covered by institutions [1][2] - Among the buy ratings, three were first-time ratings for Baijia Shenzhou-U and Gongchuang Turf [1] - The average decline for stocks with buy ratings today was 1.91%, underperforming the Shanghai Composite Index, with notable declines in SMIC, Baijia Shenzhou-U, and Yujing Co. at 7.89%, 6.20%, and 1.15% respectively [1] Group 2 - The latest buy ratings include SMIC with a target price of 238.00 yuan and a closing price of 127.95 yuan, and Gongchuang Turf with a closing price of 31.20 yuan [2] - Other stocks rated include Aorijun with a target price of 6.76 yuan and a closing price of 5.69 yuan, and Yujing Co. with a target price of 36.10 yuan [2] - Baijia Shenzhou-U received a strong recommendation with a closing price of 285.59 yuan, but no target price was provided [2]

Market Overview - The average stock price in A-shares is 13.69 yuan, with 164 stocks priced over 100 yuan, a decrease of 13 from the previous trading day [1] - The Shanghai Composite Index closed at 3897.03 points, down 0.94%, while stocks priced over 100 yuan saw an average decline of 3.30%, underperforming the index by 2.36 percentage points [1] Performance of High-Value Stocks - The highest closing price among stocks over 100 yuan is Kweichow Moutai at 1430.00 yuan, down 0.47%, followed by Cambrian and GigaDevice at 1247.08 yuan and 531.98 yuan respectively [1] - Among the 164 high-value stocks, 26 increased in price today, with notable gainers including Northern Long Dragon and TaoTao Automotive, while 136 stocks declined, with C Yunhan and Huicheng Environmental Protection experiencing the largest drops [1] Recent Trends in High-Value Stocks - Over the past month, high-value stocks have averaged a 16.67% increase, outperforming the Shanghai Composite Index's 2.36% rise [2] - Year-to-date, these stocks have shown an average increase of 108.52%, significantly higher than the index's 92.25% [2] - Notable performers include Pinming Technology, Demingli, and Jiangbolong, with increases of 173.21%, 113.25%, and 93.43% respectively [2] Sector Distribution - The high-value stocks are concentrated in the electronics, computer, and pharmaceutical industries, with 58 stocks in electronics (35.37%), 20 in computers (12.20%), and 16 in pharmaceuticals (9.76%) [2] - In terms of market segments, there are 38 stocks from the main board, 51 from the ChiNext, 3 from the Beijing Stock Exchange, and 72 from the Sci-Tech Innovation Board, with the latter representing 43.90% of high-value stocks [2] Institutional Ratings - Among the high-value stocks, two received buy ratings from institutions today, including SMIC and BeiGene, with BeiGene being newly covered by analysts [2]

Core Insights - BeiGene is positioned as a leading innovative pharmaceutical company in China, aiming to achieve profitability by 2025, marking a transition from R&D investment to commercialization [1] - The company is expanding its product pipeline into solid tumors and immunology, leveraging new technology platforms such as ADC and PROTAC [1] Global R&D and Commercialization - BeiGene has established a global clinical and commercialization system with a team of approximately 3,700, enabling clinical trials with minimal reliance on CROs [1] - Key products, Baiyueze and Baizean, have been approved in 75 and 47 markets respectively, covering hematological malignancies, solid tumors, and immune diseases, showcasing strong market penetration and product diversity [1] - In the first half of 2025, the company's product revenue reached $2.41 billion, a year-on-year increase of 44.5%, with Q2 revenue of $1.3 billion, up 41.4% [1] Hematological Malignancies - The core product, Zebutinib, saw significant sales growth, reaching $1.74 billion in the first half of 2025, a 55% increase year-on-year [2] - In the U.S., Baiyueze sales in Q2 2025 were $684 million, up 43%, while in Europe, sales were $150 million, reflecting an 85% increase [2] - The company is advancing its pipeline with Sonrotoclax expected to report data in H2 2025 and BTK CDAC (16673) recognized by the FDA for its innovative approach to BTKi resistance [2] Solid Tumors - BeiGene is focusing on next-generation solid tumor drugs based on PD-1 monoclonal antibodies, particularly in breast, lung, and gastric cancers [3] - In breast cancer, the company is developing CDK4 and CDK2 series products, with CDK4i expected to enter Phase 3 trials in 2026 [3] - In lung cancer, the combination of PRMT5i and MATA2i is set to complete patient enrollment in H2 2025, while several other candidates are in early-stage trials [3] Immunology and Inflammation - The IRAK4 CDAC is currently in Phase 2 trials for atopic dermatitis and nodular prurigo, with data expected in H2 2025 [3] - The company reported a GAAP gross margin of 87.4% in Q2 2025, a 2.4 percentage point increase year-on-year, with a net profit of $94 million and adjusted net profit of $253 million, indicating enhanced profitability [3] Revenue Forecast and Investment Recommendations - Revenue projections for Baiyueze from 2025 to 2027 are $27.96 billion, $35.60 billion, and $41.68 billion, with year-on-year growth rates of 49%, 27%, and 17% respectively [4] - Bai Zean's revenue is expected to be $750 million, $880 million, and $1.02 billion for the same period, with growth rates of 20%, 18%, and 16% [4] - The overall revenue forecast for BeiGene from 2025 to 2027 is $37.66 billion, $47.49 billion, and $55.85 billion, with growth rates of 38%, 26%, and 18% [4] - The company is valued at a significantly lower price-to-sales ratio compared to comparable companies, highlighting its investment attractiveness [4]

Core Viewpoint - BeiGene has successfully resolved a two-year patent infringement lawsuit regarding its BTK inhibitor, Zebutinib, in the U.S. market, which clears the way for its global expansion [1][5]. Group 1: Product Performance - Zebutinib is BeiGene's best-selling BTK inhibitor, achieving sales of $1.297 billion (approximately 9.138 billion RMB) in 2023, marking its entry into the "billion-dollar molecule" category [2]. - In the first half of 2023, Zebutinib's global sales exceeded 12.527 billion RMB, a year-on-year increase of 56.2%, with the U.S. market contributing 8.958 billion RMB, up 51.7% [2]. - Zebutinib has gained significant market share in the U.S. due to its superior efficacy compared to AbbVie's ibrutinib in head-to-head studies for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [2]. Group 2: Legal Developments - The lawsuit initiated by Pharmacyclics, a subsidiary of AbbVie, claimed that BeiGene's Zebutinib infringed on its "803 patent," but the U.S. Patent and Trademark Office declared the patent invalid [4]. - On September 30, 2023, both parties reached a settlement and voluntarily withdrew the lawsuit, concluding the legal dispute [4][5]. - Despite the resolution of this case, AbbVie has ongoing litigation against BeiGene regarding its drug BGB-16673, alleging theft of trade secrets [5]. Group 3: Industry Context - The pharmaceutical industry often faces patent challenges, with companies like BeiGene needing to defend their intellectual property against generic competitors [6][7]. - Patent invalidation is a common strategy used by competitors to challenge the market position of successful drugs, which can significantly impact a company's operations [7][8]. - Companies are encouraged to expand their research pipelines to mitigate risks associated with patent litigation and ensure future growth [8].

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 patent dispute between BeiGene and Pharmacyclics LLC has concluded, marking a significant milestone for BeiGene's drug, Zebrutinib, which has achieved over $1 billion in global sales, making it the first Chinese innovative drug to reach this milestone [1][2][3]. Summary by Sections Patent Dispute Conclusion - On October 8, BeiGene announced that Pharmacyclics LLC decided not to appeal the final written decision from the USPTO, leading to the voluntary withdrawal of the lawsuit filed in 2023 [1][2]. - The lawsuit claimed that BeiGene's Zebrutinib infringed on Pharmacyclics' patent rights, specifically the "803 patent" granted in June 2023 [2][3]. Zebrutinib's Market Performance - Zebrutinib, a BTK inhibitor, was approved by the FDA in November 2019 and is used for treating mantle cell lymphoma (MCL) [2]. - In 2023, Zebrutinib generated $1.3 billion in global sales, establishing it as the first Chinese-developed drug to surpass $1 billion in annual sales [2][3]. Legal Background and Implications - The "803 patent" was submitted in June 2020, seven months after Zebrutinib's market entry, and was deemed overly broad and lacking inventiveness by the USPTO [2][3]. - The resolution of this patent dispute removes a significant barrier for BeiGene in the U.S. market, where over 51% of its revenue comes from [3]. Ongoing Patent Risks - Despite the resolution of the Zebrutinib case, BeiGene still faces patent litigation risks, including a lawsuit from Pharmacyclics regarding BeiGene's compound BGB-16673, which received PRIME designation from the EMA in July 2023 [3][4]. Broader Industry Context - The rise of Chinese pharmaceutical companies in international markets has led to an increase in patent disputes, with 4.1% of Chinese pharmaceutical firms facing intellectual property disputes abroad [4][5]. - In 2024, 29 new patent litigation cases involving Chinese biopharmaceutical companies were reported, with 22 cases where Chinese firms were defendants [4][5].

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]