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 ...

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 ...

Core Viewpoint - The proposed 100% tariff on brand-name and patented drugs by President Trump could significantly increase costs for pharmaceutical companies without U.S. production capabilities, putting additional pressure on companies that have not yet initiated manufacturing in the U.S. [1] Group 1: Impact on Pharmaceutical Companies - Companies like Novartis (NVS.US) and Sanofi (SNY.US) have announced large-scale investments in the U.S., but the progress of these projects remains unclear [1] - Merck (MRK.US), Novo Nordisk (NVO.US), and Eli Lilly (LLY.US) have initiated U.S. manufacturing plans in states like Delaware, North Carolina, and Texas to support production of key drugs in oncology, diabetes, and immunology [1] - AbbVie (ABBV.US) plans to expand its production facilities in Illinois for cancer drug Imbruvica and immunology drug Skyrizi [1] Group 2: Economic Estimates and Trade Agreements - Economists estimate that the new tariffs could affect approximately $220 billion in U.S. drug imports, raising the average tariff rate by 3.3 percentage points [2] - There is uncertainty regarding whether countries with trade agreements with the U.S. can be exempt from these new tariffs, as seen in the EU's recent agreement which set drug tariffs at 15% [2] Group 3: Market Reactions and Stock Performance - Major pharmaceutical stocks in Tokyo, Seoul, and Hong Kong experienced declines following the tariff announcement, as investors assessed the risks to Japanese drugs [3] - Companies like Chugai Pharmaceutical Co. and Daiichi Sankyo Co. are particularly at risk due to their heavy reliance on the U.S. market [3] Group 4: Operational Impact on Asian Companies - The operational impact of the new tariffs on Asian pharmaceutical companies is expected to be limited, particularly for Japanese firms, as few sell brand-name drugs in the U.S. [3] - Shionogi & Co. is still considering whether to move its antibiotic production line for multi-drug resistant infections to the U.S. [3] Group 5: Chinese Pharmaceutical Companies - Few Chinese companies sell brand-name drugs in the U.S., primarily through multinational partnerships, which may mitigate the impact of the tariffs [5] - BeOne Medicines, a company with origins in China, has achieved significant sales in the U.S. with its cancer therapy Brukinsa, highlighting the complexities of defining imported drugs [5] Group 6: Long-term Market Entry Plans - The tariffs may affect the long-term plans of Chinese pharmaceutical companies aiming to enter the U.S. market, as many are eager to introduce innovative therapies [6] - There are unresolved questions regarding the implementation details of the tariff policy, including definitions of "under construction" and potential exemptions for using U.S. contract manufacturing [6]

Group 1 - The complexity of hematological tumors presents numerous investment opportunities in various subtypes of treatment [1] - The market for hematological tumors is expanding due to innovative therapies, with significant product launches expected [1] - The number of long-term patients is increasing, with approximately 4 million patients globally having survived five years or more as of 2022, which is three times the number of new patients [1] Group 2 - Future development directions for hematological tumor treatment include improving efficacy, reducing recurrence, and optimizing administration [2] - Acute leukemias like AML and ALL primarily use chemotherapy or targeted combination therapies to enhance survival rates [2] - CAR-T therapy shows high remission rates for aggressive lymphomas and multiple myeloma, providing more treatment options for patients [2] Group 3 - The competition in the targeted drug market for hematological tumors has entered a new phase, with a focus on technological iterations and exploration of new targets [3] - In the BTK field, new products are emerging to compete in the post-resistance market, with Zebutinib outperforming Ibrutinib [3] - The BCL-2 domain is seeing advancements with differentiated designs and optimized dosing strategies to gain competitive advantages [3]

Core Viewpoint - The report from China Galaxy recommends the pharmaceutical industry, highlighting the significant growth potential in the hematological oncology market driven by innovative therapies and the increasing number of long-term patients [1] Group 1: Market Dynamics - The hematological oncology market is expanding due to advancements in precision diagnostics, prognostic stratification, immunotherapy, and targeted therapies, leading to improved survival rates and quality of life for patients [1] - According to WHO, the number of long-term patients with hematological malignancies reached approximately 4 million in 2022, which is three times the number of new patients, indicating a growing market for treatments [1] - The market is expected to see blockbuster products, with global sales of Daratumumab exceeding $10 billion in 2024, and both Ibrutinib and Lenalidomide surpassing $5 billion in sales [1] Group 2: Treatment Trends - Future treatment directions for hematological malignancies focus on improving efficacy, reducing relapse rates, and optimizing administration methods, particularly in acute leukemias and chronic leukemias [2] - In chronic myeloid leukemia (CML), the use of BCR-ABL TKI therapy is being explored to overcome resistance through technological iterations and new targets [2] - CAR-T therapy is providing more treatment options for patients with high relapse rates, particularly in aggressive lymphoma and multiple myeloma [2] Group 3: Competitive Landscape - The targeted drug market for hematological malignancies is entering a new competitive phase, with innovations in BTK inhibitors and BCL-2 inhibitors leading the way [3] - Zebutinib has outperformed Ibrutinib, establishing itself as a leading product in the BTK space, while the market for post-resistance treatments is becoming increasingly competitive [3] - In the BCL-2 space, advancements in dosing and differentiated designs are giving products like Lisocabtagene Maraleucel a competitive edge [3] Group 4: Investment Opportunities - The complexity of hematological malignancies presents numerous investment opportunities, particularly as treatment approaches evolve towards chronic disease management [4] - Companies to watch include BeiGene, which is covering the CLL/SLL indications with a comprehensive product matrix, and Innovent Biologics, which is building a diversified product portfolio centered around Orelabrutinib [4] - Ascentage Pharma is focusing on third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create differentiated competitive advantages [4]

Investment Rating - The report maintains a "Buy" rating for the blood cancer drug industry [3][6]. Core Insights - The blood cancer market is expanding due to innovative therapies, with significant advancements in precision diagnosis, prognosis stratification, and targeted therapies such as CAR-T and TCE, leading to improved patient survival and quality of life [5][8]. - The number of patients with blood cancer who have survived for five years or more is approximately 4 million globally, which is three times the number of new patients, indicating a growing market for long-term treatments [5][13]. - The high cost of blood cancer drugs and the emergence of blockbuster products are driving market growth, with several drugs expected to exceed $10 billion in sales by 2024 [5][17]. Summary by Sections 1. Blood Cancer Market Expansion - The proportion of new blood cancer patients is less than 10% of all new cancer cases, with a steady increase in incidence rates [8]. - Blood cancer patients have a long survival period, resulting in a large population of existing patients [13]. - The high cost of blood cancer treatments contributes to the frequent emergence of blockbuster drugs [17]. 2. Clinical Diagnosis and Treatment of Blood Cancer - Blood cancers are classified based on cell origin, differentiation, and affected sites, including leukemia, lymphoma, and multiple myeloma [19][20]. - Treatment for acute leukemia primarily involves chemotherapy or targeted combination therapies to improve survival rates [24]. - Lymphoma treatment varies by subtype, with Rituximab being a cornerstone therapy [23]. - Multiple myeloma treatment focuses on CD38 monoclonal antibodies, with ongoing exploration of solutions for relapsed and refractory cases [23]. 3. Analysis of Popular Targets and Therapies - The BTK field is seeing intense competition, with new products emerging to address resistance issues [5]. - The BCL-2 area is advancing with differentiated designs and optimized dosing strategies [5]. - The BCR-ABL TKI domain is witnessing the introduction of third-generation inhibitors that show superior efficacy [5]. 4. Company Profiles - BeiGene is focusing on a comprehensive product matrix to cover CLL/SLL indications [5]. - Innovent Biologics is building a diversified product portfolio centered around Oubreti [5]. - Ascentage Pharma is developing third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create competitive advantages [5]. - Diligent Pharma is innovating with a globally first high-selectivity JAK1 inhibitor and a dual-target LYN/BTK inhibitor [5]. 5. Investment Recommendations - The blood cancer sector presents numerous investment opportunities due to its complexity and the variety of treatment subfields [5]. - The long survival cycle of blood cancer patients and the high costs of drug treatments indicate a significant market potential [5].

Group 1 - The core viewpoint of the news is that Dan Yi Investment has conducted research on a listed company, specifically focusing on the performance and market expansion of BeiGene's products, particularly Baiyueze and Baizean [1] - Baiyueze has seen a moderate single-digit percentage increase in net pricing in the U.S. and is expected to maintain price stability throughout the year [1] - Baiyueze has been approved in 75 markets, while Baizean has received approval in 47 markets, indicating the company's ongoing efforts to expand its global regulatory registration projects [1] Group 2 - The U.S. is identified as the largest market for BeiGene, with rapid growth in Europe and other markets, leading to a gradual diversification of the revenue structure [1] - The guidance for revenue adjustment is based on Baiyueze's leading position in the U.S. and the continuous expansion in Europe and other markets [1] - Gross margin growth is attributed to improved production efficiency of Baiyueze and Baizean, with considerations for tariff policy impacts [1] Group 3 - The ORR data from the BRUIN CLL-314 study lacks statistical significance, while the ALPINE study shows Baiyueze performing better than Ibrutinib [1] - BTK CDAC is being explored for applications in immunology and inflammation due to its long half-life, penetrative properties, and degradation characteristics [1] - The Phase III trial for CDK4 inhibitors has been postponed to early 2026, with plans to release dose optimization data this year, indicating a positive market outlook for breast cancer treatment [1] Group 4 - BTK CDAC is expected to initiate Phase III clinical trials in the second half of 2025, with pivotal Phase II trials planned for 2026 and subsequent registration submissions [1]

Group 1: Industry Overview - Major multinational pharmaceutical companies (MNCs) have reported their performance for the first half of 2025, with Johnson & Johnson leading with revenues of $45.636 billion, followed by Roche and Merck [1][2] - Nearly 200 drugs are expected to lose patent protection in the coming years, including at least 69 blockbuster drugs with annual sales exceeding $1 billion, leading to an estimated cumulative sales loss of over $300 billion for MNCs [2][3] - The competitive landscape among the top ten pharmaceutical companies remains intense, with close revenue figures among companies ranked fourth to eighth [2] Group 2: Company Performances - Johnson & Johnson reported a revenue of $45.636 billion for the first half of 2025, a year-on-year increase of 4.1%, driven by its innovative pharmaceuticals and medical technology segments [3] - Merck's total revenue was $31.335 billion, a decline of 2% year-on-year, with significant drops in its China revenue, which fell by 70% to $1.075 billion [4] - Eli Lilly achieved a remarkable revenue growth of 41%, reaching $28.286 billion, with its weight loss drug Mounjaro seeing an 85% increase in sales [5][6] - AstraZeneca reported a revenue of $28.045 billion, an 11% increase, with its China revenue growing by 5% to $3.515 billion, making it the top performer in the Chinese market [7] Group 3: Market Dynamics - The competition for the title of "King of Drugs" is intensifying, with Eli Lilly's two weight loss drugs nearing the sales figures of Novo Nordisk's semaglutide [6] - MNCs are increasingly focusing on the Chinese market, with a notable increase in collaborations with domestic innovative pharmaceutical companies, resulting in 52 outbound deals in the first half of 2025 [7][8] - The growth rates of MNCs in China are shifting, with some companies like Merck experiencing significant declines in sales, while others like AstraZeneca and Eli Lilly are capitalizing on the market opportunities [8]

Core Insights - The global pharmaceutical sales ranking for the first half of 2025 has been released, highlighting the dominance of GLP-1 drugs in the market, with the top three drugs surpassing $10 billion in sales, driving industry growth [2][5] - The competition among pharmaceutical giants is intensifying, particularly in the GLP-1 category, with Novo Nordisk and Eli Lilly leading the charge [5][6] Group 1: GLP-1 Drug Market - GLP-1 drugs are the main drivers of market growth, contributing nearly 30% to the global biopharmaceutical market [3][5] - Semaglutide from Novo Nordisk topped the sales chart with $16.632 billion, while Eli Lilly's tirzepatide followed closely with $14.734 billion, marking a significant year-on-year growth of 121.3% [5][6] - The competitive landscape is shifting, with semaglutide's various formulations (injection, oral, and weight loss) ending Keytruda's long-standing dominance [5][6] Group 2: Emerging Therapies - New therapies such as bispecific antibodies, antibody-drug conjugates (ADC), and fusion proteins are gaining traction, accounting for over 15% of the top-selling drugs [3][10] - ADC drug Enhertu made its debut in the top rankings with $3.9 billion in sales, indicating a growing interest in innovative therapies [3][10] Group 3: CDK4/6 Inhibitors - The CDK4/6 inhibitor market is experiencing a reshuffle, with Eli Lilly's Abemaciclib leading at $2.648 billion, while Novartis' Ribociclib showed a remarkable growth rate of 58.7% [10] - Pfizer's Palbociclib, once a market leader, has seen a decline, dropping to $2.026 billion in sales [10] Group 4: BTK Inhibitors - The BTK inhibitor market is projected to reach approximately $12.5 billion by 2024, with Ibrutinib, Zebrutinib, and Acalabrutinib dominating the market [11][12] - Zebrutinib from BeiGene has entered the global top 50 list with $1.742 billion in sales, marking a significant achievement for Chinese innovation in the pharmaceutical sector [12][13]