新华财经上海11月25日电 （谷青竹）2025年以来，中国创新药出海在政策红利与产业积累的双重驱动下，呈现"规模与质量同步跃升"的态势。初步统计显 示，到10月末的对外授权（License-Out）总金额已超900亿美元，较2024年全年的519亿美元近乎翻倍，大额合作与标杆企业业绩持续刷新行业纪录。这场出 海热潮不仅是中国创新药全球化布局"狂飙突进"的缩影，同时也暴露出一些行业短板需持续破解。 提质增速：三季度出海"含金量"创新高 进入下半年，中国创新药出海延续增长势头，不仅交易规模和结构显著优化，商业化能力也取得实质性突破，"含金量"明显提升。 据介绍，恒瑞医药与葛兰素史克（GSK）的合作是近期行业标志性事件之一。据介绍，双方于7月达成覆盖呼吸、自身免疫及肿瘤三大领域的全球战略合 作，涉及12款创新药，恒瑞获得5亿美元首付款、潜在里程碑付款高达120亿美元。尤为关键的是，恒瑞在协议中保留了"联合商业化选择权"，得以深度参与 全球收益分配，标志着中国药企正从传统的"授权许可方"向具备全球商业化话语权的"协同开发者"转变。 印证国际药企对中国源头创新的高度认可，并不只这一个案例。更早前的5月，三生制药将其自主 ...

Investment Rating - The report maintains an investment rating of "Outperform" [5] Core Insights - The report highlights that the global sales of the BTK inhibitor Zebutini reached $1 billion in Q3 2025, with a quarter-on-quarter growth of 5% and a year-on-year growth of 56% [2][3] - Zebutini's market share in the global market reached 28.9% in Q3 2025, surpassing Ibrutinib in the U.S. market for the first time with a share of 33.8% [3][21] Summary by Sections Weekly New Drug Market Review - From November 3 to November 9, 2025, the top five gainers in the new drug sector were: Zhongsheng Pharmaceutical (+8.13%), Yongtai Biological (+7.35%), Hansoh Pharmaceutical (+3.31%), Hehuang Pharmaceutical (+1.55%), and Youzhiyou (0.00%); the top five losers were: Saint Nor Pharmaceutical (-24.42%), Kedi (-17.80%), Yifang Biological (-17.76%), Kangning Jere (-17.65%), and Zai Ding Pharmaceutical (-14.08%) [1][16] Weekly Focused Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty: PD-1 upgraded products from Sanofi, GLP-1 assets from Lianbang Pharmaceutical, and ADC assets from Kelun-Botai [2][20] 2. Potential heavyweights for overseas authorization: PD-1 upgraded products from Kangfang Biotech and Innovent Biologics, breakthroughs in autoimmune fields from Yifang Biological and China Antibody, and innovative target ADCs from Fuhong Hanlin and Shiyao Group [2][20] 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: Heng Rui Pharmaceutical, Kangnuo Pharmaceutical, Maiwei Biological, Zhixiang Jintai, and Haichuang Pharmaceutical [2][20] Key Analysis of the New Drug Industry - BeiGene disclosed its Q3 2025 financial performance, reporting global sales of Zebutini at $1 billion, with U.S. sales of $739 million and European sales of $163 million [2][3][20] - The report notes that Zebutini's market share is continuously increasing, indicating a strong growth trend [3][21] New Drug Approval and Acceptance Status - No new drug or new indication approvals were reported this week, but 10 new drug or new indication applications were accepted [9][25] - A total of 37 new drug clinical applications were approved, and 43 new drug clinical applications were accepted this week [10][28]

Core Viewpoint - BeiGene has reached a profitability turning point, reporting a net profit of 450 million yuan for the first half of 2025, marking a significant recovery from previous losses exceeding 57 billion yuan over seven years. However, the company's revenue structure raises concerns due to its heavy reliance on core products and a single market, making it vulnerable to external fluctuations [3][4]. Revenue Structure - In the first half of 2025, BeiGene achieved total revenue of 17.518 billion yuan, with its core product, Brukinsa (Zebutinib), contributing significantly to this figure. The global sales totaled 12.527 billion yuan, reflecting a year-on-year growth of 56.2% [4][5]. - The U.S. market accounted for 51.2% of the total revenue, with sales reaching 8.958 billion yuan, a 51.7% increase year-on-year. European sales grew by 81.4% to 1.918 billion yuan, while sales in China increased by 36.5% to 1.192 billion yuan [5]. Market Challenges - The company's reliance on a "single product + single market" model poses risks, particularly from potential changes in U.S. healthcare policies and increasing market competition. The company has not responded to inquiries regarding how it would maintain profitability if U.S. healthcare negotiations require price reductions [5][6]. - The competitive landscape is intensifying, especially for Brukinsa, which faces threats from new generation competitors like Eli Lilly's Pirtobrutinib, which has shown advantages in clinical trials [7][8]. Patent Expiration Risks - The first-generation BTK inhibitor, Ibrutinib, is set to have its core patent expire in the U.S. by 2027, with some extensions possible until 2028. This will likely lead to an influx of low-cost generics in the market, which could significantly impact Brukinsa's pricing and market share, especially in price-sensitive segments [9][10]. - The approval of generic versions of Ibrutinib in China further complicates the competitive landscape, as these generics may lower prices and increase accessibility for patients, potentially affecting Brukinsa's performance [10].

Core Viewpoint - The article discusses the evolution and commercialization of BTK inhibitors in the treatment of B-cell malignancies, highlighting the shift from traditional chemotherapy to targeted therapies, particularly focusing on the success of domestic second-generation BTK inhibitors and their manufacturers [3][4][5]. Group 1: Industry Overview - Before the emergence of BTK inhibitors, chemotherapy was the standard treatment for B-cell malignancies, but it had significant side effects and limited efficacy in relapsed/refractory lymphoma [3]. - The approval of ibrutinib in 2013 marked the beginning of a new era in targeted therapy for hematological cancers, addressing the limitations of chemotherapy [3]. - The BTK inhibitor market has seen rapid development, with major pharmaceutical companies introducing second-generation products like acalabrutinib and zanubrutinib, which offer higher selectivity and improved safety [4]. Group 2: Company Focus - Among the various BTK inhibitors, zanubrutinib has gained significant recognition in the A-share market, contributing to the substantial revenue and market capitalization of BeiGene (688235.SH, 6160.HK) [4]. - The article shifts focus to another domestic second-generation BTK inhibitor and its original research manufacturer, indicating ongoing innovation in this therapeutic area [5].

Summary of BeiGene Conference Call Company Overview - **Company**: BeiGene - **Industry**: Biotechnology and Pharmaceuticals Key Points and Arguments 1. **Global Commercialization Strategy**: BeiGene adopts a global commercialization strategy, leveraging Chinese patient resources and efficient clinical execution to reduce costs and accelerate global clinical trials, collaborating with international pharmaceutical companies like Novartis and Amgen [2][3] 2. **Core Product - Zanubrutinib**: Zanubrutinib has been approved in over 70 countries globally, becoming the leading BTK inhibitor for new patients in the U.S., surpassing the first-generation BTK inhibitor ibrutinib, significantly driving revenue growth for the company [2][5] 3. **Expansion into Solid Tumors**: BeiGene has made significant progress in the solid tumor field, with upcoming data releases for ADC, ProTech, and CDK, marking the company's transition from a focus on hematological malignancies to a broader oncology treatment approach [2][5] 4. **Clinical Trial Efficiency**: The company utilizes the cost and efficiency advantages of clinical trials in China, with 25% of global clinical patients from China and over 40% from Europe and North America, supporting simultaneous domestic and international product registrations [2][7] 5. **Upcoming Milestones**: Key milestones in the coming years include data readouts for ADC, ProTech, and CDK, as well as the submission of a BCL-2 inhibitor for U.S. market approval, which is expected to enhance the cure rate for frontline lymphoma patients [2][8] 6. **Unique Position in Chinese Innovation Drug Industry**: BeiGene is the only independent innovative drug company with global R&D and commercialization capabilities, making it a rare entity in the A-share and Hong Kong markets [3] 7. **Comprehensive Treatment Landscape**: In hematological malignancies, BeiGene has established a complete treatment portfolio including BTK, CDK, and BCL-2 inhibitors, with zanubrutinib expected to capture over 50% of the U.S. market share for CLL [4][12] 8. **BCL-2 Inhibitor Development**: The company is developing a new generation BCL-2 inhibitor, which is expected to achieve significant sales, potentially reaching $3 to $5 billion, and is currently undergoing global Phase III clinical trials [14][22] 9. **CDK Inhibitor Market**: BeiGene's CDK4/6 inhibitors are crucial in breast cancer treatment, with the global market exceeding $13 billion and projected to reach $16 to $18 billion [17][21] 10. **Broad Oncology Pipeline**: The company is actively developing treatments for various solid tumors, including lung and gastrointestinal cancers, with multiple products in clinical stages [20] Other Important but Overlooked Content 1. **Zanubrutinib's Competitive Edge**: Zanubrutinib's success is attributed to its superior product profile, showing better progression-free survival (PFS) and safety compared to ibrutinib, and being included in treatment guidelines [11][12] 2. **Impact of IRA Legislation**: The IRA legislation may have long-term effects on drug pricing, but currently, zanubrutinib has not faced price pressure, and its annual price has increased [13] 3. **Market Positioning**: BeiGene's international management team and shareholder structure, including significant overseas funds, support its global operations and strategic positioning [6][22] This summary encapsulates the critical insights from the conference call, highlighting BeiGene's strategic initiatives, product developments, and market positioning within the biotechnology industry.

Core Insights - The article emphasizes that being the "first" in the biopharmaceutical industry does not guarantee long-term commercial success, as evidenced by the rapid evolution and competition in the market [1][3] - There is a growing recognition that "Best in Class" (BIC) products, which are iterations of existing drugs, may offer better commercial viability compared to "First in Class" (FIC) products [1][5] - The article highlights the importance of strategic innovation, particularly in the context of established mechanisms and pathways, to meet clinical needs and market demands [1][7] Group 1: Innovation Dynamics - The rapid iteration of drugs is compressing their lifecycle, forcing companies to maximize the value of new drugs within limited timeframes [1][9] - The success of atorvastatin, which became a blockbuster despite being a later entrant in the statin class, illustrates that FIC advantages can diminish over time as BIC products emerge [3][4] - Companies like Eli Lilly have successfully adopted a strategy focused on "me better" drugs, which are improvements on existing therapies rather than entirely new innovations [5][6] Group 2: Market Trends - The trend towards BIC products is evident in various therapeutic areas, including oncology and autoimmune diseases, where companies are focusing on improving established targets rather than pursuing new ones [7][9] - The competitive landscape is shifting as more Chinese pharmaceutical companies leverage their advantages in speed and cost-effectiveness to innovate rapidly, challenging established players [10] - The urgency to fill gaps left by patent expirations is leading to a preference for iteratively developed products based on validated mechanisms [9][10]

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 ...

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].

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]