Core Viewpoint - The potential implementation of a 100% tariff on all brand-name and patented drugs by the U.S. government starting October 1, 2025, unless companies are building drug manufacturing plants in the U.S. [2] Group 1: Market Reaction - Pharmaceutical stocks in multiple markets, including China, Japan, and South Korea, experienced a collective decline following the announcement [3] - Specific declines included a 3.03% drop in Hengrui Medicine (600276.SH/01276.HK) A-shares and a 2.23% drop in Hong Kong shares, while BeiGene (ONC.NASDAQ/06160.HK/688235.SH) saw a 4.38% drop in A-shares and a 1.55% drop in Hong Kong shares [3] - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma (600196.SH/02196.HK) down 5.82% and 3SBio (01530.HK) down 5.34% [4] Group 2: Industry Perspectives - Industry experts suggest that Chinese pharmaceutical companies aiming to expand internationally need to consider the potential implementation of this policy and explore possible solutions [5] - Some executives believe that the high cost of drugs in the U.S. may hinder the realization of this policy [5] - Hengrui Medicine's executive noted that the impact of the potential policy would be limited as their exports mainly consist of generic drugs and APIs [5] - Other companies, such as Lepu Biopharma, indicated that their licensing partnerships would not be significantly affected [5] - Investors pointed out that this is a political issue that could change with future administrations, suggesting that while there may be short-term negative impacts, the long-term effects may not be significant [5] Group 3: Historical Context - Historically, pharmaceuticals have been excluded from tariff lists, but President Trump has repeatedly threatened to impose tariffs on imported drugs this year [5] - The Trump administration initiated a "232 investigation" under the Trade Expansion Act of 1962, which allows for tariffs if imports threaten national security [6] - Previous statements from Trump indicated plans for escalating tariffs on imported drugs, with initial small tariffs leading to potential increases up to 250% [7] Group 4: Investment Commitments - In response to the tariff threats, several multinational pharmaceutical companies have committed to investing in U.S. manufacturing facilities, with significant investments announced by companies like Novartis, Roche, Sanofi, and AstraZeneca [8] - Notably, Novartis and Roche pledged $23 billion and $50 billion respectively over five years, while AstraZeneca committed to a $50 billion investment by 2030 [8]

2025 中期報告 BeOne Medicines Ltd. （根據瑞士法律註冊成立的公司） Cancer has no borders. Neither do we. 目錄 | 公司資料 | 2 | | --- | --- | | 前瞻性陳述 | 4 | | 管理層討論及分析 | 7 | | 其他資料 | 28 | | 未經審核中期簡明綜合經營表 | 82 | | 未經審核中期簡明綜合全面虧損表 | 83 | | 未經審核中期簡明綜合資產負債表 | 84 | | 未經審核中期簡明綜合股東權益報表 | 86 | | 未經審核中期簡明綜合現金流量表 | 87 | | 未經審核中期簡明綜合財務報表附註 | 89 | | 釋義 | 124 | | 技術詞彙 | 128 | 1 百濟神州有限公司 • 2025 中期報告 公司資料 董事會 執行董事 歐雷強先生 （主席兼首席執行官） 非執行董事 王曉東博士 獨立非執行董事 Olivier Brandicourt博士 Margaret Han Dugan博士 Michael Goller先生 Anthony C. Hooper先生 Ranjeev Krishana先生 A ...

BeOne Medicines Ltd. 百濟神州有限公司 (a corporation incorporated under the laws of Switzerland) （根據瑞士法律註冊成立的公司） (Stock Code 股份代號: 06160) Dear non-registered shareholder(s), September 26, 2025 Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated February 28, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", BeOne Medicines Ltd. (the "Company") is writing to remind you that the Company has ad ...

BeOne Medicines Ltd. 百濟神州有限公司 (Stock Code 股份代號: 06160) September 26, 2025 Dear registered shareholder(s), Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated February 28, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", BeOne Medicines Ltd. (the "Company") is writing to remind you that the Company has adopted electronic dissemination of corporate communications (the "Corporate Comm ...

Drug Development and Commercialization - BeOne Medicines Ltd. reported significant advancements in drug commercialization and regulatory approvals, indicating a strong pipeline for future growth[9]. - The company is focused on expanding its sales and marketing capabilities, aiming to launch and commercialize new drugs upon approval[10]. - BeOne Medicines Ltd. is actively developing both small molecule drugs and large molecule biologics to meet global demand, enhancing its production and clinical research facilities[10]. - The company emphasizes the importance of maintaining and expanding regulatory approvals for its drugs and candidates[9]. - BeOne Medicines Ltd. is assessing the potential market size for its drugs and candidates, indicating a strategic focus on market access and acceptance rates[10]. - The company is focused on the successful completion of clinical trials and obtaining regulatory approvals for its candidate drugs[10]. - The company maintains a leading position in the BTK inhibitor market with Baiyueze® across five approved indications in the U.S.[16]. - The European Medicines Agency granted priority medicine designation for BGB-16673, a BTK degrader, for patients previously treated with BTK inhibitors[17]. - The company received positive opinions from the CHMP recommending the approval of Baiyueze® for preoperative and postoperative treatment in high-risk resectable non-small cell lung cancer patients[19]. - The company has launched a new generation BCL2 inhibitor, Sotokura, showing positive results in clinical trials for adult patients with mantle cell lymphoma[17]. - The company anticipates over 20 research milestones within the next 18 months, including advancements in solid tumor pipelines targeting various high-incidence cancers[16]. Financial Performance - Total revenue increased by 44.7% from $1.680 billion for the six months ended June 30, 2024, to $2.433 billion for the six months ended June 30, 2025[28]. - Product revenue net increased by 44.5% to $2.411 billion for the six months ended June 30, 2025, compared to $1.668 billion for the same period last year[29]. - Sales of Baiyueze® reached $1.741 billion, a 54.7% increase from $1.126 billion year-over-year[29]. - Baiyueze® global sales totaled $1.741 billion, with U.S. sales at $1.247 billion, reflecting a 50.1% increase from $830 million[30]. - Baiyueze® sales in Europe reached $266 million, a 79.7% increase, driven by market share growth across major European markets[30]. - The company achieved GAAP profitability for the first time in both Q1 and Q2 of 2025, with positive free cash flow in Q2[25]. - Net profit for the six months ended June 30, 2025, was $95.6 million, compared to a net loss of $371.6 million in the same period last year[27]. - Adjusted net profit for the six months ended June 30, 2025, was $389.0 million, compared to a loss of $122.6 million in the same period of 2024[46]. Research and Development - The company has a dedicated oncology research team of over 1,200 scientists, ensuring continuous innovation and market leadership[22]. - The company has invested in various technology platforms, including CDAC protein degraders and bispecific antibodies, to enhance its research and innovation capabilities[22]. - R&D expenses rose by 10.0% to $1.007 billion, while total operating expenses increased by 12.2% to $2.004 billion[27]. - External R&D expenses increased by $70.132 million (21.2%) to $400.259 million, driven by higher costs associated with advancing clinical projects[36]. Cash Flow and Liquidity - Cash and cash equivalents were approximately $2.8 billion as of June 30, 2025[25]. - Operating cash flow provided $307,680 thousand, a significant increase of $711,800 thousand compared to the same period last year, driven by substantial revenue growth and a gross profit increase of $359,700 thousand[64]. - The company plans to utilize existing cash to meet significant cash needs, including operational, capital, and production expenditures[69]. - Cash used in investing activities was $188,546 thousand, a decrease from $320,863 thousand in the previous year, primarily due to reduced capital expenditures[65]. Debt and Equity - Total debt decreased by 6.2% from $1.018 billion as of December 31, 2024, to $954.5 million as of June 30, 2025[60]. - The company's debt-to-equity ratio decreased from 30.6% as of December 31, 2024, to 25.3% as of June 30, 2025, primarily due to a reduction in debt and an increase in shareholder equity[87]. - The company has $615.4 million in outstanding floating-rate debt as of June 30, 2025, with a potential increase of approximately $6.2 million in annual pre-tax interest expense for every 100 basis points rise in interest rates[80]. Corporate Governance - The company is committed to maintaining high standards of corporate governance and has adhered to the applicable corporate governance code principles[179]. - The audit committee consists of four independent non-executive directors, with Shalini Sharp serving as the chair, ensuring compliance with financial reporting and internal controls[181]. - The remuneration committee is composed of three independent non-executive directors, with Margaret Han Dugan as the chair, responsible for reviewing and recommending executive compensation[182]. - The nomination and corporate governance committee is currently led by Anthony C. Hooper, ensuring compliance with the Hong Kong listing rules regarding board composition[183]. Shareholder Information - The total number of issued shares as of June 30, 2025, is 1,539,858,562 shares[106]. - Amgen Inc. holds 246,269,426 shares, representing 15.99% of the total shares[101]. - The company has issued 21,880,885 shares under equity awards, which are currently considered circulating shares[97]. - The company has a stock option plan that allows for the issuance of shares to employees, with 133,000,000 shares held by a subsidiary for this purpose[106]. Employee Stock Options and Incentives - The company plans to continue expanding its stock option program to incentivize employee performance and retention[156]. - The exercise price for options granted under the revised 2016 plan must not be lower than the higher of the fair market value at the time of grant or the average closing price over the previous five trading days[133]. - The total number of unexercised stock options as of the report date is 64,383,926[155]. - The stock options granted are subject to a vesting schedule, with 25% vesting on the first anniversary and the remaining 75% vesting monthly over 36 months[152].

Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The innovative drug sector is experiencing a positive trend with significant revenue growth and a reduction in losses, indicating a potential for sector-wide profitability [2][6] - The overall revenue for the innovative drug sector in H1 2025 reached 30.649 billion yuan, a year-on-year increase of 9.77%, while the net loss attributable to shareholders was 2.096 billion yuan, showing a substantial reduction in losses [6] - The sector's gross margin remains high at 84.43%, with a slight decrease compared to the previous year, but showing signs of recovery in Q2 2025 [3][6] Summary by Sections Innovative Drug Sector - The innovative drug sector's revenue for H1 2025 was 30.649 billion yuan, with a growth rate of 9.77% year-on-year. Q2 2025 revenue was 16.387 billion yuan, reflecting a 33.24% increase [5][6] - The sector's gross margin for H1 2025 was 84.43%, slightly down from the previous year, but Q2 2025 saw an increase to 84.73% [3][6] - The number of License-out transactions with upfront payments exceeding 10 million USD reached a new high, indicating that overseas rights have become a crucial funding source for Chinese companies [4][7] Financial Performance - The innovative drug sector's net loss for H1 2025 was 2.096 billion yuan, with a significant reduction in losses of 127.58% year-on-year. The adjusted net loss was 2.880 billion yuan, reflecting a 151.25% reduction in losses [5][6] - The sector's operating cash flow was positive at 210 million yuan, indicating improved financial health [5] Traditional Pharmaceutical Sector - The traditional pharmaceutical sector, comprising 136 listed companies, reported total revenue of 254.895 billion yuan in H1 2025, a decrease of 1.64% year-on-year. The net profit attributable to shareholders was 32.099 billion yuan, down 4.83% [26][32] - The gross margin for the traditional pharmaceutical sector was 51.05% in H1 2025, showing a slight increase compared to the previous year [27][32] - The sector is adapting to policy changes, with increased industry concentration and some leading companies achieving growth through transformation and international expansion [32]

2025.09.26 华海药业（600521.SH）方面对第一财经记者表示，目前公司不受影响，公司在美销售的制剂产品为仿 制药。 海正药业（600267.SH）方面亦对第一财经记者表示，对海正药业目前业务没影响，公司仅有仿制药， 不在范围内。 科伦药业（002422.SZ）也表示，公司也不受影响。 本文字数：847，阅读时长大约1.5分钟 作者 |第一财经 林志吟 一直在喊药价高的美国总统特朗普，转头又要对药品加征关税了。 当地时间9月25日，特朗普在其社交媒体"真实社交"宣布，自10月1日起，美国将对多类进口产品实施新 一轮高额关税，措施包括对专利及品牌药品加征100%关税。 北京时间9月26日，A股的医药股出现大跌。截至上午10点45分，CRO（研发外包）、化学制药等板块 跌幅超过2%。 从上述政策看，原料药不在加征关税范围内。假如上述加征关税生效的话，对中国出口到美国的制剂药 企影响到底有多大？ 目前有部分药企人士倾向认为，特朗普拟加征关税的药品范围，主要涉及专利药，而仿制药不在范围 内。 当时，百济神州表示，这一位于新泽西州的总投资额8亿美元的基地拥有先进的生产能力和新型抗癌药 物临床开发能力，将为公 ...

Core Viewpoint - The article discusses the implications of President Trump's announcement to impose a 100% tariff on certain imported drugs starting October 1, which has led to a significant drop in A-share pharmaceutical stocks, particularly in the CRO and chemical drug sectors [3][4]. Group 1: Impact on Pharmaceutical Companies - The proposed tariffs primarily target patented and branded drugs, while generic drugs are expected to be unaffected [3][4]. - Companies like Huahai Pharmaceutical and Haisco Pharmaceutical have stated that they will not be impacted as they only sell generic drugs in the U.S. market [4][5]. - Kelun Pharmaceutical also confirmed that it is not affected by the new tariffs [5]. Group 2: Specific Company Responses - BeiGene, the only A-share company selling innovative drugs in the U.S., saw its stock drop over 4% following the announcement [6][7]. - Industry experts believe that the lack of detailed specifics in Trump's tariff policy will limit the impact on BeiGene, especially since the company has established a manufacturing base in New Jersey with an investment of $800 million [8].

Group 1 - The U.S. President Trump announced a new round of high tariffs on various imported products, including a 100% tariff on patented and branded drugs, effective from October 1 [2][3] - A-share pharmaceutical stocks experienced a significant decline, with CRO and chemical pharmaceutical sectors dropping over 2% [2] - The proposed tariffs do not apply to raw materials, and the impact on Chinese pharmaceutical companies exporting formulations to the U.S. is under consideration [2] Group 2 - Some pharmaceutical companies, such as Huahai Pharmaceutical and Haizheng Pharmaceutical, stated that they would not be affected as they primarily sell generic drugs in the U.S. [2][3] - Kelun Pharmaceutical also confirmed that it would not be impacted by the new tariffs [3] - Currently, only BeiGene is selling innovative drugs independently in the U.S. market among A-share pharmaceutical companies [5] Group 3 - BeiGene's stock price fell over 4% on September 26, but the company believes the tariff policy's lack of specific details will limit its impact [6] - BeiGene's New Jersey facility, with an investment of $800 million, is expected to support global business growth and the development of innovative cancer drugs [6]

Group 1 - The U.S. plans to impose a 100% tariff on patented and branded drugs starting October 1, which has led to a significant drop in A-share pharmaceutical stocks, particularly in the CRO and chemical pharmaceutical sectors, with declines exceeding 2% [2] - The proposed tariffs do not apply to raw materials, and it is believed that the tariffs will mainly affect patented drugs, while generic drugs will be exempt [2][3] - Companies such as Huahai Pharmaceutical and Haizheng Pharmaceutical have stated that they will not be affected as they primarily sell generic drugs in the U.S. market [2][3] Group 2 - Kelun Pharmaceutical also confirmed that it would not be impacted by the tariff changes [3] - Currently, among A-share pharmaceutical companies, only BeiGene is independently selling innovative drugs in the U.S. market [4] - BeiGene's stock price fell over 4% on September 26, but company insiders indicated that the tariff policy lacks specific details and should have a limited impact, as their New Jersey facility is in the process of testing and certification [5]