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 截至月份: 2025年7月31日 狀態: 新提交 本月底法定/註冊股本總額： USD 231,146.38 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8月6日 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. ...

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8月6日 I. 法定/註冊股本變動 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 截至月份: 2025年5月31日 狀態: 重新提交 | 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 | 請見備註(1) | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 9,500,000,000 | USD | | 0.0001 | USD | | 950,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | 0 | | 本月底結存 | | | 2,311,463,847 | USD | | 0.0001 | USD ...

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 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8月6日 I. 法定/註冊股本變動 截至月份: 2025年6月30日 狀態: 重新提交 | 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 | 第 1 頁 共 10 頁 v ...

Core Insights - The company reported total revenue of $1.3 billion for Q2 2025, a 42% increase from $929 million in the same period last year, primarily driven by sales growth of Brukinsa® (Zebutinib) in the US and Europe [1] - Product revenue for Q2 2025 was $1.3 billion, up from $921 million year-over-year, with the increase attributed to Brukinsa® sales [1] - In the US, Brukinsa® sales reached $684 million in Q2 2025, a 43% increase from $479 million in the previous year, supported by strong demand across all indications and moderate net pricing benefits [1] Revenue Breakdown - In Europe, Brukinsa® sales for Q2 2025 were $150 million, an 85% increase, driven by market share gains in major European markets including Germany, Italy, Spain, France, and the UK [1] - Baiyuean® (Tislelizumab) sales for Q2 2025 were $194 million, reflecting a 22% year-over-year growth [2] Regulatory Approvals and Market Expansion - Brukinsa® is now approved in 75 markets globally, with five new markets added or expanded for reimbursement this quarter [2] - Baiyuean® is approved in 47 markets globally, with 20 new markets added for reimbursement, including Japan, Europe, and Australia [2] - Recent approvals include the European Commission's endorsement for Baiyuean® in combination with chemotherapy for various cancer treatments [2] Profitability Metrics - The gross margin under GAAP for global product revenue was 87.4% in Q2 2025, up from 85.0% year-over-year, primarily due to the higher sales proportion of Brukinsa® [3] - Adjusted gross margin for product sales increased to 88.1% in Q2 2025 from 85.4% in the same period last year [3]

Group 1 - The core viewpoint of the news highlights the active trading and significant inflow of funds into the Hang Seng Innovation Drug ETF (159316), which reached a new high in scale and saw a notable increase in trading volume [1][2] - As of August 6, the Hang Seng Innovation Drug ETF (159316) had a total scale of 1.084 billion yuan, marking a record since its inception [1] - The ETF experienced a net inflow of 160 million yuan over the past five trading days, with four days showing positive net inflows [1] Group 2 - BeiGene reported a strong performance for Q2 2025, achieving revenues of 1.32 billion USD, a year-on-year increase of 42%, with product revenue contributing 1.30 billion USD [1] - The company turned a profit with a net income of 90 million USD, compared to a loss of 120 million USD in the same period last year, marking the second consecutive quarter of profitability [1] - Management has raised the full-year revenue guidance to 5.053 billion USD from the previous estimate of 4.953 billion USD, and for the first time, they expect positive operating cash flow for the year [1] Group 3 - The Shanghai Municipal Government issued measures to promote the high-quality development of commercial health insurance, which includes 18 initiatives aimed at supporting the biopharmaceutical industry [1] - Dongwu Securities believes that with policy support, there is potential for a win-win collaboration among medicine, insurance, and pharmaceuticals [1] - The new policies are expected to leverage the advantages of commercial insurance in medical expense settlements, facilitating the smooth progress of medical insurance payment reforms and providing strong financial support for the development of innovative drugs and medical devices [1]

Market Performance - The Hang Seng Hong Kong Stock Connect Innovative Drug Select Index (HSSCPB) decreased by 4.06% as of August 7, 2025 [3] - Notable declines in constituent stocks include: Innovent Biologics (09969) down 9.00%, Lepu Biopharma-B (02157) down 8.21%, and CanSino Biologics (09926) down 7.18% [3] - The Hong Kong Innovative Drug Select ETF (520690) fell by 2.79%, with the latest price at 0.98 yuan [3] - Over the past week, the Hong Kong Innovative Drug Select ETF has seen a cumulative increase of 1.62%, ranking in the top half among comparable funds [3] Liquidity and Trading Activity - The Hong Kong Innovative Drug Select ETF had a turnover rate of 16.49%, with a trading volume of 57.78 million yuan, indicating active market participation [3] - The average daily trading volume for the ETF over the past year was 72.86 million yuan [3] Company Performance - BeiGene reported a total revenue of 17.518 billion yuan for the first half of 2025, a year-on-year increase of 46.0% [3] - The company achieved a net profit of 450 million yuan, marking its first half-year profit since its A-share listing [3] - Revenue growth was driven by sales of self-developed products such as Baiyueze® and licensed products from Amgen, alongside improved operational efficiency through cost management [3] Industry Trends - Despite significant financing pressures in primary and secondary markets, enthusiasm for domestic innovative drug research remains high, with continuous growth in innovative outcomes [4] - In 2024, six domestic innovative drugs received their first approvals overseas, reflecting an acceleration in international recognition [4] - In clinical research, domestic innovative drug trial registrations surpassed those in the U.S. for the first time in 2023, ranking first globally [4] - The share of domestic innovative drugs in emerging therapies is notably high, with significant clinical results from products like Zebutini and AK112 [4] Fund Performance - The Hong Kong Innovative Drug Select ETF saw a significant increase of 28 million shares over the past week, ranking in the top half among comparable funds [4] - The ETF experienced a net outflow of 2.0112 million yuan recently, but had net inflows on three out of the last four trading days, totaling 27.5305 million yuan [4] - The management fee for the ETF is 0.50%, and the custody fee is 0.10%, making it the lowest among comparable funds [4] - As of August 6, 2025, the ETF's tracking error for the year was 0.173%, the highest tracking precision among comparable funds [4] Index Composition - The top ten weighted stocks in the HSSCPB index include BeiGene (06160), Innovent Biologics (01801), WuXi Biologics (02269), and others, collectively accounting for 78.31% of the index [5] - The index aims to reflect the performance of Hong Kong-listed companies involved in innovative drug research, development, and production [5]

Core Viewpoint - BeiGene reported significant financial improvements in Q2 2025, achieving profitability for the first time this year, driven by substantial revenue growth and effective cost management [1] Financial Performance - Total revenue for the first half of 2025 reached 17.518 billion RMB, representing a year-on-year increase of 46.0% [1] - Product revenue amounted to 17.360 billion RMB, with a year-on-year growth of 45.8% [1] - Operating profit was 799 million RMB, and net profit attributable to the parent company was 450 million RMB, both showing a turnaround from losses in the same period last year [1] Profitability and Guidance - This marks the first instance of BeiGene achieving comprehensive profitability in operating profit and net profit attributable to the parent company in 2025 [1] - The company updated its revenue guidance for the full year 2025, adjusting the expected range from 35.2 billion to 38.1 billion RMB to 35.8 billion to 38.1 billion RMB [1] - Gross margin guidance was updated to a mid-high range of 80% to 90% [1] Cash Flow - The net cash flow from operating activities, after deducting capital expenditures for fixed asset purchases, is expected to be positive for the full year [1]

Investment Rating - The report maintains a "Buy" rating for the company, anticipating a price increase of over 15% in the next 6-12 months [5]. Core Insights - The company reported total revenue of $1.3 billion in Q2 2025, a year-on-year increase of 42%, and achieved a GAAP net profit of $94.32 million, marking a return to profitability [2]. - The core product, Zebutinib, has rapidly gained market share, becoming the leader in the U.S. BTKi market with Q2 sales of $950 million, up 49% year-on-year and 20% quarter-on-quarter [3]. - The company has raised its full-year guidance for 2025, projecting total revenue between $5 billion and $5.3 billion, with GAAP operating expenses of $4.1 billion to $4.4 billion and a gross margin in the mid-high 80% range [3]. - The R&D pipeline is expected to see significant catalysts in the second half of 2025, including key clinical trial milestones and regulatory approvals [4]. - The company has revised its net profit forecasts for 2025-2027 to $306 million, $763 million, and $1.186 billion, respectively, reflecting a continuous improvement in profitability [5]. Summary by Sections Performance Review - In Q2 2025, the company achieved total revenue of $1.3 billion, a 42% increase year-on-year, and a GAAP net profit of $94.32 million, indicating a turnaround from previous losses [2]. Operational Analysis - Zebutinib's sales reached $950 million in Q2 2025, with a 49% year-on-year growth and a 20% quarter-on-quarter increase, establishing it as the leading product in the U.S. BTKi market [3]. - The company also reported sales of $194 million for Tislelizumab, growing 22% year-on-year and 13% quarter-on-quarter [3]. R&D Pipeline - The company anticipates several key R&D milestones in H2 2025, including clinical trial analyses and regulatory submissions for various products [4]. Financial Forecasts - The company has updated its revenue guidance for 2025 to between $5 billion and $5.3 billion, with a projected GAAP net profit for the year [3][5]. - The net profit forecasts for 2025, 2026, and 2027 are set at $306 million, $763 million, and $1.186 billion, respectively, indicating strong growth potential [5].

Group 1 - The core viewpoint of the news is that BeiGene, a leading innovative drug company in the A-share market, reported significant financial growth in the first half of 2025, marking its first half-year profit since its listing [1] - In the first half of 2025, BeiGene achieved total revenue of 17.518 billion yuan, representing a year-on-year increase of 46.0%, with product revenue reaching 17.360 billion yuan, up 45.8% year-on-year [1] - The company reported an operating profit of 799 million yuan and a net profit attributable to shareholders of 450 million yuan [1] - BeiGene updated its revenue guidance, expecting full-year revenue for 2025 to be between 35.8 billion yuan and 38.1 billion yuan [1] - Dongwu Securities noted that both the entire pharmaceutical sector and the innovative drug sub-sector have a market capitalization in A-shares and H-shares that is lower than that in the US stock market, indicating potential structural growth opportunities for domestic innovative drug companies [1] Group 2 - The Hong Kong Stock Connect Medical ETF (520510) focuses on three main lines: innovative drugs, CXO, and AI healthcare [2] - The Hang Seng Medical ETF (159892) is highly focused on the innovative drug sector and has a significant holding in BeiGene [3]

Group 1: Policy and Regulatory Developments - The Shanghai regulatory authorities issued 18 measures to promote the high-quality development of commercial health insurance, focusing on expanding coverage to include new medical technologies and services [1] - The National Medical Products Administration is seeking public opinion on the draft guidelines for the quality management of medical device online sales, aiming to standardize inspection practices [2] Group 2: Company Announcements and Developments - Heng Rui Medicine announced that its product, injection of Rui Kang Qu Mo Zhu single antibody, received orphan drug designation from the FDA, which may provide policy support for its development and commercialization [3] - Di Zhe Medicine received Fast Track Designation from the FDA for its innovative drug DZD8586, aimed at treating relapsed refractory chronic lymphocytic leukemia [4] - Tuo Jing Life Sciences' subsidiary obtained two medical device registration certificates for diagnostic kits, enhancing its competitiveness in the in vitro diagnostic field [5] - Sino Medical's subsidiary received breakthrough medical device designation from the FDA for its intracranial drug-coated stent system, marking a significant achievement in domestic neurointerventional devices [6] Group 3: Financial Performance - BeiGene reported a net profit of 450 million yuan for the first half of 2025, marking a turnaround with a 45.8% increase in product revenue [7] - Tian Tan Biology's net profit decreased by 12.88% year-on-year, despite a 9.47% increase in total revenue, attributed to declining product prices and reduced interest income [8] Group 4: Investment Activities - Pian Zai Huang plans to invest 200 million yuan in the Gao Xin Run Xin Fund, which targets a total fundraising goal of 1 billion yuan, reflecting the company's strategy in the health industry [9] Group 5: Industry Collaborations - Jing Tai Technology and DoveTree established a collaboration worth 47 billion HKD for AI drug development, setting a new record in the AI pharmaceutical sector [10] Group 6: Shareholder Actions - Qian Hong Pharmaceutical announced plans for shareholders to reduce their holdings by up to 20.9 million shares, representing 1.63% of the total share capital [11] - Shu Yu Ping Min's controlling shareholder plans to reduce their stake by up to 2%, amounting to 804,730 shares [12]