FF301 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: 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6月5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 | | | | | | | | | | 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 | | | 9,500,000,000 | USD | 0.0001 | USD | | 950,000 | 備註： | ...

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） 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5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名承授人授出可認 購合共21,140股美國存託股份的購股權並向三百六十八名承授人授出涉及合共 54,538股美國存託股份的受限制股份單位。 2016期權及激勵計劃項下的購股權 於2025年5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名 承授人可認購合共21,140股美國存託股份的購股權。 授出購股權詳情 購股權詳情如下： 授出日期： 2025年5月30日 承授人數目： 二名 授出購股權及受限制股份單位 已授出購股權涉及的相關股份數目： 274,820 購股權總數（美國存託股份）: 21,140 因已授出購股權獲行使而可予 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 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6月2日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | | 06160 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 事件 | | | 已發行股份（不包括庫存股份）變動 | | | 庫 ...

Group 1 - The Hang Seng Index opened down by 1.06% [1] - The Hang Seng Tech Index opened down by 1.33% [1] - BYD Company shares fell nearly 3% [1] - Kuaishou Technology shares dropped by 2.8% [1] - BeiGene shares decreased by 1.66% [1]

Core Insights - Baiyue Shenzhou's bispecific HER2 inhibitor, Zhenidamab (百赫安), received conditional approval from the National Medical Products Administration (NMPA) for treating HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have previously undergone systemic therapy [1][2] - This approval marks Zhenidamab as the first and only bispecific antibody approved in China for targeted therapy of HER2-positive biliary cancer, providing a new treatment option for patients [1][2] - The incidence of biliary tract cancer is on the rise, with approximately 15% to 30% of BTC patients exhibiting HER2 abnormalities, making HER2 a key target for BTC treatment [1] Clinical Data - The conditional approval is based on the results of the global multicenter clinical study HERIZON-BTC-01, which showed an objective response rate (ORR) of 51.6% in previously treated, unresectable HER2-positive advanced or metastatic BTC patients [2] - The median duration of response (mDoR) was 14.9 months, and the median overall survival (mOS) was 18.1 months, indicating a significant improvement in survival compared to previous second-line chemotherapy options [2] - The safety profile of Zhenidamab was reported to be favorable, demonstrating good overall safety [2] Mechanism of Action - Zhenidamab utilizes a dual-targeting mechanism by binding to two different non-overlapping epitopes of the HER2 protein, enhancing its binding and inhibitory capabilities, which may lead to a synergistic effect in tumor suppression [2] - This innovative mechanism allows for dual signal blockade and the formation of larger receptor clusters, potentially improving therapeutic efficacy [2] Strategic Collaboration - Zhenidamab was developed by Zymeworks, with Baiyue Shenzhou entering a strategic partnership for its development and commercialization in Asia (excluding Japan), Australia, and New Zealand [3] - The drug is also set to be available in the United States, having received FDA approval for the same indication in November 2024 [3] - The President and COO of Baiyue Shenzhou expressed confidence that this innovative drug will significantly benefit the survival of BTC patients in China [3]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 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5月29日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 ...

Investment Rating - The report maintains a "Buy" rating for the company [6][7]. Core Views - The company achieved its first quarterly GAAP net profit in Q1 2025, with total revenue of $1.117 billion, a year-on-year increase of 49% [1][14]. - The company is expected to enter a significant period in 2025, with over 10 concept validation milestones anticipated [4]. - The sales of the key product, Zebutini, are expected to stabilize and grow throughout the year, despite a slight quarter-on-quarter decline in Q1 2025 [3][15]. Financial Performance - In Q1 2025, GAAP operating profit was $11.1 million, marking the first positive result, while adjusted operating profit was $139 million, a 195% year-on-year increase [1][2]. - The company reported a GAAP net profit of $1.27 million for the first time [1][14]. - The total revenue for Zebutini in Q1 2025 was $792 million, a 62% increase year-on-year, with U.S. sales reaching $563 million, also showing significant growth [3][15]. Cost Management - R&D expenses in Q1 2025 were $482 million, with a R&D expense ratio of 43%, down 18 percentage points year-on-year [2][34]. - Sales and management expenses were $459 million, with a corresponding expense ratio of 41%, down 16 percentage points year-on-year [2][34]. Future Outlook - The company forecasts revenues of $3.7517 billion, $4.5024 billion, and $5.4034 billion for 2025, 2026, and 2027 respectively, with net profits expected to be $703 million, $4.010 billion, and $6.744 billion in the same years [6][11]. - The company anticipates a GAAP operating profit for the full year 2025, with a gross margin expected to be in the range of 80%-90% [12][13].

Investment Rating - The report maintains a "Buy" rating for the company [6][7]. Core Views - The company achieved its first quarterly GAAP net profit in Q1 2025, with total revenue of $1.117 billion, a year-on-year increase of 49% [1][14]. - The company is expected to enter a significant period in 2025, with over 10 concept validation milestones anticipated [4]. - The sales of the key product, Zebutini, showed stable growth, with Q1 2025 revenue of $792 million, a 62% year-on-year increase [3][15]. Financial Performance - In Q1 2025, GAAP operating profit was $11.1 million, marking the first positive result, while adjusted operating profit was $139 million, up 195% year-on-year [1][2]. - The company reported a GAAP net profit of $1.27 million for the first time [1][14]. - The total revenue for 2025 is projected to be between $4.9 billion and $5.3 billion, with GAAP operating expenses estimated at $4.1 billion to $4.4 billion [12][13]. Cost Management - R&D expenses in Q1 2025 were $482 million, with a R&D expense ratio of 43%, down 18 percentage points year-on-year [2][34]. - Sales and management expenses were $459 million, with a corresponding expense ratio of 41%, down 16 percentage points year-on-year [2][28]. Product Performance - Zebutini's revenue in the U.S. was $563 million, a year-on-year increase of over 60%, while European sales reached $116 million, up 73% [3][15]. - The other significant product, Trelizumab, generated $171 million in revenue in Q1 2025, reflecting an 18% year-on-year increase [3][23]. Future Outlook - The company expects to achieve a positive GAAP operating profit for the full year 2025, with a projected gross margin between 80% and 90% [12][13]. - The forecasted revenue for 2025-2027 is $37.52 billion, $45.02 billion, and $54.03 billion, respectively [6].

Group 1 - The establishment of the Business and Medical Affairs Advisory Committee aims to assist the board in overseeing the company's business activities and providing strategic advice on business factors [1] - The committee is required to regularly review and reassess its charter and submit any proposed changes to the board for approval [2] - The committee has the authority to request the attendance of any senior officer, employee, or external legal advisor at its meetings [3] Group 2 - The committee can invite directors and other individuals to attend its meetings at the discretion of the committee chair [4] - The board may appoint a committee chair at its discretion [5] - The committee is responsible for reviewing business strategies and plans, as well as medical affairs strategies and plans, and discussing reports from management [6] Group 3 - The committee assists the board and the compensation committee in developing and evaluating performance goals related to business and medical affairs incentive compensation plans [6] - The committee has the authority to access all company records and may establish subcommittees as deemed appropriate [6] - The committee can hire legal, consulting, and other advisors to assist in fulfilling its responsibilities [6]

Group 1 - The establishment of the Scientific Advisory Committee aims to assist the Board in overseeing the company's R&D activities and providing strategic scientific advice [1] - The committee must have at least two members, appointed by the Board, who will consider the scientific, clinical development, regulatory, medical, and technical expertise of the directors [1][2] - The committee has the authority to review and assist the Board in handling other matters and must report its activities and recommendations regularly to the Board [3] Group 2 - The committee is responsible for reviewing the appropriateness of its charter and submitting any proposed changes to the Board for approval [2] - The committee will receive reports from management regarding the company's R&D plans and discuss them [2] - The committee may assist the Board and the Compensation Committee in developing and evaluating any research or development performance targets under the company's incentive compensation plans [2][4] Group 3 - The committee has the right to access all company records and may invite senior officers or external legal advisors to attend meetings [3] - The committee can establish subcommittees as deemed appropriate and may hire legal, consulting, and other advisors to assist in fulfilling its responsibilities [3][4] - The committee is tasked with evaluating the capabilities and performance of key scientific personnel and the depth and breadth of the company's scientific resources [4]