Core Insights - BeOne Medicines Ltd. announced new data on sonrotoclax, a next-generation BCL2 inhibitor, showing significant clinical benefits as both a monotherapy and in combination therapies for B-cell malignancies, particularly at the 67th American Society of Hematology Annual Meeting [1][2] Summary by Category Clinical Data - Sonrotoclax demonstrated an overall response rate (ORR) of 52.4% in patients with relapsed/refractory mantle cell lymphoma (MCL), with a complete response (CR) rate of 15.5% in a Phase 1/2 study [3] - The median duration of response (DOR) was 15.8 months, with a median time to response (TTR) of 1.9 months and a median progression-free survival (PFS) of 6.5 months [4] - In combination therapies, sonrotoclax plus zanubrutinib achieved a 100% ORR in 135 efficacy-evaluable patients, with a CR/CRi rate of 55% [7] Safety and Tolerability - Treatment with sonrotoclax monotherapy was generally well tolerated, with manageable adverse events; the most common grade 3 treatment-emergent adverse events included neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%) [5] - The combination therapies also showed good tolerability, with no treatment-emergent adverse events leading to death or significant complications [13][14] Regulatory Status - Sonrotoclax is under Priority Review by the U.S. Food and Drug Administration (FDA) for potential accelerated approval, having received Breakthrough Therapy Designation and Fast Track Designation for MCL and other conditions [5][17] Market Potential - Sonrotoclax could become the first BCL2 inhibitor approved for relapsed/refractory MCL in the U.S., with the potential to transform treatment outcomes for patients with limited options [3][6]

Group 1 - The core announcement is that BeiGene has multiple commercialized products and new indications included in the National Medical Insurance Administration's 2025 drug catalogs [1] - The newly released commercial health insurance innovative drug catalog includes two products: Baihe'an (Zanidatamab injection) and Kaizebai (Daratumumab β injection), which are used for specific cancer treatments [1] - Baihe'an is indicated for patients with unresectable locally advanced or metastatic biliary tract cancer (BTC) with high HER2 expression (IHC3+) [1] - Kaizebai is indicated for high-risk and relapsed/refractory neuroblastoma patients [1]

Core Viewpoint - The recent adjustments to the national basic medical insurance directory and the introduction of the commercial insurance innovative drug directory mark significant steps towards enhancing access to innovative treatments in China, particularly for high-cost therapies like CAR-T drugs [2][6]. Summary by Sections National Basic Medical Insurance Directory Adjustments - A total of 114 new drugs were added to the basic medical insurance directory, including 50 first-class innovative drugs [2]. - The total number of drugs in the basic medical insurance directory has increased to 3,253, comprising 1,857 Western medicines and 1,396 traditional Chinese medicines [3]. - New inclusions cover various fields such as oncology, chronic diseases, mental health, and pediatric medications, with several rare disease treatments also added [3]. Commercial Insurance Innovative Drug Directory - The commercial insurance innovative drug directory aims to include high-innovation drugs that exceed the basic insurance scope but offer significant clinical value and patient benefits [6]. - A total of 121 drugs underwent formal review for the commercial insurance directory, with 24 entering price negotiation, ultimately resulting in 19 drugs from 18 companies being included [6]. - Notable inclusions are five CAR-T therapies, which previously cost over one million yuan per injection, making them unaffordable for many patients [6]. Performance of Pharmaceutical Companies - Several leading pharmaceutical companies have reported their successes in the 2025 national medical insurance negotiations, with Heng Rui Pharmaceutical having 20 drugs included, contributing 7.554 billion yuan to their total revenue [5]. - Innovent Biologics announced that 7 of its new drugs were included in the updated national medical insurance directory, with 12 of its 17 innovative drugs now covered [5]. Specific Drug Inclusions - The directory includes drugs for Alzheimer's disease, such as the monoclonal antibodies from Eisai and Eli Lilly, and several rare disease treatments [7]. - Some high-profile drugs, like Novo Nordisk's semaglutide and Bristol-Myers Squibb's nivolumab, were not included despite passing the formal review [8]. Implementation Timeline - The new directory is set to be officially implemented nationwide on January 1, 2026 [9].

Core Viewpoint - The "Commercial Health Insurance Innovative Drug Catalog (2025)" has been officially released, including 19 innovative drugs from 18 pharmaceutical companies, highlighting the growing recognition of innovative therapies in the healthcare market [1] Group 1: Company Highlights - BeiGene is the only company with two products included in the innovative drug catalog, specifically the drugs Daratumumab β Injection and Injection for Zenyda Monoclonal Antibody [1]

Market Overview - Major blue-chip stocks mostly declined, with HSBC Holdings closing at HKD 110.541, down 0.41% from the previous close; Tencent Holdings closed at HKD 608.677, down 0.22% [2] Stock Performance Summary - Tencent Holdings: Latest price HKD 610.000, down HKD 2.000 (-0.33%); ADR price HKD 608.677, down HKD 1.323 [3] - HSBC Holdings: Latest price HKD 111.000, down HKD 0.500 (-0.45%); ADR price HKD 110.541, down HKD 0.459 [3] - Alibaba Group: Latest price HKD 155.000, up HKD 0.600 (0.39%); ADR price HKD 154.057, down HKD 0.943 [3] - AIA Group: Latest price HKD 78.300, down HKD 0.700 (-0.89%); ADR price HKD 78.371, up HKD 0.071 [3] - Meituan: Latest price HKD 99.050, up HKD 0.950 (0.97%); ADR price HKD 98.981, down HKD 0.069 [3] - Ping An Insurance: Latest price HKD 60.450, up HKD 3.800 (6.71%); ADR price HKD 60.370, down HKD 0.080 [3] - BYD Company: Latest price HKD 99.150, up HKD 0.750 (0.76%); ADR price HKD 98.086, down HKD 1.064 [3]

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11月30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12月4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 | 0.0001 | USD | | 231,14 ...

2016期權及激勵計劃項下的受限制股份單位 授出受限制股份單位 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11月28 日，董事會薪酬委員會根據2016期權及激勵計劃的條款向一百四十七名承授人授 出涉及合共21,274股美國存託股份的受限制股份單位。 於2025年11月28日，董事會薪酬委員會根據2016期權及激勵計劃的條款授予一百 四十七名承授人合共21,274股美國存託股份受限制股份單位。該等受限制股份單 位相當於276,562股股份，約佔本公告之日公司發行股份總數的0.02%。 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） 授出受限制股份單位詳情 受限制股份單位詳情如下： 1 授出日期： 2025年11月28日 承授人數目： 一百四十七名 已授出受限制股份單位涉及的 相關股份數目： 276 ...

Core Viewpoint - BeiGene (06160) announced the grant of 21,300 restricted stock units to 147 recipients under the 2016 option and incentive plan, equivalent to 276,600 shares, representing approximately 0.02% of the company's total issued shares as of the announcement date [1] Summary by Category - **Company Actions** - The board's compensation committee granted a total of 21,300 restricted stock units to 147 recipients [1] - The restricted stock units correspond to 276,600 shares [1] - **Shareholder Impact** - The granted shares represent about 0.02% of the total issued shares of the company as of the announcement date [1]

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11月30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) 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 | 0.0001 | USD | | 231,146.38 | 本月底法定/註冊股本 ...

Core Viewpoint - BeiGene (06160.HK) announced the grant of a total of 21,274 restricted stock units to 147 grantees under the 2016 option and incentive plan, equivalent to 276,562 shares, representing approximately 0.02% of the company's total issued shares as of the announcement date [1] Summary by Category - **Company Actions** - The board's compensation committee granted restricted stock units to 147 individuals [1] - The total number of restricted stock units granted is 21,274 [1] - **Shareholder Impact** - The granted units correspond to 276,562 shares [1] - This represents about 0.02% of the total issued shares of the company as of the announcement date [1]