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科兴制药携手东曜药业出海拉美,贝伐珠单抗哥伦比亚获批后闪电发货
Core Insights - The successful shipment of the first batch of Bevacizumab biosimilar to Colombia marks a significant milestone for the company in deepening its presence in the Latin American market [1] Group 1: Overseas Commercialization Strategy - The company has been actively advancing the overseas registration of its collaborative products, receiving industry acclaim for its "multi-country registration" commercial efficiency [2] - The innovative "global selection + global coverage" outbound platform model has led to partnerships with several well-known pharmaceutical companies, securing over twenty key products for overseas commercialization across diverse therapeutic areas [2] - Colombia, as the fourth largest pharmaceutical market in Latin America, has seen a notable increase in the export of Chinese pharmaceutical products, with a 10.4% year-on-year growth in the first quarter of 2025 [2] Group 2: Regulatory and Market Entry - The Colombian pharmaceutical market is a key focus for the company, with the local regulatory body INVIMA's standards closely aligned with international authorities like the FDA and EMA, indicating a high level of market entry rigor [2] - The INVIMA certification is expected to facilitate the introduction of Bevacizumab in other Latin American markets, enhancing the company's overall market penetration strategy [2] Group 3: Collaborative Efforts and Future Plans - The successful commercialization of Bevacizumab overseas is attributed to the deep collaboration between the company and its partner, which ensures stringent production compliance and high product quality [3] - The company plans to continue advancing the registration of Bevacizumab in Latin America and other key markets, while also enhancing its local operational capabilities for other products [3] - The ongoing efforts aim to expand the company's international footprint and provide hope for more patients through access to essential medications [3]
东曜药业-B(01875) - 有关董事、首席执行官、授权代表及董事委员会组成的变动的补充公告
2025-10-16 09:17
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 對 因 本 公 告 全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 BioDlink International Company Limited 東曜藥業股份有限公司 (於 香 港 註 冊 成 立 的 有 限 公 司) (股 份 代 號:1875) 有 關 董 事、首 席 執 行 官、授 權 代 表 及 董 事 委 員 會 組 成 的 變動的補充公告 付山先生 執行董事 香 港,2025年10月16日 於 本 公 告 日 期,本 公 司 執 行 董 事 為 付 山 先 生;本 公 司 非 執 行 董 事 為 劉 衛 東 博 士;及 本 公 司 獨 立 非 執 行 董 事 為 孫 暉 女 士、張 勍 先 生 及 谷 學 林 博 士。 (i) 由 於 個 人 原 因,劉 博 士 辭 任 本 公 司 執 行 董 事、首 席 執 行 官、首 席 科 學 官 及 戰略及ESG委 員 會 成 員;及 (ii) 由 於 個 人 ...
东曜药业-B:付山由非执行董事调任为执行董事
Zhi Tong Cai Jing· 2025-10-13 09:23
Core Viewpoint - Dongyao Pharmaceutical-B (01875) announced significant changes in its executive leadership, effective October 11, 2025, with Mr. Fu Shan transitioning from a non-executive director to an executive director, while Dr. Liu Jun and Ms. Huang Chunying will resign from their respective positions due to personal reasons [1]. Group 1: Leadership Changes - Mr. Fu Shan will lead and oversee the management and development of the group after his transition to executive director [1]. - Dr. Liu Jun will resign from his roles as executive director, CEO, chief scientific officer, and member of the strategic and ESG committee due to personal reasons [1]. - Ms. Huang Chunying will resign from her positions as non-executive director, vice-chairman, and member of the strategic and ESG committee, also due to personal reasons [1]. Group 2: Compliance and Representation - Following Dr. Liu's departure, Mr. Fu Shan has been appointed as the company's authorized representative in accordance with Listing Rule 3.05, effective from October 11, 2025 [1].
东曜药业-B(01875):付山由非执行董事调任为执行董事
智通财经网· 2025-10-13 08:52
继刘博士离任董事后,付先生已根据上市规则第3.05条的规定获委任为公司授权代表以接替刘博士,该 委任自2025年10月11日起生效。 智通财经APP讯,东曜药业-B(01875)发布公告,付山先生自2025年10月11日起由公司非执行董事调任为 执行董事,并负责领导并监督集团的管理与发展。于调任后,付先生继续担任公司董事长、提名委员会 主席及战略及ESG委员会主席。 董事及首席执行官职务变动自2025年10月11日起生效:(i)由于个人原因,刘军博士辞任公司执行董事、 首席执行官、首席科学官及战略及ESG委员会成员;以及(ii)由于个人原因,黄纯莹女士辞任公司非执行 董事、副董事长及战略及ESG委员会成员。此外,刘博士及黄女士亦将煺任公司所有附属公司之所有董 事及(如适用)行政职务。 ...
东曜药业-B(01875.HK):付山调任为执行董事
Ge Long Hui· 2025-10-13 08:49
Group 1 - The core announcement is about the leadership changes at Dongyao Pharmaceutical-B (01875.HK), effective from October 11, 2025 [1] - Fu Shan will transition from a non-executive director to an executive director, overseeing the management and development of the group while continuing as chairman and chair of the nomination and strategic and ESG committees [1] - Liu Jun has resigned from his positions as executive director, CEO, chief scientific officer, and member of the strategic and ESG committees due to personal reasons [1] - Huang Chunying has also resigned from her roles as non-executive director, vice-chairman, and member of the strategic and ESG committees, citing personal reasons [1] - Following Liu Jun's departure, Fu Shan has been appointed as the company's authorized representative in accordance with Listing Rule 3.05, effective from October 11, 2025 [1]
东曜药业-B(01875) - 董事会成员名单及其角色和职能
2025-10-13 08:40
BioDlink International Company Limited 東曜藥業股份有限公司 (於 香 港 註 冊 成 立 的 有 限 公 司) 非執行董事 劉衛東博士 獨立非執行董事 孫暉女士 張勍先生 谷學林博士 (股 份 代 號:1875) 董事會成員名單及其角色和職能 東曜藥業股份有限公司董事會(「董事會」)成 員 載 列 如 下: 執行董事 付山先生 (董 事 長) | | 委員會 | 審計與關聯方 | | | 戰略及 | | --- | --- | --- | --- | --- | --- | | 董 事 | | 交易審核委員會 | 薪酬委員會 | 提名委員會 | ESG委員會 | | 執行董事 | | | | | | | 付山先生 | | – | – | C | C | | 非執行董事 | | | | | | | 劉衛東博士 | | M | M | – | M | | 獨立非執行董事 | | | | | | | 孫暉女士 | | C | – | M | – | | 張勍先生 | | M | C | – | – | | 谷學林博士 | | – | M | M | M | 附 註: C 有關 ...
东曜药业-B(01875) - 董事、首席执行官、授权代表及董事委员会组成的变动
2025-10-13 08:39
東曜藥業股份有限公司 (於 香 港 註 冊 成 立 的 有 限 公 司) (股 份 代 號:1875) 董 事、首 席 執 行 官、授 權 代 表 及 董 事 委 員 會 組 成 的 變 動 非執行董事調任為執行董事 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 對 因 本 公 告 全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 BioDlink International Company Limited 東曜藥業股份有限公司(「本公司」,連 同 其 附 屬 公 司 統 稱「本集團」)董事會(「董 事 會」)謹 此 宣 佈,付 山 先 生(「付先生」)自2025年10月11日起由本公司非執行董 事調任為執行董事(「調 任」),並 負 責 領 導 並 監 督 本 集 團 的 管 理 與 發 展。於 調 任 後,付先生繼續擔任本公司董事長、提名委員會主席及戰略及ESG委員會主席。 付 先 生 將 與 本 公 司 就 其 調 任 為 本 公 司 執 行 董 事 而 ...
东曜药业-B(01875) - 截至2025年9月30日止月份之股份发行人的证券变动月报表
2025-10-08 03:39
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9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: | 東曜藥業股份有限公司 | | | 呈交日期: | 2025年10月8日 | | | I. 法定/註冊股本變動 不適用 | | | FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 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) | 01875 | 說明 | | | | | | | | | | 已發行股份(不包括庫存股份)數目 | | 庫存股份數目 | | | 已發行股份總數 | | | 上月底結存 | | | 772,787,887 | | | 0 | | 772,787,887 | | 增加 / 減少 (- ...
东曜药业-B(01875) - 2025 - 中期财报
2025-09-26 08:37
Financial Performance - For the first half of 2025, the company's operating revenue was RMB 489.14 million, a decrease of 6% year-on-year, with product sales revenue at RMB 397.91 million, down 1% due to intensified competition[15]. - The CDMO/CMO business revenue was RMB 77.30 million, a decline of 32%, primarily due to some key projects not reaching delivery milestones[15]. - The net profit for the first half of 2025 was RMB 4.06 million, a significant decrease of 87%, impacted by increased depreciation and amortization from major construction projects coming into use[15]. - The company's revenue for the first half of 2025 was RMB 489,140 thousand, a decrease of RMB 31,463 thousand or 6% compared to RMB 520,603 thousand in the same period of 2024[32]. - The net profit for the first half of 2025 was RMB 4,062 thousand, down RMB 27,497 thousand or 87% from RMB 31,559 thousand in the same period of 2024[32]. - The group's product sales revenue for the first half of 2025 was RMB 397,909 thousand, a decrease of RMB 2,491 thousand from RMB 400,400 thousand in the same period of 2024, primarily due to intensified market competition[33]. - CDMO/CMO business revenue for the first half of 2025 was RMB 77,301 thousand, down RMB 36,490 thousand from RMB 113,791 thousand in the same period of 2024, mainly due to significant project milestones completed last year that have not yet been reached this year[33]. - Operating profit for the six months ended June 30, 2025, was RMB 9,178 thousand, significantly down from RMB 33,258 thousand in 2024, representing a decline of 72.5%[53]. - Total assets as of June 30, 2025, were RMB 1,476,422 thousand, down from RMB 1,508,772 thousand as of December 31, 2024, reflecting a decrease of 2.1%[55]. - Total liabilities as of June 30, 2025, were RMB 744,740 thousand, a decrease of 4.4% from RMB 779,117 thousand as of December 31, 2024[56]. Research and Development - The company added 16 new projects in the first half of 2025, including 14 ADC projects, bringing the total to 169 projects, with 12 projects advancing from preclinical to clinical stages[9]. - The company is focusing on its core business in the biopharmaceutical CDMO sector, with a continuous decrease in new drug R&D expenses while actively promoting sales of already launched products[22]. - Research and development expenses for the first half of 2025 were RMB 35,628 thousand, compared to RMB 46,059 thousand in the same period of 2024[32]. - The company has a robust pipeline with multiple candidates in various clinical stages, including TAE020 for acute myeloid leukemia and TAB014 for wet age-related macular degeneration[22]. - The company has introduced the "OS One-Step Conjugation" and HydroTrio technologies to enhance ADC development efficiency and clinical effectiveness, catering to specific customer needs[19]. - The BDKcell® (CHOk1) cell line development platform enables rapid and efficient high-expression monoclonal cell line development, accelerating IND submissions[19]. Market Expansion - The core product, Bevacizumab injection, has successfully obtained market approval in Nigeria and Pakistan, marking significant progress in international expansion[12]. - The company is responsible for the global commercialization of Bevacizumab injection, which opens new international market opportunities[12]. - The market for Bevacizumab is projected to reach nearly RMB 49 billion globally by 2030, with a CAGR of 7.6% from 2021 to 2030[23]. - The Chinese market for Bevacizumab is expected to grow to RMB 18.4 billion by 2030, with a CAGR of 8.3% from 2021 to 2030[23]. - The company successfully included its product in the 2022 National Medical Insurance Drug List, significantly improving patient affordability and drug accessibility[23]. Compliance and Quality Management - The company has passed GMP inspections in multiple countries, including Brazil and Colombia, enhancing its international compliance recognition[12]. - The company has successfully passed over 60 GMP audits, including zero-defect EU QP audits and direct approvals from various countries, ensuring compliance with international quality standards[21]. - The company has invested significantly in data integrity and quality management systems to support regulatory audits and ensure compliance with global standards[21]. Employee and Organizational Structure - The CDMO team consists of 524 members, with 77% holding advanced degrees, reflecting the company's commitment to building a strong workforce[21]. - The company continues to enhance its organizational structure and management system, leading to a slight increase in sales and management expenses[15]. - The total number of employees as of June 30, 2025, was 604, with 60.60% in production and manufacturing roles[47]. Financial Management and Risk - The company has not disclosed any significant financial risks that may impact its financial performance and position[70]. - The company’s financial risk management plan focuses on mitigating potential adverse effects on its financial condition and performance due to market unpredictability[70]. - The company plans to continue reviewing economic conditions and foreign exchange risk, considering appropriate hedging measures as necessary[52]. - The company has not made any changes to its risk management mechanisms since the fiscal year ending December 31, 2024[71]. Shareholder Information - As of June 30, 2025, the total number of issued shares is 772,787,887[114]. - Major shareholder Chengwei Evergreen Capital holds 116,250,000 shares, accounting for 15.04% of the company's equity[118]. - The largest shareholder, Chengde Pharmaceutical Co., Ltd., owns 213,311,700 shares, representing 27.60% of the company's equity[117]. - The company has a total of 7,646,300 shares held by a controlled corporation under Chengde Pharmaceutical Co., Ltd., which is 0.99% of the equity[117]. Share-Based Awards - The company adopted the Pre-IPO Share Option Scheme on February 20, 2013, to attract and retain talent, enhancing employee productivity and cohesion[120]. - The company plans to grant share-based awards under the newly adopted 2024 Restricted Share Award Scheme instead of the 2020 scheme, as the transitional arrangements for new share grants have been terminated[126]. - The 2020 Restricted Share Award Scheme is expected to terminate on May 28, 2030, subject to certain conditions[128]. - The company has outlined specific vesting conditions for shares granted, with some shares vesting based on achieving R&D targets by 2029[128]. Corporate Governance - The company has a commitment to comply with the Corporate Governance Code as per the listing rules[146]. - The audit and related party transaction review committee has reviewed the financial reporting process and internal control systems, confirming compliance with applicable accounting standards and regulations[134]. - The company is subject to regulations from the FDA and NMPA regarding drug approvals and clinical trials[147].
东曜药业-B(01875) - 截至2025年8月31日止月份之股份发行人的证券变动月报表
2025-09-04 04:00
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8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: 東曜藥業股份有限公司 呈交日期: 2025年9月4日 I. 法定/註冊股本變動 不適用 FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 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) | 01875 | 說明 | | | | | | | | | | 已發行股份(不包括庫存股份)數目 | | 庫存股份數目 | | | 已發行股份總數 | | | 上月底結存 | | | 772,787,887 | | | 0 | | 772,787,887 | | 增加 / 減少 (-) | | | | 0 | | 0 | | | | 本月底結存 | | | 772,787,887 | | | 0 | | ...