BeiGene(BGNE)
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国内BTK抑制剂一线治疗药物增至4款 临床医生:慢淋患者仍面临耐药和长期管理挑战
Mei Ri Jing Ji Xin Wen· 2025-05-28 14:53
Core Insights - The approval of multiple BTK inhibitors in China is transforming the treatment landscape for Chronic Lymphocytic Leukemia (CLL) and B-cell lymphomas, with a notable shift towards second-generation BTK inhibitors [1][3][4] Group 1: Market Overview - As of now, five BTK inhibitors have been approved in China, including three imported drugs and two domestic drugs, with the first-generation inhibitor ibrutinib and three second-generation inhibitors [3] - The global incidence of CLL is significant, with 191,000 new cases and 61,000 deaths annually, primarily affecting elderly patients with a median age of 65 in China [2] Group 2: Treatment Efficacy and Safety - The five-year survival rate for CLL patients is high, ranging from 80% to 90%, with low-risk patients having a median survival of nearly 20 years [2] - Newer BTK inhibitors demonstrate improved safety profiles compared to first-generation inhibitors, which have seen a decline in global recommendation levels due to safety concerns [3][4] Group 3: Future Directions - The development of BCL2 inhibitors is underway, with ongoing clinical trials combining these with BTK inhibitors, indicating a potential new direction for CLL treatment [5] - The increasing elderly population in China presents challenges for long-term management of CLL patients, necessitating systematic approaches to address treatment adherence and adverse effects [5]
百济神州: 商业及医学事务咨询委员会章程
Zheng Quan Zhi Xing· 2025-05-28 10:53
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]
百济神州: 科学咨询委员会章程
Zheng Quan Zhi Xing· 2025-05-28 10:53
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]
百济神州: 提名及企业管治委员会章程
Zheng Quan Zhi Xing· 2025-05-28 10:53
Core Points - The Nomination and Corporate Governance Committee of the company is established to identify qualified individuals for board membership and to provide recommendations for nominees at the annual shareholder meetings [6] - The committee is composed entirely of independent directors as per NASDAQ rules, with a minimum of two members [1] - The committee is responsible for reviewing and recommending changes to corporate governance guidelines and conducting annual performance evaluations of the board and its committees [3][6] Group 1: Committee Structure and Meetings - The committee members are appointed annually by the board and can be replaced at any time by the board [1] - Meetings can be held in person or via telecommunication, with a quorum established by a majority of members [2] - The committee chair collaborates with members to set meeting agendas, which should be provided in advance [2] Group 2: Responsibilities and Powers - The committee is tasked with reviewing the appropriateness of its charter annually and advising the board on significant developments in corporate governance [3] - It is responsible for establishing a process for identifying and recommending nominees for the board, including shareholder nominations [4] - The committee evaluates the independence of non-executive directors and oversees the hiring and termination of search firms for board candidates [9] Group 3: Succession Planning and Education - The committee provides recommendations for succession planning for key management positions, including the CEO [5] - It is also responsible for preparing educational materials and courses for directors to assist them in fulfilling their duties [9]
百济神州: 审计委员会章程
Zheng Quan Zhi Xing· 2025-05-28 10:53
Core Points - The Audit Committee of BeiGene, Ltd. is established to oversee the quality and integrity of the company's accounting and financial reporting processes, as well as compliance with legal and regulatory requirements [3][6][15] - The committee must consist of at least three members, all of whom must be independent directors according to NASDAQ rules [1][4] - The committee is responsible for appointing, retaining, and terminating the independent auditor, as well as approving all audit services and their terms [7][9][10] Membership and Appointment - The Audit Committee must have members who can read and understand basic financial statements, with at least one member possessing relevant financial or accounting experience [1][2] - The Nominating and Corporate Governance Committee is responsible for recommending candidates for the Audit Committee [1][5] Meetings and Procedures - The Audit Committee is required to meet at least quarterly and can convene via teleconference or other communication devices [2][5] - The agenda for each meeting is to be prepared in consultation with the committee chair and management [2][6] Responsibilities and Powers - The committee is tasked with reviewing and assessing the adequacy of its charter annually and reporting its findings to the board [6][9] - It must evaluate the qualifications, performance, and independence of the independent auditor and report its conclusions to the board [9][10] - The committee is authorized to hire external advisors, including legal counsel, to assist in fulfilling its responsibilities [15][19] Financial Reporting Oversight - The Audit Committee must review significant financial reporting issues and judgments made in the preparation of financial statements [11][12] - It is responsible for discussing the company's quarterly financial reports with management and the independent auditor before submission [13][14] Risk Management - The committee is required to discuss the guidelines and policies governing the company's assessment and management of financial risks [14][19] - It must establish procedures for handling complaints regarding accounting, internal controls, or auditing matters [14][19]
百济神州: 美股公告:表格S-4第一次修订
Zheng Quan Zhi Xing· 2025-05-28 10:48
美国证券交易委员会 华盛顿哥伦比亚特区 20549 表格 S-4 生效后第一份修订 注册声明 依据 《1933 年证券法》 百济神州有限公司 BEONE MEDICINES LTD. (注册人章程中载明的确切名称) 瑞士 2834 98-1209416 (注册成立或组建的州或其他司法管辖区) (主要标准行业分类代码编号) (美国国税局雇主标识号) 转交 BeOne Medicines I GmbH Aeschengraben 27 电话:+41 61 685 19 00 (注册人主要行政办事处的地址(含邮编)及电话号码(含地区编码)) John V. Oyler 首席执行官兼董事长 转交 BeOne Medicines I GmbH Aeschengraben 27 电话: +41 61 685 19 00 (送达代收人的姓名,地址(含邮编)及电话号码(含地区编码)) 抄送: Mitchell S. Bloom Edwin M. O'Connor Marishka DeToy Goodwin Procter LLP Boston, MA 02210 (617) 570-1000 拟开始向公众发售的大概日期:不 ...
百济神州(688235) - 审计委员会章程


2025-05-28 10:31
BEONE MEDICINES LTD. 百濟神州有限公司 審計委員會章程 I. 一般成立目標聲明 百濟神州有限公司「本公司」)董事會(「董事會」)審計委員會(「審計委員會」) 的宗旨是: 審計委員會亦可承擔董事會不時賦予其的其他職責。 II. 組成 A. 成員 審計委員會須至少有三名成員,每名成員均為董事會成員(「董事」),彼 (1)屬於納斯達克股票市場有限責任公司上市規則(「納斯達克規則」)第 5605(a)(2)條所界定的「獨立」成員;(2)符合1934年證券交易法(經修訂) (「交易法」)第10A(m)(3)條第10A-3(b)(1)條的獨立性標準,惟須遵守第 10A-3(c)條規定的豁免;(3)過去三年並無參與編製本公司或本公司現有 附屬公司的財務報表。 儘管有上述規定,倘董事會在特殊及少數情況下,確定董事於審計委員 會的成員資格是本公司及其股東的最佳利益所必需的,並且董事會在上 述確定後的下一年度委託書中披露(或倘本公司未在其10-K或20-F表格 中提交委託聲明)關係的性質及該確定的原因,則根據納斯達克規則第 5605(a)(2)條的規定並非「獨立」,但符合交易法第10A(m)(3)條規定的獨 ...
百济神州(688235) - 提名及企业管治委员会章程


2025-05-28 10:31
BEONE MEDICINES LTD. 百濟神州有限公司 提名及企業管治委員會章程 I. 一般成立目標聲明 百濟神州有限公司(「本公司」)董事會(「董事會」)轄下提名及企業管治委員會 (「提名委員會」)的成立目的為: A. 成員 根據納斯達克股票市場規則第5605(e)(1)(B)條,本公司的提名委員會將 會完全由符合納斯達克股票市場規則第5605(e)(1)(B)條的獨立性測試的 董事組成。提名委員會成員的董事人數由董事會不時決定,但至少由兩 名董事組成。董事會應指定提名委員會的一名成員擔任提名委員會主席。 B. 免職和替換 提名委員會的成員應每年由董事會任命,並可在提出因由或並無提出因 由的情況下隨時由董事會決定替換或免職。無論出於何種理由,董事辭 去董事會職務或董事被免職,將自動構成提名委員會的辭任或免職(如 適用)事宜。無論出於何種理由,職位空缺可由董事會填補。 1 • 物色符合董事會認可標準的合資格人士擔任董事會成員; • 就挑選在每屆股東週年大會上被推舉為董事(「董事」)的獲提名人向董事 會提供意見; • 制定及向董事會建議企業管治指引並定期檢討有關指引以及建議作出變 動;及 • 監督對董事會及 ...
百济神州(688235) - 薪酬委员会章程


2025-05-28 10:31
BEONE MEDICINES LTD. 百濟神州有限公司 薪酬委員會章程 I. 一般成立目標聲明 百濟神州有限公司(「本公司」)董事會(「董事會」)薪酬委員會(「薪酬委員 會」)的成立目標是(1)通過設計、審查和監督本公司高級管理人員薪酬計劃、政策 和規劃,履行與本公司董事(「董事」)及高級管理人員的薪酬有關的董事會職責, (2)監督本公司的整體薪酬結構、政策、以及與人才管理和繼任計劃有關的規劃, 以及(3)負責根據適用規則及規例編製一份報告供納入本公司有關其股東週年大會 的代理聲明或10-K表的年度報告。 薪酬委員會的主要目標是制定及實施薪酬政策與計劃,確保吸引並留住主要 管理人員,動員管理層實現本公司的企業目標及策略,以及把管理層的利益與本 公司股東的長期利益掛鈎。 A. 成員 薪酬委員會成員由股東在每次股東週年大會上選舉產生,任期根據董事 會的建議至下一屆股東週年大會,董事會應根據提名及企業管治委員會 的建議向股東提交該議案。 由董事會提議在薪酬委員會任職的人數應由董事會不時確定,但應由不 少於兩名成員組成,每名成員應滿足根據納斯達克股票市場規則5605(d) 訂立的獨立性標準,但受納斯達克股票市場規 ...
百济神州(688235) - 科学咨询委员会章程


2025-05-28 10:31
BEONE MEDICINES LTD. 百濟神州有限公司 科學諮詢委員會章程 I. 一般成立目標聲明 百濟神州有限公司「本公司」)董事會(「董事會」)轄下科學諮詢委員會(「委員 會」)的成立目的為協助董事會監督本公司的研發活動,並就戰略層面應考慮 的科學因素向董事會提供建議。 II. 組成 A. 成員 委員會的成員人數由董事會不時釐定,惟不得少於兩名。董事會可委任 委員會成員,其任期由董事會不時釐定。於確定董事是否合資格擔任委 員會成員時,董事會或會考慮董事的科學、臨床開發、監管、醫療及技 術專長,以及任何其他相關運營或業務經驗。 在董事會提名及企業管治委員會的指示下,委員會須定期評估自身表現。 B. 主席 董事會可酌情委任委員會主席。 C. 成員的免職、替換和辭職 董事會可在提出因由或並無提出因由的情況下隨時將任何委員會成員免 職或替換。無論出於何種理由,董事辭去董事會職務或董事被免職,將 自動構成委員會的辭任或免職(如適用)事宜。無論出於何種理由,委員 會的職位空缺可由董事會填補。 1 III. 會議 委員會可在其認為適當的時間及地點舉行會議,會議可以親身出席或通過會 議電話或其他通訊設備(所有與會者均 ...