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Zymeworks Announces Leadership Appointments and Transitions to Align with Evolution of Corporate Strategy

Investment industry veteran Mr. Brian Cherry appointed to Board of Directors Dr. Sabeen Mekan to transition to Chief Medical Officer effective February 1, 2026 and Mark Hollywood promoted to Executive Vice President and Chief Operating Officer Five new Vice Presidents appointed, underscoring our commitment to leadership development VANCOUVER, British Columbia, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced appointments, promotions, retirements, and reductions to its leadership team intended to strengthen the capabilities and experience of the organization. These updates are designed to align key leadership roles with the Company’s corporate strategy announced in November. “At Zymeworks, we recognize that our greatest asset is our people. Ensuring that we continue to have the right set of key skills and experience within our Board of Directors and leadership team is critical for successful execution of our current strategy and driving long-term shareholder value. Elevating talented individuals at Zymeworks recognizes their strong performance for the Company, our continued confidence in their abilities and the emphasis we place on cultivating leaders from within,” said Kenneth Galbraith, Chair, Chief Executive Officer, and Acting Chief Financial Officer of Zymeworks. Board of Directors Strengthened to Support Future Strategy Brian Cherry has been appointed to the Board effective January 12, 2026 to bring the current Board to nine directors. Mr. Cherry has spent more than 25 years investing in and helping build businesses across a wide range of industries including healthcare, industrials, business services, financial services, and consumer products. He has led buyout and growth equity investments in companies totaling over $25 billion in enterprise value. Previously, Mr. Cherry was a Managing Partner at Oak Hill Capital, a private equity firm. His board experience includes over a dozen private and public companies, the U.S. Air Force Academy Foundation, and the Undergraduate Financial Aid Leadership Council at the University of Pennsylvania. Mr. Cherry earned his BA from Princeton University and his MBA from The Wharton School at the University of Pennsylvania. Mr. Galbraith added, “Over the past year, we have taken deliberate steps to streamline the Board, reducing its size from twelve to nine directors, while ensuring that the collective skills and experience of the Board are well aligned to provide effective oversight of the Company’s new corporate strategy. Brian brings complementary expertise to the Board, particularly in capital allocation and strategic acquisitions, which we believe will support disciplined execution and long-term shareholder value creation.” Mr. Cherry is the fourth new director appointed to Zymeworks’ Board over the past twelve months, joining Mr. Oleg Nodelman, Mr. Greg Ciongoli, and Mr. Robert E. Landry. Leadership Appointments and Transitions Position Company for Next Phase of Growth Mr. Mark Hollywood has been promoted to Executive Vice President and Chief Operating Officer with expanded responsibilities beyond his current leadership of Technology and Manufacturing Operations, Quality, and Alliance/Program Management. Dr. Sabeen Mekan has been promoted to Senior Vice President and Chief Medical Officer (CMO) effective February 1, 2026, with overall responsibility for our clinical development, regulatory affairs, pharmacovigilance/patient safety, and clinical operations. Dr. Jeff Smith, our current CMO, will be retiring effective January 31, 2026, while continuing to provide services as an adviser for a transitional time period. Ms. Leone Patterson, our Chief Financial and Business Officer and Mr. Daniel Dex, General Counsel, will both be departing from their roles at Zymeworks during the first quarter of 2026. The Company has commenced a comprehensive search for a permanent Chief Financial Officer with the experience required to support the Company’s next phase of development. Mr. Galbraith has assumed the role of Acting Chief Financial Officer until a replacement is secured. In addition, the following individuals have been promoted or appointed to the leadership team: Ms. Laura O’Connor, Senior Vice President and Chief Human Resources Officer Ms. Bijal Desai, Senior Vice President, Finance Dr. Lindsey Foulkes, Senior Vice President, Corporate Development and Strategy Dr. Charles Chen, Vice President, Translational Sciences Ms. Shrinal Inamdar, Vice President, Investor Relations Ms. Diana Papove, Vice President, Corporate Communications Ms. Victoria Spencer, Vice President, Treasury and Tax Dr. Lingxing Zheng, Vice President, Regulatory Affairs “These outstanding individuals have consistently demonstrated exceptional leadership abilities, commitment to our vision, and a deep understanding of both our strategic objectives and our commitment to bringing meaningful medicines to patients worldwide,” stated Mr. Galbraith. “These leadership changes reflect the alignment of management resources to effectively execute against our strategic objectives in order to drive long-term shareholder value at Zymeworks.” Additional information on the background and experience of these individuals is available on the Company’s website at www.zymeworks.com. About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and the anticipated benefits thereof; implementation of its evolving asset aggregation strategy, including existing and potential future royalty streams and existing and potential new partnerships; statements that relate to the expected contributions of personnel to Zymeworks’ strategic goals and long-term shareholder value; anticipated capital allocation strategy; industry opportunities for acquisition of new revenue streams or collaborations; the commercial potential of technology platforms and product candidates; Zymeworks’ early-stage pipeline and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ evolution of its business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Investor inquiries:Shrinal InamdarVice President, Investor Relations(604) 678-1388ir@zymeworks.com Media inquiries:Diana PapoveVice President, Corporate Communications(604) 678-1388media@zymeworks.com

Zymeworks to Report Second Quarter 2025 Financial Results and Host Conference Call on August 7, 2025

Company to participate in investor conferences in July and August VANCOUVER, British Columbia, July 17, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced that management will report its second quarter 2025 financial results after market close on August 7, 2025. Following the announcement, management will host a conference call and webcast to discuss financial results and provide a corporate update on August 7, 2025 at 4:30 pm Eastern Time (ET). The event will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations. Management will also participate in the following upcoming investor conferences: BTIG Virtual Biotechnology Conference: Zymeworks’ management will participate in one-on-one meetings and a fireside chat on July 29. Stifel Biotech Summer Summit: Zymeworks’ management will participate in one-on-one meetings August 11-13 and a fireside chat on August 13 at 9:00 am ET in Newport, Rhode Island. About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab has received accelerated approval from the U.S. FDA, conditional approval from China’s NMPA, and conditional marketing authorization from the European Commission for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). It is the first and only dual HER2-targeted bispecific antibody approved for this indication in the U.S., Europe, and China. Zanidatamab is also being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with an investigational new drug application for ZW251 planned for mid-2025. In addition to Zymeworks’ pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Contacts: Investor Inquiries:Shrinal InamdarSenior Director, Investor Relations(604) 678-1388ir@zymeworks.com   Media Inquiries:Diana PapoveSenior Director, Corporate Communications(604) 678-1388media@zymeworks.com

Zymeworks Appoints Leone Patterson as Chief Business and Financial Officer

VANCOUVER, British Columbia, July 25, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced the appointment of Leone Patterson as Executive Vice President, and Chief Business and Financial Officer, effective September 1, 2024. “After an extensive search, we are delighted to have Leone Patterson join us at this exciting time as we plan for our next stage of growth and development at Zymeworks,” said Kenneth Galbraith, Chair and CEO of Zymeworks. “She brings more than 20 years of public company biotech experience with a proven track record of guiding strategy, finance, operations, and governance through multiple phases of growth, planning and executing successful financial strategies. Ms. Patterson has the financial leadership qualities to support Zymeworks as we continue to make progress in achieving our ‘5 by 5’ goal of having five novel antibody-drug conjugates or novel T cell engagers in clinical studies by 2026, and progress product candidates from our ADVANCE R&D programs into clinical studies by 2027 and beyond.” “I am very pleased to be joining Zymeworks as the Company plans for many important milestones in the months and years ahead. I look forward to working collaboratively with the experienced leadership team in maximizing the value of the rapidly expanding pipeline and addressing many critical areas of unmet medical needs for patients with difficult-to-treat cancers and other serious diseases,” said Ms. Patterson. Prior to joining Zymeworks, Ms. Patterson served as Chief Financial and Business Officer at Tenaya Therapeutics where she led corporate finance, investor relations, corporate communications, strategy and business development teams as well as other operational functions. She previously held leadership positions at Adverum Biotechnologies including Chief Financial Officer, President, Chief Executive Officer and Director. She also has held senior finance positions at Diadexus, Transcept, Exelixis, Novartis, and Chiron. Earlier in her career she worked in the audit practice of KPMG. Ms. Patterson currently serves on the board of directors of Nkarta, Inc. and Oxford Biomedica, both publicly-held companies. She earned a B.S. in business administration and accounting from Chapman University and an executive MBA from St. Mary’s College. Ms. Patterson is also a Certified Public Accountant (inactive status). Ms. Patterson’s appointment builds on the Company’s continued focus on strengthening its leadership in the biopharmaceutical industry and expanding its pipeline of pharmaceutical candidates with the potential to make a significant difference in the lives of patients around the world with difficult-to-treat cancers and other diseases. She will be responsible for assisting with the development of Zymeworks’ long-term financial strategy, providing leadership surrounding financing and capital strategies and supporting strategic business decisions. She will be based in the new Zymeworks’ location in Redwood City, California. About Zymeworks Inc.Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) has been accepted and granted Priority Review. A BLA has also been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in the U.S. and China. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody-drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Ms. Patterson’s anticipated appointment date; Ms. Patterson’s expected contributions to Zymeworks’ strategic goals; potential therapeutic effects and commercial potential of zanidatamab and Zymeworks’ other product candidates; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; the ability to advance product candidates into later stages of development; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedar.com). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Contacts: Investor Inquiries: Shrinal InamdarDirector, Investor Relations(604) 678-1388ir@zymeworks.com   Media Inquiries: Diana PapoveSenior Director, Corporate Communications(604) 678-1388media@zymeworks.com

Zymeworks To Report Second Quarter 2024 Financial Results and Host Conference Call on August 1, 2024

VANCOUVER, British Columbia, July 11, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that management will report its second quarter 2024 financial results after market close on August 1, 2024. Following the announcement, management will host a conference call and webcast to discuss financial results and provide a corporate update on August 1, 2024 at 4:30 pm Eastern Time (ET). The event will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at http://ir.zymeworks.com/events-and-presentations. About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) has been accepted and granted Priority Review. A BLA has also been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in the U.S. and China. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody-drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Contacts: Investor Inquiries: Shrinal InamdarDirector, Investor Relations(604) 678-1388 ir@zymeworks.com   investors@zymeworks.com Media Inquiries: Diana PapoveSenior Director, Corporate Communications(604) 678-1388 ir@zymeworks.com   media@zymeworks.com

全球業務持續快速增長，營收再創新高，2023年第四季度總收入達6.34億美元，同比增長67%；全年總收入達25億美元，同比增長74% 百悅澤®（澤布替尼）在血液學領域進一步鞏固領導地位，2023年第四季度全球銷售額達4.13億美元，同比增長135%；全年全球銷售額達13億美元，同比增長129% 全力推進血液學創新研發管線，sonrotoclax啟動四項註冊性試驗，包括用於治療初治慢性淋巴細胞白血病（CLL）的全球3期試驗；BTK CDAC啟動兩項用於治療復發或難治性（R/R）CLL、R/R套細胞淋巴瘤（MCL）的全球擴展佇列研究憑藉多樣化的產品和地區收入組合、不斷改善的經營杠杆效益，實現持續增長中國北京、美國麻省劍橋和瑞士巴塞爾2024年2月26日 /美通社/ -- 百濟神州有限公司（納斯達克代碼： BGNE；香港聯交所代碼：06160；上交所代碼：688235）是一家全球腫瘤創新公司，今日發佈2023年第四季度和全年財務業績以及業務亮點，進一步拓展全球業務、強化全球和美國市場收入的快速增長，並持續推進創新研發戰略。「回顧2023年第四季度和全年，百濟神州取得了長足的進展，朝著成為具有影響力的新一代腫瘤創新公司的目標不斷邁進。隨著百悅澤®在全球尤其是美國和歐洲市場持續取得成功，我們進一步鞏固了在血液學領域的領導地位。」百濟神州聯合創始人、董事長兼首席執行官歐雷強（John V. Oyler）先生表示，「憑藉在研發和生產方面的成本優勢，我們構建了業內規模最大、最令人振奮的腫瘤研發管線之一。我們期待百濟神州在新的一年裡取得變革性的突破，通過在全球不同地區推動收入的顯著增長，持續實現卓越運營。」關鍵業務進展和管線亮點 2023年第四季度，公司產品收入達6.305億美元，同比增長86%；全年產品收入達22億美元，同比增長75%。得益於對經營費用的嚴格管理，按美國公認會計原則（GAAP）計算，2023年第四季度和全年，經營虧損分別減少了18%和33%；經調整經營虧損分別減少了28%和47%。美國食品藥品監督管理局（FDA）批准百悅澤®的說明書更新，納入3期ALPINE試驗中，對比億珂®（伊布替尼）治療既往經治復發或難治性（R/R）慢性淋巴細胞白血病（CLL）患者取得的無進展生存期（PFS）優效性結果（中位隨訪時間29.6個月），進一步鞏固百悅澤®作為首選BTK抑制劑的地位。擴大百悅澤®全球適應症範圍，包括獲得歐盟委員會批准，用於治療既往接受過至少兩線系統性治療的R/R濾泡性淋巴瘤（FL）成人患者，成為迄今為止首個在該項適應症獲批、以及同類產品中獲批適應症最廣泛的BTK抑制劑。在2023年12月舉行的美國血液學會（ASH）年會上，公佈25項摘要，突出公司在血液學領域的領導地位和實力，包括： - 更新ALPINE試驗數據，在中位元隨訪39個月時，百悅澤®對比億珂®在治療R/R CLL成人患者中持續展示出更優的PFS結果。 - 公佈sonrotoclax 1/2期試驗數據，與百悅澤®聯合用於治療初治CLL時展示出良好的安全性和耐受性，且具有深度和持久的療效；sonrotoclax用於治療R/R邊緣區淋巴瘤患者具有良好的單藥活性；以及sonrotoclax與地塞米松聯合用於治療攜帶t(11,14)的多發性骨髓瘤（MM），具備令人鼓舞的療效和安全性。 - 公佈正在進行的BTK CDAC（BGB-16673）首個人體臨床試驗數據：在治療既往接受過多線治療的B細胞惡性腫瘤患者中（包括BTK抑制劑耐藥患者），BTK CDAC展現出顯著的臨床緩解和可耐受的安全性特徵。擴大抗 PD-1 抗體百澤安®（替雷利珠單抗）在全球的影響力，獲得歐洲藥品管理局（EMA）人用藥品委員會（CHMP）的積極意見，推薦其用於治療非小細胞肺癌（NSCLC）的三項適應症；用於一線治療食管鱗狀細胞癌（ESCC）成人患者的上市申請已獲EMA受理；並正在接受美國和歐洲等 10 個國家和地區監管機構的審評；持續推動創新研發戰略，在2023年內共推動5個新分子實體（NMEs）進入臨床，包括潛在「同類最佳」CDK4抑制劑BGB-43395。 2023年第四季度和全年財務亮點總收入：2023年第四季度總收入為6.344億美元，全年總收入為25億美元，上一年同期分別為3.801億美元和14億美元。本季度總收入較上年同期增長主要得益於公司核心市場產品銷售額的增長。2023年第四季度和全年，美國是公司收入最高的市場，該市場的總收入分別為3.132億美元和11億美元，而上年同期分別為1.554億美元和5.026億美元。隨著百悅澤®在美國的銷售額持續增長，公司預計將在2024年繼續保持這一趨勢。截至12月31日止三個月截至12月31日止十二個月（除每股數據外，其餘單位均為千美元） 2023年 2022年 2023年 2022年產品收入淨額 $ 630,526 $ 339,022 $ 2,189,852 $ 1,254,612 合作收入淨額 $ 3,883 $ 41,073 $ 268,927 $ 161,309 總收入 $ 634,409 $ 380,095 $ 2,458,779 $ 1,415,921 GAAP經營虧損 $ (383,795) $ (468,622) $ (1,207,736) $ (1,789,665) 經調整經營虧損* $ (267,224) $ (372,480) $ (752,473) $ (1,420,225) *關於公司使用非GAAP財務指標的說明，請參閱本新聞稿「非美國公認會計原則（GAAP）財務指標的使用」部分；關於每項非GAAP財務指標與最可比GAAP指標的調節，請參閱本新聞稿末尾的表格。產品收入：2023年第四季度，產品收入為6.305億美元，全年產品收入為22億美元，上一年同期分別為3.390億美元和13億美元。產品收入具體包括：百悅澤®2023年第四季度全球銷售額為4.130億美元，全年全球銷售額為13億美元，上一年同期分別為1.761億美元和5.647億美元；百澤安®2023年第四季度的銷售額為1.280億美元，全年銷售額為5.366億美元，上一年同期分別為1.022億美元和4.229億美元；安進公司授權產品2023年第四季度的銷售額為5,110萬美元，全年銷售額為1.883億美元，上一年同期分別為2,770萬美元和1.146億美元。毛利率：2023年第四季度和全年，毛利占全球產品收入分別為83.2%和82.7%，上年同期為78.3%和77.2%。季度及全年的毛利率同比均取得增長，主要是由於與我們的其他產品組合以及毛利率較低的授權許可產品相比，百悅澤®全球產品銷售額占比較高，且百悅澤®和百澤安®的單位成本較低。經營費用 2023年第四季度和2022年第四季度的經營費用分別匯總如下： GAAP 非GAAP （除百分比外，其餘單位為千美元） 2023年第四季度 2022年第四季度增長變化（%） 2023年第四季度 2022年第四季度增長變化（%）研發費用 $ 493,987 $ 446,023 11 % $ 437,383 $ 404,186 8 % 銷售及管理費用 $ 416,547 $ 328,984 27 % $ 361,435 $ 275,648 31 % 攤銷(1) $ 1,838 $ 188 878 % $ — $ — 不適用經營費用總計 $ 912,372 $ 775,195 18 % $ 798,818 $ 679,834 18 % 2023年和2022年全年的經營費用分別匯總如下： GAAP 非GAAP （除百分比外，其餘單位為千美元） 2023年度 2022年度增長變化（%） 2023年度 2022年度增長變化（%）研發費用 $ 1,778,594 $ 1,640,508 8 % $ 1,558,960 $ 1,474,919 6 % 銷售及管理費用 $ 1,504,501 $ 1,277,852 18 % $ 1,284,689 $ 1,077,977 19 % 攤銷(1) $ 3,500 $ 751 366 % $ — $ — 不適用經營費用總計 $ 3,286,595 $ 2,919,111 13 % $ 2,843,649 $ 2,552,896 11 % (1) 與百時美施貴寶產品分銷權相關的無形資產已於2023年12月31日攤銷完畢，屆時分銷權將根據和解協定條款歸還至百時美施貴寶。研發費用：2023年第四季度和全年，GAAP和經調整研發費用均同比增長，主要是由於對新技術平臺和藥物模式的投入，從而將臨床前項目推進臨床、早期臨床項目推進後期發展階段。2023年第四季度和全年，正在進行中的授權引入候選藥物研發相關的預付款分別為3,180萬美元和4,680萬美元，上年同期分別為4,870萬美元和6,870萬美元。銷售及管理（SG&A）費用： 2023 年第四季度和全年，GAAP和經調整SG&A費用均有所增加，主要是由於百悅澤®在全球實現商業化上市的持續投入，尤其是在美國和歐洲。淨虧損 2023年第四季度和全年，按GAAP計算，淨虧損較去年同期有所改善，主要由於經營虧損減少，並因BMS仲裁和解獲得3.629億美元的非經營收入。 2023年第四季度，每股淨虧損為0.27美元，每股美國存托股份（ADS）淨虧損為3.53美元；上一年同期每股淨虧損為0.33美元，每股ADS淨虧損為4.29美元。2023年全年，每股淨虧損為0.65美元，每股ADS淨虧損8.45美元；上一年同期每股淨虧損1.49美元，每股ADS淨虧損19.43美元。現金、現金等價物、受限資金截至12月31日止 2023年 2022年（單位：千美元）期初現金、現金等價物及受限現金 $ 3,875,037 $ 4,382,887 經營活動使用的現金淨額 (1,157,453) (1,496,619) 投資活動產生的現金淨額 60,004 1,077,123 融資活動產生（使用）的現金淨額 416,478 (18,971) 匯率變動的淨影響 (8,082) (69,383) 現金、現金等價物及受限現金淨減少額 (689,053) (507,850) 期末現金、現金等價物及受限現金 $ 3,185,984 $ 3,875,037 經營活動所用現金：2023年第四季度和全年分別為2.216億美元和12億美元，上一年同期為3.182億美元和15億美元，這一費用的減少主要是由於經營杠杆效益的改善。關於公司2023年度財務報表的更多詳細信息，請參閱百濟神州向美國證券交易委員會提交的2023年年度報告10-K表格。藥政進展和研發項目核心亮點百悅澤®在美國獲批更新說明書，納入無進展生存期（PFS）優效性結果，同時在歐盟和加拿大獲批R/R濾泡性淋巴瘤（FL）適應症，進一步鞏固其作為首選BTK抑制劑的地位。擴大百澤安®的全球足跡，目前已在美國和歐洲等 10 個市場遞交註冊申請。 Sonrotoclax用於一線治療CLL的全球3期試驗，以及針對BTK CDAC的潛在註冊可用的擴展佇列研究均已入組首例患者。類別產品近期里程碑註冊批准百悅澤®（澤布替尼）獲得美國FDA對更新說明書的批准，納入在3期ALPINE試驗中治療R/R CLL/SLL成人患者取得的PFS優效性結果獲得歐盟委員會和加拿大衛生部批准，聯合奧妥珠單抗用於治療既往接受過至少兩線系統性治療的R/R FL成人患者新增4個市場，獲得治療R/R和初治（TN）CLL適應症註冊批准百澤安®（替雷利珠單抗）獲得中國國家藥品監督管理局（NMPA）批准，用於一線治療不可切除肝細胞癌患者獲得英國藥品與健康產品管理局（MHRA）批准，用於二線治療晚期ESCC患者註冊申報替雷利珠單抗獲得EMA CHMP的積極意見，推薦批准替雷利珠單抗用於治療NSCLC的三項適應症一項聯合化療用於既往未經治療的廣泛期小細胞肺癌（ES-SCLC）患者的新適應症上市申請（sBLA）獲NMPA受理一項聯合含鉑化療作為新輔助治療、後續進行替雷利珠單抗輔助治療用於可切除的 II 期或 IIIA 期非小細胞肺癌（NSCLC）成人患者新適應症的上市申請獲NMPA受理用於一線治療ESCC成人患者的新適應症上市申請獲EMA受理臨床進展百悅澤® 在ASH年會上，公佈 3期ALPINE試驗的積極隨訪數據，百悅澤®對比億珂®在治療R/R CLL/SLL中展現出持續的PFS獲益，且心血管事件發生率持續較低替雷利珠單抗在一項皮下注射用於一線治療晚期或轉移性NSCLC的1期試驗中，入組首例患者 Sonrotoclax （BGB-11417）獲得美國FDA「孤兒藥」資格認定，用於治療多發性骨髓瘤（MM）、華氏巨球蛋白血症（WM）、急性髓系白血病（AML）和套細胞淋巴瘤（MCL）在與百悅澤®聯合用於一線治療CLL患者的全球關鍵性試驗中，入組首例患者在ASH年會上，公佈sonrotoclax多項數據： - 與百悅澤®聯用，展示出良好的安全性和耐受性，且對治療TN CLL 有深度和持久的療效 - 展示出令人鼓舞的數據，有望成為首款在攜帶 t(11,14)的MM適應症中獲批的BCL-2抑制劑 - 在治療R/R MZL中，展示出良好的單藥活性 BTK CDAC （BGB-16673）在ASH年會上，公佈正在進行的首次人體臨床試驗數據：在治療既往接受過多線治療的B細胞惡性腫瘤患者時（包括BTK抑制劑耐藥患者），BTK CDAC展現出顯著的臨床緩解和可耐受的安全性特徵在一項用於治療R/R MCL的潛在註冊可用的擴展佇列研究中，入組首例患者獲得美國FDA授予的快速通道資格、「孤兒藥」資格認定，用於治療R/R MCL LBL-007 （抗LAG3抗體）[1] 與維立志博合作，在一項與替雷利珠單抗和化療聯合用於一線治療不可手術、局部晚期或轉移性ESCC患者的2期試驗中，入組首例受試者早期研發新分子實體（NME）BGB-43395（CDK4抑制劑）的1期臨床試驗，前兩組患者已全部入組預計里程碑事件核心亮點百悅澤®預計將獲得美國FDA批准，聯合奧妥珠單抗用於治療R/R FL，成為同類產品中獲批適應症最廣泛的 BTK 抑制劑。替雷利珠單抗預計將獲得美國FDA批准，用於一線和二線治療ESCC，進一步深化公司在實體瘤領域創新產品組合的全球佈局。類別產品預計里程碑事件預計註冊批准百悅澤® 預計將於2024年3月和6月分別獲得美國FDA和NMPA批准，聯合奧妥珠單抗用於治療既往接受過至少兩線系統性治療的R/R FL成人患者替雷利珠單抗預計將於2024年上半年獲得美國FDA批准，用於治療二線ESCC 獲得美國FDA批准，用於一線治療不可切除、復發性、局部晚期或轉移性ESCC患者，《處方藥使用者付費法案》（PDUFA）目標審評日期為2024年7月預計將於2024年上半年獲得EMA批准，聯合化療用於一線和單藥用於二線治療轉移性NSCLC 預計將於2024年第三季度獲得NMPA批准，聯合化療用於治療既往未經治療ES-SCLC 預計將於2024年第二季度獲得NMPA批准，用於一線治療不可手術、局部晚期或轉移性胃或胃食管結合部（G/GEJ）腺癌預計註冊申報百悅澤® 預計將於2024年上半年，向EMA和加拿大衛生部遞交一項片劑新劑型上市申請；于2024年下半年向美國FDA遞交該項新劑型上市申請替雷利珠單抗預計將於2024年上半年，向日本藥品和醫療器械管理局（PMDA）遞交一線和二線治療ESCC患者的上市申請預計將於2024年第一季度，向EMA遞交一線治療不可手術、局部晚期或轉移性G/GEJ腺癌的上市申請 Zanidatamab[2] 與Jazz Pharmaceuticals 和Zymeworks合作，預計將於2024年下半年向NMPA遞交一項治療HER2擴增的不可手術和晚期或轉移性膽管癌的上市許可申請（BLA）預計臨床進展 Sonrotoclax 預計將於2024年第二季度完成一項潛在可用於註冊的全球2期試驗的入組工作，用於治療R/R MCL 歐司珀利單抗（抗TIGIT抗體）預計將於2024年第一季度，完成3期AdvanTIG-302試驗的入組工作，用於一線治療NSCLC Tarlatamab[3] （靶向DLL3和CD3的雙特異性抗體T細胞接合器）與安進公司合作，預計將於2024年下半年，在中國啟動一項用於治療局限期小細胞肺癌的全球3期試驗的入組工作早期研發預計將於2024年，啟動至少 10 個新分子實體的首次人體臨床試驗，包括泛 KRAS 抑制劑、 MTA協同PRMT5抑制劑、EGFR降解劑、CDK2 抑制劑、ADC 和雙特異性免疫細胞銜接器與安進公司合作[3]，預計將於2024年上半年在中國入組首例患者，推進xaluritamig（AMG 509，靶向STEAP1和CD3的XmAb® T細胞銜接分子[4]）用於治療轉移性去勢抵抗性前列腺癌的1期研究 [1]維立志博合作產品；百濟神州擁有除中國以外地區的商業化權利 [2]Jazz/Zymeworks合作產品；百濟神州擁有在亞太（除日本以外）、澳大利亞和紐西蘭的商業化權利 [3]安進合作產品；百濟神州將擁有在中國的商業化權利，並有權利從中國以外的淨銷售額獲得中個位數的分級特許權使用費 [4] XmAb®是Xencor公司的注冊商標生產運營位於美國新澤西州霍普韋爾西普林斯頓創新園區的旗艦級生物藥生產基地和臨床研發中心即將完工，預計將於2024年7月投入運營。該基地耗資8億美元，共擁有超過100萬平方英尺（約9.3萬平方米）的可開發地產，可供進一步擴建。位於中國蘇州的新建小分子創新藥物產業化基地已完工。第一階段的建設新增超過55.9萬平方英尺（約5.2萬平方米），固體制劑產能擴大至每年10億片（粒）劑次。位於中國廣州的世界一流生物藥生產基地總產能已達6.5萬升，抗體偶聯藥物（ADC）生產設施和全新生物藥臨床生產大樓均已完工，分別占地25萬平方英尺（約2.3萬平方米）和17萬平方英尺（約1.6萬平方米）。企業發展獲得昂勝醫藥公司一款差異化CDK2抑制劑的全球獨家許可權利，拓展公司在乳腺癌和其他實體瘤領域的早期研發管線。財務摘要簡明合併資產負債表摘要數據（美國公認會計原則）（單位為千美元）截至 12月31日 12月31日 2023年 2022年（經審計）資產：現金、現金等價物、受限資金和短期投資 $ 3,188,584 $ 4,540,288 應收賬款，淨額 358,027 173,168 存貨，淨額 416,122 282,346 物業、廠房及設備，淨額 1,324,154 845,946 總資產 $ 5,805,275 $ 6,379,290 負債及股東權益：應付帳款 $ 315,111 $ 294,781 預提費用及其他應付款項 693,731 467,352 遞延收入 300 255,887 研發成本分攤負債 238,666 293,960 借款 885,984 538,117 總負債 2,267,948 1,995,935 股東權益合計 $ 3,537,327 $ 4,383,355 簡明合併損益表（美國公認會計原則）（除普通股數量、ADS數量、每股普通股和每股ADS數據外，其餘單位均為千美元）截至12月31日止三個月截至12月31日止十二個月 2023年 2022年 2023年 2022年（未經審計）（經審計）收入：產品收入，淨額 $ 630,526 $ 339,022 $ 2,189,852 $ 1,254,612 合作收入 3,883 41,073 268,927 161,309 總收入 634,409 380,095 2,458,779 1,415,921 銷售成本 – 產品 105,832 73,522 379,920 286,475 毛利潤 528,577 306,573 2,078,859 1,129,446 經營費用：研發費用 493,987 446,023 1,778,594 1,640,508 銷售及管理費用 416,547 328,984 1,504,501 1,277,852 無形資產攤銷 1,838 188 3,500 751 經營費用總計 912,372 775,195 3,286,595 2,919,111 經營虧損 (383,795) (468,622) (1,207,736) (1,789,665) 利息收入，淨額 16,274 18,219 74,009 52,480 其他收益（費用），淨額 16,749 19,438 307,891 (223,852) 除所得稅前虧損 (350,772) (430,965) (825,836) (1,961,037) 所得稅費用 16,781 14,370 55,872 42,778 淨虧損 (367,553) (445,335) (881,708) (2,003,815) 每股淨虧損 $ (0.27) $ (0.33) $ (0.65) $ (1.49) 加權平均已發行股份 – 基本及稀釋 1,353,005,058 1,348,916,108 1,357,034,547 1,340,729,572 每股美國存托股份（「ADS」）淨虧損 $ (3.53) $ (4.29) $ (8.45) $ (19.43) 加權平均已發行ADS – 基本及稀釋 104,077,312 103,762,778 104,387,273 103,133,044 關於使用非美國公認會計原則（GAAP）財務指標的說明百濟神州提供某些非GAAP財務指標，包括經調整經營費用和經調整運營損失以及某些其他非GAAP利潤表項目，其中每項都已根據美國GAAP進行了調整。這些非GAAP指標旨在提供更多有關公司經營業績的信息。根據美國GAAP進行的調整（如適用）扣除了非現金項目，例如股權激勵費用、折舊和攤銷等。當某些其他特殊項目或重大事件在報告期間所發生金額較大時，也可能定期被納入到非GAAP調整中。百濟神州有一套既定的非GAAP政策，用於確定哪些費用將被排除在非GAAP財務指標之外，以及使用此類指標的相關政策、控制以及審批。公司相信，把這些非GAAP財務指標與美國GAAP數據相結合進行考慮，可以加深對百濟神州經營業績的整體理解。納入非GAAP財務指標的目的是為了讓投資者更全面地瞭解公司的歷史和預期財務業績和趨勢，以便於對不同報告期內數據和預測信息進行比較。同時，這些非GAAP財務指標也是百濟神州管理層用於規劃和預測以及衡量公司業績的指標之一。這些非GAAP財務指標應被視為對美國GAAP財務指標的補充，而不是作為替代或認為優於美國GAAP的財務指標。百濟神州使用的非GAAP財務指標可能與其他公司使用的非GAAP財務指標計算方式不同，因此可能不具有可比性。選定GAAP指標與非GAAP指標的調節（除每股數據外，其餘單位均為千美元）（未經審計）截至12月31日止三個月截至12月31日止十二個月 2023 2022 2023 2022 調節GAAP至經調整銷售成本–產品： GAAP銷售成本–產品 $ 105,832 $ 73,522 $ 379,920 $ 286,475 減：折舊 1,898 — 8,578 — 減：無形資產攤銷 1,119 781 3,739 3,225 經調整銷售成本–產品 $ 102,815 $ 72,741 $ 367,603 $ 283,250 調節GAAP至經調整研發費用： GAAP研發費用 $ 493,987 $ 446,023 $ 1,778,594 $ 1,640,508 減：股權激勵費用 39,424 34,966 163,550 139,348 減：折舊 17,180 6,871 56,084 26,241 經調整研發費用 $ 437,383 $ 404,186 $ 1,558,960 $ 1,474,919 調節GAAP至經調整銷售及管理費用： GAAP銷售及管理費用 $ 416,547 $ 328,984 $ 1,504,501 $ 1,277,852 減：股權激勵費用 53,328 43,160 204,038 163,814 減：折舊 1,784 10,176 15,774 36,061 經調整銷售及管理費用 $ 361,435 $ 275,648 $ 1,284,689 $ 1,077,977 調節GAAP至經調整經營費用： GAAP經營費用 912,372 775,195 3,286,595 2,919,111 減：股權激勵費用 92,752 78,126 367,588 303,162 減：折舊 18,964 17,047 71,858 62,302 減：無形資產攤銷 1,838 188 3,500 751 經調整經營費用 $ 798,818 $ 679,834 $ 2,843,649 $ 2,552,896 調節GAAP至經調整經營虧損： GAAP經營虧損 $ (383,795) $ (468,622) $ (1,207,736) $ (1,789,665) 加：股權激勵費用 92,752 78,126 367,588 303,162 加：折舊 20,862 17,047 80,436 62,302 加：無形資產攤銷 2,957 969 7,239 3,976 經調整經營虧損 $ (267,224) $ (372,480) $ (752,473) $ (1,420,225) 因四捨五入，表中數字與分項加總數字可能有差異關於百濟神州百濟神州是一家全球腫瘤創新公司，專注於為全世界的癌症患者研發創新抗腫瘤藥物。通過強大的自主研發能力和外部戰略合作，我們不斷加速開發多元、創新的藥物管線和產品組合，致力於為全球更多患者全面提升藥物可及性和可負擔性。在全球五大洲，我們有超過10,000人的團隊，並在中國北京、美國麻省劍橋和瑞士巴塞爾設立了主要辦事處。如需瞭解更多信息，請訪問www.beigene.com.cn或關注"百濟神州"微信公眾號。前瞻性聲明本新聞稿包含根據《1995年私人證券訴訟改革法案》（Private Securities Litigation Reform Act of 1995）以及其他聯邦證券法律定義的前瞻性聲明，包括關於以下方面的聲明：百濟神州成為一家具有影響力的新一代腫瘤創新公司的進展；百濟神州腫瘤治療管線的前景；百濟神州在新地區和現有地區（尤其是美國）實現收入增長的能力；公司在建生產設施的預期產能和完工日期，以及該等設施提高生產能力的潛力；百濟神州預期的監管審批、註冊申請和臨床活動；以及在「關於百濟神州」副標題下提及的百濟神州計畫、承諾、抱負和目標。由於各種重要因素的影響，實際結果可能與前瞻性聲明有重大差異。這些因素包括：百濟神州證明其候選藥物功效和安全性的能力；候選藥物的臨床結果可能不支持進一步開發或上市審批；藥政部門的行動可能會影響到臨床試驗的啟動、時間表和進展以及藥物上市審批；百濟神州的上市藥物及候選藥物（如能獲批）獲得商業成功的能力；百濟神州獲得和維護對其藥物和技術的智慧財產權保護的能力；百濟神州依賴協力廠商進行藥物開發、生產、商業化和其他服務的情況；百濟神州取得監管審批和商業化醫藥產品的有限經驗；百濟神州獲得進一步的營運資金以完成候選藥物開發和實現並保持盈利的能力；以及百濟神州在最近年度報告的10-K表格中「風險因素」章節裡更全面討論的各類風險及百濟神州向美國證券交易委員會期後呈報中關於潛在風險、不確定性以及其他重要因素的討論。本新聞稿中的所有信息僅及於新聞稿發佈之日，除非法律要求，百濟神州並無責任更新該等信息。億珂®為Pharmacyclics LLC的注冊商標。

本季度總收入達7.81億美元，全球產品收入達5.95億美元，分別同比增長102%和70%，同時，穩步提升經營杠杆效益得益于在美國和歐盟的上市工作，百悅澤®全球銷售額達3.58億美元，同比增長130% 百澤安®在歐盟取得首個用於二線治療食管鱗狀細胞癌（ESCC）的批准，加速推進該核心療法的全球註冊策略中國北京、美國麻省劍橋和瑞士巴塞爾2023年11月10日 /美通社/ -- 百濟神州（納斯達克代碼： BGNE；香港聯交所代碼：06160；上交所代碼：688235）是一家全球生物科技公司，今日公佈2023年第三季度財務業績和業務亮點。百濟神州聯合創始人、董事長兼首席執行官歐雷強（John V. Oyler）先生表示：「我們的團隊本季度在全球產品組合中再次取得強勁的業績，這得益於百悅澤®持續的成功上市，包括在慢性淋巴細胞白血病（CLL）等所有已獲批適應症中不斷取得快速應用。我們很高興重新獲得了百澤安®的全球權利，這一款藥品現已在歐盟獲批，同時還在其他10個市場推進監管審評。我們現在比以往任何時候更能推進全球增長策略，與此同時，穩步提升經營杠杆效益，並控制費用增長。」關鍵業務進展和管線亮點百悅澤®全球銷售額達3.577 億美元，較上年同期增長130%，主要得益於CLL等多項適應症的全球上市工作正在不斷推進。獲得歐洲藥品管理局人用藥品委員會（CHMP）的積極意見，支持百悅澤®用於治療既往接受過至少兩線系統性治療的復發或難治性（R/R）濾泡性淋巴瘤（FL）成人患者。獲得英國國家衛生與臨床優化研究所的積極評估意見，推薦英格蘭和威爾士國家醫療服務體系報銷百悅澤®治療R/R CLL 成人患者的費用。重獲百澤安®開發、生產和商業化的全球權利，加強公司在實體腫瘤領域的全球產品組合。宣佈歐盟委員會（EC）批准百澤安®作為單藥治療既往接受過含鉑化療的不可切除、局部晚期或轉移性ESCC的成人患者。宣佈美國食品藥品監督管理局（FDA）已受理一項百澤安®上市許可申請（BLA），用於一線治療不可切除、復發、局部晚期或轉移性 ESCC 患者。根據《處方藥使用者付費法案》（PDUFA），FDA預計將於2024年7月對該項申請做出決定。 2023年第三季度財務亮點總收入：截至2023年9月30日止三個月內，為7.813億美元，相比2022年同期的3.876億美元，同比增長101.6%，主要得益於產品收入的增長以及與諾華合作相關的剩餘遞延收入的確認。按地理區域劃分的總收入具體如下（單位：千美元）（1）：截至9月30日止三個月截至9月30日止九個月 2023年 2022年 2023年 2022年 $ $ $ $ 美國- 總收入 398,229 133,431 815,059 347,180 產品收入 270,084 108,104 632,391 264,373 合作收入 128,145 25,327 182,668 82,807 中國- 總收入 287,935 233,077 831,399 636,241 產品收入 284,981 233,077 825,809 636,241 合作收入 2,954 — 5,590 — 歐洲- 總收入 85,583 17,995 153,273 46,634 產品收入 30,664 5,200 76,487 9,205 合作收入 54,919 12,795 76,786 37,429 全球其他地區- 產品收入 9,561 3,125 24,639 5,771 總收入 781,308 387,628 1,824,370 1,035,826 (1) 按地理區域劃分的產品收入淨額基於客戶所在地，合作收入淨額記錄在相關收入預期來源的司法管轄區。產品收入：截至2023年9月30日的三個月內，為5.953億美元，相比2022年同期的3.495億美元，同比增長70.3%。 2023年第三季度，產品銷售額較去年同期增長2.458億美元，主要得益于自主研發產品百悅澤®與百澤安®，以及安進授權產品的銷售額增長。 2023年第三季度，百悅澤®在美國的銷售額為2.701億美元，同比增長149.8%，主要得益於該產品在初治（TN）和R/R CLL或小淋巴細胞淋巴瘤（SLL）成人患者中的市場份額持續提升，同時醫療機構擴大了在所有已獲FDA批准的適應症的使用。本季度百悅澤®在中國的銷售額為4,740萬美元，同比增長20.8%，主要得益於所有已獲批適應症領域的銷售額增長。作為中國布魯頓氏酪氨酸激酶（BTK）抑制劑市場的領軍企業，公司在這一領域的市場份額持續增加。 2023年第三季度，百澤安®在中國的銷售額為1.444億美元，同比增長12.6%。百澤安®市場滲透率的提升，以及在PD-1領域持續取得領先的市場份額，主要得益於新適應症納入國家醫保目錄所帶來的新增患者需求、銷售團隊效率的進一步提升，以及藥品進院數量的增加。在中國，百澤安®的市場份額持續增加，儘管本季度整體市場增長放緩。毛利率：2023年第三季度的毛利占全球產品收入83.8%；相比較，上一年同期為78.1%。毛利占比增長主要是由於與其他產品組合和毛利率較低的授權許可產品相比，百悅澤®在全球銷售中占比較高，以及百澤安®因產量增加使得單位成本下降。經營費用：截至2023年9月30日的三個月內，經營費用為8.190億美元；相比較，2022年同期費用為7.494億美元，增長9.3%，主要由於公司在美國和歐洲的內部研發成本以及銷售和行銷成本與上年同期相比有所增加。公司預計產品收入的增長將繼續超過經營費用的增長，從而產生持續的經營杠杆效益。淨利潤：截至2023年9月30日的第三季度內，淨利潤為2.154億美元，相比較，2022年同期錄得淨虧損5.576億美元。與上年同期相比，淨利潤提高主要歸因於經營虧損減少，以及與百時美施貴寶（BMS）仲裁解決相關的非經營收入3.629億美元。經營虧損同比減少3.044億美元，主要是由於產品收入增長和費用管理推動了經營杠杆效益的改善。此外，重新獲得歐司珀利單抗和百澤安®的全部全球商業化權利後，公司確認了與合作相關的剩餘遞延收入，從而增加了我們的總收入。截至2023年9月30日的第三季度內，基本和稀釋每股收益分別為0.16美元和0.15美元，基本和稀釋每股美國存托憑證（ADS）收益分別為2.06美元和2.01美元。截至2022年9月30日的第三季度內，每股淨虧損為0.41美元，每股ADS淨虧損5.39美元。現金、現金等價物、受限資金和短期投資：截至2023年9月30日為32億美元；相比較，截至2022年12月31日，該部分資金為45億美元。截至2023年9月30日的第三季度內，經營活動所用現金為7,820萬美元，而去年同期為5.619億美元，這主要由於經營杠杆效益的改善。關於公司2023年第三季度財務報表的更多詳細信息，請參閱百濟神州向美國證券交易委員會提交的2023年第三季度報告的10-Q表格。註冊進展和開發項目類別產品近期里程碑事件獲批 / 註冊進展百悅澤®（澤布替尼） • 基於3期ALPINE試驗中百悅澤®在治療R/R CLL取得優於億珂®的無進展生存期（PFS）結果，在歐盟和英國獲得更新標籤的批准 • 獲得歐洲藥品管理局（EMA）人用藥品委員會（CHMP）的積極意見，推薦批准其聯合奧妥珠單抗治療既往接受過至少兩線系統性治療的R/R濾泡性淋巴瘤（FL）成人患者 • 在13個市場獲批用於治療TN和R/R CLL • 獲得瑞士藥品監督管理局批准，用於治療 R/R CLL • 首次在馬來西亞獲得批准，用於治療 R/R華氏巨球蛋白血症（WM） • 獲得美國FDA批准，百濟神州蘇州基地成為另一個生產點百澤安®（替雷利珠單抗） • 獲得EC批准，作為單藥治療既往接受過含鉑化療的不可切除、局部晚期或轉移性ESCC的成人患者百拓維®（注射用戈舍瑞林微球） • 與綠葉制藥合作，獲得中國國家藥品監督管理局（NMPA）批准，用於治療可用激素治療的絕經前期及圍絕經期女性乳腺癌註冊申報百澤安® • 美國FDA已受理百澤安®聯合化療一線治療ESCC患者的BLA申請。根據PDUFA， FDA預計將於2024年7月對該項申請做出決定 • NMPA已受理一項百澤安®的新適應症上市許可申請（sBLA），作為聯合療法用於胃癌一線治療，無論患者 PD-(L)1表達狀態如何 • 用於一線治療廣泛期小細胞肺癌（ES-SCLC）的sBLA申請已獲NMPA受理臨床開發進展百澤安® • 公佈 3 期RATIONALE-315 試驗無事件生存期（EFS）的積極數據；該試驗比較百澤安®或安慰劑聯合含鉑化療進行新輔助治療，後續進行百澤安®或安慰劑輔助治療可切除的 II 期或 IIIA 期非小細胞肺癌（NSCLC）的效果 Sonrotoclax (BGB-11417) • 已啟動治療R/R WM的潛在註冊性全球關鍵試驗早期開發 • 四個新分子實體（NME）的1期臨床試驗已入組首批患者，包括二代BCL2抑制劑、CCR8單抗（mAb）、DGK抑制劑和二代HPK1抑制劑預計里程碑事件類別產品預計里程碑事件獲批 / 註冊進展百悅澤® • 基於3期ALPINE試驗中百悅澤®在R/R CLL/SLL取得的PFS優效性結果，預計將於2023年第四季度獲得美國FDA的新適應症補充說明的批准 • 一項新適應症上市申請（sNDA）預計將於2024年3月獲得美國FDA批准，聯合奧妥珠單抗用於至少經過兩線治療的R/R FL成人患者百澤安® • 預計將於2023年內或2024年上半年，獲得美國FDA批准，用於二線治療ESCC成人患者 • 獲得美國 FDA 批准，用於治療一線不可切除、復發、局部晚期或轉移性 ESCC 患者，《處方藥使用者付費法案》（PDUFA）目標審評日期為2024年7月 • 預計將於2024年上半年，獲得EMA批准，聯合化療用於一線治療轉移性 NSCLC，以及作為單藥二線治療NSCLC 註冊申報百澤安® • 將於2023年內向美國FDA遞交一線治療胃癌的新適應症上市許可申請（sBLA） • 將于2024年上半年，向日本藥品和醫療器械管理局（PMDA）遞交上市和生產許可申請，用於一線和二線治療ESCC • 將于2024年上半年，向中國NMPA遞交百澤安®聯合含鉑化療進行新輔助治療，後續進行百澤安®輔助治療可切除的II期或IIIA期NSCLC成人患者的sBLA • 將於2024年第一季度，向EMA遞交一線治療ESCC成人患者的sBLA 臨床開發進展/數據讀出百悅澤® • 將於2023年第四季度，公佈3期ALPINE研究中，百悅澤®對比億珂®治療R/R CLL/SLL的更長隨訪期數據 Sonrotoclax • 將於2023年第四季度，啟動與百悅澤®聯合用藥用於一線治療CLL的全球關鍵性試驗 BTK CDAC (BGB-16673) • 將於2023年12月，在美國血液學會（ASH）年會上公佈B細胞惡性腫瘤1期研究的首次數據結果歐司珀利單抗（抗TIGIT抗體） • 將於2024年第一季度，完成用於一線治療NSCLC的3期AdvanTIG-302試驗的入組工作科研學術大會進展即將在12月份的2023年ASH年會上展示24篇摘要，包括在3期ALPINE試驗中，百悅澤®對比億珂®用於治療R/R CLL/SLL成人患者的長期隨訪數據，以及一項百悅澤®聯合sonrotoclax用於治療TN CLL的1/2期試驗結果。在2023年歐洲腫瘤內科學會（ESMO）大會上，展示10篇摘要，其中包括5篇口頭報告，主要亮點包括：評估百澤安®聯合化療一線治療晚期胃或胃食管結合部腺癌（GC/GEJC）的全球3期RATIONALE-305研究的最終分析結果； 3期RATIONALE-315研究中，百澤安®聯合化療作為新輔助治療用於可切除的II-IIIA期非小細胞肺癌（NSCLC）患者的病理學緩解的最終分析。在 2023 年世界肺癌大會上，展示百澤安®聯合化療對比單獨化療用於一線治療ES-SCLC成人患者的3 期 RATIONALE-312 試驗最終分析數據。生產運營位於美國新澤西州霍普韋爾普林斯頓西部創新園區的旗艦級生產基地和臨床研發中心進入最後的建設階段。該基地預留了超過100萬平方英尺（約9.3萬平方米）的可開發地產，以備用于未來的進一步拓展。基地預計將於2024年夏季投入運營。位於中國廣州的世界一流生物藥生產基地目前總產能已達64,000升；該基地的抗體偶聯藥物（ADC）生產設施和全新生物藥臨床生產大樓已接近完工。本月，位於中國蘇州的新建小分子創新藥物產業化基地將會完工。第一階段的建設預計將新增超過55.9萬平方英尺（約5.2萬平方米），固體制劑產能將擴大至每年6億片（粒）劑次；基地建設完成、驗收合格並獲批後，預計我們在中國的小分子藥物生產能力將提升至目前的5倍以上。企業發展終止一項與Zymeworks就在亞洲（除日本以外）、澳大利亞和紐西蘭開發和商業化其在研靶向HER2的雙特異性抗體藥物偶聯物ZW49（zanidatamab zovodotin）的授權和合作協定。財務摘要簡明合併資產負債表摘要數據（美國公認會計準則）（單位：千美元）截至 2023年 2022年 9月30日 12月31日（未經審計）（經審計）資產：現金、現金等價物、受限資金和短期投資 $ 3,187,881 $ 4,540,288 應收賬款，淨額 309,079 173,168 存貨 316,929 282,346 物業、廠房及設備，淨額 1,178,038 845,946 總資產 5,524,879 6,379,290 負債及股東權益：應付帳款 341,857 294,781 預提費用及其他應付款項 505,824 467,352 遞延收入 300 255,887 研發成本分攤負債 255,391 293,960 借款 531,051 538,117 總負債 1,761,645 1,995,935 股東權益合計 $ 3,763,234 $ 4,383,355 簡明合併損益表（美國公認會計準則）（除普通股數量、ADS數量、每股普通股和每股ADS數據外，其餘單位均為千美元）截至9月30日止三個月截至9月30日止九個月 2023年 2022年 2023年 2022年（未經審計）（未經審計）收入：產品收入，淨額 $ 595,290 $ 349,506 $ 1,559,326 $ 915,590 合作收入 186,018 38,122 265,044 120,236 總收入 781,308 387,628 1,824,370 1,035,826 費用：產品銷售成本 96,309 76,543 274,088 212,953 研發費用 453,259 426,363 1,284,607 1,194,485 銷售及管理費用 364,421 322,892 1,087,954 948,868 無形資產攤銷 1,287 187 1,662 563 總費用 915,276 825,985 2,648,311 2,356,869 經營虧損 (133,968) (438,357) (823,941) (1,321,043) 利息收入，淨額 26,649 12,759 57,735 34,261 其他收入（費用），淨額 336,657 (125,640) 291,142 (243,290) 除所得稅前收入（虧損） 229,338 (551,238) (475,064) (1,530,072) 所得稅費用 13,925 6,318 39,091 28,408 淨利潤（虧損） 215,413 (557,556) (514,155) (1,558,480) 歸屬百濟神州的每股淨收益（虧損）：基本 $ 0.16 $ (0.41) $ (0.38) $ (1.16) 稀釋 $ 0.15 $ (0.41) $ (0.38) $ (1.16) 加權平均已發行股份：基本 1,360,716,279 1,345,303,747 1,358,392,470 1,337,976,853 稀釋 1,390,331,833 1,345,303,747 1,358,392,470 1,337,976,853 歸屬百濟神州的每股ADS淨收益（虧損）：基本 $ 2.06 $ (5.39) $ (4.92) $ (15.14) 稀釋 $ 2.01 $ (5.39) $ (4.92) $ (15.14) 加權平均已發行股份ADS：基本 104,670,483 103,484,904 104,491,728 102,921,296 稀釋 106,948,603 103,484,904 104,491,728 102,921,296 關於百濟神州百濟神州是一家全球生物科技公司，專注於為全世界的癌症患者研發創新抗腫瘤藥物。通過強大的自主研發能力和外部戰略合作，我們不斷加速開發多元、創新的藥物管線和產品組合，致力於為全球更多患者全面提升藥物可及性和可負擔性。在全球五大洲，我們有超過10,000人的團隊，並在中國北京、美國麻省劍橋和瑞士巴塞爾設立了主要辦事處。如需瞭解更多信息，請訪問www.beigene.com.cn或關注「百濟神州」微信公眾號。前瞻性聲明本新聞稿包含根據《1995年私人證券訴訟改革法案》（Private Securities Litigation Reform Act of 1995）以及其他聯邦證券法律定義的前瞻性聲明，包括關於以下方面的聲明：百濟神州推進全球增長策略的能力；百濟神州藥品和候選藥物臨床活動、註冊申報和批准的進展和預期；在「預計里程碑事件」標題下的百濟神州計畫、預期事件和里程碑事件；公司在建生產設施的預期產能和完工日期，以及該等設施提高生產能力的潛力；以及在「關於百濟神州」副標題下提及的百濟神州計畫、承諾、抱負和目標。由於各種重要因素的影響，實際結果可能與前瞻性聲明有重大差異。這些因素包括：百濟神州證明其候選藥物功效和安全性的能力；候選藥物的臨床結果可能不支持進一步開發或上市審批；藥政部門的行動可能會影響到臨床試驗的啟動、時間表和進展以及藥物上市審批；百濟神州的上市藥物及候選藥物（如能獲批）獲得商業成功的能力；百濟神州獲得和維護對其藥物和技術的智慧財產權保護的能力；百濟神州依賴協力廠商進行藥物開發、生產、商業化和其他服務的情況；百濟神州取得監管審批和商業化醫藥產品的有限經驗，及其獲得進一步的營運資金以完成候選藥物開發和實現並保持盈利的能力；百濟神州在最近季度報告的10-Q表格中「風險因素」章節裡更全面討論的各類風險；以及百濟神州向美國證券交易委員會期後呈報中關於潛在風險、不確定性以及其他重要因素的討論。本新聞稿中的所有信息僅及於新聞稿發佈之日，除非法律要求，百濟神州並無責任更新該等信息。