內幕消息 百濟神州有限公司 截至2023年12月31日止三個月未經審核業績 及截至2023年12月31日止全年經審核業績以及 業務進展最新情況 本公告乃根據香港聯合交易所有限公司證券上市規則（「上市規則」）第13.09條及 根據證券及期貨條例（香港法例第571章）第XIVA部而刊發。 百濟神州有限公司（「本公司」或「百濟神州」）欣然公佈其截至2023年12月31日 止第四季度的未經審核綜合財務業績及截至2023年12月31日止全年的經審核綜 合財務業績以及業務進展最新情況。 本公司欣然公佈本公司及其附屬公司截至2023年12月31日第四季度未經審核綜合 財務業績（「季度業績」）及截至2023年12月31日止全年經審核綜合財務業績（「全 年業績」）以及關鍵業務進展和管線亮點和2024年預計里程碑（「業務進展最新情 況」）。季度業績及全年業績乃根據美國證券交易委員會的適用規則刊發。 季度業績及全年業績乃根據美國公認會計準則編製，而美國公認會計準則有別於 國際財務報告準則。 本公告附件一是本公司於2024年2月26日就季度業績及全年業績以及業務進展最 新情況發佈的新聞稿的全文（除另有規定外，下文所列全部金額均以美元 ...

Financial Performance - Total revenue for Q4 2023 reached $634 million, a year-over-year increase of 67%; total revenue for the full year 2023 was $2.5 billion, up 74% year-over-year[3] - In Q4 2023, the company's product revenue reached $630.5 million, a year-over-year increase of 86%, while total product revenue for the year was $2.2 billion, up 75% from the previous year[4] - The company reported total revenue of $2,458.8 million for the year ended December 31, 2023, a 73.6% increase from $1,415.9 million in 2022[24] - The company’s net loss for the year ended December 31, 2023, was $881.7 million, compared to a net loss of $2,003.8 million in 2022, representing a 56.0% improvement[24] - The company reported a decrease in cash used in operating activities, with $221.6 million for Q4 and $1.2 billion for the full year, compared to $318.2 million and $1.5 billion in the previous year[13] Product Sales and Market Growth - Global sales of BeiGene's flagship product, Brukinsa (Zebutinib), in Q4 2023 amounted to $413 million, representing a 135% year-over-year growth; total global sales for the full year reached $1.3 billion, a 129% increase year-over-year[3] - The total revenue from the U.S. market in Q4 2023 was $313.2 million, up from $155.4 million in the same quarter last year, indicating strong sales growth[6] - The company plans to maintain the sales growth trend of Bruton’s Tyrosine Kinase inhibitor in the U.S. market throughout 2024[6] Research and Development - BeiGene is advancing its hematology innovation pipeline, initiating four registrational trials for sonrotoclax, including a global Phase 3 trial for treatment of treatment-naive chronic lymphocytic leukemia (CLL)[3] - The company announced five new molecular entities (NMEs) entering clinical trials in 2023, including a potential best-in-class CDK4 inhibitor[5] - R&D expenses for Q4 2023 were $494 million, an 11% increase from $446 million in Q4 2022, while total operating expenses for the quarter rose by 18% to $912.4 million[9] - R&D expenses for Q4 2023 and the full year increased year-over-year, driven by investments in new technology platforms and drug models, with ongoing preclinical and early clinical projects advancing to later stages[11] - The company plans to initiate at least 10 first-in-human clinical trials for new molecular entities in 2024, including KRAS inhibitors and EGFR degraders[20] Regulatory Approvals and Product Development - The FDA approved an update to the label for the drug Bruton’s Tyrosine Kinase (BTK) inhibitor, further solidifying its position as the preferred treatment for relapsed or refractory chronic lymphocytic leukemia (CLL) patients[4] - The company expanded the global indications for Bruton’s Tyrosine Kinase inhibitor, receiving EU approval for treating adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies[4] - Baiyueze® is expected to receive FDA approval in March 2024 for use in combination with obinutuzumab for treating R/R FL patients[18] - The company expects to receive FDA approval for Tarelizumab for second-line ESCC treatment in the first half of 2024, with a PDUFA target review date of July 2024 for first-line treatment of unresectable, recurrent, locally advanced, or metastatic ESCC patients[19] Operational Efficiency - The company reduced its GAAP operating loss by 18% in Q4 and 33% for the full year, with adjusted operating losses decreasing by 28% and 47%, respectively[4] - The gross margin for Q4 2023 was 83.2%, up from 78.3% in the same quarter last year, attributed to higher sales of Bruton’s Tyrosine Kinase inhibitor[8] - GAAP operating loss for Q4 2023 was $(383,795) thousand, an improvement from $(468,622) thousand in Q4 2022, indicating a reduction of 18.1%[26] - Adjusted operating loss for Q4 2023 was $(267,224) thousand, compared to $(372,480) thousand in Q4 2022, showing a decrease of 28.3%[26] Strategic Initiatives - The company aims to solidify its leadership position in hematology, particularly in the U.S. and European markets, through ongoing success with Brukinsa[3] - The company is focused on expanding its oncology pipeline and expects to achieve revenue growth in new and existing markets, particularly in the U.S.[28] - The company is actively engaged in strategic collaborations to accelerate the development of its drug pipeline[27] - The company aims to enhance drug accessibility and affordability for cancer patients worldwide through innovative drug development[27] Financial Position - Cash and cash equivalents decreased to $3,185,984 thousand by the end of Q4 2023, down from $3,875,037 thousand at the beginning of the year, with net cash used in operating activities of $1,157,453 thousand for the year[13] - The company’s cash, cash equivalents, restricted cash, and short-term investments totaled $3,188.6 million as of December 31, 2023, down from $4,540.3 million in 2022[23] - The company’s total assets decreased to $5,805.3 million as of December 31, 2023, from $6,379.3 million in 2022[23] Employee and Operational Growth - The company has over 10,000 employees globally, with major offices in Beijing, Cambridge, and Basel[27] - The company’s flagship biopharmaceutical manufacturing facility in New Jersey is expected to commence operations in July 2024, with an investment of $800 million and over 1 million square feet of developable space[21]

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today reinforced its continued global expansion, rapid global and U.S. revenue growth, and innovative R&D strategy with the presentation of results from the fourth quarter and full year 2023 and business highlights. “BeiGene made great progress in the fourth quarter and full year 2023 toward our goal to become an impactful next-generation oncology innovator. ...

Core Viewpoint - BeiGene's (06160) application for the marketing authorization of Tislelizumab has received a positive opinion from the European Medicines Agency (EMA) for treating three indications of non-small cell lung cancer (NSCLC) [1][2] Group 1: Approval and Indications - The EMA's Committee for Medicinal Products for Human Use (CHMP) recommends Tislelizumab for use in combination with chemotherapy for adult patients with locally advanced or metastatic squamous NSCLC [1] - The drug is also recommended for use in combination with pemetrexed and platinum-based chemotherapy for adult patients with locally advanced or metastatic non-squamous NSCLC who have specific genetic markers [1] - Tislelizumab can be used as a monotherapy for adult patients with locally advanced or metastatic NSCLC who have previously received platinum-based therapy [1] Group 2: Clinical Trials and Data - The marketing authorization application (MAA) is based on results from three Phase 3 clinical trials involving a total of 1,499 patients [1] - The results of the RATIONALE 307 and RATIONALE 304 studies, which evaluated Tislelizumab in combination therapies, were published in JAMA Oncology and Journal of Thoracic Oncology [1] - The RATIONALE 303 study, which assessed Tislelizumab as a monotherapy, was also published in the Journal of Thoracic Oncology [1] Group 3: Strategic Development and Market Impact - The positive opinion from CHMP marks another significant milestone for Tislelizumab, following its recent approval for treating advanced esophageal squamous cell carcinoma (ESCC) in the EU [2] - BeiGene is advancing Tislelizumab as both a monotherapy and combination therapy to address unmet needs in global patient populations [2] - Over 17 potential registration studies for Tislelizumab have been initiated, enrolling more than 13,000 patients, with 15 studies reporting positive data results [2]

A股代码：688235 A股简称：百济神州 公告编号：2024-003 港股代码：06160 港股简称：百济神州 美股代码：BGNE 百济神州有限公司 自愿披露关于百泽安®（替雷利珠单抗注射液）获欧洲 药品管理局人用药品委员会积极意见的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、 误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性依 法承担法律责任。 重要内容提示： 1、欧洲药品管理局（EMA）人用药品委员会（CHMP）近日发布 其推荐百济神州有限公司（以下简称"公司"）产品百泽安®（替雷利 珠单抗注射液）获得上市许可的积极意见，建议批准其用于治疗三项 非小细胞肺癌（NSCLC）适应症：联合紫杉醇和卡铂或注射用紫杉醇 （白蛋白结合型）和卡铂用于不可手术切除或不适合含铂放化疗的局 部晚期或转移性鳞状非小细胞肺癌成人患者的一线治疗；联合培美曲 塞和铂类化疗用于 PD-L1表达≥50%且无表皮生长因子受体（EGFR）和 间变性淋巴瘤激酶（ALK）阳性突变、不可手术切除或不适合含铂放 化疗的局部晚期或转移性非鳞状非小细胞肺癌成人患者的一线治疗； 以及单药用于治疗既往接受含铂药物治疗后的局部晚 ...

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications: In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatm ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of $275, HKD 165, and RMB 175 [1][3]. Core Insights - The company is actively advancing its internationalization process, with expectations of total revenue of approximately $660 million in Q4 2023. The second overseas product, Tislelizumab (PD-1), is anticipated to receive approval in the U.S. in the first half of the year [1]. - The report highlights that the impact of anti-corruption measures on hospital sales is gradually diminishing, which is expected to lead to a sequential increase in product sales revenue in Q4 2023 [1]. - The company forecasts revenues of $2.486 billion, $3.014 billion, and $3.671 billion for 2023, 2024, and 2025, respectively, representing a CAGR of 37% from 2023 to 2025 [1][4]. Financial Projections - Revenue for 2023 is projected at $2.486 billion, with a year-on-year growth of 75.6%. The net loss for the same year is expected to be $771 million [2][4]. - The report provides detailed financial metrics, including a gross profit margin of 84.2% for 2023 and a projected operating loss of $1.089 billion [4][26]. - The company’s cash and cash equivalents are expected to decrease from $3.557 billion in 2023 to $2.836 billion in 2024 [27]. Market Performance - The current stock price is $153.8, with a potential upside of 79% to the target price of $275 [3]. - The report notes a market capitalization of approximately $16.6 billion [3]. Upcoming Catalysts - Key upcoming catalysts include the expected approval of Tislelizumab for esophageal squamous cell carcinoma (ESCC) in the U.S. and the expansion of indications for other products [1]. - Other anticipated developments include the launch of Zebrutinib in the U.S. and data readouts for various clinical trials [1].

Exhibit 99.1 BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates • Continued rapid global growth with record total revenues of $634 million in fourth quarter and $2.5 billion in full-year 2023, increases of 67% and 74% from the prior-year periods • Strengthened leadership in hematology with global BRUKINSA® (zanubrutinib) sales of $413 million and $1.3 billion for the quarter and full year, increases of 135% and 129% • Progressed innovative hematology pipeline with initi ...

Regulatory Approvals - BRUKINSA received FDA approval for CLL and SLL in January 2023, with a label update in December 2023 showing superior progression-free survival results from the Phase 3 ALPINE trial[27]. - BRUKINSA is approved in over 65 markets as of February 2024, including multiple indications in the EU and China, with all five approved indications included in the updated National Reimbursement Drug List[29]. - TEVIMBRA is approved in China for twelve indications, including first-line treatments for various cancers, with ongoing reviews for additional indications[32][34]. - PARTRUVIX received conditional approval in China for gBRCA mutation-associated recurrent advanced ovarian cancer, with full approval contingent on ongoing trials[39]. - XGEVA is approved in over 70 countries, with inclusion in the National Reimbursement Drug List in China for GCTB and SRE indications[41]. - BLINCYTO has been approved in 60 countries for acute lymphoblastic leukemia, with commercialization in China starting in August 2021[42]. - KYPROLIS was approved in China for R/R multiple myeloma in July 2021, with inclusion on the National Reimbursement Drug List beginning in March 2023[44]. - REVLIMID and VIDAZA have been included in the National Reimbursement Drug List in China, with various approved indications for treating multiple myeloma and myelodysplastic syndromes[46][47]. - SYLVANT was approved in China in December 2021 for treating adult patients with idiopathic multicentric Castleman disease and will be included in the NRDL starting January 2024[49]. - QARZIBA received conditional approval from the NMPA for treating high-risk neuroblastoma in patients aged 12 months and above, with commercialization beginning in December 2021[50]. - BAITUOWEI was approved in June 2023 for prostate cancer requiring androgen deprivation therapy and included in the NRDL in 2023[55]. - The NRDL now includes Tislelizumab for eleven indications effective January 1, 2024, expanding access to various cancer treatments[60]. - BRUKINSA was included in the NRDL for all five of its approved indications, enhancing its market presence in China[61]. - The 2023 NRDL introduced new rules for contract renewals, allowing for price renegotiation and potential price cuts for long-listed drugs[58]. Market Trends and Projections - Global revenues for BTK inhibitors were approximately $8.5 billion in 2022, projected to exceed $15 billion by 2028[31]. - The global market for PD-1/PD-L1 antibody medicines reached approximately $36 billion in 2022, with projections exceeding $50 billion by 2025[38]. Clinical Trials and Research - The company is conducting 11 registration or registration-enabling clinical trials for zanubrutinib, with six in Phase 3 and three designed as registration-enabling Phase 2 trials[79]. - Tislelizumab (TEVIMBRA) is being evaluated in over 17 potentially registration-enabling clinical trials globally, including 13 Phase 3 randomized trials[85]. - A Phase 3 trial of zanubrutinib in combination with sonrotoclax is ongoing for front-line CLL/SLL treatment[83]. - Tislelizumab is being tested in multiple Phase 3 trials for NSCLC, including a global trial comparing it to docetaxel in advanced or metastatic cases[85]. - The company has initiated broad global pivotal programs for zanubrutinib across various B-cell malignancies, indicating a strong pipeline for future growth[78]. - The company is exploring combination studies for zanubrutinib with both sonrotoclax and tislelizumab, enhancing its therapeutic potential[83]. - As of December 2023, over 13,000 subjects have been enrolled in clinical trials of tislelizumab across more than 30 countries, with 3,500+ subjects outside of China[89]. - Sonrotoclax has shown safety and tolerability in combination with BRUKINSA, with deep and durable responses observed in over 700 patients enrolled by December 2023[92]. - A Phase 3 study of sonrotoclax combined with BRUKINSA versus venetoclax plus obinutuzumab has started enrollment to support sonrotoclax's development in the first-line CLL indication[93]. - Ociperlimab has enrolled more than 2,000 subjects across eight global trials in patients with various cancers, including lung cancers and esophageal squamous cell carcinoma[97]. - Zanidatamab is in late-stage clinical development, with positive topline results announced in 2022 for a Phase 2b study in advanced or metastatic HER2-amplified biliary tract cancers[99]. - Lifirafenib is being developed for cancers with aberrations in the MAPK pathway, including BRAF and KRAS/NRAS mutations, showing antitumor activities in preclinical models[106]. Manufacturing and Supply Chain - The manufacturing facility in Suzhou has an annual production capacity of approximately 100 million tablets and capsules, with a new facility capable of producing up to 1 billion solid oral dosages annually[114]. - The Guangzhou manufacturing facility has a total committed capacity of 64,000 liters, with an additional expansion of 10,000 liters expected to be qualified by the end of 2024[115]. - The U.S. flagship manufacturing and clinical R&D facility in New Jersey is expected to be operational in summer 2024, with 8,000 liters of large molecule biologics manufacturing capacity[116]. - The company has commercial supply agreements with Catalent and Boehringer Ingelheim for the production of BRUKINSA and tislelizumab, respectively[119]. - The Guangzhou facility is approved for the end-to-end commercial production of tislelizumab for the China market[115]. - The company is in the process of building a new campus for clinical R&D and biologics manufacturing in New Jersey to support future demand[113]. Collaborations and Agreements - The company entered into a collaboration agreement with Amgen, committing up to $1.25 billion for global development costs and sharing profits and losses for oncology products in China[125]. - Under the Novartis collaboration agreement, the company received an upfront cash payment of $650 million and is eligible for up to $1.3 billion in regulatory milestone payments[135]. - The Novartis Collaboration and License Agreement for tislelizumab was mutually terminated in September 2023, allowing the company to regain full global rights for development and commercialization without royalty payments[137]. - The termination of the Novartis Option, Collaboration and License Agreement for ociperlimab occurred in July 2023, also resulting in the company regaining full global rights and recognizing all remaining deferred revenue balances[142]. - Under the Novartis Option, Collaboration and License Agreement, the company received an upfront cash payment of $300 million and could receive up to $2.045 billion in additional payments upon the exercise of options and achievement of milestones[140]. - The company entered into a settlement agreement with BMS in August 2023, terminating the License and Supply Agreement for ABRAXANE, effective December 31, 2023, while retaining rights to sell REVLIMID and VIDAZA until inventory is depleted or December 31, 2024[144]. Intellectual Property and Patent Strategy - The company has filed for and obtained 63 issued U.S. patents and 46 issued China patents as of February 14, 2024, with ongoing efforts to secure additional patent protections[146]. - The company has a right to commercialize three medicines in China under its collaboration with Amgen, with key patents expiring between 2025 and 2029[148]. - The company relies on trade secrets and unpatented know-how to protect its proprietary technology, alongside its patent strategy[153]. Competitive Landscape - The company faces competition from established BTK inhibitors like IMBRUVICA and CALQUENCE in the lymphoma treatment market, which may impact its product positioning[154]. - The company is competing with multiple PD-1 and PD-L1 antibody medicines, with nine approved PD-1 antibodies and five approved PD-L1 antibodies in China as of December 25, 2023[156]. - The company acknowledges the presence of several pharmaceutical companies developing TIGIT antibodies, with no approved anti-TIGIT antibodies currently available[157]. - The company is aware of the competitive landscape, including the development of BCL2 inhibitors by various pharmaceutical companies, with venetoclax being a notable approved product[157]. Regulatory Environment and Compliance - The company is subject to extensive government regulations in the U.S., China, Europe, and other jurisdictions regarding drug development, testing, and marketing[160]. - The FDA's drug approval process involves multiple stages, including preclinical tests, human clinical trials, and submission of an NDA or BLA for review[163]. - Human clinical trials are conducted in three phases, with Phase 3 trials evaluating overall risk/benefit relationships for the product[169]. - Post-approval trials (Phase 4) may be mandated by the FDA to gather additional safety data after initial marketing approval[170]. - The approval process can be lengthy, with the FDA potentially issuing a complete response letter detailing deficiencies that must be addressed before approval[176]. - The FDA may grant a seven-year exclusive marketing period for orphan drugs after approval[201]. - The FDA provides a five-year period of non-patent data exclusivity for the first applicant to gain approval of an NDA for a new chemical entity[195]. - The FDA may approve a drug under accelerated approval regulations if it provides meaningful therapeutic benefit over available treatments[183]. - The FDA may withdraw product approval if compliance with regulatory requirements is not maintained[192]. - The FDA requires that post-approval studies be conducted to confirm clinical benefits for drugs approved under accelerated regulations[183]. Economic and Pricing Considerations - The U.S. government is implementing cost containment programs that may reduce drug profitability, including increased Medicaid rebates and mandatory discounts for Medicare beneficiaries[210]. - The Inflation Reduction Act of 2022 reduces out-of-pocket spending for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025[212]. - The Bipartisan Budget Act of 2018 increased the point-of-sale discount owed by pharmaceutical manufacturers in Medicare Part D from 50% to 70%[211]. - The ACA includes provisions that may reduce drug product profitability, such as increased rebates and annual fees based on sales to federal healthcare programs[210]. - The company may need to conduct pharmacoeconomic studies to demonstrate cost-effectiveness for third-party payor coverage[207]. - Legislative changes at the state level are increasingly controlling pharmaceutical pricing and reimbursement[218]. - The federal transparency requirements under the ACA mandate manufacturers to report annual payments or transfers of value to physicians and teaching hospitals[224]. - Manufacturers must disclose ownership and investment interests held by physicians and their immediate family members[224]. - Federal price reporting laws require manufacturers to accurately calculate and report complex pricing metrics to government programs[224]. - Federal consumer protection laws regulate marketplace activities that may harm consumers[225]. - The Foreign Corrupt Practices Act prohibits improper payments to non-U.S. officials to obtain or retain business[225].

BeiGene, Ltd. 百濟神州有限公司 （於開曼群島註冊成立的有限公司） （股份代號：06160） 香港，2024年2月9日 審計委員會會議日期 於本公告日期，本公司董事會包括主席兼執行董事歐雷強先生、非執行董事 王曉東博士，以及獨立非執行董事Olivier Brandicourt博士、Margaret Han Dugan 博士、Donald W. Glazer先生、Michael Goller先生、Anthony C. Hooper先生、 Ranjeev Krishana先生、Alessandro Riva博士、Corazon (Corsee) D. Sanders博士及 易清清先生。 百濟神州有限公司（「本公司」）謹此公佈，本公司董事會（「董事會」）審計委員會 會議將於2024年2月26日舉行，以（其中包括）審議及批准本公司及其附屬公司根 據美國公認會計原則及美國證券交易委員會適用規則編製的截至2023年12月31日 止年度的經審核財務業績及其發佈。本公司另將於2024年3月28日或之前公佈其 根據香港聯合交易所有限公司證券上市規則（「香港上市規則」）編製的截至2023年 12月31日止年度的經審核 ...