来源：环球网 "索托克拉在中国加速获批并实现全球首发，无疑是百济神州血液学产品管线进展的重要里程碑，标志 着我们的又一款自研药物将正式开始帮助患者，也进一步印证了百济神州在B细胞恶性肿瘤治疗领域的 引领性。"百济神州总裁、全球研发负责人汪来博士表示，"索托克拉在中国从受理至获批仅用时8个 月，此得益于索托克拉在研究中展现出深度且持久的缓解获益与良好的安全性，展示出其具备成为同类 最佳BCL2抑制剂的潜力，另外也反映出中国血液肿瘤患者出现耐药后的迫切治疗需求已被重视。我们 还在进一步探索索托克拉的潜力，以期帮助到全球更多患者。" 1月6日，百济神州宣布，旗下新一代BCL2抑制剂索托克拉片（百悦达®）获得国家药品监督管理局 （NMPA）附条件批准上市，用于治疗既往接受过至少包含布鲁顿酪氨酸激酶（BTK）抑制剂在内的一 种系统治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）成人患者，以及既往接受过至少 两种系统性治疗（含布鲁顿酪氨酸激酶[BTK]抑制剂）的复发或难治性套细胞淋巴瘤（MCL）成人患 者。此前，这两项适应症的上市申请已被NMPA药品审评中心（CDE）纳入优先审评程序。 据悉，索托克拉此次以 ...

BeOne Medicines (ONC/688235.SS): Quick China approval for sonro; eyes on market feedback for differentiation; Buy Sonro approved in China for late-line CLL/MCL: On Jan 5th, China NMPA approved sonrotoclax (BCL2 inhibitor) in R/R CLL/SLL and R/R MCL (post CD20/BTKi treatment), marking the first approval of sonrotoclax across markets (the FDA accepted NDA in R/R MCL in Nov. 2025 with priority review). The China approval took only eight months to complete the NDA review, which we view as quick compared to typi ...

Core Insights - The company announced the presentation of three studies on its novel BCL2 inhibitor Mesutoclax (ICP-248) at the 67th American Society of Hematology (ASH) annual meeting [1] - Mesutoclax demonstrated excellent efficacy and safety in treating relapsed/refractory mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML) [1] - The study on Mesutoclax for relapsed/refractory MCL was selected for oral presentation, while the studies for CLL/SLL and AML were selected for poster display [1]

Investment Rating - The investment rating for the company is "Buy" [5] Core Insights - The company reported a total revenue of approximately 27.595 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 44.2%. The net profit attributable to shareholders was approximately 1.139 billion yuan, with a non-recurring net profit of about 969 million yuan. For Q3 2025, the total revenue was approximately 10.077 billion yuan, up 41.1% year-on-year, with a net profit of about 689 million yuan and a non-recurring net profit of approximately 708 million yuan. The company has raised its full-year revenue guidance for 2025, expecting total revenue to be between 36.2 billion yuan and 38.1 billion yuan [1][2][3]. Revenue Growth Drivers - The adjustment in expected revenue growth is primarily attributed to the leading position of Baiyueze® in the U.S. market and its ongoing expansion in Europe and other key global markets. The adjustments in R&D, sales, and management expenses are mainly due to prudent investments that promote revenue and pipeline growth, achieving significant operational efficiency [2]. Market Performance - In Q3, Baiyueze® generated global revenue totaling 1 billion USD, a year-on-year increase of 50.8%. In the U.S., revenue reached 738.7 million USD, up 46.6% from the previous year, driven by robust demand across all indications and moderate gains from net pricing. In Europe, revenue totaled 163.2 million USD, a 67.8% increase year-on-year, benefiting from market share growth in major European markets. In China, revenue was 92.4 million USD, up 36.2% year-on-year, while sales in other countries reached 46.4 million USD, a 116.6% increase [3]. Pipeline and Future Prospects - The company announced that nearly 50 abstracts from its hematology research projects will be presented at this year's ASH annual meeting, including 6 oral presentations. Sotokura is gradually becoming a potential best-in-class BCL2 inhibitor, offering better efficacy, higher safety, and greater convenience compared to the first-generation BCL2 inhibitor, venetoclax. The U.S. FDA has granted breakthrough therapy designation to Sotokura for the treatment of relapsed/refractory mantle cell lymphoma [4]. Financial Forecast - The company forecasts revenues for 2025-2027 to be 37.7 billion yuan, 48 billion yuan, and 55.1 billion yuan respectively, with year-on-year growth rates of 38%, 28%, and 15%. The net profit attributable to shareholders is expected to be 736 million yuan, 4.692 billion yuan, and 7.982 billion yuan for the same years, reflecting significant growth [8][10].

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapies [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, assessing safety, tolerability, and efficacy of Sotorasib at doses of 160 mg and 320 mg [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] - BeiGene is submitting data to the FDA and other global regulatory agencies for potential approval of Sotorasib in MCL, with the drug already accepted for priority review by China's NMPA [2] Industry Context - The study's results mark a significant milestone in BeiGene's product portfolio for hematologic malignancies, which currently includes three major products aimed at addressing the evolving clinical needs of B-cell malignancy patients [2] - The ongoing Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302) has already enrolled its first patient earlier this year, further supporting the development of Sotorasib [2]

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its investigational BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapies [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Group 1: Clinical Trial Details - The BGB-11417-201 study is a global, multicenter, single-arm, open-label Phase 1/2 trial that enrolled 125 adult MCL patients previously treated with BTK inhibitors and anti-CD20 therapies [1] - In the first part of the study, 22 patients received daily doses of either 160 mg or 320 mg of Sotorasib to assess safety and tolerability, leading to the determination of the recommended dose for the second part [1] - The second part involved 103 patients receiving the recommended daily dose of 320 mg to evaluate the efficacy and safety of Sotorasib [1] Group 2: Efficacy and Safety Results - The study achieved the primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), indicating clinically meaningful responses in the patient population [2] - Secondary efficacy endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS), also showed positive results [2] - The safety profile of Sotorasib was generally well-tolerated, with manageable toxicity, marking an important milestone in BeiGene's product portfolio for hematologic malignancies [2] Group 3: Regulatory and Market Implications - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in the MCL indication [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study, CELESTIAL-RRMCL (BGB-11417-302), is ongoing, with the first patient enrolled earlier this year [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 自願性公告－業務發展最新情況 百濟神州宣佈索托克拉用於治療套細胞淋巴瘤(MCL)患者 的臨床研究取得積極結果 百濟神州有限公司（「百濟神州」或「本公司」）於2025年8月29日宣佈新一代且具有 同類最優潛力的在研BCL2抑制劑索托克拉用於治療既往接受過布魯頓氏酪氨酸激 酶(BTK)抑制劑和抗CD20治療的套細胞淋巴瘤(MCL)成人患者的1/2期臨床研究 (BGB-11417-201)取得積極結果，並計劃在即將召開的學術大會上公佈全部數據。 「對於MCL患者來說，疾病依然具有侵襲性，且治療選擇有限，療效也不盡如人 意。索托克拉的臨床研究結果表明其有潛力為MCL患者帶來顯著且持久的緩解。 若獲得批准，將為這部分患者提供首個BCL2抑制劑的治療選擇。」百濟神州全球 研發負責人汪來博士表示，「在過 ...

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]

Core Insights - The National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Baiyue Shenzhou's BCL2 inhibitor, Sonrotoclax, which is prioritized for review for treating adult patients with mantle cell lymphoma (MCL) who have previously undergone anti-CD20 and BTK inhibitor treatments [1] - Sonrotoclax is also under review for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) indications in China, which have also been prioritized [1] - MCL is a life-threatening B-cell lymphoma with aggressive progression and poor prognosis, with an incidence rate of approximately 62 per 100,000 in China, and the median age of onset is around 60 years [1][2] Industry Context - The application of targeted therapies like BTK inhibitors has shifted MCL treatment from traditional immunochemotherapy to a combination of immunotherapy and targeted therapy, improving progression-free survival and overall survival rates [2] - There is currently no standard treatment for patients who fail immunotherapy and BTK inhibitors, leading to a low long-term survival rate and a median overall survival of 1-2 years, highlighting the urgent need for new treatment options [2] - The discovery of the BCL2 target offers new hope for MCL treatment, as BCL2 protein is overexpressed in MCL and is associated with disease aggressiveness and poor prognosis [2][3] Company Development - Sonrotoclax, developed by Baiyue Shenzhou, aims to block the BCL2 protein that helps tumor cells survive, potentially providing a precise attack on cancer cells while minimizing damage to normal cells [3] - The specificity of BCL2 inhibitors in regulating apoptosis pathways may offer synergistic effects with other drugs in signal pathway blockade, apoptosis induction, microenvironment modulation, and overcoming drug resistance, providing a theoretical basis for combination therapies in hematological malignancies [3]

Financial Data and Key Metrics Changes - The company raised a total of $1,340 million since its inception, with $2,100 million still available, demonstrating effective and efficient operations [5][12] - Cumulative revenue from 2021 to the third quarter of the previous year reached $310 million [12] Business Line Data and Key Metrics Changes - The company has 13 assets in clinical trials, with 12 from internal efforts, and has two marketed products [9] - The hematology oncology franchise includes two marketed products in liquid cancer and six differentiated assets in the pipeline [10] Market Data and Key Metrics Changes - The company has a comprehensive coverage of indications and mechanisms of action in the liquid tumor space, including multiple myeloma and non-Hodgkin lymphoma [13] - The autoimmune disease portfolio includes six large indications in Phase II and III, with plans to cover more than 15 indications in the next couple of years [11] Company Strategy and Development Direction - The company aims to become a global pharmaceutical leader by developing innovative therapies for oncology and autoimmune diseases, addressing significant unmet medical needs [4] - The strategy includes continuous development of oncology products outside of China and a focus on launching multiple drugs in the next three to four years [40] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of maintaining strict cost-effective operations despite having cash and revenue generation capabilities [12] - The company is optimistic about the upcoming NDA submissions and the progress of ongoing clinical trials, with several milestones expected in 2024 [42] Other Important Information - The company has established a fully integrated drug innovation platform, covering basic research, discovery, clinical development, manufacturing, and commercialization [9] - The company has filed more than 350 patents and established two GMP-compliant manufacturing facilities [9] Q&A Session Summary Question: What are the upcoming milestones for the company? - The company has several NDA submissions planned for 2024, including for arolabronib and tafasitamab, with significant progress in ongoing clinical trials [42]