Core Viewpoint - BeiGene's stock price increased nearly 3% in pre-market trading following the announcement of conditional approval for its self-developed BCL2 inhibitor, SOTYKTU (sotatercept), by the National Medical Products Administration (NMPA) for specific cancer treatments [1] Group 1: Drug Approval and Market Impact - BeiGene announced that its BCL2 inhibitor, SOTYKTU, received conditional approval from the NMPA for treating adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received at least one systemic treatment including a BTK inhibitor [1] - The approval also covers adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two systemic treatments, including a BTK inhibitor, making SOTYKTU the first and only BCL2 inhibitor approved for MCL treatment in China [1] - Following the news, BeiGene's stock price rose to $329.5 in pre-market trading, reflecting a 2.86% increase [2] Group 2: Stock Performance Metrics - The closing price of BeiGene's stock was $320.00, with a pre-market price of $329.50, indicating a significant upward movement [2] - The stock's trading volume was 293,100 shares, with a market capitalization of approximately $37.966 billion [2] - The stock has a 52-week high of $385.22 and a low of $174.74, showcasing its volatility in the market [2]

FF301 致：香港交易及結算所有限公司 公司名稱: 百濟神州有限公司 (根據瑞士法律註冊成立的公司) 呈交日期: 2026年1月7日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06160 | 說明 | 請見備注 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,311,463,847 | USD | | 0.0001 USD | | 231,146.38 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 2,311,463,847 | USD | | 0.0001 USD | | 231,146.38 | 本月底法定/註冊股本總額： USD 231,146.38 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人 ...

Core Viewpoint - BeiGene (06160.HK) announced the grant of a total of 53,322 restricted stock units to 155 participants under the 2016 option and incentive plan, equivalent to 693,186 shares, representing approximately 0.04% of the company's total issued shares as of the announcement date [1] Summary by Category - **Company Actions** - The board and/or the remuneration committee granted 53,322 restricted stock units to 155 participants [1] - The restricted stock units correspond to 693,186 shares [1] - **Shareholder Impact** - The granted shares represent about 0.04% of the total issued shares of the company as of the announcement date [1]

Core Viewpoint - BeiGene (06160) announced the grant of a total of 53,300 restricted stock units to 155 grantees under the 2016 Option and Incentive Plan, which equates to approximately 693,200 shares, representing about 0.04% of the company's total issued shares as of the announcement date [1] Summary by Categories - **Company Announcement** - The company has granted 53,300 restricted stock units to 155 individuals [1] - This grant is part of the 2016 Option and Incentive Plan [1] - **Shareholder Impact** - The restricted stock units correspond to approximately 693,200 shares [1] - This represents about 0.04% of the total issued shares of the company as of the announcement date [1]

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） 授出受限制股份單位 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。於2025年12月31 日，董事會及╱或董事會薪酬委員會根據2016期權及激勵計劃的條款向一百五十 五名承授人授出涉及合共53,322股美國存託股份的受限制股份單位。 受限制股份單位詳情如下： 授出日期： 2025年12月31日 2016期權及激勵計劃項下的受限制股份單位 承授人數目： 一百五十五名（包括一名服務提供者，其根據聘任就 本集團主要業務有關或附屬領域向本集團提供科學 諮詢服務，以幫助維持或提高本集團的競爭力） 於2025年12月31日，董事會及╱或董事會薪酬委員會根據2016期權及激勵計劃 的條款授予一百五十五名承授人合共53,322股美國存託股份受限制股份單位。該 等受限制股份單位相當 ...

Group 1 - The core point of the news is that BeiGene's new BCL2 inhibitor, SOTUCLAR (百悦达®), has received conditional approval from the National Medical Products Administration (NMPA) in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy including a BTK inhibitor, as well as for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic therapies including a BTK inhibitor [1][2] - SOTUCLAR is the first of its kind to be approved in China, allowing Chinese patients to benefit from this innovative therapy ahead of other markets [1] - The approval process in China took only 8 months from acceptance to approval, highlighting the urgent treatment needs of patients with blood cancers who have developed resistance [2] Group 2 - The approval of SOTUCLAR marks a significant milestone in BeiGene's hematology product pipeline and reinforces the company's leadership in the treatment of B-cell malignancies [2] - SOTUCLAR has also received breakthrough therapy designation and priority review qualification from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory MCL who have received BTK inhibitors, potentially making it the first BCL2 inhibitor approved for this indication in the U.S. [1]

Group 1 - The A-share market experienced narrow fluctuations on January 7, with coal, chips, and innovative drug sectors leading in gains. The Southern Innovative Drug ETF (159858.SZ) rose by 1.60%, and Baijie Shenzhou increased by 3.29% [1] - The Chinese innovative drug industry is expected to undergo a value return and structural reshaping by 2025, with a shift in core logic towards product strength, platform capability, and global operational ability [1] - Policies are transitioning from encouraging innovation to a new phase of systematic and precise guidance, providing institutional support for original innovation [1] Group 2 - Capital is concentrating on companies with core technology platforms, clear clinical value, and global potential, favoring mid-to-late-stage projects in areas such as ADC, bispecific antibodies, CGT, and AI drug development [1] - The transaction amount for innovative drugs going overseas has reached a historical high, with deepening collaboration models [1] - Domestic ADC and bispecific antibody products have been approved and show globally leading data, while breakthroughs have been made in small molecule drugs targeting "undruggable" targets, and significant progress has been observed in cell therapies and nucleic acid drugs [1] Group 3 - The industry is transitioning from following innovation to original innovation, and from technology input to systematic output [1] - The trend for the innovative drug industry is positive, with strengthened global competitiveness, ongoing international expansion, and gradual realization of commercial profitability [1] - The medical device industry is experiencing a calming of influencing factors, with accelerated innovation and internationalization [1] Group 4 - The innovative drug industry is showing enhanced innovation vitality and significant internationalization results, with sufficient long-term development momentum [1] - The Southern Innovative Drug ETF (159858.SZ) can focus on innovative drugs and the industry chain, sharing the growth dividends of truly competitive companies amid industry differentiation and seizing opportunities for value reshaping [1]

Summary of BeOne Medicines Conference Call Company Overview - **Company**: BeOne Medicines (ONC/688235.SS) - **Industry**: Oncology - **Headquarters**: Switzerland - **Focus**: Discovering and developing innovative cancer treatments, with a portfolio in hematology and solid tumors, including products like Brukinsa and Tevimbra [7][10] Key Points from the Conference Call Approval and Market Entry - **Sonro Approval**: On January 5th, 2025, the China NMPA approved sonrotoclax (BCL2 inhibitor) for relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and mantle cell lymphoma (R/R MCL) [1] - **Approval Timeline**: The NDA review took only eight months, which is considered quick compared to the typical 12-18 months for new drug approvals, indicating a significant unmet need for BCL2 inhibitors in China [1] Market Dynamics - **Sales Ramp-Up**: There is a focus on tracking the sales ramp-up of venetoclax and lisaftoclax, as well as feedback from physicians and patients regarding the new BCL2 inhibitors [2] - **Differentiation Potential**: Sonrotoclax and lisaftoclax are expected to disrupt the market due to: 1. **Better Tolerability**: Both drugs showed lower rates of neutropenia and discontinuation compared to venetoclax, with sonrotoclax showing a lower rate than lisaftoclax [2] 2. **Quicker Dose Ramp-Up**: Lisaftoclax has a 4-6 days daily dose ramp-up scheme, while sonrotoclax and venetoclax follow a weekly ramp-up [2] Financial Projections - **Earnings Adjustments**: FY2025-2027 earnings estimates were adjusted, with EPS revised from US$3.78/US$6.26/US$6.64 to US$3.59/US$4.65/US$4.46 [6] - **Sales Estimates**: Near-term sales estimates for sonro were fine-tuned with increased SG&A investment, and R&D spending was increased due to multiple pipeline assets entering the proof of concept stage [6] - **Target Prices**: The 12-month target prices were updated to US$385.79 for ONC and Rmb345.86 for the A-share [6] Risks and Challenges - **Key Risks**: 1. Uncertainties in R&D and regulatory approvals, especially for the early-stage solid tumor franchise [7][10] 2. Competition from BTK and PD-1 inhibitors [7][10] 3. Development risks for clinical-stage assets [7][10] 4. Market access bottlenecks [7][10] Investment Rating - **Current Rating**: The company maintains a "Buy" rating, with shares trading at a modest discount due to broader macroeconomic factors and concerns around its product pipeline [7][10] Additional Insights - **Clinical Development Team**: BeOne Medicines has a growing internal clinical development team, which may provide cost savings and advantages in product launch times compared to peers [7] - **Market Position**: The company is well-positioned to grow and bring additional therapies to both the local Chinese market and the global pharmaceutical stage [7] This summary encapsulates the critical insights from the conference call regarding BeOne Medicines, its market strategies, financial outlook, and associated risks.

Group 1: Market Performance - Hong Kong's innovative drug ETF (159570) surged by 3%, with a trading volume exceeding 1.5 billion yuan, following a net inflow of over 62 million yuan today after a previous inflow of 430 million yuan [1][3] - As of January 6, the latest scale of the Hong Kong innovative drug ETF reached over 23.3 billion yuan, leading its peers in the same category [1] Group 2: Economic Signals - Federal Reserve Governor Milan indicated that upcoming economic data may support further interest rate cuts, with expectations of a reduction exceeding 100 basis points this year [3] - Wall Street analysts suggest that if the U.S. unemployment rate rises to 4.7% by December 2025, the Fed may cut rates by 25 basis points this month [3] Group 3: Company Developments - Brain-computer interface "unicorn" Strong Brain Technology completed a financing round of 2 billion yuan, second only to Musk's Neuralink [3] - AI pharmaceutical company Insilico Medicine announced a long-term collaboration with Siveya for anti-tumor drug development, with a total deal value of 888 million USD [3] Group 4: New Drug Approvals - On January 6, BeiGene announced that its self-developed BCL2 inhibitor, Baiyueda® (sotucumab), received conditional approval from the National Medical Products Administration [3] - Shiyao's SYS6017 has initiated Phase II clinical trials for the prevention of shingles [3] Group 5: Investment Insights - Zhongtai Securities predicts that the pharmaceutical sector's opportunities in 2025 will focus on innovation and industry upgrades, with investment strategies continuing into 2026 [5] - The report emphasizes the importance of "innovative drugs and industry chains, demand recovery, and AI" as key investment dimensions [5] Group 6: J.P. Morgan Healthcare Conference - The 44th J.P. Morgan Healthcare Conference is set to take place from January 12 to 15, 2026, in San Francisco, attracting over 8,000 global participants [6] - The conference will feature over 500 listed companies and thousands of startups, focusing on "capital + strategy" discussions [6] Group 7: Industry Trends - Three major trends are highlighted for 2026: the continued rise of gene and cell therapies, deep integration of AI in pharmaceuticals, and the emergence of new market forces [7] - The report notes that over 20 gene editing companies will showcase breakthroughs in CAR-T and base editing at the conference [7] Group 8: MNC Engagement - Multinational corporations (MNCs) are willing to pay higher prices for innovative drugs from China, with the average total package for drugs purchased from China being 2.76 billion USD, compared to 1.29 billion USD for those from overseas [8] - The willingness of MNCs to pay a premium for Chinese innovations is driven by the need to fill significant pipeline gaps due to impending patent expirations [8] Group 9: Investment Focus - Investment strategies should focus on companies with strong clinical development capabilities and those in popular therapeutic areas such as ADCs, GLP-1, and dual antibodies [11] - Companies that can produce high-quality late-stage clinical assets are likely to attract MNC interest [11] Group 10: Key Therapeutic Areas - The report identifies key therapeutic areas for investment, including ADCs, GLP-1, dual antibodies, and neuroscience, emphasizing the need for innovative platforms and clinical data superiority [12]

Core Viewpoint - The approval of the BCL-2 inhibitor Sotorakra by BeiGene marks a significant advancement in the treatment of hematologic malignancies, with potential implications for the competitive landscape of BCL-2 inhibitors in the market [1][3]. Company Developments - BeiGene's Sotorakra has received approval for two indications: treatment of adult patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) [1]. - The approval came just eight months after the new drug application was accepted by the NMPA, indicating a rapid development timeline [1]. - Sotorakra is positioned as a next-generation BCL-2 inhibitor, designed to block the BCL-2 protein that aids tumor cell survival, and has shown strong efficacy and specificity in clinical trials [1][2]. Clinical Trial Results - Early clinical trials of Sotorakra combined with Zebutini have demonstrated unprecedented rates of undetectable minimal residual disease in treatment-naive CLL patients [2]. - Recent data from five clinical studies indicate significant clinical benefits for Sotorakra, suggesting its potential as a cornerstone therapy for various B-cell malignancies [2]. Market Landscape - The global BCL-2 inhibitor market is projected to reach $5.2 billion by 2028, with the Chinese market expected to reach 1.4 billion yuan [5]. - The approval of Sotorakra follows the approval of another BCL-2 inhibitor, Lisatoclax, from Ascentage Pharma, indicating a growing presence of Chinese companies in the BCL-2 space [3][5]. - The competitive landscape is intensifying as multiple Chinese pharmaceutical companies, including Innovent Biologics and Zai Lab, are developing BCL-2 inhibitors [3][4]. Financial Performance - BeiGene's Zebutini has become a significant revenue driver, with global sales reaching $1.3 billion in 2023, marking a 129% year-over-year increase [6]. - In the first half of 2025, BeiGene reported a revenue of 17.52 billion yuan, a 46% increase year-over-year, largely driven by Zebutini sales [6][7]. - The company is under pressure to identify the next blockbuster product as Zebutini's growth may slow down in the future [7].