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 ...

6 January 2026 | 8:05AM HKT Equity Research 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 rev ...

Chautauqua Capital Management, a division of Baird Asset Management, is a boutique investment firm that released its third-quarter 2025 investor letter for the “Baird Chautauqua International and Global Growth Fund”. A copy of the letter can be downloaded here. Global equity markets delivered solid results in the third quarter, driven by the resolution of significant trade conflicts and a shift in U.S. monetary policy toward a more dovish stance. Baird Chautauqua International Growth Fund underperformed the ...

BeOne Medicines, a global drug company that originated as a research and development (R&D) firm in Beijing, promoted Wang Lai to the newly created role of co-president, marking a leadership expansion as the company advances its late-stage pipeline and globalisation efforts. The 48-year-old has served as the company's global head of R&D since April 2021. Effective January, Wang would take the helm of an expanded portfolio, retaining his R&D responsibilities while also overseeing business development and th ...

Core Viewpoint - BeiGene is positioned for sustainable revenue growth through the launch of new products, with a revenue target of $5.1 billion to $5.3 billion likely to be achieved [1] Group 1: Revenue Growth and Product Launch - BeiGene's cancer therapy Brukinsa is expected to continue boosting global sales in the coming years due to its best-in-class characteristics and expanding market penetration [1] - The company is entering a new development phase, projected to achieve positive profits and positive free cash flow starting in 2025 [1] Group 2: Operational Efficiency and Rating - BeiGene is anticipated to leverage its global operational platform to enhance operational efficiency and cash generation capabilities [1] - The rating for BeiGene is set at "Buy," with a target price of HKD 252 [1]

大华继显分析师Carol Dou和Sunny Chen报告称，百济神州可通过推出新产品实现可持续的收入增长。 他们认为该公司51亿-53亿美元的新收入目标极有可能实现，并预计将利用其全球运营平台进一步提高 运营效率和现金生成能力。大华继显的分析师称，百济神州的抗癌疗法Brukinsa未来几年可能会继续提 振全球销售额，这得益于其同类最佳的特性和不断扩大的市场渗透率。他们表示："百济神州已进入一 个新的发展时代，从2025年起将实现正利润和正自由现金流。"他们称，理由是收入结构更加多元化， 利润率不断提高。大华继显对该股的评级为买入，目标价为252.00港元。 ...

Core Insights - Novo Nordisk's stock rose due to a lighter-than-expected discount for its semaglutide-based products, Ozempic and Wegovy, under the Inflation Reduction Act, with discounts ranging from 38% to 85% [1][3] - The Centers for Medicare and Medicaid Services (CMS) estimates that price negotiations will save patients $685 million in out-of-pocket costs, focusing on the 15 most expensive drugs in Medicare [2] - Teva Pharmaceutical's Austedo received a 38% discount, with projected sales of $2.5 billion in 2027, contributing to a 4% rise in its stock [5][6] Novo Nordisk - Semaglutide will face a 71% discount, reducing its Medicare price to $274 per month in 2027 from a list price of $959 in 2024 [3] - The discount aligns with a Most Favored Nation deal, allowing Medicare to cover obesity drugs for the first time [4] - Novo Nordisk's stock is currently trading below key moving averages, indicating potential pressure [9] Teva Pharmaceutical - Teva's Austedo will see its price drop from $6,623 to $4,093 by 2027, leading to a positive outlook for the drug [5] - Teva's stock increased by over 4% following the news, reflecting investor confidence [6] AstraZeneca and BeOne Medicines - AstraZeneca's Calquence faces a 40% discount, dropping from $14,228 to $8,600 per month by 2027, but is not expected to significantly impact its market position against BeOne's Brukinsa [7][8] - BeOne's stock rose more than 2%, indicating a favorable market response despite AstraZeneca's discount [8]

Key Takeaways from China Biopharma Trip Industry Overview - The trip focused on the Chinese biopharmaceutical industry, highlighting the rapid development of local biotech companies and their competitive landscape in drug discovery and clinical R&D [3][5][9]. Core Insights 1. **Rapid Development of Biotech Companies**: Local Chinese biotech firms have shown a remarkable pace of development, with examples like Pyrotech achieving clinical proof-of-concept in 4 years and Hengrui progressing from preclinical studies to IND acceptance in 6 months [3]. 2. **Factors Driving Speed**: Key factors contributing to this accelerated development include streamlined decision-making, a concentrated ecosystem of contract research organizations (CROs), strong fundamental research, and experienced clinical investigators [3]. 3. **Licensing and Partnerships**: Chinese biotech companies generally prefer licensing out their products, but more mature firms are increasingly seeking co-development and co-commercialization agreements, as seen with Innovent's partnership with Takeda [4]. 4. **Pipeline Diversity**: Companies visited exhibited broad pipelines across multiple disease areas, with a notable focus on antibody-drug conjugates (ADCs) and a competitive landscape characterized by intense pressure [5]. 5. **Obesity Market Developments**: Eccogene is optimistic about its obesity drug ECC5004, while Innovent noted rapid uptake of mazdutide, indicating strong competition in the obesity segment [7]. 6. **Vaccine Market Challenges**: Zhifei highlighted ongoing challenges in the vaccine market due to vaccine hesitancy and pricing pressures, complicating commercialization efforts [8]. Competitive Landscape 1. **ADC Focus**: Nearly half of the companies visited are engaged in ADC research, particularly in oncology, indicating China's emergence as an ADC hub [5]. 2. **Emerging Therapies**: Companies are exploring bispecific/trispecific antibodies and new-generation cell therapies, with a focus on innovative approaches to cancer treatment [5][31]. 3. **Market Dynamics**: The Chinese pharmaceutical market is valued at $160-180 billion, with the innovative market growing at 20-30% annually, expected to reach $50-60 billion in five years [23]. Company-Specific Highlights 1. **3SBio and Pfizer**: 3SBio expressed optimism regarding its PD-1xVEGF bispecific antibody program, with plans for multiple trials to establish the compound as a backbone therapy [9]. 2. **Kelun Biotech**: Kelun is advancing its TROP2 targeting ADC, sac-TMT, with expectations of significant peak sales based on recent clinical data [10]. 3. **Hengrui's Lp(a) Program**: Hengrui is encouraged by Phase 2 data for its Lp(a) targeted oral small molecule drug, which could transform cardiovascular disease treatment [10]. 4. **Zhifei's Gardasil Challenges**: Zhifei reported difficulties in the vaccine market, particularly with Gardasil, due to pricing pressures and vaccine hesitancy [10]. Additional Observations - **Regulatory Environment**: Sanofi noted that early-stage R&D in China is 50% cheaper and 60% faster than in the US, with plans to invest more in local partnerships [23]. - **Pricing Dynamics**: The conversation with obesity experts revealed insights into pricing dynamics and the competitive landscape for obesity treatments [7]. Conclusion The trip underscored the dynamic nature of the Chinese biopharma industry, characterized by rapid innovation, strategic partnerships, and a competitive landscape that poses both opportunities and challenges for local and multinational companies [3][5][23].

Summary of BeOne Medicines FY Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Industry**: Biotechnology - **Key Achievement**: First year of profitability and recognized as one of the fastest-growing large biotech companies [3][4] Competitive Advantages - **Integrated Development**: Fully integrated CRO-free clinical development organization with over 3,600 professionals [4] - **Product Pipeline**: Deep product pipeline with 10 internally developed New Molecular Entities (NMEs) entering the clinic in 2024 and 16 to date [3] - **Cost Efficiency**: 70% of the cost to develop medicines is in clinical development; BeOne aims to reduce this through its integrated approach [4] Product Performance - **Brukinsa**: - Leading market share in the BTK inhibitor market with 47% year-over-year growth in the U.S. and 71% growth in Europe [6][8] - Demonstrated durable progression-free survival (PFS) with 74% landmark PFS at 72 months [6][7] - Significant real-world impact and prescription growth globally [8][9] Market Dynamics - **Fixed Duration Treatments**: - BeOne supports finite treatments that meet four criteria: deep response, sustained PFS, acceptable safety profile, and convenience [10][11] - Current market dynamics show continuous use BTK inhibitors capturing about 50% of the market, with opportunities for growth through fixed-duration offerings [11][12] Pipeline Developments - **Sonrotoclax**: - Designed to be more potent and selective than venetoclax, with a half-life of five hours [14][15] - Breakthrough designation in relapsed refractory MCL, with plans for global filing based on upcoming data [30] - Phase 3 study planned for multiple myeloma, targeting the translocation 11;14 population [32][33] - **BDK CDAC**: - A degrader molecule with a different mechanism, potentially effective against mutations that standard inhibitors cannot target [24][25] - Phase 2 cohort fully enrolled, with data expected in the first half of next year [26] Competitive Landscape - **Comparison with Competitors**: - BeOne's zanubrutinib shows superior response rates compared to pirtobrutinib and acalabrutinib in specific patient populations [20][21] - Ongoing head-to-head studies to validate BeOne's offerings against competitors [16][17] Future Outlook - **Clinical Trials**: - Upcoming data presentations at ASH for various products, including BDK CDAC and sonrotoclax [28][29] - Commitment to advancing solid tumor pipeline, particularly CDK4/6 inhibitors, with a focus on first-line breast cancer [34][36] Conclusion - BeOne Medicines is positioned strongly within the biotechnology sector with a robust product pipeline, innovative clinical development strategies, and a commitment to addressing patient needs through differentiated therapies. The company is actively pursuing growth opportunities in both hematology and solid tumors while maintaining a competitive edge against established players in the market.

Group 1 - The article discusses Stephen's background as a Registered Nurse (RN) and an MBA, highlighting his unique approach to analyzing healthcare and tech stocks through the "Dizzy Framework" [1] - The "Dizzy Framework" is designed to mitigate common behavioral errors in investing, such as reacting to market noise or adhering too rigidly to prior beliefs [1] - The framework emphasizes the importance of quality and timing of information, promoting a patient and disciplined investment strategy that translates complex scientific and market dynamics into actionable investment theses [1] Group 2 - Influences on Stephen's investment analysis include concepts from "Superforecasting" and "Fooled by Randomness," which inform his probabilistic approach to market predictions [1]