Investment Rating - The report maintains a "Positive" investment rating for the healthcare industry [9]. Core Insights - Chinese pharmaceutical companies are increasingly enhancing their original research capabilities, leading to a surge in high-quality innovative products gaining international recognition. This trend is facilitating the acceleration of domestic innovative drugs entering global markets through two primary pathways: "building ships" and "borrowing ships" [2][6]. - The total value of license-out transactions from China reached over $43 billion in 2024, accounting for nearly 20% of the global total, indicating a significant shift in the global pharmaceutical landscape as Chinese innovative drugs gain traction [6][17]. Summary by Sections Innovative Drug Globalization - Chinese innovative drug companies are transitioning from "following overseas" to "independent innovation," with a notable increase in original research capabilities. The number of Chinese companies participating in major international conferences like AACR and ASCO has reached historical highs, with 126 companies presenting nearly 300 new drug research results at the 2025 AACR conference [17][18]. - The number of original innovative drugs approved in China has increased from 11 in 2015 to 92 in 2024, with the proportion of globally developed first-in-class (FIC) drugs rising from 9% to 24% during the same period [21][22]. "Building Ships" and "Borrowing Ships" Models - "Building ships" refers to domestic companies independently conducting overseas clinical trials and obtaining market approvals. Notable examples include BeiGene's BTK inhibitor, which achieved over $2.6 billion in global sales, and Legend Biotech's CAR-T therapy, which reached $963 million in global sales in 2024 [25][26]. - "Borrowing ships" involves leveraging partnerships for international development and commercialization. The total value of license-out transactions in the Chinese innovative drug sector reached $51.9 billion in 2024, with over 50 transactions reported in the first half of 2025, totaling $48.4 billion [27][28]. Investment Perspective - The report emphasizes that the ongoing transformation in the healthcare sector, driven by innovative drug globalization, presents significant investment opportunities. Companies with strong cash flow, innovative capabilities, and established research platforms are particularly well-positioned for growth [43].

Investment Rating - The report maintains a "Buy" rating for the company [4][6]. Core Insights - The CDK4 inhibitor BGB-43395 is progressing well and is expected to enter the registration clinical stage within the next 6-12 months, potentially becoming the second CDK4 inhibitor to do so globally [1][12]. - BGB-43395 demonstrates superior selectivity and efficacy compared to existing CDK4/6 inhibitors, with a significantly lower IC₅₀ of 126 nM, outperforming Pfizer's PF-07220060 by 4.3 times [2][17]. - The overall response rate for BGB-43395 is expected to improve with extended follow-up time, as historical data suggests that response rates for CDK4/6 inhibitors increase over time [3][28]. Financial Projections - Projected revenues for 2025-2027 are estimated at 375.17 billion, 450.24 billion, and 540.34 billion CNY, respectively [4]. - Expected net profits for the same period are projected to be 7.03 billion, 40.10 billion, and 67.44 billion CNY [4]. - The company anticipates a significant revenue growth rate of 82.13% in 2023, followed by 56.19% in 2024, and a gradual decline to 20.01% by 2026 and 2027 [5][40]. Clinical Development - BGB-43395 is currently involved in three Phase I clinical trials, focusing on monotherapy and combination therapies for HR+/HER2- breast cancer [1][12]. - The drug has shown promising pharmacokinetic and pharmacodynamic profiles, with rapid absorption and a half-life of approximately 13 hours [21][19]. - Initial clinical data indicates a favorable tumor response rate, with a stable disease plus partial response rate of 67% to 83% across different dosing groups [3][31]. Market Context - The global market for CDK4/6 inhibitors is projected to exceed 18 billion USD, with a 17% year-over-year growth expected in 2024 [16]. - BGB-43395's high selectivity minimizes the risk of toxicity associated with CDK6 inhibition, positioning it favorably against competitors [16][2].

FF301 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的證券變動月報表 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: 2025年7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 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 2. 股份分類 | 其他分類 (請註明) | 股份類別 | 其他類別 (請註明) | | ...

Core Viewpoint - The rise of the innovative drug sector in the first half of 2025 has become a significant highlight in the investment market, driven by policy support, technological breakthroughs, and market demand, leading to outstanding performance of related funds and marking a critical battle for active equity funds to prove their worth [1][15]. Group 1: Performance of Active Equity Funds - In the first half of 2025, active equity funds have outperformed broad-based indices, with the average return of equity mixed funds at 4.81% and 75% of these funds achieving positive returns [3]. - The top-performing funds in the first half of 2025 include 汇添富香港优势精选A with a return of 86.48%, 中信建投北交所精选两年定开A at 82.45%, and 长城医药产业精选A at 75.18% [5][6]. Group 2: Innovative Drug Sector Growth - The innovative drug sector has experienced explosive growth in the first half of 2025, with the 万得创新药概念指数 rising over 21% and the 恒生创新药指数 increasing by more than 66% [4]. - The top holdings of 汇添富香港优势精选 include stocks like 荣昌生物 and 科伦博泰生物-B, which have shown significant price increases, with 荣昌生物's stock price rising over 370% year-to-date [9][10]. Group 3: ETF Performance - The innovative drug sector has also played a crucial role in the performance of ETFs, with 汇添富国证港股通创新药ETF leading the market with a return of 68.98% [12][13]. - Other notable ETFs in the innovative drug space include 银华国证港股通创新药ETF and 华泰柏瑞恒生创新药ETF, both achieving returns above 67% [12]. Group 4: Long-term Investment Value - The innovative drug industry, after years of stagnation, is now recognized for its market value and commercial potential, highlighting the importance of long-term investment strategies [14][15]. - The historical context shows that since 2010, the A-share market has shifted towards structural opportunities, with sectors like healthcare, consumption, and technology becoming the main drivers of economic growth [20].

R&D Strategy and Pipeline - BeiGene's R&D strategy focuses on developing a deep and impactful portfolio, executing fast-to-PoC for value maximization, initiating combination therapies early, and advancing only transformative medicines to late-stage development[18] - BeiGene has an extensive investment in innovative platforms, supporting a robust preclinical pipeline of 69 programs, with 51% biologics and 43% small molecules[19, 20] - BeiGene is transforming its pipeline with a focus on heme leadership and solid tumor diversification, expecting POC data readouts for many NMEs in the next 1-2 years[21] Solid Tumor Programs - BGB-43395 (CDK4i) is undergoing dose escalation in monotherapy and in combination with endocrine therapy (ET) in breast cancer patients[34] - Preliminary data from the BGB-43395-101 study shows a manageable safety profile, with diarrhea and nausea being the most commonly reported AEs[28] - BGB-43395 exhibits rapid absorption with a median Tmax of approximately 2 hours, and exposures increased approximately dose proportionately[42] Hematology Programs - Brukinsa (Zanubrutinib) - Brukinsa has demonstrated sustained PFS superiority over Ibrutinib in the ALPINE H2H study with 42.5 months follow-up, with a HR of 0.68 (95% CI: 0.54, 0.84)[74] - In the ALPINE study, Zanubrutinib showed sustained superiority and risk reduction in the TP53/Del17p population, with a HR of 0.51 (95% CI: 0.33, 0.78)[78, 80] - In the SEQUOIA study, Zanubrutinib demonstrated a sustained PFS benefit in treatment-naive unfit CLL/SLL patients, with a 71% reduction in risk of progression or death[88, 96] Hematology Programs - Sonrotoclax - In a Phase 1/1b study, Sonrotoclax combined with Zanubrutinib as frontline treatment for CLL demonstrated high MRD clearance rates, with 90% achieving uMRD by week 48 in the 320mg cohort[68, 122] - The CELESTIAL-TNCLL trial is an ongoing Phase 3 study assessing Sonrotoclax + Zanubrutinib vs Venetoclax + Obinutuzumab for treatment-naive CLL[68, 142] Hematology Programs - BTK CDAC (BGB-16673) - In a Phase 1 study, the BTK degrader BGB-16673 showed an ORR of 77.6% in heavily pre-treated R/R CLL/SLL patients, with an ORR of 93.8% at 200 mg[169, 181] - BGB-16673 demonstrated promising activity in patients with Richter Transformation, with an ORR of 58.3%[175, 180] - BGB-16673 also showed high overall response rates and VGPRs in R/R WM patients, with an ORR of 81.5%[190, 193]

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6月30 日，董事會薪酬委員會根據2016期權及激勵計劃的條款向二百一十六名承授人授 出涉及合共43,839股美國存託股份的受限制股份單位。 2016期權及激勵計劃項下的受限制股份單位 於2025年6月30日，董事會薪酬委員會根據2016期權及激勵計劃的條款授予二百 一十六名承授人合共43,839股美國存託股份受限制股份單位。該等受限制股份單 位相當於569,907股股份，約佔本公告之日公司發行股份總數的0.04%。 授出受限制股份單位詳情 受限制股份單位詳情如下： 1 授出日期： 2025年6月30日 承授人數目： 二百一十六名 已授出受限制股份單位涉及 的相關股份數目： 569,90 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 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： 2025年7月2日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | 事件 | | 已發行股份（不包括庫存股 ...

Investment Rating - The report assigns an "Outperform" rating to multiple companies in the healthcare sector, including JD Health, WuXi AppTec, and Innovent Biologics, among others [1]. Core Insights - The innovative drug revenue for the companies is expected to exceed 10 billion yuan in 2025, with innovative drugs projected to account for over 80% of total revenue [22]. - The oncology pipeline leadership is expanding, with core products like Ameitini expected to reach peak sales of 8 billion yuan [22]. - The ADC (Antibody-Drug Conjugate) market is projected to reach $64.7 billion by 2030, with a CAGR of 30% [17]. Summary by Sections Company Ratings - Companies rated as "Outperform" include JD Health, WuXi AppTec, Innovent Biologics, and BeiGene [1]. - Neutral rating is assigned to China National Pharmaceutical Group [1]. Market Trends - The report highlights a strong performance in the online pharmacy sector, driven by chronic disease drugs and innovative weight-loss medications [34]. - JD Health's revenue growth accelerated to 25.5% YoY in Q1 2025, indicating a robust market position [34]. Pipeline and Product Development - The report emphasizes the importance of ADC technology platforms, with several companies establishing global partnerships valued over $6 billion [22]. - Upcoming catalysts include approvals for various ADC products and significant clinical data releases expected in 2025 [34]. Financial Projections - The innovative drug industry chain is expected to grow by over 15% YoY, with high-margin polypeptide business projected to maintain over 60% growth [29]. - Companies like BeiGene are expected to see peak sales in their hematological oncology segment exceed $8 billion [24].

Core Viewpoint - The former president of Takeda China, Dan Guohong, will join BeiGene on August 18, taking the role of General Manager for Greater China, Central Asia, and South Asia, reporting to BeiGene's President and COO, Wu Xiaobin [1] Group 1 - Dan Guohong's appointment is expected to strengthen BeiGene's leadership in the specified regions [1] - The transition reflects BeiGene's strategy to enhance its operational capabilities in Greater China and surrounding areas [1]

Core Viewpoint - The innovative drug sector in China has experienced significant growth in 2023, exemplifying a narrative of China's rise in the capital market, with the Huatai-PB Hong Kong Innovative Drug ETF increasing by 57.87% year-to-date and numerous stocks doubling in value [1]. Group 1: Market Performance and Trends - Chinese innovative drug companies are entering a "Deepseek" moment, a culmination of two decades of development, as stated by industry analysts [2][10]. - The recent surge in the innovative drug sector is attributed to the performance of leading pharmaceutical companies, driven by increased sales of commercialized innovative drugs and a surge in licensing deals for clinical trial assets [4][10]. - The total amount of licensing deals by Chinese innovative drug companies reached $45.5 billion in the first five months of 2025, surpassing the total for the first half of 2024, indicating a robust growth in international licensing transactions [8]. Group 2: Company Highlights - A notable example is BeiGene, which created China's first billion-dollar blockbuster drug, Zebrutinib, achieving global sales of $1.3 billion in 2023 [6]. - BeiGene is projected to generate $3.8 billion in revenue in 2024, with Zebrutinib contributing $2.6 billion, leading to a reduction in the company's losses [7]. Group 3: Future Outlook - Analysts believe that the innovative drug sector in China is on a long-term upward trajectory, with the industry poised for a growth phase characterized by the approval of new drugs and increased licensing revenue [11][12]. - The next 3-5 years are expected to see accelerated globalization and a shift towards original innovation in the Chinese innovative drug sector, with companies that have strong pipelines and clinical advantages likely to lead the next growth wave [13]. - Despite recent market volatility, the long-term outlook remains positive, with expectations of a return to reasonable valuations as innovative results continue to materialize [16].