Investment Rating - The report provides an "Outperform" rating for multiple companies in the healthcare sector, including BeiGene, JD Health, WuXi Biologics, and others, indicating a positive outlook for these stocks [1]. Core Insights - The macro and industry environment is improving due to the resolution of policy uncertainties, the release of significant clinical data, and a resurgence in global M&A activity, leading to a notable increase in investor sentiment towards innovative drugs for 2026 [4][11]. - In oncology, the PD-1/VEGF dual antibody approach is transitioning from "mechanism validation" to "clinical and industrial resonance," with multiple global Phase III trials underway, expected to catalyze approvals and data releases within the year [5][17]. - The metabolic sector is seeing growth in the cash-pay market for GLP-1 drugs, driven by limited insurance coverage and high out-of-pocket costs, prompting companies to enhance accessibility through direct sales and pricing adjustments [6][25]. - In the autoimmune space, there is a growing concentration risk among major products from multinational corporations (MNCs), with new antibody platforms expected to yield significant data in 2026, potentially leading to new business development opportunities [7]. - The central nervous system (CNS) investment focus remains on advancing Aβ monoclonal antibody treatments, with key data expected to open up early intervention market opportunities [9]. Summary by Sections Oncology - The PD-1/VEGF dual antibody's clinical and industrial certainty is strengthening, with major companies conducting multiple global Phase III trials across high-value indications [17]. - The Pan-RAS precision therapy is entering a realization phase, with key Phase III data expected in 2026 for pancreatic cancer and NSCLC [22]. Metabolic - The cash-pay market for GLP-1 drugs is expanding due to limited insurance coverage, with companies like Eli Lilly and Novo Nordisk adopting different direct-to-consumer strategies to enhance accessibility [25][26]. - Small nucleic acid therapies are expected to upgrade treatment paradigms, showing competitive data in weight loss and safety profiles when combined with GLP-1 [30]. Autoimmune - MNCs are increasingly reliant on a few blockbuster products, with structural opportunities arising from new antibody platforms expected to report data in 2026 [7]. - The trend towards oral formulations in autoimmune diseases is gaining traction, offering advantages in adherence and competitive differentiation [7]. CNS - The focus in CNS remains on Aβ monoclonal antibody treatments, with advancements expected to shift treatment towards earlier intervention populations [9]. - New delivery methods, such as systemic administration of small nucleic acids, are being explored as complementary approaches [9].

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 | 截至月份: | 2026年1月31日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 亞盛醫藥集團 | | | | | | 呈交日期: | 2026年2月5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 | | 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) | 06855 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | 0.0 ...

Core Viewpoint - The article discusses the significant progress in China's innovative drug development, highlighting the increase in the number of new drugs approved and the growing competitiveness of Chinese pharmaceutical companies in both domestic and international markets [4][16]. Group 1: Growth of Innovative Drugs - In 2024, the number of domestically developed Class 1 new drugs in China reached 40, a substantial increase from just 9 in 2018 [2][3][4]. - Since the beginning of the 14th Five-Year Plan, 113 innovative drugs have been approved, which is 2.8 times the number approved during the 13th Five-Year Plan [4]. - As of August 2024, there are 910 new drugs available in China, indicating a robust growth in the pharmaceutical market [6]. Group 2: Clinical Trials and Breakthroughs - In a head-to-head clinical trial, the drug Ivoris (依沃西单抗) developed by Kangfang Biopharma outperformed the global best-selling cancer drug, Pembrolizumab (K drug), marking a significant achievement for Chinese innovation [7][9]. - The global sales of Pembrolizumab reached $29.482 billion in 2024, underscoring the competitive landscape [8]. Group 3: Market Dynamics and International Expansion - Chinese innovative drugs are not only performing well domestically but are also gaining traction in international markets, with products like Sidakio (西达基奥仑赛) achieving $1.596 billion in cumulative sales since its launch [12][13]. - The total transaction scale of technology licensing by Chinese pharmaceutical companies exceeded $34 billion in 2024, indicating a shift towards international collaboration [14][15]. Group 4: R&D Landscape and Challenges - As of August 2024, there are 5,380 new drug candidates in development in China, accounting for over one-third of the global pipeline [18]. - The average cost of developing an innovative drug is around $1 billion, with a typical development timeline of 10 years [20][21]. - The efficiency of drug development in China is improving, with preclinical phases taking 12-20 months compared to 24-36 months internationally [23]. Group 5: Policy Support and Ecosystem - The Chinese government has implemented various policies since 2008 to support innovative drug development, including expedited approval processes and financial incentives [28][29]. - The combination of government support, industry collaboration, and technological advancements is creating a conducive environment for innovation in the pharmaceutical sector [41]. Group 6: Future Outlook - The article emphasizes that the development of innovative drugs in China has made significant strides over the past decade, transitioning from imitation to innovation [42]. - The government's continued support for innovative drugs is expected to enhance the industry's growth and provide hope for patients [42].

APG-3288是亚盛医药自主研发的首个新型高效和高选择性BTK降解剂。该分子通过促进三元复合物的 形成，随之经蛋白酶体降解BTK。临床前研究结果显示，与其他在研BTK降解剂相比，APG-3288具更 强的BTK降解能力、更高的选择性及更优越的PK特征，呈现潜力。 消息面上，据医药观澜消息，2月2日，中国国家药监局药品审评中心(CDE)官网公示，亚盛医药申报的 1类新药APG-3288片获批临床，拟开发治疗复发/难治性血液系统恶性肿瘤。公开资料显示，这是亚盛 医药研发的新一代BTK靶向蛋白降解疗法。该产品于今年8月已经在美国获批临床，拟开发治疗复发/难 治B细胞恶性肿瘤。 亚盛医药-B(06855)涨超3%，截至发稿，涨2.6%，报47.44港元，成交额3151.52万港元。 ...

智通财经APP获悉，亚盛医药-B(06855)涨超3%，截至发稿，涨2.6%，报47.44港元，成交额3151.52万港 元。 APG-3288是亚盛医药自主研发的首个新型高效和高选择性BTK降解剂。该分子通过促进三元复合物的 形成，随之经蛋白酶体降解BTK。临床前研究结果显示，与其他在研BTK降解剂相比，APG-3288具更 强的BTK降解能力、更高的选择性及更优越的PK特征，呈现潜力。 消息面上，据医药观澜消息，2月2日，中国国家药监局药品审评中心(CDE)官网公示，亚盛医药申报的 1类新药APG-3288片获批临床，拟开发治疗复发/难治性血液系统恶性肿瘤。公开资料显示，这是亚盛 医药研发的新一代BTK靶向蛋白降解疗法。该产品于今年8月已经在美国获批临床，拟开发治疗复发/难 治B细胞恶性肿瘤。 ...

Core Insights - The 2026 JPM conference showcased a positive outlook for Chinese innovative pharmaceutical companies, with significant interest from multinational corporations in collaboration opportunities [2][3][4] - Chinese companies are shifting from merely licensing patents to deeper involvement in clinical development and commercialization in international markets [3][8] - The FDA's stance at JPM was relatively moderate, acknowledging the R&D efficiency of Chinese companies and suggesting improvements in approval processes using AI [3][6] Group 1: Conference Overview - The JPM conference, held in San Francisco, attracted numerous founders, executives, and investors from Chinese innovative pharmaceutical companies, indicating a vibrant atmosphere compared to previous years [2][5] - The event has evolved from a small gathering to a major industry benchmark, with participation from nearly all multinational pharmaceutical companies [5][10] - The number of attendees increased significantly in 2026, reflecting a more optimistic market sentiment compared to the previous year [5][10] Group 2: Market Trends - The Chinese innovative drug sector experienced a substantial stock price increase from March to August 2025, driven by business development (BD) transactions and foreign capital inflow, but faced a market correction afterward [4][11] - The interest in Chinese assets is growing, with many multinational companies expressing intentions for mergers and acquisitions (M&A) and BD transactions [11][12] - The trend of Chinese companies seeking deeper engagement in global markets is evident, moving beyond simple patent licensing to collaborative operational models [8][9] Group 3: Regulatory Environment - FDA officials at JPM highlighted the efficiency of Chinese clinical trials, with China completing Phase I trials in four weeks compared to much longer timelines in the U.S. [6][12] - The FDA's comments suggested a focus on optimizing clinical trial approval processes rather than emphasizing protectionist policies [5][6] Group 4: Future Outlook - The absence of major transactions at JPM 2026 was noted, but many multinational companies expressed a willingness to explore significant deals in the near future [11][12] - The upcoming expiration of patents for several blockbuster drugs is expected to drive increased M&A activity as companies seek to replenish their pipelines [12][13] - The trend of U.S. biotech firms considering establishing operations in China to leverage R&D efficiencies is emerging, indicating a shift in cross-border collaboration dynamics [10][11]

Core Insights - The company, Ascentage Pharma, is focused on addressing unmet clinical needs in oncology and has established a strong positioning in global innovation through its deep expertise in apoptosis pathways and related drug development [1][2] Pipeline and Product Development - Ascentage Pharma has developed a rich pipeline of innovative drugs, including the next-generation BTK-targeted protein degrader APG-3288, which is a highlight of its global innovation strategy [2] - The company has successfully launched two major Class 1 new drugs: Nilotinib, approved in 2021 as China's first third-generation BCR-ABL inhibitor, and Lisenglitazone, set to be approved in July 2025 as China's first domestically developed Bcl-2 inhibitor [2][3] - Lisenglitazone is expected to break the nine-year monopoly of AbbVie’s Bcl-2 inhibitor Venetoclax, with a broader approval scope for chronic lymphocytic leukemia (CLL) patients compared to Venetoclax [3] Research and Development Strategy - The company adheres to two core principles: focusing on unmet clinical needs and ensuring true innovation, which have been pivotal in the successful launch of its core products [3] - Ascentage Pharma employs a rigorous pipeline selection process based on three criteria: addressing unmet clinical needs, emphasizing disease biology research, and ensuring drug viability [4] Global Development and Commercialization - The company is conducting over 40 clinical trials globally, including three global Phase III trials for Nilotinib, which have received approval from the FDA and EMA [5][6] - Ascentage Pharma has established significant partnerships, including a major collaboration with Takeda for Nilotinib, which has provided substantial financial benefits and enhanced brand recognition [6] - The company plans to list on NASDAQ in January 2025, becoming the first biopharmaceutical company to achieve dual listing in Hong Kong and the U.S., which is crucial for attracting international investors [7] Financial Performance and Market Strategy - In the first half of 2025, Ascentage Pharma reported revenues of 234 million yuan, with Nilotinib sales reaching 217 million yuan, a 93% increase year-on-year due to its inclusion in the national medical insurance directory [8] - The company has developed a dual approach for commercializing its products, partnering with established firms for initial market entry while building its own commercialization team for long-term growth [8][9] - Following the approval of Lisenglitazone, the company quickly signed agreements with major pharmaceutical distributors to facilitate rapid market entry and patient access [9] Future Outlook - Ascentage Pharma aims to expand its commercialization team significantly, from over 200 to 400 members by 2026, to enhance market presence and patient accessibility [9] - The company plans to accelerate multiple key global Phase III clinical projects and push for the inclusion of Lisenglitazone in the medical insurance directory, continuing its global innovation strategy [9]

Core Insights - The company aims to transform into a biopharmaceutical enterprise by focusing on clinical needs and leveraging its expertise in apoptosis pathways and innovative drug development [2][4] Company Overview - Established in 2009, the company specializes in developing innovative drugs for unmet clinical needs in oncology, with a strong pipeline including key products like APG-3288, a next-generation BTK-targeted protein degrader [2][4] - The company has successfully launched two major Class 1 new drugs: Nairike, approved in 2021, and Lishengtuo, expected to be approved in July 2025 [2][3] Product Highlights - Lishengtuo breaks the nine-year monopoly of AbbVie’s Bcl-2 inhibitor Venetoclax, representing a significant achievement after 21 years of development [3][4] - Nairike addresses limitations of first and second-generation treatments for chronic myeloid leukemia, filling a domestic treatment gap [4][10] Clinical Development - The company is conducting over 40 clinical trials globally, including three global Phase III studies for Nairike and four for Lishengtuo, with significant milestones achieved in regulatory approvals [6][7] - Lishengtuo is the only Bcl-2 inhibitor currently advancing in Phase III trials for high-risk myelodysplastic syndromes (MDS) [7] Global Expansion Strategy - The company emphasizes a dual approach of clinical and business development, with significant partnerships, including a major collaboration with Takeda for Nairike [8][9] - The company plans to list on NASDAQ in January 2025, marking a significant step in its global market strategy [8] Financial Performance - In the first half of 2025, the company reported revenues of 234 million yuan, with Nairike sales reaching 217 million yuan, a 93% increase year-on-year due to its inclusion in the national medical insurance directory [9][10] - The company has over 3 billion yuan in cash reserves, indicating strong financial health [10] Commercialization Strategy - The company has developed a short- and long-term commercialization plan for Nairike, partnering with established firms to enhance market penetration [10][11] - Following the launch of Lishengtuo, the company has signed agreements with major pharmaceutical distributors to expedite its market entry [10] Future Outlook - The company plans to expand its commercial team significantly, aiming for 400 members by 2026, to enhance its market presence in the hematology oncology sector [11] - The focus will remain on advancing key global clinical projects and integrating Lishengtuo into the medical insurance system [11]

Core Insights - The company aims to transform into a biopharmaceutical enterprise by focusing on innovative drug development and global commercialization, driven by clinical needs [1][10] - The company has established a strong pipeline of innovative drugs targeting unmet clinical needs, particularly in oncology [2][3] Company Overview - Founded in 2009, the company specializes in developing innovative drugs for oncology and other areas with unmet clinical needs, leveraging expertise in apoptosis pathways and protein degradation [2] - The company has successfully launched two major first-class innovative drugs: Nairike and Lishengtuo, with the former being the first third-generation BCR-ABL inhibitor in China [2][3] Product Highlights - Lishengtuo, as China's first original Bcl-2 inhibitor, is expected to break the monopoly of AbbVie’s Venetoclax, with a projected global sales of $2.6 billion in 2024 and over $3 billion in 2025 [3] - Nairike has been recognized for addressing limitations of previous treatments for chronic myeloid leukemia, with ongoing global clinical trials [3][5] Research and Development Strategy - The company’s R&D pipeline is guided by three core criteria: focusing on unmet clinical needs, emphasizing disease biology, and ensuring drug viability [4] - The company adheres to a principle of "early failure, low-cost failure" to balance R&D investment and output [4] Global Expansion and Clinical Trials - The company is conducting over 40 clinical trials globally, including three pivotal Phase III studies for Nairike and four for Lishengtuo [5][6] - The company has received approvals from the FDA and EMA for several clinical studies, marking significant milestones in its internationalization efforts [5][6] Commercialization Strategy - The company reported a revenue of 234 million yuan in the first half of 2025, with Nairike sales reaching 217 million yuan, a 93% increase year-on-year [8] - The company has established partnerships with major pharmaceutical distributors to enhance the commercialization of Lishengtuo, achieving rapid market penetration [9] Future Outlook - The company plans to expand its commercial team significantly, aiming to enhance market share and patient accessibility for its core products [9] - The transition to a biopharmaceutical company will rely on self-generated sales profits to fund ongoing innovation, distinguishing it from traditional biotech models [10]

Core Insights - The article emphasizes the significant advancements and global presence of Chinese companies in the biopharmaceutical sector, particularly at the JPM 2026 conference, showcasing their capabilities in both service and innovation [7][10]. Group 1: Chinese Companies at JPM 2026 - WuXi Biologics reported a substantial increase in its CRDMO business, achieving 209 comprehensive project collaborations by 2025, up from 150 in 2024, with a focus on complex projects like bispecific antibodies and ADCs [7][8]. - Ascentage Pharma highlighted its global innovation pipeline, featuring key products like the third-generation BCR-ABL inhibitor and BCL-2 inhibitor, which are driving growth in hematological oncology [9]. - Approximately 24 Chinese innovative pharmaceutical companies presented their clinical data and R&D progress at the conference, indicating a shift from being followers to systemic innovators in the global market [9][10]. Group 2: Multinational Pharmaceutical Companies - AbbVie projected an 8% revenue growth for 2025, with a 19% increase in sales from growth platforms, emphasizing the potential of its core immunology products [11]. - Sanofi reiterated its commitment to commercializing respiratory and vaccine-related assets while enhancing its pipeline through external collaborations [11]. - Gilead focused on its long-term strategy in virology, aiming for extended dosing forms and broader disease coverage [12]. Group 3: Healthcare Services and Capital Markets - The third day of the conference saw a shift towards discussions on cash flow, asset quality, and operational resilience among healthcare systems, with many reporting progress in cost control and operational integration [13]. - There was a cautious approach to mergers and acquisitions, with executives indicating a preference for manageable, cash-flow-positive targets rather than high-premium, long-cycle assets [13]. Group 4: Overall Conference Signals - The overall tone of the conference shifted towards practicality, focusing on verifiable results and execution capabilities rather than speculative narratives [14].