Company Overview - The stock price of Ascentage Pharma has shown volatility despite positive developments in research and development, with the stock performance not meeting expectations [1] - The company's new generation BTK degrader APG-3288 received clinical approval from the National Medical Products Administration of China on February 6, 2026, and initiated a global multi-center Phase I clinical trial for relapsed/refractory hematologic malignancies on February 11, 2026 [1] - As of February 13, the closing price of the stock was HKD 47.50, with a daily increase of 2.41%, but a year-to-date decline of 9.09% [1] Industry Context - The innovative drug sector is currently facing valuation adjustment pressure, with the market showing impatience towards the long-term commercialization of unprofitable biotech companies, focusing more on short-term profitability [1] - The Hong Kong biotechnology sector declined by 0.95%, while the Hang Seng Index fell by 1.72%, indicating that the sector underperformed the broader market, further intensifying individual stock pressures [1] Financial Performance - The core product, Nairik, saw sales revenue increase by 93% year-on-year to CNY 217 million in the first half of 2025, with another product, Lishengtuo, approved for market launch in July 2025 [2] - However, the net loss expanded to CNY 591 million during the same period, primarily due to reduced intellectual property licensing income and increased R&D expenditures [2] - Market focus is on key catalysts, such as overseas indication approvals, which are concentrated post-2027, leading to a lack of patience for long-term narratives and a greater emphasis on short-term performance [2] Market Sentiment - On February 12, there was a net outflow of HKD 4.926 million from major funds in the Hong Kong stock market, and a net outflow of HKD 11.534 million from retail investors, indicating strong short-term risk-averse sentiment [2] - Although there was a net inflow of HKD 1.4948 million on February 13, major funds still experienced a net outflow of HKD 193,900, reflecting cautious institutional attitudes [2] - Technical indicators show that while the MACD histogram has turned positive, the KDJ is in the oversold zone, suggesting weak short-term momentum [2] Future Outlook - The R&D progress of Ascentage Pharma provides long-term value support, but it has not fully offset industry adjustments, risk aversion in funding, and market concerns regarding profitability in the short term [2] - The stock's volatility reflects the market's balancing act between technological innovation and short-term performance [2]

Company Overview - Recent positive developments in research for Ascentage Pharma, including the clinical approval of the next-generation BTK degrader APG-3288 by the National Medical Products Administration of China, have not significantly boosted the stock price, which has seen a decline of 0.38% in Hong Kong and 0.62% in the US from February 5 to February 12, 2026 [2] - The company's core product, Nairik, reported a 93% year-on-year increase in sales revenue to 217 million yuan in the first half of 2025, while the net loss widened to 591 million yuan due to reduced intellectual property licensing income and increased R&D investment [4] Industry Context - The innovative drug sector is under pressure, with a valuation correction for unprofitable biotech companies as the market shows impatience for long-term commercialization and focuses more on short-term profitability [3] - On February 12, 2026, there was a net outflow of 4.926 million HKD from major funds and 11.534 million HKD from retail investors in the Hong Kong stock market, indicating a risk-averse sentiment among short-term investors [3] Stock Performance - The stock price of Ascentage Pharma reached a low of 44.92 HKD on February 3, 2026, followed by a slight rebound; however, technical indicators suggest weak short-term momentum, with the MACD showing a bearish trend and KDJ in the oversold zone [5] - The stock's decline reflects market caution regarding the long-term valuation logic of innovative drug companies, as the recent R&D progress and improvements in fundamentals have not fully offset the pressures from sector adjustments and funding [5]

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 company aims to transform into a biopharmaceutical enterprise by focusing on clinical needs and leveraging global commercialization strategies [1][5] Company Overview - Established in 2009, the company specializes in innovative drugs targeting unmet clinical needs in oncology, with a strong emphasis on apoptosis pathways and protein degradation [1][2] - The company has developed a rich pipeline of high-value innovative drugs, including the new generation BTK-targeted protein degrader APG-3288, which is a highlight of its global innovation strategy [1][2] Product Development - The company has successfully launched two major Class 1 new drugs: Nairike, approved in 2021, and Lishengtuo, expected to be approved in July 2025 [1][2] - Lishengtuo breaks the nine-year monopoly of AbbVie’s Bcl-2 inhibitor Venetoclax, with a broader approval scope for chronic lymphocytic leukemia (CLL) patients compared to its predecessor [2][3] Clinical Trials and Research - The company is conducting over 40 clinical trials globally, including three global Phase III trials for Nairike and four for Lishengtuo, with significant milestones achieved in international regulatory approvals [3][4] - Nairike's global Phase III trials have received approval from both the FDA and EMA, marking a significant step in the company's internationalization efforts [3][4] Commercialization Strategy - The company has established a dual approach to commercialization, focusing on both short-term and long-term strategies for its products [6][7] - For Nairike, a partnership with Sinopharm was formed to leverage existing commercial resources, while Lishengtuo will be marketed independently by the company [6][7] Financial Performance - In the first half of 2025, the company reported revenues of 234 million yuan, with Nairike's sales reaching 217 million yuan, a 93% increase year-on-year due to its inclusion in the national medical insurance directory [5][6] - The company has over 3 billion yuan in cash reserves, indicating strong financial health [5] Future Outlook - The company plans to expand its commercial team significantly, aiming for a team of 400 by 2026, to enhance market penetration and patient accessibility [7] - The transition to a biopharmaceutical company will rely on self-generated sales profits to fund ongoing innovation, distinguishing it from traditional biotech firms that depend on investor funding [7]

Core Viewpoint - Ascenta Therapeutics, now known as Ascent Pharma, has transformed from a near-bankrupt startup to a globally recognized player in the biopharmaceutical industry, achieving significant milestones such as dual listings in Hong Kong and NASDAQ, and securing a $1.3 billion partnership with Takeda Pharmaceutical [2][5][26]. Group 1: Company Evolution - The company was founded in 2003 by three scientists in Pennsylvania, focusing on innovative cancer therapies targeting apoptosis pathways [9]. - After facing severe setbacks, including the failure of the Bcl-2 inhibitor AT-101 and the 2008 financial crisis, the company was on the brink of collapse but chose to continue operations in China [10][12]. - From 2009 to 2014, the company focused on survival and redefined its research direction towards safer apoptosis-targeting drugs, laying the groundwork for future successes [13]. Group 2: Product Development and Financial Growth - The third-generation BCR-ABL inhibitor, Nairike, was approved in China and became a significant revenue driver, contributing 2.17 billion yuan in sales by mid-2025, representing over 90% of the company's revenue [6][23]. - The company secured a $1.3 billion global collaboration with Takeda in 2024, marking a record for Chinese small molecule drugs in international partnerships [5][26]. - Ascent Pharma's product pipeline has expanded to include multiple promising candidates, establishing a comprehensive portfolio in apoptosis-targeting therapies [34]. Group 3: Market Position and Future Prospects - The dual listing on NASDAQ in January 2025 marked a significant milestone, allowing the company to access global capital markets and enhance its valuation [36]. - The company is now positioned to leverage its successful products and partnerships to drive further growth and innovation in the global biopharmaceutical landscape [41]. - Future focus areas include the market penetration of Nairike, the competitive positioning of its products like APG-2575, and the potential of its pipeline to replicate the success of its leading products [43][44].

Core Insights - Ascentage Pharma (亚盛医药-B) announced that three of its products (Neratinib, Lisatinib, APG-5918) have multiple clinical and preclinical advancements selected for presentation at the 67th American Society of Hematology (ASH) Annual Meeting, with one receiving an oral presentation [1][2] Group 1: Product Developments - Neratinib (耐立克) is the first third-generation BCR-ABL inhibitor approved in China, with commercialization jointly managed by Ascentage Pharma and Innovent Biologics. The company will present the latest data from the global Phase III POLARIS-1 study on Neratinib combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients at the ASH meeting [2] - The company will also update data from a randomized controlled Phase II study on Neratinib for patients with tyrosine kinase inhibitor-resistant chronic myeloid leukemia in chronic phase (CML-CP) during the conference [2] - Lisatinib (利生妥), a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, has broad therapeutic potential in various hematological malignancies and solid tumors. It has been approved in China for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor. The latest progress of its Phase II clinical study for monotherapy in relapsed/refractory CLL/SLL patients will be reported orally at the ASH meeting [2] Group 2: ASH Annual Meeting - The ASH Annual Meeting is one of the largest international academic events in the field of hematology, covering research on the etiology and treatment of blood diseases. The 67th ASH Annual Meeting will be held from December 6 to December 9, 2025, in Orlando, Florida, in a hybrid format [3]

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全部內容概不負責，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 倚賴該等內容而引致的任何損失承擔任何責任。 ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 （於開曼群島註冊成立的有限公司） （股份代號：6855） 自願公告 亞盛醫藥耐立克®、利生妥®、APG-5918的多項臨床進展將 在2025年美國血液學會年會(ASH)展示，其中一項獲口頭報告 亞盛醫藥集團（「本公司」或「亞盛醫藥」）欣然宣佈，本公司3個品種（耐立克®、利 生妥®、APG-5918）有多項臨床和臨床前進展入選第67屆美國血液學會(American Society of Hematology, ASH)年會展示及報告，其中一項獲口頭報告。其中，本 公司原創1類新藥奧雷巴替尼（商品名：耐立克®）有多項臨床進展獲選第67屆ASH 年會，這是該品種的臨床進展連續第8年入選ASH年會。此外，本公司原創1類新 藥利沙托克拉（商品名：利生妥®；研發代碼：APG-2575）共有2項臨床進展獲選 第67屆ASH年會， ...

Core Insights - The article highlights the journey of Ascentage Pharma, emphasizing its commitment to addressing unmet clinical needs through innovation and perseverance in the pharmaceutical industry [2][6]. Group 1: Company Overview - Ascentage Pharma, founded in 2009, has evolved from a small startup to a publicly listed company on both the Hong Kong Stock Exchange and NASDAQ, marking significant milestones in its growth [2][5]. - The company has successfully developed and commercialized two products: Nilotinib, which treats drug-resistant chronic myeloid leukemia, and a new Bcl-2 selective inhibitor, Lisenglitazone, which is the first domestically developed Bcl-2 inhibitor approved in China and the second globally [2][6]. Group 2: Financial and Investment Highlights - Ascentage Pharma has secured substantial funding over the years, including a $300 million investment from 3SBio in 2010, which was crucial for its survival during challenging times [4]. - The company raised nearly $100 million in Series A financing in 2015, which facilitated its establishment in Suzhou, benefiting from the region's vibrant biopharmaceutical ecosystem [4]. Group 3: Research and Development Focus - The company is dedicated to developing drugs that meet real clinical needs, with a pipeline that includes six products in clinical stages targeting various cancers, including non-small cell lung cancer and ovarian cancer [6][7]. - Ascentage Pharma aims to accelerate the internationalization of Nilotinib and further commercialize Lisenglitazone while expanding its pipeline to benefit more patients globally [6][8]. Group 4: Strategic Partnerships and Market Position - The company has engaged in significant business development (BD) transactions, including a notable $1 billion deal with Takeda Pharmaceutical for the global development and commercialization of Nilotinib, setting a record for domestic small molecule oncology drugs [7]. - Ascentage Pharma is transforming into a full-cycle enterprise encompassing drug research, production, and commercialization, enhancing its role in the biopharmaceutical industry ecosystem [7].