ROCKVILLE, Md. and SUZHOU, China, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that its novel next-generation Bruton's tyrosine kinase (BTK)-targeted protein degrader, APG-3288, has received investigational new drug (IND) application clearance fr ...

ROCKVILLE, Md. and SUZHOU, China, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that its novel next-generation Bruton's tyrosine kinase (BTK)-targeted protein degrader, APG-3288, has received investigational new drug (IND) application clearance fr ...

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]

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Core Insights - Ascentage Pharma Group International presented its achievements in 2025 and outlined its global innovation strategy for 2026 at the J.P. Morgan Healthcare Conference [1][2] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [9] - The company has a diverse pipeline that includes inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [9] Milestone Achievements - In 2025, Ascentage Pharma accelerated its global expansion, advancing product commercialization, clinical development, and pipeline innovation [2] - The company has established a strong foundation for sustained growth through its innovative engine in hematologic malignancies and solid tumors [2] Product Development - The two core products, Olverembatinib (a third-generation BCR-ABL inhibitor) and Lisaftoclax (a Bcl-2 inhibitor), are key growth drivers for 2026 [3] - Both products have shown significant progress in 2025 and are expected to generate a "dual-engine" effect for future growth [3] Clinical Studies and Innovations - Ascentage Pharma has made advancements in multiple clinical studies for its key drug candidates, presenting data at international academic congresses [4] - The company received IND clearance from the U.S. FDA for APG-3288, a novel BTK degrader, marking a significant step in targeted degradation [4][5] Pipeline Progress - The company is advancing several key clinical programs, including APG-5918 (EED inhibitor) and APG-2449 (FAK/ALK/ROS1 inhibitor), which are in various stages of clinical trials [6][7] - Multiple global registrational Phase III trials are progressing rapidly for its key products [5] Future Outlook - Potential milestones for 2026 include ongoing investigations of Olverembatinib, Lisaftoclax, and other pipeline candidates, which have not yet received FDA approval [8] - The company aims to continue its growth in commercial sales and expand patient accessibility across hospitals in China [12]

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index declining approximately 0.2% on Wednesday [1] Company Highlights - Monte Rosa Therapeutics Inc (NASDAQ:GLUE) experienced a significant increase in share price, rising 45.2% to $23.25 after announcing interim data from a Phase 1 clinical study for MRT-8102 [1] - Ventyx Biosciences Inc (NASDAQ:VTYX) shares surged 37.5% to $13.82 following reports of advanced acquisition talks with Eli Lilly & Co. (NYSE:LLY) for over $1 billion [2] - Neumora Therapeutics Inc (NASDAQ:NMRA) saw a rise of 24.7% to $2.27 [2] - Regencell Bioscience Holdings Ltd (NASDAQ:RGC) increased by 21.1% to $40.00 [2] - Erasca Inc (NASDAQ:ERAS) rose 17.1% to $4.25, with Piper Sandler initiating coverage with an Overweight rating and a price target of $5 [2] - Anywhere Real Estate Inc (NYSE:HOUS) gained 15.6% to $16.71 [2] - AXT Inc (NASDAQ:AXTI) increased by 13.8% to $22.96 [2] - Immuneering Corp (NASDAQ:IMRX) rose 13.1% to $7.60 [2] - Compass Therapeutics Inc. (NASDAQ:CMPX) gained 13.1% to $5.56 [2] - MBX Biosciences Inc (NASDAQ:MBX) rose 11.2% to $31.90 [2] - Rezolve AI PLC (NASDAQ:RZLV) increased by 10.8% to $3.36 [2] - United Microelectronics Corp (NYSE:UMC) gained 10.4% to $8.96 after reporting sales growth for December and the full year [2] - PBF Energy Inc (NYSE:PBF) rose 9.2% to $29.73 [2] - Navan Inc (NASDAQ:NAVN) increased by 8.3% to $18.42 [2] - Ascentage Pharma Group International (NASDAQ:AAPG) gained 8.3% to $28.17 after announcing IND clearance for BTK Degrader APG-3288 by the U.S. FDA [2] - Intel Corp (NASDAQ:INTC) rose 6.4% to $42.60 as the company is enhancing its gaming strategy by developing a new chip for handheld gaming devices [2]

Core Viewpoint - Ascentage Pharma has received IND clearance from the U.S. FDA for its next-generation BTK-targeted protein degrader, APG-3288, which will enter clinical studies for patients with relapsed/refractory B-cell malignancies, marking a significant expansion of the company's innovative pipeline [1][7]. Company Overview - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [11]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [11]. Product Development - APG-3288 is the first highly potent and selective BTK degrader developed using Ascentage Pharma's proprietary PROTAC technology, designed to induce proteasome-mediated degradation of the BTK target [4]. - The drug aims to overcome resistance associated with existing BTK inhibitors by blocking the BCR-BTK signaling axis at its source, providing a novel therapeutic strategy [4][6]. Clinical Study - A global, multicenter, open-label Phase I study will evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies [2][7]. - Preclinical studies have shown that APG-3288 demonstrates more potent BTK degradation and higher selectivity compared to other BTK degraders in development [5]. Strategic Importance - The FDA clearance for APG-3288 represents a major milestone for Ascentage Pharma, validating its innovative design capabilities and strategic pipeline expansion in the field of hematologic malignancies [6]. - The company plans to accelerate the global clinical development of APG-3288 and explore its combinatory potential with existing proprietary small-molecule agents [6].

Group 1 - The core viewpoint of the article highlights the steady recovery of global capital markets in 2025, with US stock markets continuing to be a key platform for Chinese companies seeking cross-border financing, despite a notable structural differentiation in the number and scale of listings [3][17] - In 2025, a total of 93 Chinese companies successfully listed on US stock markets through various methods, marking a 7.8% increase from 64 companies in 2024, with 149 additional companies having publicly submitted applications for US listings, indicating strong future momentum [3][17] - The traditional IPO remains the dominant listing method, with 90.3% of the successful listings (84 out of 93) being through IPOs, while De-SPAC and OTC transfers accounted for 8.6% and 1.1% respectively, showcasing a clear preference for IPOs among Chinese companies [4][17] Group 2 - The fundraising characteristics of Chinese companies in the US IPO market are marked by a concentration of capital, with the top three companies (Smithfield, Bawang Chaji, and Yasheng Pharmaceutical) accounting for 33.9% of the total $2.822 billion raised, while over half (58.3%) of the companies raised less than $10 million [11][17] - The industry distribution of companies going public in the US is diverse, with significant representation from application software, traditional industries like construction and manufacturing, and modern service sectors such as pharmaceuticals and logistics, reflecting the dynamic nature of China's economic transformation [14][17] - The average listing cycle for Chinese companies in the US has improved, with an average duration of approximately 198 days and a median of 185 days, indicating enhanced efficiency in the listing process [16][17] Group 3 - The Nasdaq remains the most attractive exchange for Chinese companies, with 82 out of 93 companies choosing to list there, while one company opted for the NYSE and another for the AMEX, demonstrating the exchange's strong appeal for cross-border financing [8][17] - The structural characteristics of the 2025 US listings reflect the resilience and vitality of Chinese companies in their internationalization efforts, with a focus on compliance and strategic alignment with regulatory environments being crucial for future listings [17]

Group 1 - By the end of 2025, 93 Chinese companies successfully listed on US stock markets, with 149 companies publicly submitting listing applications, showing moderate growth compared to 69 companies in 2024 [1] - Nasdaq maintained its absolute advantage with 89 companies listed, accounting for 96% of the total, while only 4 companies chose the New York Stock Exchange [1] - The industry distribution is diverse, with technology companies like application software leading, while traditional industries such as construction and industrial sectors follow steadily, and modern service industries like pharmaceuticals and food logistics show vibrant growth, reflecting the robust momentum of China's economic transformation [1] Group 2 - Among the three main listing paths, IPO remains the mainstream route, favored for its direct financing and brand premium advantages, with 84 Chinese concept stocks completing their US listings through IPOs [1] - Smithfield (SFD) topped the list with over $500 million raised, becoming the largest IPO project of the year, followed by Bawang Tea (CHA) with $411 million, and Ascentage Pharma (AAPG) with $126 million [1] - The majority of other companies raised amounts mostly under $20 million, with nearly 70% of companies financing not exceeding $10 million [1] Group 3 - De-SPAC (Special Purpose Acquisition Company) and OTC transfer models play important supplementary roles, with 8 companies listing through De-SPAC, including Global IBO Group Ltd, which achieved a valuation of $8.3 billion, marking one of the largest transactions of the year [2] - One company, Tianci International Inc (CIIT), successfully transferred from the OTC market to Nasdaq, a path more suitable for companies that have built liquidity and valuation on the OTC market [2] - The outlook for 2026 suggests that with new Nasdaq regulations increasing the net income standard by 200%, the barriers for traditional IPOs will rise, potentially providing greater opportunities for small and medium enterprises in OTC transfers [2]

12月22日，格隆汇在线上举办"科技赋能·资本破局"分享会。本次分享会，备受瞩目的卓越公司评选榜单将隆重揭晓，其中格隆汇"金格奖"年度卓越公司评选 中，百利天恒(688506.SH)、东阳光药(06887.HK)、东曜药业-B(01875.HK)、和铂医药-B(02142.HK)、华领医药-B(02552.HK)、先声药业(02096.HK)、亚盛 医药(06855.HK/AAPG.US)、真实生物8家企业荣获"年度卓越生物医药企业"奖项。（排名不分先后，按公司首部字母顺序排列） "年度卓越生物医药企业"是从技术创新、研发实力、成果转化等多方面综合评估，旨在表彰在生物医药领域具有自主核心技术、持续创新并能高效将科研成 果转化为临床或商业应用的领军企业。本次评选通过定量数据分析和专家评审团等方式得出最终结果。 格隆汇以"全球视野，下注中国"为初衷，本次评选旨在打造出投资圈中最具参考价值的上市公司及独角兽公司排行榜。此次"金格奖"上市公司评选覆盖港交 所、上交所、深交所、纽交所、美国证券交易所、纳斯达克证券交易所挂牌上市的全部上市公司及独角兽公司。 ...