Ascentage Pharma Group International(AAPG)

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时隔九年全球第二款Bcl-2抑制剂上市,对慢淋白血病治疗改变多大
Di Yi Cai Jing· 2025-07-23 05:47
早在三十年前,亚盛医药的创始团队就在钻研Bcl-2这个靶点。 Bcl-2抑制剂的作用机制是达到目标剂量以后诱导细胞凋亡,药物不需要在血液里停留很长时间,否则 就会打击正常细胞引起不良反应。肿瘤溶解综合征曾被视为Bcl-2抑制剂临床应用中需要重点警惕的严 重不良反应之一,若未及时发现和干预,可能因电解质紊乱、急性肾衰竭等引发严重后果,甚至可能引 起患者死亡。 亚盛医药董事长、CEO杨大俊对第一财经记者表示,此次支持利生妥获批上市的关键注册临床试验数据 显示,利生妥安全性表现突出,研究中未发生肿瘤溶解综合征不良反应。 慢性淋巴细胞白血病/小淋巴细胞淋巴瘤高危患者(如TP53突变)即便采用最佳化疗方案,无进展生存 期也仅约12个月。 近日,亚盛医药(06855.HK,AAPG.US)宣布,该公司自主研发的新型Bcl-2选择性抑制剂利生妥(通 用名:利沙托克拉)正式在国内上市,用于既往经过至少包含布鲁顿酪氨酸激酶(BTK)抑制剂在内的 一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)患者。 这是国内首个获批上市的国产原创Bcl-2抑制剂,也是全球第二个上市的Bcl-2抑制剂。 Bcl-2是一种 ...
专访亚盛医药董事长杨大俊:研发难成药的靶点堪比登珠峰,做创新药更应避免内卷
Mei Ri Jing Ji Xin Wen· 2025-07-22 05:00
Core Insights - The successful launch of the drug Lisatoclax (also known as Lishengtuo) by Ascentage Pharma marks a significant milestone in the development of Bcl-2 inhibitors, breaking a nine-year monopoly held by AbbVie in this field [3][10] - The research on the Bcl-2 target has spanned over three decades, highlighting the challenges and complexities involved in drug development [3][5] - Ascentage Pharma aims to differentiate its products from existing therapies, focusing on innovative solutions to address unmet clinical needs [4][6] Company Overview - Ascentage Pharma's Lisatoclax is the first domestically developed Bcl-2 inhibitor in China and the second globally, showcasing the company's commitment to innovation [3][10] - The company has also developed another product, Olverembatinib (brand name: Nairike), which took 13 years to develop, further emphasizing its long-term investment in research [3] - The CEO of Ascentage Pharma, Yang Dajun, emphasizes the importance of targeting difficult drug targets and conducting rigorous clinical designs to achieve superior drug efficacy [4][6] Clinical Development - The Bcl-2 target is likened to PD-1 in blood cancer treatment, with the potential to treat various B-cell tumors effectively [5][6] - Lisatoclax has a unique dosing regimen that allows for a rapid escalation to the target dose, which is crucial for minimizing severe side effects like Tumor Lysis Syndrome (TLS) [6][7] - Clinical data suggest that Lisatoclax has a lower incidence of TLS compared to its competitors, enhancing its safety profile and making it a more convenient treatment option [6][7] Market Position and Strategy - Ascentage Pharma's stock has seen significant growth, with a year-to-date increase of over 70% in Hong Kong and more than 120% in the US market, indicating strong investor confidence [12] - The company aims to navigate the competitive landscape of innovative drugs by focusing on unique therapeutic targets rather than following trends in the market [12][13] - Yang Dajun believes that the current wave of innovation in the pharmaceutical industry is a result of accumulated experience, technological breakthroughs, and supportive policies [10][11] Future Outlook - Ascentage Pharma is optimistic about achieving profitability by 2027, reflecting its strategic focus on developing proprietary products that can generate revenue [13] - The company is positioned to capitalize on the evolving landscape of the biopharmaceutical industry, where the distinction between biotech and large pharmaceutical companies is increasingly defined by the ability to generate profits from self-developed products [13]
亚盛医药啃下“硬骨头”,百亿Bcl-2药物市场格局生变
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-18 02:46
Core Insights - A Chinese original drug, APG-2575 (brand name: Lisatoclax), has broken the nearly decade-long monopoly of multinational pharmaceutical companies in the global anti-cancer drug market, marking a significant shift in the competitive landscape [2][9] - The drug has received conditional approval from the National Medical Products Administration (NMPA) in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic treatment including a BTK inhibitor [2][5] Drug Development Challenges - The Bcl-2 target, discovered in 1985, has only two approved drugs: AbbVie's venetoclax and APG-2575, due to the high difficulty of drug development associated with protein-protein interactions and the need for drugs to penetrate cell membranes and mitochondrial membranes [3][4] - Major pharmaceutical companies have attempted to develop Bcl-2 inhibitors over the past 20 years without success, highlighting the complexity of this target [4] Market Potential - The global targeted apoptosis therapy market is projected to grow at a compound annual growth rate (CAGR) of 24% from 2023 to 2030, reaching a market size of $22 billion by 2030 [6] - The approval of Lisatoclax is expected to change treatment paradigms and expand the market for Bcl-2 inhibitors, especially in combination therapies [6] Commercialization Strategy - The company plans to independently drive the commercialization of Lisatoclax in China, aiming to explore additional indications beyond CLL/SLL [7][8] - The CEO emphasizes the importance of generating profits from product sales to support ongoing research and development, aiming for the company to achieve overall profitability by 2027 [8] Industry Trends - Following the success of APG-2575, other Chinese companies like BeiGene and Innovent Biologics are also developing Bcl-2 inhibitors, indicating a shift towards a new ecosystem of anti-cancer drugs led by Chinese enterprises [9]
Ascentage Pharma Announces Closing of Placement Shares in Top-Up Placement
Globenewswire· 2025-07-17 08:30
Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement of 22 million ordinary shares, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization and global clinical development efforts in the biopharmaceutical sector [1][2]. Group 1: Offshore Placement Details - The offshore placement involved the sale of 22 million ordinary shares at a price of HKD68.60 per share, with the shares representing approximately 6.29% of the company's issued share capital prior to the placement [1]. - The net proceeds from the placement will be utilized for commercialization efforts, global clinical development of core pipeline candidates, and strengthening global operations [2]. Group 2: Regulatory and Transactional Aspects - The offshore placement was conducted outside of the United States and was not offered to the public, complying with Regulation S under the Securities Act of 1933 [3]. - The Replacement Shares will be issued in a transaction not involving a public offering, and the securities have not been registered under the Securities Act [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a rich pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [7].
Ascentage Pharma Announces Closing of Placement Shares in Top-Up Placement
GlobeNewswire News Room· 2025-07-17 08:30
Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization efforts and global clinical development [1][2]. Group 1: Offshore Placement Details - The company closed an offshore placement involving the sale of 22 million ordinary shares at HKD68.60 per share, with the shares representing about 6.29% of the company's issued share capital prior to the placement [1]. - The vendor, an affiliate of the CEO, will subscribe for the same number of new shares at the same price, resulting in net proceeds for the company [1]. - The issuance of the new shares is expected to occur by July 28, 2025 [1]. Group 2: Use of Proceeds - The net proceeds from the offshore placement will be utilized for commercialization efforts, enhancing patient access, advancing global clinical development of core pipeline candidates, and strengthening global operations through infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a robust pipeline of innovative drug candidates [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [7].
亚盛医药上涨2.27%,报37.02美元/股,总市值32.30亿美元
Jin Rong Jie· 2025-07-15 14:06
Core Viewpoint - As of July 15, 2023, AAPG's stock price increased by 2.27% to $37.02 per share, with a total market capitalization of $3.23 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][3]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases. The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - The company has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway. AAPG has established a pipeline of nine Class 1 small molecule new drugs in clinical development, including inhibitors targeting key proteins in the apoptosis pathway [2]. - AAPG is conducting over 40 clinical trials across China, the United States, Australia, and Europe. Its core product, Orebate (brand name: Nairike), has received priority review and breakthrough therapy designation from the China National Medical Products Administration (NMPA) and has been approved for sale in China [2]. Regulatory and Collaborative Achievements - The product Nairike has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) in China. It has also received fast track designation, orphan drug designation from the FDA, and orphan drug designation from the EU [2]. - AAPG has four investigational new drugs that have received 16 FDA orphan drug designations, two FDA fast track designations, and two FDA designations for pediatric rare diseases [2]. - The company has undertaken several national science and technology major projects, including five projects under the "Major New Drug Creation" initiative and one project for "Enterprise Innovative Drug Incubation Base" [2]. Research and Development Capabilities - AAPG has established a strong international talent team with extensive experience in original drug research and clinical development. The company is also building a high-standard commercialization and marketing team [2]. - The company aims to enhance its R&D capabilities and accelerate the clinical development of its product pipeline to meet unmet clinical needs for patients in China and globally [2].
7月15日电,亚盛医药在港交所公告,拟通过先旧后新配售不超过2200万股股票,配售价为每股68.6港元,筹集约15.1亿港元。
news flash· 2025-07-14 23:02
智通财经7月15日电,亚盛医药在港交所公告,拟通过先旧后新配售不超过2200万股股票,配售价为每 股68.6港元,筹集约15.1亿港元。 ...
Ascentage Pharma Announces Pricing of Top-Up Placement
Globenewswire· 2025-07-14 14:35
ROCKVILLE, Md. and SUZHOU, China, July 14, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855) (“Ascentage” or the “Company”), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, today announced the pricing of 22 million ordinary shares, par value $0.0001 per share, of the Company (the “Placement Shares”), at a price of HKD68.60 per share, in the offering by Dajun Yang Dynasty Trust, an affiliate of the Company’s Chief Executiv ...
文件显示:亚盛医药寻求通过先旧后新配股筹资至多1.96亿美元
news flash· 2025-07-14 10:45
交易文件显示,亚盛医药寻求通过先旧后新方式配股,筹资至多15.4亿港元(1.96亿美元)。将配售 2,200万股股份,配售价为每股68.35-70港元,较周一收盘价74.70港元折让6.3%-8.5%。(彭博) ...
Ascentage Pharma Announces Proposed Top-Up Placement
Globenewswire· 2025-07-14 09:23
Core Viewpoint - Ascentage Pharma Group International Inc. is conducting an offshore placement of ordinary shares to raise funds for commercialization, clinical development, and operational strengthening [1][2]. Group 1: Offshore Placement Details - The Dajun Yang Dynasty Trust, affiliated with the CEO, will offer ordinary shares in an offshore transaction to non-U.S. persons under Regulation S of the Securities Act [1]. - The Vendor will subscribe for new ordinary shares equal to the number of Placement Shares offered, at the same price per share [1]. - The transaction is subject to customary closing conditions and will occur after the Offshore Placement [1]. Group 2: Use of Proceeds - The net proceeds from the Offshore Placement will be utilized for commercialization efforts, expanding patient access, global clinical development of core pipeline candidates, and enhancing infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing a global Phase III trial [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global Phase III trials [7]. Group 4: Partnerships and Collaborations - Ascentage Pharma has established a portfolio of global intellectual property rights and partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as research institutions like Dana-Farber Cancer Institute and Mayo Clinic [8].