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
每经记者|金喆 每经编辑|魏官红 如果一个靶点历经三十年才有一款药物成功上市,其成药难度之高,不言而喻。 "研究这样的靶点如同攀登珠穆朗玛峰。"亚盛医药董事长、CEO(首席执行官)杨大俊在接受《每日经济新闻》记者采访时说。他和搭档王少萌从1995年 开始研究Bcl-2靶点,在2004年筛选出化合物进入临床研究后,一做就是21年。今年7月,亚盛医药的利沙托克拉(利生妥)获得国家药品监督管理局附条 件批准上市,成为国产原研首家、全球第2款Bcl-2抑制剂,打破了艾伯维在这一领域长达9年的垄断。 Bcl-2靶点早在上世纪80年代就被发现,直到2025年,杨大俊的团队终于针对该靶点获得成功,而亚盛医药另一款产品奥雷巴替尼片(商品名:耐立 克),研发历程也长达13年。 杨大俊觉得,做药就是这样,找最难的靶点、做最好的临床设计、让药物效果发挥到极致,才能在同类药物竞争中胜出。 "me-too也好、快速跟进也好、生物类似药也好,我一直说我们不做这类创新。这些在研发阶段的风险比较小,但上市后的商业化风险更大,那时候(失 败的)成本更高。"杨大俊认为,在信息发达的今天已经很难有"唯一、独一、缺一不可"的品种,不管在什么样的阶段 ...
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
7月15日,亚盛医药(AAPG)盘中上涨2.27%,截至21:48,报37.02美元/股,成交7.18万美元,总市值 32.30亿美元。 资料显示,亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局新药审评中心(CDE)纳入优先审评和突破性治疗品种,并已在中国 获批,是公司的首个上市品种。目前,耐立克已被成功纳入《国家基本医疗保险、工伤保险和生育保险药 品目录(2022 ...
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].