Core Insights - Ascentage Pharma Group International is participating in the Evercore China Biotech Summit from August 19 to 21, 2025, in Shanghai, China [1][2] - The company is focused on addressing unmet medical needs in cancers and has developed a pipeline of innovative drug candidates [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company with a rich pipeline targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [3] - The lead asset, olverembatinib, is the first third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is included in the China National Reimbursement Drug List [4] - 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) [5] Clinical Trials and Research - Ascentage Pharma is conducting several global registrational Phase III trials for olverembatinib and lisaftoclax, targeting various patient populations and conditions [4][5] - The company has established partnerships with leading biotechnology and pharmaceutical companies, enhancing its research and development capabilities [6]

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年)》。该品种还获得了美国FDA快速通道资格、孤儿药资格认定、以及欧盟孤儿药资格认 定。截至目前,公司共有4个在研新药获得16项FDA和1 ...

Core Insights - Ascentage Pharma Group International is participating in the BTIG Virtual Biotechnology Conference on July 29-30, 2025, to engage with investors [1][2] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a strong pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [3][6] Lead Assets - The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for treating patients with chronic myeloid leukemia (CML) with T315I mutations and is included in the China National Reimbursement Drug List [4] - 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) in China, with multiple global registrational Phase III trials currently underway [5] Research and Development - Ascentage Pharma has established a robust R&D framework, securing global intellectual property rights and forming partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as collaborations with prominent research institutions [6]

Core Viewpoint - The recent approval of the novel Bcl-2 selective inhibitor, Lisangtuo (generic name: Lishatoclax), by Ascentage Pharma marks a significant advancement in the treatment of high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients, particularly those with TP53 mutations, who have limited treatment options and a poor prognosis [1][2][4] Group 1: Product and Market Impact - Lisangtuo is the first domestically developed Bcl-2 inhibitor approved in China and the second globally, indicating a milestone in the development of targeted therapies for hematological malignancies [1][2] - The mechanism of Bcl-2 inhibitors involves specifically binding to and inhibiting the Bcl-2 protein, which is overexpressed in certain malignancies, thereby restoring the apoptotic pathway in cancer cells [1][3] - The global incidence of CLL/SLL exceeds 100,000 new cases annually, with an increasing trend in China due to an aging population, despite a lower incidence compared to Western countries [2][3] Group 2: Clinical and Safety Profile - Clinical trial data supporting Lisangtuo's approval demonstrated a favorable safety profile, with no reported cases of tumor lysis syndrome, a serious adverse reaction previously associated with Bcl-2 inhibitors [3][4] - Traditional treatment options for high-risk patients, such as chemotherapy, yield a progression-free survival of only about 12 months, highlighting the need for more effective therapies [2][4] Group 3: Future Directions and Industry Trends - The emergence of new-generation Bcl-2 inhibitors addresses limitations of existing therapies, such as BTK inhibitors, by reducing drug interactions and allowing for potential intermittent dosing, which can alleviate long-term economic burdens and risks of resistance [5] - There are currently 42 Bcl-2 inhibitors in development globally, indicating a growing interest and investment in this therapeutic area [5] - The future goals for blood cancer treatment include moving towards non-chemotherapy approaches and achieving clinical cures in certain patient populations [5]

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]

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]

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].

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].

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].

Group 1 - The company, Ascentage Pharma, announced a plan to issue up to 22 million shares through a placement, with a price of HKD 68.6 per share, aiming to raise approximately HKD 1.51 billion [1]