利生妥®是亚盛医药自主研发的新型口服Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白，恢复癌细胞 的正常凋亡过程，从而达到治疗肿瘤的目的。目前，该产品已在中国获批上市，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。利生妥®为中国首个获批上市的国产原研Bcl-2抑制剂。 作为利生妥®在欧美监管机构获批的第二个全球注册III期研究，GLORA-4研究(NCT06641414)在多国家 多中心同步入组，将加速新药上市进程。利生妥®也是目前国际上唯一正推进中高危MDS注册III期临床 的Bcl-2抑制剂。该研究有望打破中高危MDS领域长期存在的临床空白，是利生妥®全球临床开发的又 一重要里程碑。 据了解，GLORA-4研究为国际多中心、随机、双盲III期临床试验，旨在评估利生妥®联合AZA对比安 慰剂联合AZA在新诊断的成人HR-MDS患者中的疗效及安全性。GLORA-4研究已于2024年获CDE临床 试验许可。目前该研究正在全球同步推进患者入组，并已完成中国及欧洲地区的首例患者入组。全球主 要研究者(Leading P ...

智通财经APP讯，亚盛医药-B(06855)发布公告，公司自主研发的Bcl-2选择性抑制剂利沙托克拉(商品 名：利生妥;研发代码：APG-2575)联合阿扎胞苷(AZA)一线治疗新诊断的中高危骨髓增生异常综合症 (HR-MDS)患者的全球注册III期临床研究(GLORA-4)获美国食品药品监督管理局(FDA)和欧洲药品管理 局(EMA)同意开展。作为利生妥在欧美监管机构获批的第二个全球III期研究， GLORA-4 (NCT06641414)在多国家多中心同步入组，将加速新药上市进程。截止本公告日期，利生妥也是国际上 唯一正推进中高危MDS注册III期临床的Bcl-2抑制剂。该研究有望打破中高危MDS领域长期存在的临床 空白，是利生妥全球临床开发的又一重要里程碑。 GLORA-4研究为国际多中心、随机、双盲III期临床试验，旨在评估利生妥联合AZA对比安慰剂联合 AZA在新诊断的成人HR-MDS患者中的疗效及安全性。 GLORA-4研究已于2024年获CDE临床试验许 可。目前该研究正在全球同步推进患者入组，并已完成中国及欧洲地区的首例患者入组。全球主要研究 者(Leading PI)为美国得克萨斯大学MD安 ...

Group 1 - As of recent announcements, the company has completed a fundraising of approximately HKD 14.93 billion (around CNY 1.368 billion), bringing total fundraising to over CNY 2.2 billion within six months [1][3] - The core purpose of the fundraising is to commercialize the newly approved core product, APG-2575, a selective Bcl-2 inhibitor, which is the first domestically developed Bcl-2 inhibitor approved for market [1][4] - The company plans to establish its own commercialization team for APG-2575, with expectations to achieve breakeven by 2027 [1][6] Group 2 - The recent fundraising was completed through the sale of 22 million shares at HKD 68.60 each, with all preconditions for the placement being met [2][3] - The net proceeds from the recent fundraising are expected to be allocated as follows: 40% for expanding coverage and improving patient access (approximately CNY 5.47 billion), 35% for global clinical development of core pipeline products (approximately CNY 4.76 billion), and 25% for infrastructure and operational funding (approximately CNY 3.42 billion) [3] - The company has signed cooperation agreements with major pharmaceutical distributors to advance the commercialization of APG-2575 [6] Group 3 - The company reported a revenue of CNY 981 million in 2024, with a loss of CNY 405 million, marking the lowest loss level in recent years [6] - The company is currently conducting four global Phase III clinical trials for APG-2575, targeting multiple indications including acute myeloid leukemia and multiple myeloma [7] - The global sales of the first Bcl-2 inhibitor, Venclexta, are projected to exceed USD 3 billion in 2024, indicating a strong market potential for Bcl-2 inhibitors [7]

Core Insights - The article highlights the launch of a new oral Bcl-2 selective inhibitor, Lisangtuo® (generic name: Lishatoklaku), developed by Ascentage Pharma, which is now exclusively available on JD Health [1][3] - Lisangtuo® is the first domestically approved original Bcl-2 inhibitor in China and the second globally, aimed at treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one prior systemic therapy including BTK inhibitors [1][3] - The drug works by selectively inhibiting the Bcl-2 protein, restoring normal apoptosis in tumor cells, and is expected to have fewer interactions with common drugs and more controllable effects on platelets compared to traditional CLL/SLL medications [1][3] Industry Context - The development of Bcl-2 inhibitors is challenging due to complex protein-protein interactions and the need for the drug to penetrate both the cell membrane and mitochondrial membranes [3] - Prior to Lisangtuo®, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in the field [3] - The successful launch of Lisangtuo® represents a major step for China in the treatment of hematological malignancies and showcases Ascentage Pharma's leading capabilities in global innovative research and development [3] Distribution Strategy - JD Health is leveraging its capabilities in pharmaceutical supply chain and healthcare services to provide comprehensive support, including drug consultation, doctor consultations, and efficient delivery for users in need [4]

Company Update - The company announced that its self-developed Bcl-2 selective inhibitor, APG-2575 (also known as Lisangtuo), received conditional approval from the National Medical Products Administration of China for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor [1] - Lisangtuo is the first Bcl-2 inhibitor approved in China for the treatment of CLL/SLL and the second globally, following AbbVie's venetoclax [1] Clinical Value and Research - The approval of Lisangtuo is based on a pivotal Phase II clinical study (APG2575CC201) that demonstrated an overall response rate (ORR) meeting the predefined endpoint for patients who failed BTK inhibitors and/or immunochemotherapy, with a favorable safety profile [2] - The drug has been included in the "CSCO Lymphoma Diagnosis and Treatment Guidelines 2025" as of April 2025 [2] - The company is conducting four global Phase III clinical studies to further explore Lisangtuo's indications, including studies for treated CLL/SLL patients and newly diagnosed acute myeloid leukemia (AML) patients [2] Profit Forecast and Valuation - The company maintains its net profit forecast for 2025 and 2026 at a loss of 1.09 billion yuan and 320 million yuan, respectively [2] - Given the approval of Lisangtuo and the potential for global indication expansion, the company maintains an outperform rating and raises the target price by 27.5% to 88 HKD, indicating a 15.3% upside from the current stock price [2]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has received conditional approval from the National Medical Products Administration (NMPA) for its self-developed Bcl-2 selective inhibitor APG-2575, marking it as the first domestically produced Bcl-2 inhibitor to be launched in China [7] - APG-2575 is positioned as a new treatment option for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, including BTK inhibitors [7] - The company expects rapid revenue growth driven by the sales of its drug Aolebatin and potential payments from Takeda, with projected revenues of 5.19 billion, 32.15 billion, and 20.95 billion yuan for 2025, 2026, and 2027 respectively [1][7] Financial Projections - Total revenue is projected to reach 980.65 million yuan in 2024, followed by 519 million yuan in 2025, and then a significant increase to 3,215 million yuan in 2026, before declining to 2,095 million yuan in 2027 [1][8] - The net profit attributable to the parent company is expected to be (405.43) million yuan in 2024, (726.53) million yuan in 2025, 1,097.79 million yuan in 2026, and (841.66) million yuan in 2027 [1][8] - The earnings per share (EPS) are forecasted to be (1.16) yuan in 2024, (2.08) yuan in 2025, 3.15 yuan in 2026, and (2.42) yuan in 2027 [1][8]

Core Viewpoint - The approval of the new Bcl-2 selective inhibitor, Lisengmato, by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, making it the first domestically developed Bcl-2 inhibitor to be conditionally approved for marketing and the second globally [2][3]. Group 1: Product Development and Market Position - Lisengmato is an oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore the normal apoptosis process in tumor cells, thereby treating tumors [2]. - The approval of Lisengmato highlights Ascentage Pharma's strong innovation capabilities and establishes its leading position in the hematological oncology field [4]. - The company has been engaged in Bcl-2 target drug development for over 30 years, indicating deep expertise in this area [2]. Group 2: Clinical Relevance and Market Need - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a prevalent blood cancer in aging populations, with an increasing incidence in China despite lower rates compared to Europe and the U.S. [3]. - The introduction of Bcl-2 inhibitors like Lisengmato addresses unmet clinical needs in the treatment of CLL/SLL, providing new therapeutic options for patients facing challenges such as drug resistance and complex long-term management [3]. - Ascentage Pharma is conducting four global Phase III clinical trials for Lisengmato, indicating ongoing commitment to expanding its clinical applications [4].

Core Viewpoint - The approval of the novel Bcl-2 inhibitor, Lisatoclax (APG-2575), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, as it becomes the first domestically developed Bcl-2 inhibitor approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China and the second globally [1][2]. Group 1: Product Approval and Significance - Lisatoclax is the first Bcl-2 inhibitor approved in China for CLL/SLL, highlighting its potential in the treatment landscape [2][3]. - The drug is expected to restore normal apoptosis in tumor cells by selectively inhibiting the Bcl-2 protein, offering new treatment options for patients [2][3]. - The approval signifies Ascentage Pharma's commitment to global clinical innovation and represents a key milestone in its journey to enter the global market [2]. Group 2: Clinical Research and Development - Ascentage Pharma is conducting four global Phase III clinical trials for Lisatoclax, targeting various patient groups, including those with previously treated CLL/SLL and newly diagnosed acute myeloid leukemia (AML) [2]. - The ongoing studies include the GLORA study for treated CLL/SLL patients and GLORA-2 for treatment-naive CLL/SLL patients, among others [2]. Group 3: Challenges in Bcl-2 Inhibition - The development of Bcl-2 inhibitors has been challenging due to the complex nature of protein-protein interactions and the need for drugs to penetrate cellular membranes and mitochondrial membranes [3]. - Prior to Lisatoclax, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in addressing this treatment gap [3].

Company Updates - The company presented data on Bcl-2 inhibitor APG-2575 (lisaftoclax) in combination with azacitidine for myeloid malignancies at the 2025 ASCO annual meeting, along with updates on MDM2-p53 inhibitor APG-115 (alrizomadlin) for advanced adenoid cystic carcinoma (ACC) and other solid tumors [1][2] Clinical Data Highlights - APG-2575 demonstrated promising results in a global multicenter Ib/II study for relapsed/refractory acute myeloid leukemia (R/R AML) with an overall response rate (ORR) of 43.2% among 44 evaluable patients, including a complete response (CR) or complete response with incomplete blood count recovery (CRi) rate of 31.8% [1] - In a subgroup of 22 patients previously treated with venetoclax, the ORR was 31.8%, with 22.8% achieving CR/CRi [1] - For newly diagnosed myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), APG-2575 showed an ORR of 80% in 15 evaluable patients, with 40% achieving CR [2] - Among 22 evaluable R/R MDS/CMML patients, the ORR was 50%, with 27.3% achieving CR [2] - APG-115 showed anti-tumor activity with an ORR of 16.7% in advanced ACC patients and 100% disease control rate (DCR) in a cohort of cholangiocarcinoma patients [2] Financial Forecast and Valuation - The company maintains its net loss forecast for 2025 and 2026 at 1.095 billion and 319 million respectively [3] - Due to the promising data from APG-2575, the company sees potential for unlocking more commercial value in AML/MDS indications and has raised its target price by 25.5% to HKD 69, indicating a 16.2% upside from the current stock price [3]

Core Viewpoint - Ascentage Pharma's stock surged over 7%, reaching a historic high of 59.55 HKD, following the presentation of promising clinical trial data for its Bcl-2 inhibitor, APG-2575 (lisaftoclax), at the 61st American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Clinical Research and Development - The latest data from the Ib/II clinical study of APG-2575 combined with azacitidine for treating newly diagnosed or previously treated myeloid malignancies demonstrated both excellent efficacy and safety [1] - The study reported for the first time that lisaftoclax showed good therapeutic responses in patients who previously failed treatment with venetoclax, highlighting its differentiated efficacy and potential advantages over similar products [1] Group 2: Regulatory Progress - Lisaftoclax, a novel Bcl-2 selective inhibitor developed by Ascentage Pharma, has had its New Drug Application (NDA) accepted for priority review by the National Medical Products Administration (NMPA) in November 2024 for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - It is the second Bcl-2 inhibitor globally to submit an NDA and the first domestically developed Bcl-2 inhibitor in China to enter priority review [2] - Currently, there are four global registration III clinical trials underway for Lisaftoclax, covering indications such as CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with one trial being FDA-approved for global registration [2]