Lisaftoclax

Product sales from Olverembatinib in the first half of 2025 increased 93% year-over-year to US$30.3 million (RMB217.4 million), primarily attributable to the expansion of NRDL coverage Commenced commercial sales of Lisaftoclax in China, following approval on July 10, 2025 by China’s NMPA for the treatment of adult patients with CLL/SLL who have previously received at least one systemic therapy including BTK inhibitors Registrational Phase 3 trial for 1L HR MDS (GLORA-4) cleared by FDA and EMA, and first patients enrolled in Europe and China Completed a top-up placement in July 2025, resulting in US$190.1 million in net proceeds Nine registrational clinical trials are in progress, including three cleared by FDA Chinese (Mandarin) language investor webcast at 9:00 pm EDT on August 20, 2025 / 9:00 am HKT on August 21, 2025, and English language investor webcast at 8:00 am EDT / 8:00 pm HKT on August 21, 2025 Ascentage Pharma Group International (Ascentage Pharma) (NASDAQ: AAPG; HKEX: 6855) (referred hereinto as “Ascentage Pharma,” the “Company,” “we,” “us” or “our”), today reported its unaudited financial results for the six months ended June 30, 2025, and provided updates on key ongoing clinical programs and commercial activities. Dr. Dajun Yang Chairman and Chief Executive Officer of Ascentage Pharma “We reported strong momentum across our business in the first half of 2025, highlighted by the remarkable 93% year-over-year growth in Olverembatinib sales of $30.3 million, driven by expanded National Reimbursement Drug List (NRDL) coverage that has significantly improved patient access in China. In addition, the historic approval of Lisaftoclax in July marks a pivotal milestone as the first Bcl-2 inhibitor to receive conditional approval for CLL/SLL treatment in China. Our robust pipeline continues to advance with nine registrational clinical trials, all of which are actively ongoing, including three cleared by the FDA, demonstrating our commitment to bringing innovative cancer therapies to patients globally. The successful completion of our financing in July, raising US$190.1 million in net proceeds, strengthens our balance sheet and provides additional resources needed to execute our commercialization strategy and development programs. These achievements highlight our capability to execute globally and our commitment to delivering novel therapies to patients worldwide.” Key Commercial Product and Pipeline Updates Olverembatinib (HQP1351) is a novel, next-generation TKI and the first third-generation BCR-ABL1 TKI approved in China for treatment of patients with chronic myeloid leukemia (CML) in chronic-phase (-CP) or CML in accelerated phase (-AP) with T315I mutations, and in CML-CP that is resistant and/or intolerant to first and second-generation TKIs. Since 2021, commercialization of Olverembatinib in China continues to perform well. Additional potential indications for Olverembatinib are being evaluated in ongoing clinical trials. Commercial progress Revenue from sales of Olverembatinib in China increased 93% to US$30.3 million for the six months ended June 30, 2025, compared to US$15.5 million for the six months ended June 30, 2024. All approved indications for Olverembatinib have been covered since January 2025 by the China’s NRDL, which has bolstered the affordability and accessibility of Olverembatinib. The number of direct-to-patient (DTP) pharmacies and hospitals where Olverembatinib is on formulary reached 782 as of June 30, 2025, a 17% increase compared to June 30, 2024. In particular, the number of hospitals where Olverembatinib is on formulary increased 47% over the same period to 295 hospitals as of June 30, 2025 from 201 hospitals as of June 30, 2024. Clinical progress Enrollment continues in a registrational Phase III clinical trial of Olverembatinib for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who have not responded to prior systemic treatment (POLARIS-3). Enrollment continues in an FDA-cleared registrational Phase III clinical trial of Olverembatinib for previously treated CML-CP patients, both with and without T315I mutation (POLARIS-2). Enrollment continues in a registrational Phase III clinical trial of Olverembatinib in combination with chemotherapy versus imatinib in combination with chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive ALL (Ph+ ALL) (POLARIS-1). Anticipated progress Plan to seek clearance from the FDA to initiate a registrational Phase III clinical trial of Olverembatinib in newly diagnosed Ph+ ALL patients. Lisaftoclax (APG-2575) is a novel, oral B-cell lymphoma 2 (Bcl-2) inhibitor developed to treat a variety of hematologic malignancies and solid tumors by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Lisaftoclax is approved in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL) / small lymphocytic leukemia (SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors and is being evaluated for additional potential indications in ongoing clinical trials. Commercial progress Lisaftoclax was approved on July 10, 2025, by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with CLL/SLL who have previously received at least one systemic therapy including BTK inhibitors, which makes Lisaftoclax the first Bcl-2 inhibitor to receive conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally. Shortly after the approval, commercial sales of Lisaftoclax commenced in China. Lisaftoclax received its first recommendation in April 2025 in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies as a monotherapy for the treatment of patients with relapsed/refractory (R/R) CLL/SLL. Clinical progress Enrollment continues in a multicenter, registrational Phase III clinical trial of Lisaftoclax in combination with azacitidine for the treatment of patients who are newly diagnosed with higher-risk (HR) myelodysplastic syndrome (MDS) (GLORA-4). GLORA-4 has been cleared by the FDA and EMA and was originally approved by the China CDE in 2024. Currently, the study is enrolling patients globally, with the first patients  dosed in Europe and China. Enrollment continues in a registrational Phase III clinical trial of Lisaftoclax for the treatment of newly diagnosed old or unfit patients with acute myeloid leukemia (AML) (GLORA-3). Enrollment continues in a registrational Phase III clinical trial to evaluate Lisaftoclax in combination with the BTK inhibitor acalabrutinib, versus immunochemotherapy in treatment-naïve patients with CLL/SLL (GLORA-2) to validate a fixed duration combination regimen as a first-line treatment. Enrollment continues in an FDA-cleared registrational Phase III clinical trial of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors (GLORA). Enrollment advancing in the Phase 1b/2 clinical trials of Lisaftoclax in combination therapies for the treatment of patients with multiple myeloma (MM) in the United States. Recent Developments Completed a top-up placement of ordinary shares in July 2025, resulting in US$190.1 million in net proceeds. Appointed Dr. Veet Misra as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance. Half Year 2025 Unaudited Financial Results Revenue for the six months ended June 30, 2025 was US$32.6 million, compared to US$113.4 million for the six months ended June 30, 2024, which represented a decrease of US$80.7 million, or 71.6% on a constant currency basis. The decrease in revenue was primarily due to intellectual property revenue of US$93.4 million recorded during the six months ended June 30, 2024. Product sales of Olverembatinib in China increased by US$14.8 million, or 92.5% on a constant currency basis, to US$30.3 million for the first half of 2025 from US$15.5 million for the six months ended June 30, 2024. Selling and distribution expenses for the six months ended June 30, 2025 were US$19.2 million, compared to US$12.3 million for the six months ended June 30, 2024, which represented an increase of US$6.9 million, or 53.7% on a constant currency basis. The increase was attributable to expansions in commercialization efforts of Olverembatinib and preparation for anticipated launch of Lisaftoclax. Research and development expenses for the six months ended June 30, 2025 were US$73.8 million, compared to US$61.1 million for the six months ended June 30, 2024, which represented an increase of US$12.7 million, or 19.0% on a constant currency basis. The increase was attributable to increased external research and development expenses related to our ongoing global clinical trials. Administrative expenses for the six months ended June 30, 2025 were US$13.9 million, compared to US$12.0 million for the six months ended June 30, 2024, which represented an increase of US$1.9 million, or 14.6% on a constant currency basis. The increase was due to the increase in the consulting fees and agency fees. Financing costs for the six months ended June 30, 2025 were US$3.9 million, compared to US$4.7 million for the six months ended June 30, 2024, which represented a decrease of US$0.8 million, or 18.4% on a constant currency basis. The decrease was due to lower effective interest rates in relation to bank borrowings. Other expenses for the six months ended June 30, 2025 were US$5.6 million, compared to US$1.0 million for the six months ended June 30, 2024, which represented an increase of US$4.6 million, or 465.6% on a constant currency basis. The increase was primarily attributable to the increase in fair value loss of contingent consideration related to acquisition of Guangzhou Healthquest Pharma Co., Ltd. Loss for the six months ended June 30, 2025 was US$82.5 million, compared to the profit of US$22.4 million for the six months ended June 30, 2024. The loss per share attributable to ordinary equity holders was $0.24 per ordinary share for the six months ended June 30, 2025, compared to the earnings per share of $0.08 per ordinary share for the six months ended June 30, 2024. Cash and bank balances as of June 30, 2025, were US$231.9 million, compared to US$172.8 million as of December 31, 2024, which represented an increase of US$59.1 million, or 31.7% on a constant currency basis. The increase was primarily due to the net proceeds of US$132.5 million from the U.S. initial public offering in January 2025. Following the top-up placement in July 2025, which resulted in US$190.1 million in net proceeds, these net proceeds together with existing cash and cash equivalents, loan facilities and future sales will enable the Company to fund operating expenses and capital expenditure requirements. Investor Conference Call and Webcast Ascentage Pharma will be holding investor webcasts to discuss its six months 2025 unaudited interim results. Ascentage Pharma will host a Chinese (Mandarin) language investor webcast at 9:00 pm EDT on August 20, 2025 / 9:00 am HKT on August 21, 2025. To access the Chinese language investor event or conference call, please register in advance here. The English language investor conference call and webcast will be held at 8:00 am EDT / 8:00 pm HKT on August 21, 2025. To access the English language webcast, please register in advance here. The webcast replay for English language conference call and presentation will also be available on the News & Events page of the Ascentage Pharma website. Statement Regarding Unaudited Financial Information This press release includes unaudited condensed consolidated financial information as of and for the six months ended June 30, 2025, which has not been audited by the Company’s auditors. The unaudited information for the six months ended June 30, 2025, is preliminary, based on the information available at this time and subject to changes in connection with the completion of the review of the Company’s financial statements. As such, the Company’s actual results and financial condition as reflected in the financial statements that will be included in the Company’s Annual Report on Form 6-K, may be adjusted or presented differently from the financial information herein and the variations could be material. The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. All periods presented have been accounted for in conformity with IFRS accounting standard as issued by the International Accounting Standards Board and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). Currency and Exchange Rate Information Unless otherwise indicated, translations from RMB to U.S. dollars for the six months ended June 30, 2025 and 2024 and as at December 31, 2024 are made at RMB7.1636 to US$1.00, RMB 7.2672 to US$1.00 and RMB 7.2993 to US$1.00, representing the noon buying rate in the City of New York, as certified by the Federal Reserve Bank of New York, on June 30, 2025, June 28, 2024 and December 31, 2024, respectively. Ascentage Pharma makes no representation that the RMB or U.S. dollar amounts referred to in this press release could have been or could be converted into U.S. dollars or RMB, as the case may be, at any particular rate or at all. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is 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. The company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors. The Company’s first approved product, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA-cleared registrational Phase III trial, called POLARIS-2, of Olverembatinib for CML, as well as registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/ Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this press release do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release is issued by Ascentage Pharma solely for the purpose of disclosing the company’s latest business developments and is not intended as advertising. The drug-related information contained herein is for reference only by healthcare professionals and does not constitute commercial promotion of any drug or recommendation of treatment options. For further disease or drug information, please consult a qualified healthcare professional.

8月18日，亚盛医药宣布，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）治疗新诊断的中高危骨髓增生异常综合征（HR-MDS）患者的全球注册3期临床研究（GLORA-4）获美国FDA和欧洲药品管理局（EMA）同意开展。作为利沙托克拉在欧美监管机构获批的第二个全球注册3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。 亚盛医药首席医学官翟一帆博士表示："去甲基化药物（HMA）或异基因造血干细胞移植（allo-HSCT）仍是当下中高危MDS的主流治疗方案，全球层面没有用于一线治疗中高危MDS患者的靶向药物问世，该领域存在较大未被满足的临床需求。而在前期研究中，利生妥已在MDS患者中展现出良好的临床获益和耐受性。此次GLORA-4研究获美国FDA、欧洲EMA与中国CDE同步批准开展，希望该药成为全球首个获批用于一线治疗中高危MDS患者的Bcl-2抑制剂，和自HMA获批20年多年来首个获批的靶向药，或将从根本上重塑中高危MDS的治疗格局。目前，GLORA-4研究正在中国、美国和欧洲同步开展，这将极大助力加速利生妥后续在MDS适应症的临床开发和上市注册程序。未来，我们将秉承‘解决中国乃至全球患者尚未满足的临床需求'这一使命，积极推进相关临床试验的开展，以造福更多患者。" GLORA-4研究为国际多中心、随机、双盲3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。 作为起源于造血干细胞的髓系克隆增殖性疾病， MDS具有显著的年龄相关性特征，全球流行病学研究显示其发病率随年龄呈指数级增长（65岁以上人群年发病率达22/10万），中位诊断年龄达70岁，且>75%患者病情复杂常伴有至少两种合并症。该疾病的核心风险在于克隆演化导致的急性髓系白血病（AML）转化，其中中高危组（IPSS-R高危/极高危）患者5年内AML转化率高达40-60%，转化后预后极差，中位生存期不足6个月。去甲基化药物作为中高危MDS的一线标准方案，总缓解率（ORR）仅 30-40%，完全缓解（CR）率仅10-17%，且中位缓解持续时间仅9-12个月，治疗应答不足；allo-HSCT虽可提供治愈可能，但受限于患者中位年龄、复杂病情、MDS常见的造血干细胞储备衰退及移植相关死亡率（TRM）达25-35%，仅5-10%适宜患者可接受移植，根治手段受限。IPSS-R高危患者5年生存率仍停滞于16-24%，亟待创新性疗法改写治疗范式。 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。 此前，在2024年美国血液学年会（ASH）和2025年美国临床肿瘤学会（ASCO）年会上，利生妥联合AZA治疗初治（TN）MDS的数据显示：利生妥联合AZA在TN MDS中，ORR达75%，远高于HMA，显示了卓越的临床获益；且安全性良好，严重血液学毒性以及粒细胞减少相关感染的发生率低，需要剂量调整的患者比例低，未报告60天内治疗相关死亡。 参考资料：[1]亚盛医药利生妥®一线治疗中高危MDS患者的全球注册III期临床研究获美国FDA和欧洲EMA批准. From https://www.prnasia.com/story/499946-1.shtml免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。