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SHANGHAI and HONG KONG, Aug. 23, 2024 /PRNewswire/ -- Antengene Corporation (6996.HK) today announced its interim results for the period ending June 30, 2024, along with several significant milestones achieved in recent months. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, stated, "In the first half of 2024, the company has made significant progress in both R&D and commercialization. Our four global rights assets — ATG-022 (Claudin 18.2 ADC), ATG-037 (CD73 small molecule), ATG-101 (PD-L1/4-1BB bispecific antibody), and ATG-031 (CD24 monoclonal antibody) have all advanced steadily as planned. Among them, ATG-022, currently in Phase II dose expansion stage, has demonstrated efficacy not only in gastric cancer patients with moderate-to-high Claudin 18.2 expression but also in those with low and ultra-low expression levels. This unprecedented data reinforces our belief that ATG-022 is poised to become a globally best-in-class molecule targeting Claudin 18.2. While we remain focused on building a differentiated and innovative pipeline, the company has also established a robust self-sustaining revenue-generating capability. XPOVIO® has achieved three significant milestones within the past six months, including a supplementary new drug approval (NDA) for diffuse large B-cell lymphoma (DLBCL) in the Mainland of China, National Health Insurance Service Approval for Reimbursement in South Korea, and NDA approvals for multiple myeloma (MM) in Malaysia. To date, XPOVIO® has been approved for marketing in eight countries and regions across the Asia-Pacific markets and included in the national health insurance of four of these markets, generating product revenue of RMB 60.8 million in the first half of 2024." Dr. Mei continued, "Antengene's innovative R&D capabilities, strategic approach to drug discovery and development, and rigorous cost-efficiency measures ensure the company is well positioned for sustained operations and growth in the coming years. With a cash and bank balance of RMB 1.024 billion, we have sufficient runway to provide strong support to the continuous growth, development, and operations of Antengene. We look forward to sharing more of our progress in the second half of 2024, with a key highlight being the latest research results of ATG-037, which will be presented in a mini oral presentation at the ESMO Annual Meeting on September 16." 1. Global Rights Assets with Advancing Steadily at Clinical Stage ATG-022 (Claudin 18.2 Antibody-Drug Conjugate, ADC): Currently at Phase II Dose Expansion Stage, Effectively Targeting Gastric Cancer with both High and Ultra-low Claudin 18.2 (CLDN18.2) Expression ATG-022 is a highly differentiated asset demonstrating activity across a wide range of CLDN18.2 expression levels, including both high and low/ultra-low expression level. ATG-022 has received two Orphan Drug Designations (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. The Phase I CLINCH dose escalation study was completed earlier this year, 2.4 mg/kg was selected as the recommended Phase II dose (RP2D). ATG-022 has now progressed to the Phase II monotherapy dose expansion stage. As of Aug 21st 2024, Data from the on-going Phase II CLINCH dose expansion study, shows that 21 CLDN18.2 positive gastric cancer patients have been treated with ATG-022. Among the 12 patients who at least underwent their first tumor assessment after study treatment, 5 achieved partial response (PR), resulting in an overall response rate (ORR) of 41.7% (including one patient with ultra-low CLDN18.2 expression), and a disease control rate (DCR) of 100%. The Phase II CLINCH study is currently progressing smoothly in China and Australia. ATG-037 (CD73 Small Molecule Inhibitor): Demonstrated Potential in Reversing Resistance to anti-PD-1 Therapies during Dose Escalation Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with locally advanced or metastatic solid tumors. ATG-037 demonstrated an excellent safety profile during the dose escalation stage. Notably, four partial responses in patients previously treated with a checkpoint inhibitor were observed — two in melanoma patients and two in non-small cell lung cancer patients. With the Phase I dose escalation now complete, the company plans to initiate the Phase II dose-expansion of the STAMINA study in China and Australia in the third quarter of 2024. ATG-101 (PD-L1/4-1BB Bispecific Antibody): Durable Responses and Preliminary Efficacy in "Cold Tumors" Observed at Low Doses Without Off-target Liver Toxicity ATG-101's differentiated approach to targeting PD-L1 resistant cancers incorporates the conditional activation of the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity. ATG-101 is currently undergoing dose-escalation studies in the US, the Mainland of China, and Australia. The treatment has demonstrated excellent tolerability, with no significant liver toxicity observed to date. Encouragingly, durable stable disease has been observed even at low dose levels, as along with a partial response in a patient with microsatellite stable (MSS) colorectal cancer. The Phase I dose escalation phase is on track for completion by the first half of 2025. ATG-031 (Anti-CD24 Monoclonal Antibody): First-in-Class Macrophage Activator Targeting CD24 ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. In the Phase I PERFORM study, 19 late-stage cancer patients have been treated with early low doses in the dose escalation segment, with no dose-limiting toxicities (DLTs) observed. Observations include stable disease (SD), objective tumor shrinkage, and clinical improvements among enrolled patients. The company targets a Phase I data readout in the first half of 2025. Promising Pre-clinical Programs: Antengene is committed to advancing its proprietary "2+1" T-cell engager platform, AnTenGagerTM. T cell engagers developed from this platform are designed to induce disease-associated antigen (DAA)-dependent T-cell binding and activation, delivering strong therapeutic activity while minimizing the risk of cytokine release syndrome (CRS). The development of preclinical candidates, including ATG-042, a selective PRMT5 inhibitor targeting MTAP-null tumors, and ATG-201, a CD19 x CD3 T-cell engager, is ongoing. 2. Expanding APAC Presence with Inclusion in Multiple National Health Insurance Programs In June 2024, South Korea's National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO®, effective from July 1, 2024. This marks the fourth Asia-Pacific market, following the Mainland of China, Australia, and Singapore, where the company has secured reimbursement/insurance coverage for XPOVIO®. The company is actively working to secure health insurance inclusion for XPOVIO® in more Asia-Pacific markets. In July 2024, XPOVIO® received approval for a new indication in the Mainland of China, offering a new treatment option for patients with DLBCL. This is the second indication approved for XPOVIO® in the Mainland of China, following its approval for relapsed/refractory multiple myeloma (R/R MM). In August 2024, XPOVIO® was officially approved for marketing in Malaysia. To date, XPOVIO® has received multiple new drug approvals across eight countries and regions in the Asia-Pacific market (the Mainland of China, Taiwan, Hong Kong, Macau, Australia, South Korea, Malaysia, and Singapore). The company has also submitted NDA for XPOVIO® in other ASEAN markets such as Thailand and Indonesia, with approvals expected later this year. Since being included in the National Reimbursement Drug List (NRDL) in December 2023, XPOVIO® has shown impressive revenue performance in the first half of 2024. As of June 30, 2024, XPOVIO® sales revenue has reached RMB 60.8 million. 3. Strong Cash and Bank Balance to Support Strategic Objectives As of June 30, 2024, the company held RMB 1.024 billion in cash and bank balance. The steady growth in revenue, strong cash and bank balance coupled with careful spending, will provide strong support to the continuous growth, development, and operations of Antengene. For more details on the 2024 interim financial results, please refer to the full announcement available in the "Investor Relations" section of the company's official website. About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited

中国上海和香港，2024年8月23日——德琪医药（6996.HK）今日公布公司截至2024年6月30日的中期业绩以及在过去几个月内取得的多项重要里程碑。 梅建明 德琪医药创始人、董事长兼首席执行官 “2024上半程，公司在产品研发和商业化方面均取得了诸多里程碑式进展。分别靶向作用于Claudin 18.2, CD73, PD-L1/4-1BB和CD24的四个全球权益产品ATG-022、ATG-037、ATG-101和ATG-031的临床开发正按计划稳步推进。其中，处于II期临床研究阶段的ATG-022不仅在Claudin 18.2中高度表达的胃癌患者中显示了疗效，还为低表达和极低表达的患者带来了临床获益。这些具有突破性意义的临床数据让我们更加相信，ATG-022将成为一款靶向作用于Claudin 18.2的全球同类最优药物。在全力打造差异化创新研发管线的同时，公司已建立起强劲的自主造血能力。希维奥®于半年之内接连斩获3项佳绩，包括在中国大陆的新适应症弥漫性大B细胞淋巴瘤（DLBCL）的获批，在马来西亚针对治疗多发性骨髓瘤（MM）的新药上市许可，以及韩国的医保收录。截至目前，希维奥®已在亚太市场的8个国家和地区获批上市，并被纳入其中4个市场的医保，上半年创造产品营收6080万元人民币。 德琪医药领先的创新研发能力、药物发现和开发策略以及严格的成本控制将保证公司在未来几年的持续成长和稳定运营。公司现持有现金10.24亿元人民币，这将足以保障公司的发展和运营。我们期待与大家分享更多将于2024年后半阶段取得的更多进展，尤其是将于9月16日在ESMO年会上以小型口头报告形式展示的ATG-037的最新研究成果。” 全球权益产品 临床稳进提质 ▶ATG-022（Claudin 18.2 抗体偶联药物ADC）：目前处于II期剂量扩展阶段，初步数据显示，不仅可以有效靶向作用于Claudin 18.2（CLDN18.2）表达水平较高的胃癌患者，而且同时可以有效靶向作用于CLDN18.2表达水平极低的肿瘤 •  ATG-022是一款高差异化产品，它在广泛的CLDN18.2表达水平下具有较高活性，在低表达和极低水平下仍然有效。ATG-022已获得美国食品药品管理局（FDA）授予的2项孤儿药资格认定（ODD），分别用于治疗胃癌和胰腺癌。 •  I期CLINCH剂量爬坡研究已于今年年初结束。目前，ATG-022已进入II期试验的单药剂量扩展部分，2.4 mg/kg被选定为II期推荐使用剂量（RP2D）。 •  正在进行的II期CLINCH剂量扩展研究数据显示，截至8月21日，已有21 例CLDN18.2阳性的胃癌患者接受了ATG-022治疗。在12 例至少接受了一次治疗后肿瘤评估的患者中，5 例获得了部分缓解（PR）。总体缓解率（ORR）为41.7%（包括一名 CLDN18.2 表达极低的患者），疾病控制率（DCR）为100%。目前，II期CLINCH研究正在中国和澳大利亚顺利开展中。 ▶ATG-037（CD73小分子抑制剂）：在剂量爬坡阶段已显示逆转抗PD-1耐药的潜力 •  抑制CD73的目的是为了阻止腺苷的产生，因为腺苷是肿瘤微环境中一个重要的免疫抑制分子。作为一款CD73小分子抑制剂，ATG-037在临床前研究中显示了克服 “弯钩效应” 的能力，而 “弯钩效应” 可限制疗效并常见于抗CD73抗体药物的治疗。德琪医药已与默沙东达成一项全球临床合作，并正在局部晚期或转移性实体瘤患者中对ATG-037联合抗PD-1药物KEYTRUDA®（帕博利珠单抗）进行评估。 •  ATG-037在剂量爬坡研究中显示了良好的安全性。值得一提的是，研究已在既往接受过检查点抑制剂治疗的受试患者中观察到4例PR，其中2例为黑色素瘤患者，另外2例为非小细胞肺癌患者。I期剂量爬坡研究已经结束，公司计划于2024年第三季度在中国和澳大利亚启动STAMINA研究的II期剂量扩展部分。 ▶ATG-101（PD-L1/4-1BB双特异性抗体）：研究已在低剂量观察到持久缓解和对于 “冷肿瘤” 的初步疗效且未发现脱靶肝脏毒性 •  ATG-101对于PD-L1耐药性肿瘤的差异化靶向作用结合了对于T细胞共刺激受体4-1BB的条件性激活。ATG-101具有对于PD-L1的高亲和力和条件性激活4-1BB的能力，可有效降低肝脏毒性风险。 •  ATG-101的剂量爬坡研究正在美国、中国大陆和澳大利亚进行中。目前，研究已观察到良好的耐受性，且未发现明显的肝脏毒性。令人鼓舞的是，研究还在低剂量水平观察到持久的疾病稳定，并在1例微卫星稳定（MSS）的结直肠癌患者身上观察到PR。公司将按计划于2025年上半年完成I期剂量爬坡研究。 ▶ATG-031（抗CD24单抗）：可靶向作用于CD24的同类首款巨噬细胞激活剂 •  ATG-031是首款在美国进入肿瘤临床研究的人源抗CD24单克隆抗体。ATG-031可通过阻断CD24-Siglec10信号通路，增强由巨噬细胞介导的肿瘤细胞吞噬。ATG-031的主要研究单位包括美国的4个知名癌症中心，它们是德州大学MD安德森癌症中心、加州大学旧金山分校、科罗拉多大学和耶鲁大学癌症中心。 •  正在开展中的I期PERFORM研究中，19例晚期癌症患者在剂量爬坡阶段接受了早期低剂量治疗，且未出现剂量限制毒性（DLT）。该研究已在受试患者中观察到包含疾病稳定（SD）、肿瘤客观缩小和临床改善在内的初步疗效。公司计划在2025年上半年发布PERFORM研究的I期研究数据。 ▶极具前景的临床前开发项目 •  德琪医药将继续推进自研“2+1”T细胞衔接器平台AnTenGagerTM的开发。基于该平台开发的T细胞衔接器可通过诱导疾病相关抗原（DAA）依赖的T细胞结合和激活，在实现较强的疗效的同时将发生细胞因子释放综合征（CRS）的风险最小化。 •  德琪医药将继续推进临床前资产的开发，这些资产包括可靶向作用于MTAP-null肿瘤的选择性PRMT5抑制剂ATG-042和CD19 x CD3 T细胞衔接器ATG-201。 力拓亚太版图 纳入多国医保 •  2024年6月，希维奥®在韩国获得医保批准，于2024年7月1日起正式生效。这是继中国大陆、澳大利亚和新加坡之后，公司在第4个亚太市场实现对于希维奥®的医保覆盖。公司正为希维奥®于亚太更多市场获得医保收录做努力。 •  2024年7月，希维奥®新适应症在中国大陆获批上市，为中国DLBCL患者带来新选择。这是继复发/难治性多发性骨髓瘤（R/R MM）之后，希维奥®在中国大陆获批的第二项适应症。 •  2024年8月，希维奥®在马来西亚正式获批上市。截至目前，希维奥®已在亚太市场的8个国家和地区（中国[大陆地区、台湾、香港、澳门]、澳大利亚、韩国、马来西亚和新加坡）获得多项新药上市批准。公司还在泰国和印度尼西亚等东盟市场提交了希维奥®的新药上市申请（NDA），预计于今年下半年陆续获批。 •  自2023年12月获纳入国家医保目录，希维奥®于2024上半年取得了亮眼的产品收入表现。截至2024年6月30日，希维奥®的销售收入为6080万元人民币。 现金储备充裕 保障各项战略目标实现 截至2024年6月30日，公司持有现金和银行结余10.24亿元人民币。产品收入的稳健增长、充裕的现金储备以及严格的成本管控将为公司的发展和企业运营提供坚实的保障。 如需了解2024中期财务业绩的更多详情，请查阅公司官网“投资者关系”一栏中的完整公告。 关于德琪医药    德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）是一家以研发为驱动，并已进入商业化阶段的生物制药领先企业，以“医者无疆，创新永续”为愿景，德琪医药专注于血液及实体肿瘤领域的同类首款和同类最优疗法的早期研发、临床研究、药物生产及商业化，致力于通过提供突破性疗法，改善全球患者生活质量。 自2017年以来，德琪医药现已建立起一条拥有9款从临床延展至商业化阶段的肿瘤药物资产研发管线，其中，6款产品具有全球权益，3款产品具有亚太权益。公司已在美国及多个亚太市场获得29个临床批件（IND），并递交了10个新药上市申请（NDA）。目前，希维奥®（塞利尼索片）已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡、马来西亚和澳大利亚的新药上市批准。 前瞻性陈述    本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内有关任何董事或本公司意向的陈述或提述乃于本文刊发日期作出。任何该等意向均可能因未来发展而出现变动。有关这些因素和其他可能导致未来业绩与任何前瞻性声明存在重大差异的因素的进一步讨论，请参阅我们截至2023年12月31日的公司年报中描述的其他风险和不确定性，以及之后向香港证券交易所提交的文件。