Aldesleukin

序号 受理号 药品名称 申请人名称 适应症 注册分类 1 CXSL2600364 BBT001注射液 杉竹曜（北京）生物医药科技有限公司 慢性自发性荨麻疹 1 2 CXSL2600367 特瑞普利单抗注射液 上海君实生物医药科技股份有限公司;苏州众合生物医药科技有限公司;上海君实生物工程有限公司 本品联合GT101注射液一线治疗复发或转移性头颈部鳞状细胞癌。 2.2 3 CXSL2600366 特瑞普利单抗注射液 上海君实生物医药科技股份有限公司;苏州众合生物医药科技有限公司;上海君实生物工程有限公司 本品联合GT101注射液一线治疗复发或转移性头颈部鳞状细胞癌。 2.2 4 CXHL2600395 注射用WP1302 百明信康生物技术（浙江）股份有限公司 甲状腺眼病 1 5 CXHL2600365 ODV混悬滴眼液 深圳若见辉瞳生物科技有限公司 拟用于由角膜炎及角膜移植术后诱发的角膜新生血管患者的治疗。 1 6 CXHL2600366 ODV混悬滴眼液 深圳若见辉瞳生物科技有限公司 拟用于由角膜炎及角膜移植术后诱发的角膜新生血管患者的治疗。 1 7 CXSL2600371 注射用GenSci136 长春金赛药业有限责任公司 眼肌型重症肌无力（oMG） 1 8 CXHL2600364 ODV混悬滴眼液 深圳若见辉瞳生物科技有限公司 拟用于由角膜炎及角膜移植术后诱发的角膜新生血管患者的治疗。 1 9 JXSB2600055 GSK3862995B注射液 GlaxoSmithKline Research & Development Limited 本品适用于治疗非囊性纤维化支气管扩张症 1 10 CXSL2600375 注射用DXC018 杭州多禧生物科技有限公司 晚期实体瘤。 1 11 JXSL2600088 Depemokimab注射液 GlaxoSmithKline Research & Development Limited 有风险的中重度成人和青少年2型哮喘患者 2.2 12 JXHL2600095 ASP3082注射液 Astellas Pharma Global Development, Inc. ASP3082注射液联合以氟尿嘧啶为基础的化疗方案，用于转移性KRAS G12D突变型胰腺导管腺癌患者的一线治疗。 1 13 CXHB2600091 TRD303溶液 北京泰德制药股份有限公司 术后镇痛。 2.2 14 CXHB2600090 TRD303溶液 北京泰德制药股份有限公司 术后镇痛。 2.2 15 CXHL2600400 HRS9531注射液 福建盛迪医药有限公司 肥胖合并膝骨关节炎 1 16 CXHL2600399 HRS9531注射液 福建盛迪医药有限公司 肥胖合并膝骨关节炎 1 17 CXHL2600398 HRS9531注射液 福建盛迪医药有限公司 肥胖合并膝骨关节炎 1 18 CXHL2600401 ARD-489AD片 科辉智药（深圳）新药研究中心有限公司 化疗诱导的周围神经病变 1 19 CXSL2600363 注射用QLF4113 齐鲁制药有限公司 晚期前列腺癌 1 20 CXSL2600360 IBI354 信达生物医药科技（杭州）有限公司 本品联合内分泌治疗±CDK4/6抑制剂用于治疗不可切除的局部晚期或转移性HR阳性、HER2低表达/超低表达乳腺癌 1 21 CXHL2600397 DMET25001缓释片 武汉龙升医药科技有限责任公司 癌症患者顺铂化疗期间的听力保护。 2.2;2.4 22 CXHL2600402 ARD-489AD片 科辉智药（深圳）新药研究中心有限公司 化疗诱导的周围神经病变 1 23 CXHL2600396 DMET25001缓释片 武汉龙升医药科技有限责任公司 癌症患者顺铂化疗期间的听力保护。 2.2;2.4 24 JXHB2600049 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 25 CXHL2600382 INV-6452片 广东省创新药转化医学研究院有限公司;深圳市原力生命科学有限公司;佛山市原力生物科技有限公司;上海聚原生物科技有限公司 联合内分泌治疗药物治疗激素受体阳性、人表皮生长因子受体2阴性的（HR+/HER2-）晚期/转移性乳腺癌或其他局部晚期/转移性实体瘤 1 26 CXHL2600374 APH03571片 广州一品红制药有限公司 用于携带FLT3突变的复发性或难治性急性髓系白血病（AML）成人患者的治疗。 1 27 CXHL2600381 INV-6452片 广东省创新药转化医学研究院有限公司;深圳市原力生命科学有限公司;佛山市原力生物科技有限公司;上海聚原生物科技有限公司 联合内分泌治疗药物治疗激素受体阳性、人表皮生长因子受体2阴性的（HR+/HER2-）晚期/转移性乳腺癌或其他局部晚期/转移性实体瘤 1 28 CXSL2600349 ATG-201注射液 德琪（杭州）生物有限公司 系统性红斑狼疮（SLE） 1 29 CXHL2600376 TUL321胶囊 珠海联邦制药股份有限公司;珠海联邦制药股份有限公司中山分公司 本品拟用于治疗阵发性睡眠性血红蛋白尿症（PNH）。 1 30 CXHL2600377 TUL321胶囊 珠海联邦制药股份有限公司;珠海联邦制药股份有限公司中山分公司 本品拟用于治疗阵发性睡眠性血红蛋白尿症（PNH）。 1 31 CXHL2600375 TUL321胶囊 珠海联邦制药股份有限公司;珠海联邦制药股份有限公司中山分公司 本品拟用于治疗阵发性睡眠性血红蛋白尿症（PNH）。 1 32 CXHL2600373 APH03571片 广州一品红制药有限公司 用于携带FLT3突变的复发性或难治性急性髓系白血病（AML）成人患者的治疗。 1 33 CXSL2600488 注射用AX-023（冻干） 北京安信怀德生物技术有限公司 晚期实体瘤 1 34 CXZL2600031 三皮强心颗粒 为因医药科技有限公司 补气利水强心。用于治疗慢性心力衰竭，属气虚兼水饮证；症见：乏力气短，心悸浮肿，小便不利，喘促不得卧，活动易劳累，咳吐清稀或泡沫痰。 中药:1.1类 35 JXHB2600047 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 36 JXHB2600050 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 37 JXHB2600046 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 38 JXHB2600048 TAK-360片 Takeda Development Center Americas, Inc. 不伴猝倒的发作性睡病（II型发作性睡病） 1 39 JXHB2600038 AMG 410 Amgen Inc. 携带 KRAS 改变的晚期或转移性实体瘤。 1 40 JXHB2600037 AMG 410 Amgen Inc. 携带 KRAS 改变的晚期或转移性实体瘤。 1 41 JXHB2600036 AMG 410 Amgen Inc. 携带 KRAS 改变的晚期或转移性实体瘤。 1

First T cell therapy for a solid tumor cancer and first treatment option approved in Australia for advanced melanoma after anti-PD-1 and targeted therapy SAN CARLOS, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi® (li ), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. “This approval in Australia is our third marketing authorization for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “We are in the process of authorizing our first Australian treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma.” Australia has the highest rate of melanoma globally, with an estimated 17,000 new cases diagnosed each year and more than 1,500 deaths annually. 1,2 Similar to the U.S. and other global markets, there is a significant need for new therapies for patients with advanced melanoma. TGA granted approval based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, if applicable. About the C-144-01 Clinical Trial C-144-01 is a global, multicenter Phase 2 study in which patients received li monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor or a BRAF inhibitor with a MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025. Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904) , as well as in additional solid tumor types. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi ® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit Amtagvi ® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. 1. Cancer Australia, Melanoma of the Skin Statistics, (Accessed March 2026) 2. Melanoma Institute Australia, Melanoma Facts, (Accessed March 2026) Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our Iovance Cell Therapy Center facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of authorized treatment centers, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS Investors IR@iovance.com 650-260-7120 ext. 150 Media PR@iovance.com 650-260-7120 ext. 150