BEIJING, Feb. 16, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, proudly announced the administration of the first dose of FOLOTYN® (Pralatrexate Injection) to a patient in China.

北京，2024年2月16日/PRNewswire/--CASI制药公司（纳斯达克：CASI）是一家专门从事创新治疗和制药产品开发和商业化的生物制药公司，自豪地宣布向中国患者服用第一剂FOLOTYN®（普拉曲塞注射液）。

This remarks a pivotal step in CASI's commitment to addressing critical medical needs in peripheral T-cell lymphoma in China market..

这是CASI致力于解决中国市场外周T细胞淋巴瘤关键医疗需求的关键一步。。

FOLOTYN® (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma ('PTCL'). Compared with methotrexate, pralatrexate could be more effectively internalized into tumor cells which may translate to a greater anti-cancer effect.

FOLOTYN®（Pralatrexate）是一种二氢叶酸还原酶抑制剂，用于治疗复发或难治性外周T细胞淋巴瘤（“PTCL”）患者。与甲氨蝶呤相比，普拉曲塞可以更有效地内化到肿瘤细胞中，这可能转化为更大的抗癌作用。

Clinical studies have demonstrated that pralatrexate has significant activity against PTCL1. With the results of an overall response rate ('ORR') of 52% and a median progression-free survival ('PFS') of 4.8 months from the Chinese registrational study2, in comparison to an ORR of 29% and a median PFS of 3.5 months from the PROPEL study3 in the US.

临床研究表明，普拉曲塞对PTCL1具有显着的活性。中国注册研究2的总有效率（“ORR”）为52%，中位无进展生存期（“PFS”）为4.8个月，而美国PROPEL研究3的ORR为29%，中位PFS为3.5个月。

Pralatrexate was approved in the United States, Japan and China as treatment for PTCL. Pralatrexate is a promising treatment option for Chinese patients with relapsed or refractory PTCL..

Pralatrexate在美国，日本和中国被批准用于治疗PTCL。普拉曲塞是中国复发或难治性PTCL患者的一种有前途的治疗选择。。

Dr. Wei-Wu He, CEO of CASI, expressed his enthusiasm for this milestone, 'The dosing of the first patient with FOLOTYN® in China marks a significant achievement for CASI. It reflects our unwavering commitment to bringing advanced therapeutic options to patients, particularly in therapeutic areas with substantial unmet medical needs.

CASI首席执行官魏武和博士对这一里程碑表示了热情，“中国首例服用FOLOTYN®的患者标志着CASI取得了重大成就。这反映了我们坚定不移地致力于为患者带来先进的治疗选择，特别是在医疗需求尚未得到满足的治疗领域。

This is a proud moment for our team and a step forward in our mission to transform patient care through innovation.'.

对于我们的团队来说，这是一个值得骄傲的时刻，也是我们通过创新改变患者护理的使命向前迈出的一步。”。

About CASI Pharmaceuticals

关于卡西制药

CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need.

卡西制药有限公司是一家生物制药公司，专注于在中国、美国和全世界开发和商业化创新疗法和药品。该公司专注于收购、开发和商业化产品，以增强其血液肿瘤治疗重点以及其他未满足医疗需求的领域。

The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.

该公司打算通过在大中华区市场推出药物，利用该公司在中国的监管和商业能力及其全球药物开发专业知识，实施其成为领导者的计划。该公司在中国的运营是通过其位于中国北京的全资子公司卡西制药（中国）有限公司进行的。

More information on CASI is available at www.casipharmaceuticals.com..

有关CASI的更多信息，请访问www.casipharmaceuticals.com。。

Forward-Looking Statements

前瞻性声明

This announcement contains forward-looking statements. These statements are made under the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as 'will,' 'expects,' 'anticipates,' 'future,' 'intends,' 'plans,' 'believes,' 'estimates,' 'confident' and similar statements.

本公告包含前瞻性声明。这些声明是根据1995年《美国私人证券诉讼改革法案》的“安全港”条款做出的。这些前瞻性陈述可以通过“意愿”、“预期”、“预期”、“未来”、“打算”、“计划”、“相信”、“估计”、“自信”等术语来识别。

Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the 'SEC'), in in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties.

除其他外，本公告中的业务前景和管理层的报价，以及公司的战略和运营计划，都包含前瞻性陈述。公司还可以在向美国证券交易委员会（“SEC”）提交的定期报告、向股东提交的年度报告、新闻稿和其他书面材料以及高管、董事或员工向第三方的口头陈述中，做出书面或口头的前瞻性陈述。

Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability.

非历史事实的陈述，包括关于公司信念和期望的陈述，都是前瞻性陈述。前瞻性陈述涉及固有风险和不确定性。许多因素可能导致实际结果与任何前瞻性声明中包含的结果存在重大差异，包括但不限于以下因素：由于我们无法筹集足够的资金满足运营需求，我们可能无法持续经营的风险；如果我们不符合适用的继续上市标准，我们可能会在纳斯达克资本市场上被摘牌；我们普通股市场价格的波动性；未来股票发行中现有股东被大幅稀释的风险；在包括中国在内的全球范围内执行我们的业务战略的困难；我们的无能。

FOLOTYN® is proprietary to Acrotech Biopharma Inc and its affiliates.

FOLOTYN®是Acrotech Biopharma Inc及其附属公司的专有技术。

Reference1. Casanova, M., et al. Critical appraisal of pralatrexate in the management of difficult-to-treat peripheral T cell lymphoma. Ther Clin Risk Manag. 2011; 7: 401–408.2. Hong X., et al. Pralatrexate in Chinese Patients with Relapsed or Refractory Peripheral T-cell Lymphoma: A Singlearm, Multicenter Study.

参考文献1.Casanova，M。等人对普拉曲塞治疗难治性外周T细胞淋巴瘤的关键评估。临床风险管理。2011年；7： 401–408.2。Hong X.等人，Pralatrexate治疗中国复发或难治性外周T细胞淋巴瘤患者：一项单臂多中心研究。

Target Oncol. 2019 Apr;14(2):149-158.3. O'Connor OA, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol, 2011, 29(9):1182-1189. .

目标Oncol。2019年4月；14（2）：149-158.3。Pralatrexate治疗复发或难治性外周T细胞淋巴瘤：关键性PROPEL研究的结果。临床肿瘤学杂志，2011,29（9）：1182-1189。

COMPANY CONTACT:Rui ZhangCASI Pharmaceuticals, Inc.240.864.2643[email protected] www.casipharmaceuticals.com

公司联系人：Rui ZhangCASI Pharmaceuticals，Inc.240.864.2643[受电子邮件保护]www.casipharmaceuticals.com

SOURCE CASI Pharmaceuticals

来源CASI Pharmaceuticals