BEIJING, Nov. 8, 2023 /PRNewswire/ -- CASI Pharmaceuticals Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, is thrilled to announce a major milestone in its partnership with Juventas Cell Therapy Ltd. (Juventas).

北京，2023年11月8日/PRNewswire/-CASI制药公司（纳斯达克股票代码：CASI）是一家专注于开发和商业化创新疗法和药品的生物制药公司，很高兴宣布与青少年合作的一个重要里程碑细胞治疗有限公司（青少年）。

The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China..

中国国家医药产品监督管理局（NMPA）已批准市场批准青少年研究细胞疗法Inaticabtagene Autoleucel（CNCT 19），用于治疗复发和难治性B细胞急性淋巴细胞白血病（r/r B-ALL）在中国。。

Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product comprised of a unique CD19 scFv（HI19a）structure and utilizes leading CMC manufacturing techniques. Inaticabtagene Autoleucel has demonstrated a high level of efficacy, with durable remissions, and substantially improved safety profile with reduced CAR-T related toxicities in the pivotal clinical study for the treatment of adults with r/r B-ALL..

Inaticabtagene Autoleucel是一种CD19 CAR-T细胞治疗产品，由独特的CD19 scFv（HI19a）结构组成，并利用领先的CMC制造技术。在用于治疗患有r/r B-ALL的成人的关键临床研究中，Inaticabtagene Autoleucel已显示出高水平的功效，持久的缓解以及显着改善的安全性和降低的CAR-T相关毒性。。

This approval is based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China. The 9.3-month follow up data demonstrated very high durable response, overall response rate ('ORR'): 82.1%, complete response rate ('CR'): 66.7% within 3 month after infusion and median duration of response (DoR) has not reached.

该批准基于对中国39名成人r/r B-ALL患者的单臂，多中心，关键性研究的临床结果。9.3个月的随访数据显示非常高的持续反应，总体反应率（'ORR'）：82.1%，完全反应率（'CR'）：输注后3个月内66.7%和中位反应持续时间（DoR）没有达到。

The safety profile shown the decreased severity of CAR T-Cell related adverse events in patients with r/r B-ALL. Given the currently available treatment options in China, Inaticabtagene Autoleucel will be the first treatment CAR-T therapy option with a positive benefit-risk ratio for adult patients with r/r B-ALL and potentially be a best-in-class CAR-T product..

安全性概况显示r/r B-ALL患者CAR T细胞相关不良事件的严重程度降低。鉴于目前中国可用的治疗方案，Inaticabtagene Autoleucel将成为第一个治疗CAR-T治疗方案，对成人r/r B-ALL患者具有正风险比，可能是一流的CAR-T产品。。

This pivotal development not only marks a significant achievement for CASI and Juventas but also represents a remarkable advancement in the field of hematology-oncology and cell therapy. CNCT19 is the first CD19-directed CAR-T product with Chinese independent intellectual property rights, making it a trailblazer in the Chinese biopharmaceutical landscape.

这一关键发展不仅标志着CASI和青少年的重大成就，而且代表了血液肿瘤学和细胞治疗领域的显着进步。CNCT19是第一个拥有中国独立知识产权的CD19定向CAR-T产品，使其成为中国生物制药领域的开拓者。

It is also the first commercialized cell therapy product in China designed to treat B-ALL..

它也是中国第一个用于治疗B-ALL的商业化细胞治疗产品。。

Dr. Wei-Wu He, Chairman and CEO of CASI, expressed his enthusiasm for the commercial and clinical significance of CNCT19. He stated, 'The approval of CNCT19 represents a transformative moment not only for CASI and Juventas but for all B-ALL patients in China. We are committed to making this groundbreaking therapy accessible to those in need and aspire to extend its reach globally.

CASI主席兼首席执行官何伟武博士对CNCT19的商业和临床意义表示了热情。他说，“CNCT19的批准不仅代表了CASI和青少年，而且代表了中国所有B-all患者的变革时刻。我们致力于使有需要的人能够获得这种开创性的治疗，并渴望在全球范围内扩大其范围。

CNCT19 offers new hope to patients battling relapsed B-ALL, and this partnership between CASI and Juventas aims to ensure that this innovative therapy reaches those in need across China and beyond.'.

CNCT19为抗击复发性B-ALL的患者提供了新的希望，CASI与青少年之间的这种合作旨在确保这种创新疗法能够满足中国及其他地区的需求。

About Juventas Cell Therapy Ltd.

关于青少年细胞治疗有限公司。

Established in June 2018, Juventas Cell Therapy Ltd., a biopharmaceutical company powered by cutting-edge cell and gene technologies, has become the leader of innovative CGT drug development in China. Juventas' innovation is stemmed from its integrated R&D platforms including CAR, iPSCs, and gene-editing technologies.

Juventas Cell Therapy Ltd成立于2018年6月，是一家由尖端细胞和基因技术驱动的生物制药公司，已成为中国创新CGT药物开发的领导者。青少年的创新源于其综合研发平台，包括CAR，iPSC和基因编辑技术。

With more than 10 drug candidates in its pipeline, featured with solo, dual, or multiple target autologous CAR-T and universal cellular products, Juventas is well on its way to fulfil its mission - providing novel solutions to unmet clinical needs in the treatment of blood cancers, solid tumors, and other diseases.

拥有超过10种候选药物，具有单独，双重或多靶点自体CAR-T和通用细胞产品，青少年正在努力实现其使命-为治疗中未满足的临床需求提供新的解决方案血癌，实体瘤和其他疾病。

In November 2023, Juventas' first core product - Inaticabtagene Autoleucel (CNCT19) was approved by NMPA, for the treatment of adult B-cell relapsed and refractory acute lymphoblastic leukemia (B-ALL)..

2023年11月，青少年的第一个核心产品-自噬白细胞（CNCT19）被NMPA批准用于治疗成人B细胞复发和难治性急性淋巴细胞白血病（B-ALL）。。

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.

CASI Pharmaceuticals，Inc。是一家生物制药公司，致力于在中国，美国和全世界开发和商业化创新疗法和药品。该公司专注于获取，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.

该公司打算利用公司在中国的监管和商业能力以及全球药物开发专业知识，通过在大中国市场推出药品来执行其成为领导者的计划。该公司在中国的运营是通过位于中国北京的国有子公司CASI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。这些陈述是根据1995年“美国私人证券诉讼改革法案”的“安全港”规定作出的。这些前瞻性陈述可以用“意志”，“期望”，“预期”，“未来”，“意图”，“计划”，“相信”，“估计”，“自信”等术语来确定。和类似的陈述。

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.

除此之外，本公告管理层的业务前景和报价以及公司的战略和运营计划均包含前瞻性声明。本公司还可在其向美国证券交易委员会（“SEC”）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口头声明中作出书面或口头前瞻性声明。其官员，董事或雇员向第三方。

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.

不是历史事实的陈述，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大不相同，包括但不限于以下内容：由于我们无法继续关注我们可能无法为我们的运营需求筹集足够的资金；如果我们不符合适用的持续上市标准，我们可能会从纳斯达克资本市场交易中退出；我们普通股市场价格波动；现有股东在未来股票发行中大量稀释的风险；包括中国在内的全球业务战略执行难度；我们无能为力。

COMPANY CONTACT:Rui ZhangCASI Pharmaceuticals, Inc.240.864.2643ir@casipharmaceuticals.com

公司联系人：Rui ZhangCASI Pharmaceuticals，Inc.240.864.2643ir@casipharmaceuticals.com

SOURCE CASI Pharmaceuticals

来源CASI制药