– Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced that the European Commission (EC) has approved ROMVIMZA™ (vimseltinib) in the European Union (EU) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

小野药品工业株式会社（总部：日本大阪；总裁兼首席运营官：泷野藤一；“小野药品”）今日宣布，欧盟委员会 (EC) 已批准 ROMVIMZA™（维姆西替尼）在欧盟 (EU) 用于治疗伴有临床相关身体功能恶化的症状性腱鞘巨细胞瘤 (TGCT) 成年患者，这些患者的手术选择已耗尽或会导致不可接受的发病率或残疾。

“The European Commission’s approval of vimseltinib for TGCT is a significant milestone for Deciphera, Ono, and TGCT patients across the European Union who are in need of a non-invasive treatment option. We are excited to leverage our global commercial infrastructure to bring vimseltinib to these patients,” said Ryota Udagawa, President and Chief Executive Officer of Deciphera.

“欧盟委员会批准维米塞替尼用于治疗腱鞘巨细胞瘤（TGCT）是Deciphera、Ono以及欧盟地区需要非侵入性治疗选择的TGCT患者的重要里程碑。我们非常高兴能够利用我们的全球商业基础设施，将维米塞替尼带给这些患者，”Deciphera总裁兼首席执行官Ryota Udagawa表示。

“We look forward to working with health authorities to ensure all eligible patients who can benefit from vimseltinib have access as quickly as possible.”.

“我们期待与卫生当局合作，确保所有符合条件的患者能够尽快获得维米塞替尼。”

“This is welcome news for the TGCT community as vimseltinib is now the first approved therapy for TGCT in Europe,” said Jean-Yves Blay, M.D., Ph.D., Leon Berard Center. “TGCT can significantly impact the daily lives of patients by causing pain, stiffness and mobility limitations. Vimseltinib is a differentiated treatment that has demonstrated the ability to address these unmet patient needs while remaining well-tolerated.”.

“这对TGCT患者群体来说是一个好消息，因为vimseltinib现在是欧洲首个获批的TGCT疗法，”里昂贝拉中心的Jean-Yves Blay博士表示。“TGCT可能通过引起疼痛、僵硬和活动受限显著影响患者的日常生活。Vimseltinib是一种与众不同的治疗方法，它在满足这些未被满足的患者需求的同时，仍然具有良好的耐受性。”

The EC approval is supported by compelling efficacy and safety results from the pivotal Phase 3 MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase 1/2 study of vimseltinib.

欧盟的批准得到了关键的 3 期 MOTION 研究的有力疗效和安全性结果的支持，该研究针对无法手术且之前未接受过抗 CSF1/CSF1R 治疗（允许之前使用伊马替尼或尼洛替尼治疗）的 TGCT 患者使用维姆塞替尼与安慰剂进行比较，同时也基于维姆塞替尼的 1/2 期研究。

. The primary endpoint was supported by statistically significant and clinically meaningful improvements in active range of motion, patient-reported physical functioning, and patient-reported pain observed in the vimseltinib arm compared to the placebo arm at week 25

主要终点得到了以下方面的支持：在第25周时，与安慰剂组相比，vimseltinib组在活动范围、患者报告的身体功能和患者报告的疼痛方面均有统计学显著性且临床意义重大的改善。

. The secondary endpoint was supported by statistically significant and clinically meaningful improvements versus placebo in all six key secondary endpoints assessed at Week 25 including objective response rate (ORR) by tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain.

．在第25周评估的所有六个关键次要终点中，与安慰剂相比，次要终点得到了统计学上显著且临床意义重大的改善支持，这些终点包括通过肿瘤体积评分（TVS）评估的客观缓解率（ORR）、活动范围（ROM）、身体功能、僵硬程度、生活质量和疼痛。

In a descriptive analysis at Week 97, 23% (n=19/83) of the patients randomized to receive vimseltinib had best overall response of complete response (CR) according to RECIST v1.1, as assessed by blind independent radiological review (IRR), with a median time to CR of 11.5 months.

在第97周的描述性分析中，根据RECIST v1.1标准，盲态独立影像学审查（IRR）评估显示，随机分配接受vimseltinib治疗的患者中有23%（n=19/83）获得了完全缓解（CR）的最佳总体反应，达到CR的中位时间为11.5个月。

. The safety profile of vimseltinib is manageable and consistent with results previously disclosed in the Phase 1/2 clinical trial

维米塞替尼的安全性特征是可控的，并且与之前在1/2期临床试验中披露的结果一致。

About Tenosynovial Giant Cell Tumor (TGCT)

关于腱鞘巨细胞瘤 (TGCT)

TGCT is caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion.

TGCT是由集落刺激因子1（CSF1）基因的易位引起的，导致CSF1过度表达并将集落刺激因子1受体（CSF1R）阳性的炎症细胞募集到病灶中。

TGCT is a locally aggressive neoplasm that can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability.

TGCT是一种局部侵袭性肿瘤，可以生长并对周围组织和结构造成损害，诱发疼痛、肿胀以及关节活动受限。手术是主要的治疗选择；然而，这类肿瘤容易复发，尤其是在弥漫型TGCT中。若未治疗或肿瘤反复复发，受影响的关节及周围组织可能会出现损伤和退化，从而导致显著的残疾。

For a subset of patients, surgical resection will potentially cause worsening functional limitation or severe morbidity, systemic treatment options are limited and a new therapeutic option for TGCT is needed..

对于一部分患者，手术切除可能会导致功能限制加重或严重并发症，系统治疗选择有限，需要一种新的TGCT治疗方法。

About Deciphera Pharmaceuticals Inc.

关于Deciphera制药公司

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. Deciphera is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Deciphera，小野药品工业株式会社的成员，是一家致力于发现、开发和商业化重要新药以改善癌症患者生活的生物制药公司。Deciphera利用其专有的开关控制激酶抑制剂平台和在激酶生物学方面的深厚专业知识，开发一系列创新药物。

In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

除了在临床研究中推进来自Deciphera平台的多个候选产品外，QINLOCK®（利普替尼）是Deciphera公司获批的开关控制激酶抑制剂，在包括欧盟和美国在内的许多国家被批准用于治疗先前接受过3种或更多激酶抑制剂（包括伊马替尼）治疗的晚期胃肠道间质瘤（GIST）成年患者。

ROMVIMZA™ (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

ROMVIMZA™（vimseltinib）是一种激酶抑制剂，在美国获批用于治疗症状性腱鞘巨细胞瘤（TGCT）的成年患者，这些患者的手术切除可能会导致功能限制加重或严重并发症；在欧盟，该药物获批用于因TGCT导致身体功能显著恶化的成年患者，以及手术选择已用尽或会导致不可接受的并发症或残疾的患者。

About Ono Pharmaceutical Co., Ltd

关于小野药品工业株式会社

Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery.

日本小野药品工业株式会社为全球患者提供创新疗法。秉承“致力于抗击疾病和痛苦”的理念，小野专注于肿瘤学、免疫学和神经学等未满足医疗需求的领域，并与学术和生物技术组织合作，加速药物研发。

Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at .

通过其附属公司Deciphera Pharmaceuticals，Ono正在加速在美国和欧洲的临床开发和商业运营，以推动全球业务扩展，并进一步履行对患者护理的承诺。欲了解更多信息，请访问公司网站。