Merck, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment.

默克公司，一家领先的科技公司，今天宣布中国国家药品监督管理局（NMPA）药品审评中心（CDE）正式受理了该公司关于将pimicotinib作为一类创新药用于需要系统性治疗的成人腱鞘巨细胞瘤（TGCT）患者的上市授权申请。

The submission follows the granting of Priority Review to pimicotinib by the CDE in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., also has been granted breakthrough therapy designation (BTD) by the NMPA..

该上市申请基于CDE于今年5月授予pimicotinib用于治疗需要系统性治疗的TGCT患者的优先审评资格，预计将加快审评进程。Pimicotinib是一款由和誉医药开发的潜在“同类最佳”集落刺激因子1受体（CSF-1R）抑制剂，此前已获得NMPA突破性疗法认定（BTD）。

“With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country,” said Hong Chow, Head of China and International, Healthcare business of Merck.

“随着我们对pimicotinib的申请被接受并启动优先审评，我们的目标是为中国患者提供首个获批的TGCT系统治疗，满足该国巨大的未满足需求，”默克医疗保健业务中国及国际负责人周虹表示。

“Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets.”.

“Pimicotinib 不仅展示了缩小影响关节的肿瘤的能力，还改善了活动性、疼痛和僵硬等结果，突显了其成为 TGCT 最佳治疗药物的潜力。同时，我们正努力向美国食品药物管理局提交新药申请，并计划在其他市场进行更多申报。”

TGCT is a locally aggressive and often recurring tumor of the joints that can cause high morbidity associated with swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting daily activities and quality of life in the primarily working-age population that it affects.

TGCT是一种局部侵袭性且常复发的关节肿瘤，可导致受影响关节出现肿胀、疼痛、僵硬和活动受限等症状，造成高发病率，严重影响主要处于工作年龄的患者群体的日常生活和生活质量。

If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. This highlights the need for well-tolerated and effective systemic treatments that can impact tumor growth while relieving the symptoms of the disease..

如果未治疗或反复发作，腱鞘巨细胞瘤 (TGCT) 可能导致骨骼、关节和周围组织的不可逆损伤。这突显了需要能够影响肿瘤生长同时缓解疾病症状的耐受性良好且有效的全身治疗方法。

The application is based on results from

该应用程序基于以下结果

Part 1 of the global Phase 3 MANEUVER study

全球3期MANEUVER研究的第一部分

, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain.

在第25周时，每日一次的pimicotinib与安慰剂相比，在由盲态独立审查委员会（BIRC）评估的主要终点客观缓解率（ORR）上显示出统计学显著改善（pimicotinib为54.0％，安慰剂为3.2％；p<0.0001）。该研究还表明，在TGCT所有与关键患者报告结果相关的次要终点上，均取得了统计学显著性和临床意义的改善，包括活动范围和身体功能的改善，以及僵硬和疼痛的减轻。

The data were presented earlier this month at the 2025 ASCO Annual Meeting..

本月初在2025年ASCO年会上公布了这些数据。

About MANEUVER

关于机动

The pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21)..

关键的 III 期 MANEUVER 研究是一项三部分、随机、双盲、安慰剂对照的研究，旨在评估 pimicotinib 在需要系统治疗且未接受过抗 CSF-1/CSF-1R 治疗的 TGCT 患者中的疗效和安全性。该研究由 Abbisko Therapeutics 在中国（n=45）、欧洲（n=28）以及美国和加拿大（n=21）进行。

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population.

在双盲的第一部分中，94名患者被随机分为2:1的比例，接受每日50毫克的匹米替尼（n=63）或安慰剂（n=31），持续24周。主要终点是由独立中心审查委员会根据实体瘤疗效评价标准（RECIST）1.1版在意向治疗（ITT）人群中评估的第25周的客观缓解率（ORR）。

Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS)..

次要终点包括肿瘤体积评分、活动范围、数字评分量表（NRS）评估的僵硬程度、简要疼痛量表（BPI）评估的疼痛，以及患者报告结果测量信息系统（PROMIS）评估的身体功能。

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

在双盲的第一部分之后，符合条件的患者可以继续进入开放标签的第二部分，进行最长24周的给药，其结果预计将在2025年年中公布。完成第二部分的患者随后可进入开放标签扩展阶段（第三部分），以获得延长的治疗和安全性随访。

About Pimicotinib (ABSK021)

关于Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy.

和誉医药研发的Pimicotinib（ABSK021）是一种新型的、口服的、高选择性且强效的小分子CSF-1R抑制剂。Pimicotinib近期被中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入优先审评，用于治疗需要系统性疗法的腱鞘巨细胞瘤（TGCT）患者。

Pimicotinib has been granted breakthrough therapy designation (BTD) by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds .

Pimicotinib 已获得中国国家药品监督管理局 (NMPA) 和美国食品药物管理局 (FDA) 的突破性疗法认定 (BTD)，以及欧洲药品管理局 (EMA) 的优先药物 (PRIME) 认定。默克持有 。

worldwide commercialization rights for pimicotinib

全球商业化权利，涉及pimicotinib

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Advancing the Future of Cancer Care

推进癌症治疗的未来

At Merck, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer’s deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors.

在默克，我们每天都在努力改善癌症患者的生活前景。基于我们作为制药先驱350年的全球传统，我们正集中最前沿的科学力量，针对癌症最深层的弱点，研发独特的分子以直击癌症核心。通过开发能够促进癌症治疗的新疗法，我们决心创造一个让更多的癌症患者成为癌症幸存者的世界。