— NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 — — NDA is supported by data from successful Phase III ESLIM-01 trial in patients with adult primary immune thrombocytopenia who have received at least one previous therapy — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan.

-在2022年1月获得突破性治疗指定后，NDA接受并获得优先审查-NDA得到了成功的III期ESLIM-01试验数据的支持，该试验针对至少接受过一次治疗的成人原发性免疫性血小板减少症患者-香港和上海以及新泽西州弗洛勒姆公园，1月。

10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”).

2024年10月10日（环球通讯社）--哈奇米德（中国）有限公司（“哈奇米德”）（纳斯达克/AIM：​HCM；香港交易所：​13） 今天宣布，用于治疗成人原发性免疫性血小板减少症（“ITP”）患者的索维列尼新药申请（“NDA”）已被中国国家医药产品管理局（“NMPA”）接受审查并获得优先审查。

Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy.

Sovleplenib是一种新型的，选择性的，靶向脾酪氨酸激酶（“Syk”）的口服抑制剂，正在开发用于治疗血液系统恶性肿瘤和免疫疾病。NDA得到了ESLIM-01的数据支持，ESLIM-01是一项在中国进行的随机，双盲，安慰剂对照的III期临床试验，对188名成年原发性ITP患者进行了治疗，这些患者至少接受了一种标准治疗。

In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib as compared to patients treated with placebo. Secondary endpoints including response rate and safety were also met.   Full results will be published in due course.

2023年8月，HUTCHMED宣布，该试验达到了其主要终点，证明与安慰剂治疗的患者相比，接受sovleplenib治疗的患者的持久缓解率具有临床意义和统计学显着增加。次要终点包括缓解率和安全性也得到了满足。完整的结果将在适当的时候公布。

Results from the proof of concept study that led to the ESLIM-01 study were published in The Lancet Haematology. The NMPA granted Breakthrough Therapy designation (“BTD”) to sovleplenib for the indication studied in ESLIM-01 in January 2022. The NMPA granted this designation to sovlepleni.

导致ESLIM-01研究的概念验证研究结果发表在《柳叶刀血液学》上。2022年1月，NMPA授予索夫列尼突破性治疗指定（“BTD”），用于ESLIM-01研究的适应症。NMPA将这一称号授予了索夫列尼。