CHENGDU, China

中国成都

,

,

Feb. 8, 2025

2025年2月8日

/PRNewswire/ -- Keymed Biosciences (HKEX: 02162) today announced the National Medical Products Administration (the '

/美国国家医药产品管理局（National Medical Products Administration）今天宣布，Keymed Biosciences（香港交易所：02162）

NMPA

NMPA公司

') of

'）的

China

中国

has recently approved the supplemental New Drug Application (the '

最近批准了补充新药申请（the'

sNDA

sNDA

') of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the treatment of seasonal allergic rhinitis.

'）的Stapokibart（抗IL-4Rα单克隆抗体，商品名：康悦达，用于治疗季节性过敏性鼻炎。

The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III study to confirm the efficacy and safety of Stapokibart injection in treatment of adult patients with seasonal allergic rhinitis who are poorly controlled with nasal corticosteroids or other therapies. The study findings demonstrate that during the pollen season, in comparison with the standard treatment group, which consists of nasal spray hormones combined with antihistamine drugs, the administration of Stapokibart for two weeks effectively controls the typical nasal allergic symptoms of patients, including runny nose, nasal congestion, nasal itching, and sneezing.

该批准是基于一项多中心，随机，双盲，安慰剂对照的III期研究，以确认司他布吉巴特注射液治疗成人季节性变应性鼻炎患者的疗效和安全性，这些患者的鼻皮质类固醇或其他疗法控制不佳。研究结果表明，在花粉季节，与标准治疗组（由鼻喷雾剂激素联合抗组胺药物组成）相比，服用司他布吉巴特两周可有效控制患者典型的鼻过敏症状，包括流鼻涕，鼻塞，鼻痒和打喷嚏。

The least-squares mean (LSMean) of the inter-group difference is -1.3, and its 95% confidence interval (CI) is also -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits.

组间差异的最小二乘平均值（LSMean）为-1.3，其95%置信区间（CI）也为-1.3，表明统计学差异非常显着（P=0.0008）。这种差异远远超过了0.23的最小临床重要差异（MCID），清楚地表明了实质性的临床益处。

Moreover, Stapokibart can effectively alleviate ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. It comprehensively enhances the quality of life of patients and exhibits excellent safety..

此外，Stapokibart可以有效缓解眼部过敏症状，如眼睛瘙痒或灼热，眼睛流泪或流泪，以及眼睛发红。它全面提高了患者的生活质量，并表现出优异的安全性。。

About Stapokibart

关于斯塔博基巴特

Stapokibart is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling.

Stapokibart是一种靶向白细胞介素-4受体α亚基（IL-4Rα）的高效人源化抗体，是NMPA批准上市的第一种国产IL-4Rα抗体药物。通过靶向IL-4Rα，Stapokibart可以阻断白细胞介素-4（IL-4）和白细胞介素-13（IL-13）信号传导。

IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults and the indication of chronic rhinosinusitis with nasal polyposis have been approved for marketing in .

IL-4和IL-13是引发II型炎症的两种关键细胞因子。Stapokibart在之前的多项临床试验中表现出良好的安全性和令人鼓舞的疗效，其治疗成人中度至重度特应性皮炎的适应症和慢性鼻-鼻窦炎伴鼻息肉病的适应症已被批准在年上市。

September 2024

2024年9月

and

和

December 2024

2024年12月

, respectively.

，分别。

About Keymed Biosciences

关于Keymed Biosciences

Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in

Keymed Biosciences Inc.（香港交易所：02162）专注于尚未满足的迫切临床需求，并致力于为

China

中国

and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad.

和海外。Keymed由在国内外科技成果转化为商业化方面具有丰富经验的医学和科学专家创立。

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