2024年2月26日，天辰生物（"Longbio Pharma"）在2024年美国过敏、哮喘和免疫学学会年会（AAAAI 2024）上公布了新一代抗IgE抗体LP-003的初步II期数据。 这是中国首个针对过敏性鼻炎（AR）的抗IgE抗体的注册临床试验，预计于2024 年初启动III 期临床研究。 关于II 期研究. 该II 期临床是一项随机、双盲、安慰剂对照研究，180名患有中重度季节性AR的成年受试者，随机接受LP-003 100mg (n=40)、LP-003 200mg (n=80)或安慰剂 (n=60)。 主要终点为花粉高峰期鼻症 …

2024年6月6日 · LP-003拟用于治疗过敏性鼻炎、慢性荨麻疹、哮喘、食物过敏等疾病。 过敏性鼻炎II期临床是LP-003首个关键性注册临床，也是抗IgE抗体在该适应症的国内首个注册临床研究，在今年2月份华盛顿特区举行的美国过敏、哮喘和免疫学会年会上，天辰生物首次公开了LP-003的II期临床主要数据，获得了与会专家和企业的高度关注。 此次在欧洲过敏年会上，该临床再次作为全球7个临床研究之一，入选大会年度哮喘和鼻炎临床研究口头汇报。 此次欧洲过敏与临床免疫年 …

The current data of Phase I and Phase II shows LP-003 is potentially to become a best-in-class treatment. Simultaneously, a Phase II study focusing on chronic spontaneous urticaria (CSU) is underway (NCT06228560), showcasing Longbio Pharma's commitment to exploring diverse therapeutic avenues.

2025年3月3日 · Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is already in Phase III stage, and prepare for pre-BLA in 2025H2. LP-003 has started clinical studies of several indications, like allergic rhinitis, CSU and asthma.

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2025年3月2日 · LP-003 demonstrated superior improvement compared to Omalizumab in mean change of UAS7 (urticaria activity score 7) from baseline and percentage% of patients with UAS7=0 at week 4 and week 12.

A new anti-IgE antibody, LP-003 developed by Longbio, of even higher IgE binding affinity, stronger FcεRI inhibition and much longer half-life compared to Omalizumab and Ligelizumab, was investigated in refractory CSU patients.

CONCLUSIONS: In patients with moderate to severe AR, LP-003 added to SoC demonstrated better efficacy in improving symptoms and was well tolerated. These results indicate that LP-003 renders a promising therapeutic option for AR.

In patients with moderate to severe AR, LP-003 added to SoC demonstrated better efficacy in improving symptoms and was well tolerated. These results indicate that LP-003 renders a promising therapeutic option for AR. Allergic rhinitis (AR) is a common IgE-mediated disorder that affects large population worldwide.

A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis (EAACI 2024) - "Omalizumab was the only approved anti-IgE antibody for several allergic diseases. In patients with moderate to severe SAR not well controlled despite SoC, LP-003 added to SoC demonstrated better efficacy in improving symptoms ...