Tianchen Bio’s LP-003 Phase II Trial Underway, Poised to Become China’s First Biologic for Allergic Rhinitis

The protocol discussion meeting for the LP-003 Phase II clinical trial in allergic rhinitis (Registration No. CTR20231145), led by Professor Wang Xueyan of Beijing Shijitan Hospital, Capital Medical University, was successfully held in Beijing in March 2023 through a hybrid format combining offline and online participation. Investigators from all participating centers engaged in active and in-depth discussions on the Phase II clinical trial protocol for the LP-003 project.

Professor Wang Xueyan stated: "Allergic rhinitis is a common chronic disease in clinical practice, affecting 10%–20% of the global population. Meanwhile, its prevalence in China has risen from 11.1% in 2005 to 17.6%. Approximately 25% of patients experience limited efficacy with conventional pharmacological treatment, highlighting the clinical need for a medication with superior efficacy and better adherence."

LongBio’s LP-003 is a next-generation anti-IgE antibody. Phase I clinical trial data demonstrate that, compared with omalizumab, the first-generation anti-IgE antibody, LP-003 exhibits superior biological activity, higher affinity, and a longer half-life, positioning it as a potential best-in-class therapy. As a representative of domestically developed antibody drugs in China, LongBio’s LP-003 holds significant importance for the field of allergic rhinitis treatment through its Phase II clinical study, and is expected to deliver clinical benefits to patients with allergic rhinitis in China and worldwide.

As the principal inventor of omalizumab, the first-generation anti-IgE antibody, Dr. Sun Naichao, Co-founder of LongBio, stated that allergic rhinitis, chronic urticaria, and asthma are all IgE-mediated diseases, and first-generation anti-IgE antibodies have been widely used in clinical practice. Based on insights into both first- and second-generation anti-IgE antibodies, LP-003, developed by LongBio, features enhanced potency, improved safety, lower dosing requirements, and an ultra-long duration of action, holding promise to become a best-in-class therapeutic agent.

We aim to expedite the market launch of LP-003, providing better treatment options and solutions for patients with allergic conditions such as allergic rhinitis, chronic urticaria, and asthma, thereby improving their quality of life and alleviating their burden.

Participating centers in this clinical trial also include 17 hospitals and centers from across China, such as Peking Union Medical College Hospital, Peking University Third Hospital, Shengjing Hospital of China Medical University, Tianjin People's Hospital, the First Affiliated Hospital of Shanxi Medical University, the Second Affiliated Hospital of Shanxi Medical University, and Dongfang Hospital of Beijing University of Chinese Medicine.