QX005N
Target
IL-4Rα
Generic Name
Recombinant humanized anti IL-4Rα monoclonal antibody injection
Indication
AD PN CRSwNP CSU asthma COPD

Oturkibart (QX005N/HDM3016), one of the core products of Qyuns, is an innovative humanized monoclonal antibody targeting the human IL-4 receptor alpha subunit (IL-4Rα). Through specifically binding with IL-4Rα, Oturkibart blocks the binding of IL-4Rα with both IL-4 and IL-13, and also inhibits the signaling pathways and biological effects mediated by IL-4 and IL-13, thus exerting therapeutic effects on type 2 inflammatory allergic diseases. Oturkibart is  one of only two IL-4Rα monoclonal antibodies in China to have received the Breakthrough Therapy Designation (BTD).

As of April 2026, the Phase III clinical trials of Oturkibart for the treatment of Prurigo Nodularis (PN) and Atopic Dermatitis (AD) have met their primary endpoints. Qyuns plans to submit New Drug Applications (NDAs) for the PN and AD indications in the first and second half of 2026, respectively.

In July 2024, Qyuns entered into a collaboration agreement (the "QX005N Agreement") with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Zhongmei Huadong), a subsidiary of Huadong Medicine. According to the agreement, the two parties will jointly develop Oturkibart (R&D code of Huadong Medicine: HDM3016) within mainland China, the Hong Kong SAR, the Macao SAR, and the Taiwan region (collectively, the "Licensed Territory"). The collaboration includes: granting Zhongmei Huadong the exclusive co-development rights for the product (with both parties sharing the costs of Phase III clinical trials for designated indications on a 50:50 basis), an exclusive option for commercialization, and a right of first refusal for the transfer of the Marketing Authorization Holder (MAH).