Huatide’s Self-Developed Il-36R Monoclonal Antibody Rixikibart (HB0034) Injection Included in CDE Priority Review List

Recently, according to the public information released by the Center for Drug Evaluation (hereinafter referred to as "CDE") of the National Medical Products Administration,Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota") independently developed Recombinant Anti-IL-36R Monoclonal Antibody Injection (Research and Development Code: HB0034), which has been included in the list of products eligible for priority review and approval process.According to the requirements of the Announcement of the National Medical Products Administration on the Issuance of Three Documents Including the Procedures for the Review of Breakthrough Therapy Drugs (Trial) (No. 82 [2020]), the CDE prioritizes the allocation of resources for the review of drug marketing authorization applications included in the expedited review and approval process, based on the order of the registration application acceptance time.

[About HB0034]

Generalized Pustular Psoriasis (GPP) is a rare, life-threatening, systemic neutrophilic dermatosis. During an episode, it mainly manifests as widespread erythema and pustules accompanied by systemic inflammatory symptoms such as fever, arthralgia, myalgia, elevated C-reactive protein, and leukocytosis. Acute episodes of GPP are directly associated with mortality, and if not promptly controlled, may lead to sepsis and multi-system organ failure, endangering the patient’s life. Therefore, the immediate priority in treating GPP is controlling acute episodes, necessitating rapid therapeutic interventions. Generalized Pustular Psoriasis was included in China's "Second List of Rare Diseases" in 2023.

Currently, globally, no self-developed targeted IL-36R antibody from a Chinese company has been approved for marketing.HB0034, as the first self-developed innovative anti-IL-36R antibody in China, can exert anti-inflammatory biological effects by inhibiting the IL-36 pathway.In March 2025, the pivotal multicenter, double-blind, randomized, placebo-controlled parallel clinical trial of HB0034 injection for the treatment of acute exacerbations of generalized pustular psoriasis met the primary efficacy endpoint and all secondary efficacy endpoints. According to the study analysis results, compared with the placebo,HB0034 Achieves Primary Endpoint with Significant Clearance of Skin Pustules in GPP Flare-ups During the First Week After Single Intravenous Dosing; Safety Profile Remains Favorable with No New Safety Signals Detected.

Moreover,HB0034 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Generalized Pustular Psoriasis.

[About Huaota]

Huaota Biologics, a subsidiary of Huahai Pharmaceuticals, is a biopharmaceutical R&D company that focuses on independent research and development with a global perspective. The company specializes in the R&D of biologics for cancer and autoimmune diseases. Currently, it has 12 projects in clinical stages, including: a PD-L1/VEGF bispecific antibody showing positive signals in Phase II clinical trials for endometrial cancer, non-small cell lung cancer, and other cancers; the first CD73-ADC with dual cytotoxic effects targeting refractory tumors; the world’s first self-developed TSLP/IL-11 bispecific antibody for severe asthma treatment by Shanghai Huaota Biopharmaceutical Co., Ltd.; and the world’s first bispecific antibody targeting IL-17A and IL-36R.

Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop, aiming to provide high-quality, cutting-edge biopharmaceuticals to the global market. These efforts are intended to meet the needs of a broad patient base for innovative biologics that are safe, effective, accessible, and affordable, with a commitment to changing the world through innovation!