China's First Homegrown IL-36R Monoclonal Antibody HB0034 (Risankizumab Biosimilar) Receives NDA Acceptance for Generalized Pustular Psoriasis

(Source:Huahai Pharmaceutical）

Source: Hua Hai Pharmaceutical

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Abstract

Recently, Shanghai HuaotaAutoTest BioShanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota" or "the Company") receivedThe "Acceptance Notice" for the application of the registration and marketing authorization of Recombinant Anti-IL-36R Humanized Monoclonal Antibody (R&D code: HB0034) Injection, produced in China, issued by the National Medical Products Administration (hereinafter referred to as "NMPA")。

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About HB0034

In March 2025, the company's HB0034 injection for the treatment of acute episodes of generalized pustular psoriasis will undergo a multicenter, double-blind, randomized, placebo-controlled parallel study.Pivotal Clinical Trial Meets Primary Efficacy Endpoint and All Secondary Efficacy Endpoints。

In August 2025, Huaota's HB0034 InjectionIncluded in the priority review list of the Center for Drug Evaluation of the National Medical Products Administration。

Recently, the company receivedThe Acceptance Notice for the Application of Registration and Marketing Authorization of HB0034 Injection Produced in China issued by the National Medical Products Administration。

In addition, the company's HB0034 hasGranted Orphan Drug Designation by the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA"), for the treatment of Generalized Pustular Psoriasis (GPP).

Generalized Pustular Psoriasis(generalized pustular psoriasis，GPP)It is a rare, life-threatening, systemic neutrophilic dermatosis, with episodes mainly characterized by generalized erythema and pustules accompanied by systemic inflammatory symptoms such as fever, arthralgia, and myalgia.CIncreased C-reactive protein, elevated white blood cell count, etc.GPPThe acute attack is directly related to death. If not controlled in time, it may lead to sepsis and multi-system organ failure, endangering life; therefore, treatmentGPPThe top priority is to control acute attacks, and there is an urgent need for treatment methods that can quickly control acute attacks. Generalized pustular psoriasis has...2023Included in China's "Second Batch of Rare Disease Catalog" in [Year].

Currently, globally, there has not been a domestically developed targetedIL-36RAntibody Approved for Marketing.HB0034As the first self-developed innovative anti-IL-36RAntibody, by inhibitingIL-36Pathway exerts anti-inflammatory biological effects.2025Year3Month,HB0034The pivotal multicenter, double-blind, randomized, placebo-controlled parallel clinical trial of the injection for the treatment of acute episodes of generalized pustular psoriasis met the primary efficacy endpoint and all secondary efficacy endpoints.. According to the results of the research analysis,Compared with placebo,HB0034After a single intravenous administration on Day1WeekGPPThe skin pustules of the patients in the episode were significantly cleared, reaching the primary endpoint preset by the protocol. The safety performance was good, and no new safety signals were found.

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About Huaota

Huaota Biopharmaceuticals, a subsidiary of Huahai Pharmaceuticals, is a biopharmaceutical company focused on independent research and development with a global perspective. Specializing in the development of novel biologics for oncology and autoimmune diseases. Currently, 12 projects are 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 tumors; CD73-ADC, the first dual-action antibody targeting refractory cancers; TSLP/IL-11 bispecific antibody, independently developed as the world’s first for severe asthma treatment; 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. We strive to meet the widespread patient demand for safe, effective, accessible, and affordable innovative biologics, dedicated to changing the world through innovation!