Domestic Innovative Drug Rixikibart Injection Nominated for Priority Review, Offering New Hope for GPP Patients

　　【Pharmaceutical Network Product InformationOn August 8, the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that the Recitibant Injection, submitted by Shanghai Huaota Biopharmaceutical Co., Ltd., is proposed to be included in the priority review. The public announcement period is from August 8 to August 15, and its proposed indication is for the treatment of adult generalized pustular psoriasis (GPP) flares. This news is expected to bring new hope to many patients suffering from GPP.
 

Generalized Pustular Psoriasis (GPP) is a rare and severe skin condition. The patient's skin unexpectedly develops widespread pus-filled blisters (pustules) accompanied by pain, and may also present with systemic symptoms such as high fever, joint pain, and myalgia. GPP not only severely impacts the patient’s quality of life, but repeated flare-ups can also lead to liver and kidney damage, and even life-threatening secondary infections or organ failure. Due to its high heterogeneity and insufficient disease awareness, patients often face misdiagnosis or missed diagnosis. Currently, conventional treatments lack precise mechanisms, struggle to control recurrence, and tend to cause significant side effects, leaving patients in urgent need of more precise and safer medications.
 

Recibayliumab (HB0034) is a humanized IgG1-type monoclonal antibody targeting IL-36R independently developed by Huaota. It has high affinity for IL-36R, can specifically bind to IL-36R, and competitively block the binding of receptor agonists (IL36α, β, and γ) to IL-36R, thereby interrupting IL-36 inflammatory pathway signaling, reducing the release of cellular inflammatory factors that drive pathogenesis in inflammatory diseases, and achieving therapeutic effects.
 

Notably, Recibizumab has received orphan drug designation from the U.S. FDA for the treatment of generalized pustular psoriasis (GPP). In March this year, the pivotal Phase II study for its treatment of acute GPP flares met the primary endpoint. The results showed that compared with the placebo group, patients in the Recibizumab group experienced significant clearance of skin pustules by the first week after a single intravenous dose. Additionally, the drug demonstrated a good safety profile, with no new safety signals identified. Detailed results of the study will be presented at an upcoming medical conference.
 

As of March this year, the HB0034 injection project has accumulated R&D expenses of approximately RMB 210.38 million, demonstrating Huaota's determination and investment in the drug's development. The proposed inclusion in the priority review means that the drug is expected to be approved for marketing more quickly, providing a new treatment option for GPP patients.
 

In recent years, with the advancement of immunological research, the medical community has continued to make breakthroughs in the field of GPP treatment. Previously, Boehringer Ingelheim's intravenous formulation of Pefolicimab for treating adult GPP flares was approved in China in December 2022. In March 2024, its subcutaneous injection formulation also received approval for a new indication in China, used to reduce flares of Generalized Pustular Psoriasis (GPP) in adolescents aged 12 years and older (weighing ≥40kg) and adults.
 

The addition of Recibacimab will further enrich the treatment options for GPP. According to available information, Huaota Bio is a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd. Since its establishment, Huaota has continuously focused on innovation and development, building a comprehensive integrated biopharmaceutical R&D platform and system with a rich product pipeline covering major disease areas such as oncology, autoimmune diseases, and ophthalmic diseases. The progress of Recibacimab reflects Huaota's strong R&D capabilities in the field of autoimmune diseases.
 

Risankizumab injection is proposed for priority review, which is an encouraging piece of news for the GPP patient population. It is expected that this drug will be successfully approved and launched on the market, providing patients with effective treatment, improving their quality of life, and freeing them from the suffering caused by the disease. Meanwhile, this will also promote further development in the field of rare skin disease treatment in China and encourage more pharmaceutical companies to invest in the research and development of drugs for rare diseases.
 

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