Recently, Hua'otai, a holding subsidiary of Huahai Pharmaceutical, has submitted a marketing authorization application (MAA) for Risankizumab Injection (R&D Code: HB0034) to the National Medical Products Administration (NMPA). The application has been accepted, and the drug is intended for the treatment of acute exacerbation of generalized pustular psoriasis (GPP).
This domestically developed IL-36R monoclonal antibody applying for marketing approval is a pioneer in the industry. It is also Huahai Pharmaceutical's first innovative drug candidate to file for marketing, marking that the company's over-a-decade-long journey of transformation towards innovation has finally seen a promising breakthrough.
1 The Only Domestic IL-36R Monoclonal Antibody
Generalized Pustular Psoriasis (GPP) is a rare systemic neutrophilic skin disease. Its acute exacerbation is directly associated with mortality; without timely control, it may lead to sepsis and multiple organ failure, which is life-threatening. Therefore, the top priority in GPP treatment is to control acute exacerbations, and there is an urgent need for therapeutic methods that can rapidly manage such episodes. This disease was included in China's Second Batch of Rare Diseases Catalog in 2023.
Currently, both the intravenous and subcutaneous injection formulations of spesolimab have been successfully approved for marketing in China. In December 2024, the drug was included in the National Reimbursement Drug List (NRDL) through health insurance negotiations, with the price of the intravenous formulation reduced from RMB 18,000 to RMB 12,000 per vial.
However, no domestic IL-36R-targeted antibody has been approved for marketing yet. Among the candidate drugs under development, Hua'otai's HB0034 is progressing the fastest and has successfully submitted a marketing application.
2 Bispecific Antibodies Hold Greater Potential
After monoclonal antibodies, bispecific antibodies have become the mainstream of next-generation therapies.
Recognizing the potential of the IL-36R target, Hua'otai has proactively laid out its pipeline with HB0043, a bispecific antibody targeting both IL-36R and IL-17A. As the world's only bispecific antibody targeting IL-17A and IL-36R, it has the potential to be a First-in-Class (FIC) drug. Currently, this drug has obtained approval from the U.S. FDA to initiate a Phase I clinical trial of injectable HB0043 in the United States.
HB0043 is expected to break through the limitations of existing single-target therapies. Compared with monoclonal antibodies, HB0043 exhibits stronger inhibition of cytokine-induced inflammation and fibrotic responses. By dual blocking of IL-17A and IL-36R, it is expected to be widely applied in various T helper 17 (Th17)-associated and interleukin-36-related immune-mediated diseases.
3 Conclusion
Facing the narrowing profit margins of API and generic drug businesses, as well as the high R&D expenditures of innovative drugs, Huahai Pharmaceutical's transformation towards innovation has entered the most critical "deep-water zone".
Currently, although Huahai Pharmaceutical has no innovative drug products on the market, it has already submitted a marketing application for one of its innovative drugs. Meanwhile, its PD-L1/VEGF bispecific antibody demonstrates Best-in-Class (BIC) potential, and returns are expected to materialize in the near future.
