Chinese Biopharma Huahai's Subsidiary Announces Successful Phase III Trial for Novel IL-17A Inhibitor HB0017 in Psoriasis, with R&D Investment of CNY 3.72 Billion
Huahai Pharmaceutical
Medical and Health Product Provider
Huaota
Biological New Drug Developer
On November 19, Huahai Pharmaceutical issued an announcement,WeighIts subsidiary, Huaota Biopharmaceutical and Huabo Biopharm, independently developed the Class 1 new drug HB0017 injection.LiquidTreatmentPsoriasisPhase III Clinical TrialAchieve AllPrimary Efficacy Endpoint and Key Secondary Efficacy Endpoint。
Source of screenshot: Corporate announcement
This is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study, aiming toEvaluation of the Efficacy and Safety of HB0017 Injection in the Treatment of Moderate to Severe Plaque Psoriasis, with a total of 408 Chinese patients with moderate to severe plaque psoriasis enrolled.
The results of the study showed that the study met all the pre-specified primary efficacy endpoints.(Proportion of subjects achieving PASI 75 (PASI score improved by ≥75% from baseline) at Week 12, Proportion of subjects achieving sPGA 0/1 (sPGA score of 0 or 1) at Week 12)And key secondary efficacy endpoints(Proportion of subjects achieving PASI 90 (PASI improved by ≥90% from baseline) at Week 12)。
Maintenance Treatment RegimenExpected to achieve the longest dosing interval among similar products,and various efficacy indicators continued to increase and remained stable during the maintenance treatment period. Compared with the marketed products of the same target, HB0017Core Treatment Period(First 12 Weeks)And Maintenance Treatment Period(12-52 weeks)Efficacy data show strong competitive advantages。
In terms of safety, HB0017 demonstrated a good overall safety and tolerability profile. Compared with previous clinical study data and drugs targeting the same pathway, the types and severity of common adverse events were within the expected range, and no new safety risk signals were identified.
HB0017 Injection is a self-developed product by Huaota targeting interleukin-17A.（IL-17A）Monoclonal antibody targeting, intended for the treatment ofModerate to Severe Plaque Psoriasis, Ankylosing Spondylitis, and Other Autoimmune DiseasesHB0017 has completed Phase III clinical trials for the treatment of moderate to severe plaque psoriasis and is currently conducting Phase III clinical trials for ankylosing spondylitis. In the completed Phase II clinical study of ankylosing spondylitis, HB0017 injection demonstrated positive efficacy and good safety. Based on this encouraging data, Huaota will rapidly advance the Phase III clinical trial for ankylosing spondylitis.
Screenshot source: Insight database
In addition, the announcement pointed out that, as of now, the company has invested a total of approximately RMB in the HB0017 injection project.RMB 372,050,000。
Insight database shows that there are currently 6 IL17 monoclonal antibodies globally.Approved for marketing,RespectivelySelicrelumab(Zhixiang Jintai)Funaqizumab(Hengrui), BechiZumab（UCB）、Secukinumab(Novartis)、Ixekizumab(Eli Lilly), andNitaqimab(Biocad/Shanghai Pharmaceuticals)Among them, Bimekizumab is an IL-17A/IL-17F monoclonal antibody, and the other five are all IL-17A monoclonal antibodies.
Besides, SSGJ-608(3SBio)、Gomuqi Monoclonal Antibody(Akeso Biopharma)And BAT2306（Secukinumab Biosimilar, Huaota）Currently in the review stage for market approval.
Screenshot source: Insight database
Cover source: ZCOOL HELLOR
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