HB0043 / Zhejiang Huahai Pharma, Huaota Biopharm, Huabo Biopharmaceutical Technology - LARVOL DELTA

Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced that its subsidiary has received clinical trial approval for adding a subcutaneous injection route of administration for HB0043 for injection. (FUTU)

New trial • Immunology

A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

A clinical trial to evaluate the efficacy and safety of HB0043(IL-17A/IL-36R bispecific antibody) in adult subjects with moderate to severe acne (ChiCTR) - P2 | N=21 | Sponsor: Shandong Provincial Institute of Dermatology and Venereology; Shandong Provincial Institute of Dermatology and Venereology

New P2 trial • Acne Vulgaris

A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris. (clinicaltrials.gov) - P1/2 | N=21 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1/2 trial • Acne Vulgaris • Dermatology

HB0043 (IL-17A and IL-36R dual antibody) independently developed by Huaotai completed the first case in New Zealand... (Sohu.com) - "Shanghai Huaotai Biopharmaceutical Co., Ltd...announced that HB0043, the world's first dual-antibody independently developed by Huaotai that simultaneously targets IL-17A and IL-36R, has completed the first subject dosing in New Zealand on June 30, 2025, marking that this innovative therapy has officially entered the clinical development stage....This randomized, double-blind, placebo-controlled, single-dose escalation study in healthy subjects will evaluate the safety, tolerability and pharmacokinetic characteristics of HB0043."

Trial status • Immunology

HB0043-HS-0-01: Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients. (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | N=52 ➔ 15

Enrollment change • Dermatology • Hidradenitis Suppurativa • Immunology

A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1 trial

Zhejiang Huahai Pharmaceutical Co., Ltd.'s announcement on its subsidiary obtaining drug clinical trial license [Google translation] (Sina Corp) - "Recently, Shanghai Huaotai Biopharmaceutical Co...has obtained approval from the New Zealand Medicines and Medical Devices Safety Authority (hereinafter referred to as 'MEDSAFE') and the Health and Disability Ethics Committee (hereinafter referred to as 'HDEC') to conduct a Phase I clinical trial of HB0043 for injection in the local area....In April 2025, Huaotai, a subsidiary of the company, submitted a clinical trial application for HB0043 for injection to MEDSAFE and HDEC; recently, MEDSAFE and HDEC approved Huaotai to conduct a Phase I clinical trial of HB0043 for injection in New Zealand."

New P1 trial • Immunology

HB0043-HS-0-01: Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients. (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

HB0043-HS-0-01: Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients. (clinicaltrials.gov) - P1/2 | N=52 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1/2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Single-center clinical trial of dose escalation of HB0043 for injection in subjects with moderate-to-severe hidradenitis suppurativa (ChiCTR) - P1/2 | N=12 | Sponsor: Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University &a

New P1/2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Dual blockade of IL-17A and IL-36 pathways via a bispecific antibody exhibits enhanced anti-inflammatory potency. (PubMed, Front Immunol) - "To investigate whether dual targeting interleukin-17 (IL-17) and IL-36 enhances anti-inflammatory activity, bispecific Ab HB0043 was generated by linking the single chain fragment variables (scFvs) from humanized anti-IL-36R antibody (HB0034) to the C-terminus of the heavy chain of anti-IL-17A IgG1 (HB0017) Fc using a flexible peptide linker...In a mouse model of Oxazolone (OXA)-induced atopic dermatitis and Imiquimod (IMQ)-induced skin inflammation, administration of both anti-IL17A mAb HB0017 and anti-mouse IL-36R surrogate antibody HB0034SA showed improved effectiveness in alleviating skin thickening and inflammation based on histological assessment...Together, dual blockade of IL-17A and IL-36R in the form of a bispecific antibody may have advantages in blocking the overlapping and non-overlapping functions of these two cytokines in skin inflammation that could not optimally be curtailed with single mAbs. In conclusion, as monotherapy may reach therapeutic celling..."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Fibrosis • Immunology • Inflammation • CXCL8 • IL17A • IL6