Delving into the Latest Updates on Libevitug with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

立贝韦塔, HH 003, HH-003

+ [2]

Target

HBV pre-S1

Action

inhibitors

Mechanism

HBV pre-S1 inhibitors(HBV pre-S1 inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System DisordersOther Diseases

Active Indication

Hepatitis D, ChronicViremiaHepatitis B, Chronic

Inactive Indication-

Originator Organization

Huahui Health Ltd.

Active Organization

Huahui Health Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (20 Jan 2025),

Hepatitis D, Chronic

RegulationBreakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

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Structure/Sequence

Sequence Code 669343199H

Source: *****

Sequence Code 669343200L

Source: *****

This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.

Start Date20 Jul 2022

Sponsor / Collaborator

Huahui Health Ltd.

100 Clinical Results associated with Libevitug

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100 Translational Medicine associated with Libevitug

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100 Patents (Medical) associated with Libevitug

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2

Literatures (Medical) associated with Libevitug

01 Jul 2018·Journal of pharmacological sciencesQ3 · MEDICINE

Discovery of a potent hedgehog pathway inhibitor capable of activating caspase8-dependent apoptosis

Q3 · MEDICINE

ArticleOA

Author: Wang, Qin ; Luo, Lusong ; Zhang, Xiaohu ; Wu, Meng ; Chen, Qin ; Zhang, Haoran ; Ma, Haikuo ; He, Sudan

Aberrant activation of Hedgehog (Hh) signaling is associated with the development of numerous human cancers. Vismodegib is the first Hh inhibitor approved for anti-cancer therapy by targeting Smoothened (SMO), a critical regulator of the Hh pathway. However, acquisition of drug resistance to vismodegib occurs overtime. Apoptosis is a prevalent form of programmed cell death that is executed by caspases. Induction of tumor cell apoptosis represents an attractive therapeutic strategy to eliminate tumor cells. To explore new Hh antagonists with apoptosis-inducing activity, we screened a set of ∼300 potential SMO antagonists with novel scaffold structures. Hh003 was found to induce caspase-dependent apoptosis while vismodegib did not activate apoptotic response in human colon and pancreatic cancer cells. Compared to vismodegib, Hh003 exerted similar inhibitory effects on the Hh pathway. Hh003 could induce caspase8 activation and the silence of caspase8 significantly inhibited Hh003-induced apoptosis. Remarkably, Hh003 showed stronger inhibitory effects on the formation of tumor colonies in vitro and colorectal tumor growth in vivo than vismodegib. These findings suggest that Hh003 exerts enhanced anti-tumor effects by activating caspase8-dependent apoptosis compared to vismodegib. The combined property of Hh inhibition and apoptosis induction of Hh003 presents great potential for the development of novel anti-cancer therapy.

World Journal of Hepatology

Hope on the horizon: Emerging therapies for hepatitis D

Review

Author: Abbas, Minaam ; Abbas, Zaigham

Current treatment options for hepatitis D are limited, with pegylated interferon-alpha (PEG-IFNα) being the only therapy available in the Asia-Pacific region. However, PEG-IFNα has limited efficacy and significant side effects. Pegylated interferon lambda acts on interferon-lambda (Type III) receptors predominantly expressed in hepatocytes. In 2023, bulevirtide was approved in the European Union and Russia for treating chronic hepatitis D. This drug works by binding to and inhibiting the sodium taurocholate co-transporting polypeptide receptor on liver cells, which is the primary entry point for the virus. Recently, several new drugs have entered various stages of development, offering hope for improved hepatitis D virus (HDV) management. Two more viral entry inhibitors are HH003 and tobevibart. Other agents include nucleic acid polymers (REP 2139-Mg), prenylation inhibitors (lonafarnib), and RNA interference-based therapies (elebsiran). Emerging trials are now considering combination therapies, such as SOLSTICE, a Phase 2 clinical trial evaluating tobevibart alone or combined with elebsiran. The combination dosed monthly achieved > 50% virologic and biochemical response at 24 weeks of therapy. The efficacy and safety of these drugs will further be evaluated in ECLIPSE 1, 2, and 3 trials. With these new treatments on the horizon, the prospects for improved HDV patient outcomes are promising.

2

News (Medical) associated with Libevitug

18 Nov 2024

·www.prnewswire.com

FDA Grants Breakthrough Therapy Designation to Huahui Health's Libevitug (HH-003) for treatment of chronic Hepatitis D virus infection

BEIJING, Nov. 18, 2024 /PRNewswire/ -- Huahui Health, a clinical-stage biotechnology company focused on discovering and developing novel therapies in the areas of viral hepatitis, hepatology, and oncology, today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an anti-PreS1 human monoclonal antibody, received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic hepatitis delta virus (HDV) infection. The BTD is based on the clinical results from two independent clinical trials in subjects with chronic HDV infection, HH003-201 (NCT05674448) and HH003-204 (NCT05861674). The result of HH003-201 study has been presented at the European Association of Liver Diseases 2023 Annual Meeting. The HH003-204 study remains ongoing, and Huahui Health will publish the final results when it is completed. The FDA BTD is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening disease or condition. The BTD grant for Libevitug enables it to benefit from all Fast Track designation features, including FDA's guidance on efficient drug development and expedited regulatory review in the U.S., and ultimately can accelerate its development and enhance accessibility for chronic HDV infected patients worldwide. "Libevitug received BTD from the China NMPA (National Medical Products Administration) in April 2023 for the treatment of chronic HDV infection. Today's FDA BTD further signifies a remarkable step forward in the clinical development of Libevitug. We are fully committed to bringing this new therapeutic option to HDV patients worldwide the soonest we can." commented Dr. Bin Chen, CEO of Huahui Health. About chronic HDV infection: HDV is a liver targeting RNA virus dependent on Hepatitis B Virus (HBV) in replication. HDV requires HBV for assembly and infects hepatocytes via the receptor sodium taurocholate co-transporting polypeptide (NTCP). Chronic HDV infection always co-exists with HBV infection, and the co-infection is regarded as the most severe viral hepatitis due to rapid progression into cirrhosis and hepatocellular carcinoma. According to the WHO, it is estimated that 15 to 20 million people worldwide are chronically infected with HDV. The WHO 2024 guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection recommend reflecting test for HDV infection in populations that are hepatitis B surface antigen (HBsAg) positive, where it is practical. At present, there are no approved drugs for the treatment of chronic HDV infection in China and in the U. S.. About Libevitug (HH-003): Libevitug is an innovative anti-HBV/HDV neutralizing antibody specifically targeting the pre-S1 domain of the viral large envelope protein. It blocks the binding of HBV and HDV to their receptor NTCP, thereby preventing the virus from entering hepatocytes and neutralizing HBV/HDV infection infection. About Huahui Health Ltd. (HHHbio)： Founded in 2015, Huahui Health Ltd. (HHHbio) is committed to developing innovative therapies for liver diseases and oncology, with a focus on chronic hepatitis B and D (HBV and HDV), two of the world's most prevalent and devastating infectious diseases. Leveraging deep expertise in disease biology and protein engineering, we have further expanded our pipeline to include multiple first- and best-in-class candidates in the area. Guided by our core values—Innovation, Truth-Seeking, and Collaboration—we strive to become a globally respected leader in biopharmaceuticals. SOURCE Huahui Health Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Breakthrough TherapyFast TrackClinical Result

04 Apr 2024

·www.prnewswire.com

Huahui Health to Present Preclinical Data of HH018-sesutecan at the 2024 AACR Annual Meeting

BEIJING, April 4, 2024 /PRNewswire/ -- Huahui Health Ltd.("Huahui Health"), a clinical stage biotechnology company focused on discovering and developing virology, hepatology, and oncology therapies, announced that it will present the results of preclinical data of HH018-sesutecan, a tumor microenvironment targeting CD98-directed ADC, at the American Association for Cancer Research (AACR) Annual Meeting 2024. The AACR meeting will be held April 5–10, 2024, in San Diego, California. Topic: A tumor microenvironment-targeting CD98-directed ADC confers robust anti-tumor activity in multiple cancers with favorable pharmacokinetics and safety profiles in preclinical models Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 4 Session Date and Time: Wednesday Apr 10, 2024 9:00 AM - 12:30 PM Location: Poster Section 54 Poster Board Number: 1 Abstract Presentation Number: LB425 Presenter: Bin Chen, CEO of Huahui Health. Zhu Chen, CSO of ProfoundBio About Huahui Health Huahui Health is a clinical-stage biotechnology company founded in 2015 in Beijing, China. With a focus on virology, hepatology, and oncology, the company is dedicated to drug discovery, development, and antibody engineering. It has expanded its pipeline to include promising drug candidates in virology and oncology, aiming to launch multiple groundbreaking products and lead the way in antiviral and oncology research. Two leading programs have entered the pivotal clinical trial stage. One is HH-003, the first anti-preS1 HBV/HDV neutralizing antibody to enter a pivotal study for chronic HDV infection. The other is HH-120, an IgM-like ACE2-Fc recombinant fusion protein via nasal spray, currently undergoing a phase 3 trial for post-exposure prophylaxis of SARS-CoV-2. For more information, please visit . SOURCE Huahui Health Ltd.

Phase 3AACR

100 Deals associated with Libevitug

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis D, Chronic	China	Huahui Health Ltd.	20 Jan 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Viremia	Phase 2	China	Huahui Health Ltd.	14 Jul 2022
Hepatitis B, Chronic	Phase 2	China	Huahui Health Ltd.	05 Aug 2021

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05861674 (HH003-204, NEWS \| AASLD2025) Manual	Phase 2	Hepatitis D, Chronic	94	立贝韦塔单抗20 mg/kg	xsfeivhbep(uxrgsjbyxp) = pttzaxhmmh hegnvgvcdj (gdhyqkrtze ) Met View more	Positive	10 Nov 2025
				立贝韦塔单抗10 mg/kg	xsfeivhbep(uxrgsjbyxp) = btnsimvvqh hegnvgvcdj (gdhyqkrtze ) Met View more
NCT05674448 (EASL2023) Manual	Phase 2	Hepatitis B, Chronic \| Hepatitis D	9	HH-003	skmkcullve(hbeslvwytk) = czotmpvebo vixaywokpq (ohyhoshpil, -3.88 to 0.35) View more	Positive	21 Jun 2023
CTR20191480 \| NCT05542979 (NEWS) Manual	Phase 1	Hepatitis B, Chronic	68	HH-003	slpsqvqovn(nnicvhbbun) = HH-003在研究中展现出了良好的安全性和抗病毒活性，在免疫清除组受试者中，经HH-003每两周一次静脉注射，共三次给药后，明确观察到了HBV DNA及乙肝表面抗原的下降 crypxzfvio (kqaknahjoh )	Positive	08 Nov 2022
				Placebo

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