BELX BioPharma

What BELX BioPharma does

BelleX Bio-Pharmaceutical (Taiwan) Corporation is a privately-held, pre-revenue R&D-stage biotech founded in March 2016 as an ITRI spinoff and headquartered in the Hsinchu Biomedical Science Park, Taiwan. The company develops botanical new drugs to treat chronic hepatitis B, cancer cachexia, and advanced refractory solid tumors, with its lead candidate BEL-X positioned as a single-compound botanical drug that operates through a novel reactive oxygen species (ROS) inhibition mechanism to reduce oxidative stress and inflammation. The company's development program traces back to MOEA-funded research programs initiated in 2000 on Chinese herbal medicines for liver disease and inflammation, with technology transferred exclusively from ITRI in September 2016.

The BEL-X platform is anchored on proprietary wet-lab science: a HBV Stable Expression Cell Platform demonstrating that BEL-X used as an add-on to nucleoside analogs (NAs) inhibits both HBV replication and production of HBe and HBs antigens, complemented by PIC/S-cGMP manufacturing standards, DNA-authenticated raw materials, and a GACP plantation partnership with Taiwan's Council of Agriculture. Global IP coverage comprises 45 patents across 7 families in 28 countries (exclusively authorized by MOEA in February 2022), with BELX trademarks registered in Taiwan, China, and Hong Kong during 2021. The company also operates a TAF-accredited (Accreditation No. 3607) ISO/IEC 17025:2017 testing laboratory providing cellular oxidative stress and ROS-related enzyme assay services.

Commercially, BelleX is pre-revenue and depends on Phase I trial sites (National Taiwan University Hospital and National Cheng Kung University Hospital) and government programs for clinical advancement. The Phase I trial of BEL-X in advanced refractory solid tumors was completed in April 2020 with reported excellent safety and body-weight maintenance outcomes; an IND for a Phase II adaptive design trial in HBeAg-positive chronic hepatitis B was filed with both US FDA and Taiwan FDA in H1 2023. The leadership team is composed of PhD-level scientists with prior ITRI backgrounds, including CEO Dr. Shau-Feng Chang (former ITRI principal researcher). Revenue generation is presently limited to ancillary TAF testing services, with primary commercial returns contingent on future licensing or commercialization events post-regulatory approval.

Name

BELX BioPharma

Legal name

BELX Bio-Pharmaceutical (Taiwan) Corporation

Website

https://belxbiopharma.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

BELX BioPharma is a Taiwan-based, ITRI-spinoff biotech developing the botanical new drug BEL-X, which uses ROS inhibition to treat chronic hepatitis B, cancer cachexia, and refractory solid tumors, currently pre-revenue at the Phase I/II clinical stage.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412), Medicinal and Botanical Manufacturing (325411)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Botanical drug development
• Hepatitis B treatment
• Cancer cachexia therapy
• Biotech clinical trials
• Oxidative stress research

Headquarters

HQ city

Taipei

HQ country

Taiwan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations

Revenue model

1. Botanical New Drug Development and Commercialization: BELX is a pre-revenue R&D stage biotech company developing botanical new drug BEL-X for treatment of chronic hepatitis B, cancer cachexia, and solid tumors. Revenue will be generated through drug commercialization upon regulatory approval.
2. TAF Accredited Testing Services: BELX provides independent, impartial, confidential, and cost-effective testing services for accredited items including cellular oxidative stress tests and ROS-related enzyme tests. Services help customers enter international markets.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels8 records

Core offering

BELX BioPharma develops botanical new drugs, with lead candidate BEL-X targeting chronic hepatitis B, cancer cachexia, and advanced refractory solid tumors through a novel ROS inhibition mechanism that reduces oxidative stress and inflammation. The company also operates a TAF-accredited (ISO/IEC 17025:2017) testing laboratory providing cellular oxidative stress and ROS-related enzyme testing services for pharmaceutical and biotech clients.

Product overview

BELX BioPharma is a research and development biotech company focused on botanical new drug development. Its core product portfolio consists of BEL-X, a botanical new drug targeting chronic hepatitis B, solid tumors, and cancer cachexia through mechanisms involving ROS inhibition and oxidative stress reduction. Additionally, the company operates a TAF-accredited (Accreditation No. 3607) testing laboratory providing ISO/IEC 17025:2017 compliant testing services for intracellular oxidative stress and ROS-related enzymes. The company is in clinical development stage with Phase I completed and Phase II trials planned.

Differentiator

Problem solved

Functional benefit

Products and services

• BEL-X (Botanical New Drug) BEL-X is a botanical new drug candidate composed of a single medicinal plant compound that targets ROS imbalance. It blocks viral attachment in HBV cell-based infection systems, reduces viral entry into hepatocytes, and inhibits both HBV replication and HBe/HBs antigen production when used with nucleoside analogs. It also maintains body weight, muscle mass and strength in cancer cachexia and solid tumor patients. Currently Phase I completed; Phase II IND filed for chronic hepatitis B in first half of 2023.
• TAF Testing Laboratory Services (Accreditation No. 3607) ISO/IEC 17025:2017 accredited testing services covering cellular oxidative stress biological activity tests, ROS-related enzyme tests (MDA, Catalase, Glutathione peroxidase), microbial limit tests, and cytokine tests. Provides independent, impartial, and confidential testing for pharmaceutical companies and Chinese herbal medicinal material clients to support entry into international markets.

Quantifiable outcome

• Excellent safety with no serious side effects at maximum tolerated dose in Phase I trial
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Council of Agriculture, Executive YuancoreStrategic or Co-development Partner · 1 May 2021Successfully technology transferred GACP (Good Agricultural and Collection Practice) plantation from Council of Agriculture. Cooperation to carry out medicinal material GACP plantation for botanical raw material quality control.
• Taiwan Accreditation Foundation (TAF)minorOthers · 1 June 2020TAF accredited BELX Testing Laboratory (Accreditation No. 3607) under ISO/IEC 17025:2017 standards in December 2019. TAF-ILAC combination logo licensed effective January 2020.
• National Taiwan University HospitalcoreStrategic or Co-development Partner · 1 January 2017Phase I clinical trial site for botanical new drug BEL-X in patients with advanced refractory solid malignancies. IRB approval obtained April 2017. Prof. Pei-Jer Chen serves as main principal investigator for Phase II HBV trial.
• National Cheng Kung University HospitalcoreStrategic or Co-development Partner · 1 January 2017Phase I clinical trial site for botanical new drug BEL-X. IRB approval obtained April 2017.
• ITRI (Industrial Technology Research Institute)coreStrategic or Co-development Partner · 1 September 2016Exclusive technology transfer agreement signed September 2016 for botanical new drug BEL-X development. BELX spun off from ITRI. Company stationed in ITRI Incubation Center.

Scale indicators7 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• TaiMed Biologics: Taiwan-based clinical-stage biotech developing biologics for infectious disease and oncology indications. Comparable as a same-country clinical developer with similar regulatory pathway and Asian commercialization considerations.
• Lumosa Therapeutics: Taiwan specialty pharmaceutical company developing therapeutics for neurological and inflammatory conditions. Comparable as a same-country specialty drug developer at similar company size and partnership-oriented business model.
• Assembly Biosciences: Clinical-stage biotechnology company developing curative therapies for chronic hepatitis B, directly competing with BEL-X in the HBV functional cure space. Comparable as a focused, single-disease HBV therapeutics developer pursuing novel mechanisms.
• Medigen Biotechnology: Taiwan-based clinical-stage biotech developing novel therapeutics including cell therapy and small molecules. Comparable as a same-country, similar-stage biotech navigating similar regulatory and partnership dynamics in Asia.
• PharmaEngine: Taiwan-based clinical-stage oncology biotech focused on novel oncology drug development, with comparable company size, stage, and Taiwan-based operational footprint. Most directly comparable regional peer in clinical-stage biotech development.
• Arbutus Biopharma: Clinical-stage biopharmaceutical company focused on developing a functional cure for chronic hepatitis B via RNAi and oral antiviral approaches, with the same lead indication as BELX. Directly comparable as a pre-commercial HBV cure competitor at a similar development stage.

Emerging players

• Virion Therapeutics: Emerging biotechnology company developing novel immunotherapies and functional cures for chronic hepatitis B. Comparable as an early-stage competitor pursuing differentiated HBV cure mechanisms in the same niche.

Regional players

• SciClone Pharmaceuticals: Asia-Pacific focused specialty pharmaceutical company with established presence in chronic HBV treatment markets across China and surrounding region. Comparable as a regional player sharing the HBV therapeutic commercial footprint BELX targets.

Broad incumbents

• Gilead Sciences: Established HBV market leader through Vemlidy (tenofovir alafenamide) and broader antiviral franchise, and major oncology participant. Comparable as the dominant large-cap incumbent that BEL-X would either partner with or compete against in HBV.
• Roche: Major pharmaceutical incumbent with established HBV franchise (Pegasys/peginterferon alfa-2a) and global oncology leadership. Comparable as a likely partnership counterparty and competitive incumbent across both of BELX's lead indications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BELX BioPharma