What HiFiBiO Therapeutics does

HiFiBiO Therapeutics is a clinical-stage biotechnology company that develops antibody immunotherapies for oncology and inflammatory/immunology diseases, anchored by its proprietary Drug Intelligence Science (DIS®) platform. The platform combines proprietary single-cell microfluidic screening (CelliGo™), ML-driven bioinformatics (AbSolution™) and predictive biomarker analytics to drive target identification, antibody selection and patient stratification from discovery through clinical development. HiFiBiO has discovered eight clinical candidates, cleared six FDA INDs and completed four Phase I dose-escalation trials, with three active Phase I programs in immuno-oncology (emunkitug/HFB200301 TNFR2 agonist, nivustotug/HFB301001 OX40 agonist, HFB200603 BTLA antagonist) and one Phase I-ready I&I asset (HFB200604 BTLA agonist), plus preclinical assets in I&I.

The company operates a global R&D footprint spanning Cambridge, Massachusetts (headquarters), Paris, Shanghai and Hong Kong. Its commercial model is partnership-driven rather than product-based: HiFiBiO out-licenses pipeline assets, engages in co-development, and collaborates on translational science with pharmaceutical and biotech partners, with economics structured as upfront payments, development and commercial milestones, and royalties. The largest disclosed commercial relationship is a transformative 2021 partnership with FibroGen covering three programs (Galectin-9, CXCR5, CCR8), worth $25 million upfront, a $35 million CCR8 option-exercise payment and up to $1.1 billion in potential milestones plus royalties, supplemented by 12+ additional partnerships, academic collaborations (Institut Gustave Roussy REMISSION program, UMass Chan Medical School) and grant funding (Balvi/Patient-Led Research Fund).

The company is privately held, raised approximately $179.5 million across Series B ($37.5M, 2018), Series C ($67M, 2019) and Series D ($75M, 2021) rounds led respectively by HSG/LYFE Capital, IDG Capital and Mirae Asset Financial Group. Its investor base and board include IDG Capital, Mirae Asset Capital, Nest.Bio Ventures and HongShan. Revenue from product sales is non-existent as of the input data; reported top-line activity derives from collaboration milestones, upfronts, grants and option-exercise payments.

Name

HiFiBiO Therapeutics

Legal name

HiFiBiO Inc.

Website

https://hifibio.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

HiFiBiO Therapeutics is a clinical-stage biotech developing antibody immunotherapies for cancer and inflammatory diseases using its proprietary Drug Intelligence Science (DIS®) platform, which combines single-cell technology with AI/ML analytics for antibody discovery and biomarker identification.

Ownership category

akta.pro rank

Product category

Clinical-stage Biotechnology (Immuno-Oncology / Immunology & Inflammation Therapeutics)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

akta.pro secondary industries

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA), High-Throughput Screening & Assay Platforms (HTS/HCS, phenotypic screening) (HLAAAIAA), AI/ML-Enabled Biologic Discovery Platforms (computational design, in silico screening) (HLAAAIAE)

Keywords

• Single cell antibody discovery
• Immuno-oncology drug development
• Clinical stage biotechnology
• Predictive biomarker discovery
• AI driven immunotherapy

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Partnership and Licensing Revenue: Out-licensing of pipeline assets and technology platforms to pharmaceutical partners. Includes upfront payments, milestone payments (clinical, regulatory, commercial), and royalty payments based on net sales.
2. Equity Financing: Series D funding round of $75 million led by Mirae Asset Financial Group to accelerate immuno-oncology pipeline and advance antibody assets into Phase I trials.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

HiFiBiO Therapeutics is a clinical-stage biotech that develops transformative immunotherapies using its proprietary Drug Intelligence Science (DIS®) platform, which combines microfluidic single-cell technology with AI/ML analytics for target discovery, antibody selection, and predictive biomarker identification. The company advances a pipeline of antibody programs in immuno-oncology and immunology/inflammation, out-licensing pipeline assets, co-developing with pharma partners, and offering technology collaborations to enhance clinical probability of success.

Product overview

HiFiBiO Therapeutics is a clinical-stage biotech company that has developed a unified product ecosystem centered on its Drug Intelligence Science (DIS®) platform. The DIS® platform combines proprietary single-cell technology (including CelliGo™ for B cell screening and AbSolution™ for bioinformatics analysis) with AI/ML analytics to drive drug discovery and development. The company applies this platform to build a sustainable pipeline of immunomodulatory antibody programs across two therapeutic areas: Immuno-Oncology (including Emunkitug/HFB200301, HFB200603, and Nuvustotug/HFB301001 in clinical Phase I) and Immunology & Inflammation (including HFB200604 in Phase I and HFB3024, HFB100204 in preclinical). The company also leverages the DIS® platform to discover novel targets and predictive biomarkers, and has established 12+ partnerships with pharmaceutical companies.

Differentiator

Problem solved

Functional benefit

Products and services

• Drug Intelligence Science (DIS®) Platform

Quantifiable outcome

• 8 clinical candidates discovered since 2017
• +3 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature3 records

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• AbCellera Biologics: Antibody discovery platform company combining microfluidics, single-cell screening, and ML to generate therapeutic antibody candidates. Highly comparable to HiFiBiO's CelliGo™/AbSolution™ workflow and partnership-driven business model.
• Compass Therapeutics: Clinical-stage biotech developing a pipeline of antibody therapeutics in immuno-oncology with a proprietary discovery platform. Directly comparable therapeutic focus (IO antibodies) and platform-enabled pipeline model.
• Adagene: Clinical-stage antibody therapeutics company using AI-powered discovery platforms (POWERbody, SAFEbody) to generate IO candidates. Comparable platform-plus-pipeline biotech with similar discovery-to-clinical-stage profile.
• Werewolf Therapeutics: Clinical-stage biotech developing conditionally activated IO therapeutics including TNFR2 and other immune agonists. Directly comparable IO pipeline and IND-to-Phase I clinical-stage positioning.

Emerging players

• Bicara Therapeutics: Clinical-stage biotech developing antibody therapeutics that combine IO and I&I mechanisms, with a focus on bispecifics. Comparable clinical-stage status and dual IO/I&I therapeutic scope.
• Immuneering: Clinical-stage biotech applying AI/ML to drug discovery and translational medicine, with oncology and I&I programs. Comparable AI-driven translational approach though applied to small molecules as well as biologics.
• Harbour BioMed: Clinical-stage antibody therapeutics company with proprietary transgenic animal platforms for antibody discovery. Comparable antibody-discovery-platform-plus-pipeline model and historical HiFiBiO investor relationship (BD leadership alumni).
• Pandion Therapeutics: Was a clinical-stage biotech developing targeted I&I therapies (acquired by Merck in 2021). Representative peer for the I&I autoimmune therapeutic area HiFiBiO is now entering with HFB200604 and related programs.

Broad incumbents

• Compugen: Computational biology company using predictive discovery platforms to identify novel IO targets and antibody candidates. Broader and more established than HiFiBiO but with a comparable AI/predictive-platform-plus-IO-pipeline model.
• Schrödinger: Computational drug discovery platform company combining physics-based simulation with ML for biologics and small molecules. Broader scope than HiFiBiO but a comparable AI/ML-enabled discovery philosophy.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/hifibio
• Xx.com/hifibio

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds5 records

Investors21 records

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

M&A1 record

Investments

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

Frequently asked questions about HiFiBiO Therapeutics