GenFleet Therapeutics

Name

GenFleet Therapeutics

Legal name

劲方医药科技（上海）股份有限公司

Website

https://genfleet.com

Company type

Public

Founded year

2017

Operating status

Ipo

Headcount range

51–100 employees

Ownership category

akta.pro rank

Product category

Oncology Pharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

akta.pro secondary industry

Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)

Keywords

• Oncology drug development
• Small molecule inhibitors
• Bispecific antibodies
• KRAS targeted therapy
• Antibody drug conjugates

Headquarters

HQ city

Shanghai

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Drug Development and Commercialization: GenFleet develops proprietary drug candidates through clinical stages and commercializes approved drugs in China, with out-licensing partnerships covering global development and commercialization rights outside mainland China. Revenue will come from drug sales in China and milestone/royalty payments from international partners upon regulatory approvals and sales milestones.
2. Out-licensing Deal Payments: The company generates upfront, development milestone, and sales milestone payments through technology out-licensing deals. Examples include: GFH925 to Innovent Biologics ($22M upfront + up to $500M milestones + royalties), GFH009 to SELLAS Life Sciences ($10M upfront + up to $130M milestones + royalties), GFH375/VS-7375 to Verastem Oncology (option exercise + milestones + royalties).

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

GenFleet Therapeutics is a clinical-stage biotechnology company that discovers, develops, and out-licenses innovative small-molecule and large-molecule drugs targeting oncology and immunology indications. Its portfolio centers on a RAS-targeted therapy matrix (KRAS G12C, G12D, and Pan-RAS inhibitors), complemented by proprietary FAScon™ antibody-drug conjugate platform programs and a bispecific antibody pipeline. The company's first commercial product, fluorzerasib (Dabote®, GFH925), is China's first approved KRAS G12C inhibitor and was included in the 2025 National Reimbursement Drug List.

Product overview

GenFleet Therapeutics is a globally positioned innovative drug development company focused on oncology and immunology. Its portfolio spans small molecule inhibitors and bispecific antibodies, centered on a deeply-invested RAS targeting therapy matrix covering multiple targets (KRAS G12C, KRAS G12D, Pan RAS), molecular types (selective and pan-RAS inhibitors), and several drug modalities including small molecules, bispecific antibodies, and ADCs. The lead product is 达伯特® (氟泽雷塞, GFH925), a KRAS G12C inhibitor marketed in China under license to Innovent Biologics. GFH375/VS-7375, a KRAS G12D (ON/OFF) inhibitor, is partnered with Verastem Oncology for ex-Greater China rights and is in Phase 3 (PDAC) and Phase 2 registration trials (PDAC/NSCLC/CRC). The company also has the proprietary FAScon™ ADC platform, which generated GFS784 (EGFR-Pan RAS ADC) in pre-clinical stage. Other clinical programs include GFH018 (TGF-β R1 inhibitor), GFH009 (CDK9 inhibitor, licensed to SELLAS), GFH312 (RIPK1 inhibitor), and GFS202A (GDF15/IL-6恶病质 bispecific antibody).

Differentiator

Problem solved

Functional benefit

Brands

• 达伯特: Brand name for fluorzerasib (GFH925), China's first domestically approved KRAS G12C inhibitor and the third globally approved KRAS G12C inhibitor; the first product in GenFleet's pipeline to receive marketing approval in China.
• FAScon

Products and services

• Fluorzerasib (Dabote® / GFH925) Oral small molecule KRAS G12C inhibitor developed by GenFleet for the treatment of KRAS G12C-mutated non-small cell lung cancer (NSCLC). Licensed to Innovent Biologics for China development and commercialization. The drug covalently binds the KRAS G12C mutant protein, locking it in an inactive GDP-bound state and inhibiting downstream MAPK pathway signaling.
• GFH375/VS-7375 Oral high-activity, high-selectivity non-covalent small molecule KRAS G12D (ON/OFF) inhibitor targeting KRAS G12D-mutant solid tumors including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), and colorectal cancer (CRC). Global development ex-Greater China is partnered with Verastem Oncology (VS-7375) under an exclusive license.
• GFH018 Oral small molecule TGF-β R1 inhibitor that targets the tumor microenvironment by inhibiting TGF-β signaling, with potential synergistic effects when combined with PD-1 inhibitors. In Phase 2 clinical trials for solid tumors (lung cancer, liver cancer, urothelial carcinoma) as monotherapy and in combination with PD-1 inhibitors and chemoradiotherapy. Developed independently by GenFleet.
• GFH009 Highly selective CDK9 inhibitor for injection that targets the transcription elongation factor P-TEFb, inducing apoptosis in cancer cells by suppressing anti-apoptotic proteins such as MCL-1 and c-MYC. Licensed to SELLAS Life Sciences (NASDAQ: SLS) for global development and commercialization outside Greater China. In Phase 1/2 trials for hematological malignancies (AML, CLL, lymphoma) and solid tumors.
• GFH312 RIPK1 inhibitor for oral administration targeting the necroptosis pathway. Being developed for peripheral arterial disease with intermittent claudication and primary cholangitis. Phase I trial completed in Australia; Phase II initiated in the US. Phase I showed excellent safety with RIPK1 phosphorylation inhibition observed at all doses and CNS exposure at 120 mg. China's first clinical-stage RIPK1 inhibitor.
• GFS202A World's first GDF15/IL-6 bispecific antibody for the treatment of cancer cachexia, designed to address cancer wasting through dual-pathway inhibition of GDF15 and IL-6. Phase 1 data showed excellent safety/tolerability with complete and sustained GDF15 inhibition at 200 mg Q3W dose, mean body weight increase ≥5% at 6 weeks, and L3 skeletal muscle index improvement of 2.94 cm²/m².
• GFH276 Pan-RAS (ON) inhibitor in pre-clinical/early clinical development as part of GenFleet's multi-target, multi-molecule-type RAS therapy matrix. Animal studies showed lower effective dose than overseas competitors, with significant synergistic effects in combination with standard-of-care treatments. Leading domestic pan-RAS inhibitor in China.
• GFS784 EGFR-Pan RAS ADC developed on GenFleet's proprietary FAScon™ platform. First-in-class ADC combining a molecular glue Pan RAS (ON) inhibitor payload with cetuximab (EGFR antibody). Preclinical data showed potent antitumor activity in RAS-mutant, EGFR-mutant, TKI-resistant, and DXd-sensitive/insensitive tumor models, with single-agent activity comparable to combination of oral RAS inhibitor plus cetuximab.

Quantifiable outcome

• GFH375 Phase 1/2 monotherapy in PDAC: ORR 41%, DCR 96.7%, mOS not reached; in CCA (biliary tract cancer): ORR 40%, DCR 95%, mPFS 6.2 months; in CRC: mPFS 4.1 months, mOS 10.3 months
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered supporting, core and major.

• ErascasupportingStrategic or Co-development Partner · 1 October 2025Verastem Oncology (GenFleet's partner for VS-7375) announced plans to enter into a collaboration with Erasca to explore preclinical evaluation and potential clinical studies combining KRAS G12D inhibitors with pan-RAS inhibitors, announced June 2026.
• Verastem Oncology (NASDAQ: VSTM)coreStrategic or Co-development Partner · 1 August 2023In August 2023, GenFleet and Verastem Oncology entered into an exclusive license and early-stage co-development agreement for three product candidates including GFH375. Verastem exercised its option for GFH375 (renamed VS-7375) in January 2025, acquiring global development and commercialization rights outside mainland China, Hong Kong, Macau, and Taiwan. Verastem is conducting Phase 1/2 TARGET-D 101 trial and Phase 2 registration-directed trials for PDAC, NSCLC, and CRC in the US. The collaboration also includes ongoing Phase 1/2 trials for other indications.
• SELLAS Life Sciences (NASDAQ: SLS)majorStrategic or Co-development Partner · 1 April 2022In April 2022, GenFleet and SELLAS Life Sciences entered into an exclusive license agreement for GFH009 (CDK9 inhibitor) outside Greater China. Deal terms: $10M upfront + up to $130M in development and sales milestones + royalties. SELLAS is conducting Phase 1/2 trials in AML (including combination with venetoclax) and solid tumors (Ewing sarcoma, rhabdomyosarcoma).
• Junshi Biosciences (君实生物) - toripalimabmajorStrategic or Co-development Partner · 21 October 2021GenFleet's GFH018 (TGF-β R1 inhibitor) is being evaluated in a global multi-center Ib/II clinical trial in combination with toripalimab (特瑞普利单抗), Junshi Biosciences' PD-1 inhibitor. The first patient was dosed in Australia in October 2021. Trial evaluating combination therapy in advanced solid tumors including nasopharyngeal carcinoma.
• Innovent Biologics (HKEX: 01801)coreStrategic or Co-development Partner · 2 September 2021In September 2021, GenFleet and Innovent Biologics entered into a global exclusive license agreement for GFH925 (dabulizumab/KRAS G12C inhibitor). Innovent received exclusive China (mainland, Hong Kong, Macau, Taiwan) development and commercialization rights with global development and commercialization options. Deal terms included $22M upfront + up to $500M in development and sales milestones + royalties. Dabulizumab (达伯特®) became China's first approved KRAS G12C inhibitor and was included in the 2025 NRDL.
• Insilico Medicine (英矽智能)supportingTechnology or Integration · 23 July 2021In July 2021, GenFleet entered into a strategic partnership with Insilico Medicine, a leading AI-driven drug discovery company, to leverage Insilico's end-to-end AI drug development platform for novel target identification and molecule design in oncology and immunology.
• Baiyao De (佰翱得)supportingTechnology or Integration · 23 July 2021In July 2021, GenFleet entered into a strategic partnership with Baiyao De (佰翱得), a leading structural biology platform company, to leverage their protein expression, purification, and structural analysis services for target validation and structure-based drug design.

Scale indicators5 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• Erasca: US-based clinical-stage biotech developing pan-RAS and ERK inhibitor programs (ERAS-007, ERAS-801). Direct competitor in the pan-RAS targeting space where GenFleet's GFH276 also operates.
• Revolution Medicines: US clinical-stage oncology company developing RMC-6236 (pan-RAS(ON) inhibitor) and RMC-9805 (KRAS G12D selective) in Phase III for PDAC and NSCLC. Direct competitor to GFH375 targeting the same RAS-mutant patient populations.
• Hutchmed (HUTCHMED): Hong Kong-listed Chinese oncology biotech with multiple approved drugs (surufatinib, savolitinib, fruquintinib) and similar pathway from China-innovation-rooted drug development toward global commercialization. Closest comparable in size, geography, and stage.
• Jacobio Pharmaceuticals: Beijing-based clinical-stage biotech developing KRAS G12C inhibitor glecirasib (approved in China 2024) and KRAS G12D inhibitor JAB-30300. Direct competitor in Chinese KRAS space with same target focus and 18A-style funding trajectory as GenFleet.
• Mirati Therapeutics (Bristol-Myers Squibb): Developed Krazati (KRAS G12C inhibitor) and MRTX1133 (KRAS G12D inhibitor) prior to BMS's $4.8B acquisition. Direct competitive overlap with GenFleet's KRAS programs in PDAC and NSCLC.
• Cstone Pharmaceuticals: HKEX-listed (2616.HK) Chinese clinical-stage oncology innovator with similar 18A-style biotech positioning. Comparable for size, stage, and oncology focus, including GAVRETO and other targeted oncology programs.

Broad incumbents

• BeiGene: Large global Chinese-rooted oncology biotech with approved Brukinsa, tislelizumab, and pamiparib. Comparable for Chinese-innovator-to-global commercialization trajectory, though substantially larger scale and more diversified.
• Innovent Biologics: Larger Chinese biopharma (HKEX-listed) commercializing tyvyt and multiple oncology assets. Partner for GenFleet's GFH925 (Dabote®) in China and broadly comparable as a leading Chinese oncology innovator, though larger and more diversified.

Emerging players

• Relay Therapeutics: US clinical-stage precision oncology company with RLY-4008 (FGFR2) and PI3Kα programs. Comparable as a target-driven oncology biotech pursuing biomarker-defined patient populations, relevant to GenFleet's RAS mutation focus.
• Verastem Oncology: Smaller US oncology company commercializing VS-7375/GFH375 outside Greater China. Direct commercial partner for GenFleet's lead KRAS G12D asset and a smaller emerging oncology player with overlapping pipeline.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/genfleet-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors25 records

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M&A

Investments

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Frequently asked questions about GenFleet Therapeutics