What Pregene does

Pregene is a Shenzhen-based clinical-stage biopharmaceutical company founded in 2012 and listed on the Shenzhen Stock Exchange (stock code: 874090) since March 2022, focused on cell and gene therapy drugs. The company operates an integrated five-platform technology stack covering nanobody screening, immune cell drug discovery (CAR-T/CAR-NK/TCR-T), plasmid/viral vector process development, cell process development and manufacturing, and iPSC reprogramming with multi-gene editing. Its lead clinical asset PRG1801 is an autologous anti-BCMA CAR-T therapy that has received NMPA clinical trial approvals for multiple indications including relapsed/refractory multiple myeloma (March 2020, first CAR-T clinical approval in South China) and three autoimmune indications (refractory lupus nephritis, IgG4-related disease, and primary immune thrombocytopenia) cleared in March 2026.

The business model is asset-light and licensing-centric rather than direct commercialization. Pregene monetizes through (i) upfront payments and development/regulatory milestones plus tiered royalties on net sales of licensed products — exemplified by a $120M upfront / up to $1.52B biobucks deal with Kite Pharma (Gilead) for next-generation in vivo therapies signed October 2025 and a $5M upfront / up to $150M royalty deal with Dr. Reddy's for India rights to PRG1801; (ii) ongoing supply of lentiviral vectors as the exclusive raw-material supplier to licensees; and (iii) regional sublicensing across Greater China, India, and Europe. Customers are global pharmaceutical partners rather than end patients; clinical-stage product evidence includes treatment of 34 patients with PRG1801 in non-registered trials and durable drug-free remission exceeding 17 months in IgG4-RD patients. Operational footprint is approximately 80+ R&D personnel and 10,000 sqm of laboratory space in Pingshan District, Shenzhen.

Name

Pregene

Legal name

深圳普瑞金生物药业股份有限公司

Website

https://pregene.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Pregene is a Shenzhen-based, publicly listed clinical-stage biotech developing CAR-T, CAR-NK, TCR-T, and nanobody-based cell and gene therapies across hematologic malignancies, solid tumors, and autoimmune diseases, monetizing through global licensing deals and exclusive viral vector supply to pharma partners.

Ownership category

akta.pro rank

Product category

Cell and Gene Therapy Biopharmaceuticals

NAICS

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

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

akta.pro secondary industries

Genome Editing Gene Therapies (CRISPR/TALEN/ZFN; in vivo/ex vivo) (HLAAACAD), Stem Cell–Based Regenerative Therapies (HLAAAGAA), Engineered Protein Therapeutics (de novo/AI-designed proteins, novel scaffolds) (HLAAAAAJ)

Keywords

• Cell therapy drugs
• Gene therapy platform
• CAR-T cell therapy
• Nanobody screening
• Viral vector production

Headquarters

HQ city

Pingshan

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Licensing and Milestone Payments: Revenue from upfront payments, contingent milestone payments tied to development and regulatory achievements, and tiered royalties based on net sales of licensed products. Examples include $120M upfront from Kite with up to $1.52B in milestones, and $5M upfront from Dr. Reddy's with up to $150M in royalties.
2. Viral Vector Supply: As the exclusive supplier of core raw materials (viral vectors) for licensed CAR-T products, Pregene receives ongoing supply revenue from partners for manufacturing and supplying lentiviral vectors.
3. Product Commercialization: Revenue from commercialization of proprietary cell and gene therapy products in global markets through regional partnerships and direct sales.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

Pregene is a clinical-stage biopharmaceutical company that discovers, develops, and licenses cell and gene therapy drugs. Its integrated platform spans nanobody screening, immune cell drug discovery, plasmid/viral vector process development, cell process development and production, and iPSCs reprogramming and multi-gene editing. Core therapeutic products include autologous anti-BCMA CAR-T cell therapy (PRG1801), allogeneic CAR-NK cell therapies, TCR-T programs, and stem cell therapies targeting hematologic malignancies, solid tumors, and autoimmune diseases.

Product overview

Pregene is a clinical-stage biopharmaceutical company developing cell and gene therapy products. The company operates an integrated platform combining multiple technology systems: nanobody screening platform, immune cell agent discovery platform, plasmid/viral vector process development and production platform, cell process development and production platform, and iPSCs reprogramming and multi-gene editing platform. The core product portfolio includes CAR-T cell therapies (such as PRG1801 anti-BCMA CAR-T), CAR-NK cell therapies, TCR-T programs, and nanobody-based therapeutics. Products target hematologic malignancies, solid tumors, and autoimmune diseases. The company has achieved IND approvals and conducted clinical trials in China, and has established global licensing partnerships for its CAR-T technology.

Differentiator

Problem solved

Functional benefit

Products and services

• Nanobody Screening Platform High-throughput nanobody (VHH) screening platform producing antigen-binding domains with high affinity and specificity for use in CAR-T cell therapies and multi-functional antibody construction. For biopharma partners and internal drug discovery.
• CAR-T Cell Therapy Chimeric antigen receptor T cell therapy products that engineer patient T lymphocytes to recognize and attack tumor cells. Targets include BCMA and other antigens for hematologic malignancies and autoimmune diseases. Licensed to partners for global/regional commercialization.
• CAR-NK Cell Therapy Allogeneic off-the-shelf CAR-NK cell drugs prepared by engineering NK cells from healthy donors with CAR constructs. Universal cell drugs that do not cause graft-versus-host disease and generally do not induce cytokine storm. Licensed for indications including multiple myeloma.
• PRG1801 Anti-BCMA CAR-T Autologous anti-BCMA CAR-T cell therapy utilizing humanized single-domain antibody as antigen binding domain and lentivirus as vector. In development for relapsed/refractory multiple myeloma with demonstrated efficacy and excellent safety profile in 34 non-registered clinical trial patients. Licensed to Dr. Reddy's for India.
• Immune Cell Drug Discovery Platform CAR-T/CAR-NK design platform enabling CAR structure design, plasmid vector construction, lentivirus packaging, and CAR-T/CAR-NK cell preparation with evaluation of CAR molecule expression stability, cell killing and proliferation, cytokine expression, and in vivo efficacy.
• Plasmid/Viral Vector Process Development and Production Platform Self-developed third-generation vector and four-plasmid lentiviral vector system meeting regulatory requirements. Platform technology for plasmid and lentivirus lab-scale and pilot-scale production with comprehensive quality control. Also supplies lentiviral vectors as exclusive supplier to license partners.
• Cell Process Development and Production Platform

Quantifiable outcome

• Over 17 months drug-free remission achieved in IgG4-RD patients
• +2 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Kite Pharma (Gilead Sciences subsidiary)coreStrategic or Co-development Partner · 16 October 2025Global licensing and collaboration agreement for next-generation in vivo therapies. Pregene received $120 million upfront payment with potential milestones up to $1.52 billion. Collaboration aims to accelerate development of in vivo cell therapies by combining Kite's cell therapy expertise with Pregene's proprietary technology platforms.
• CellPoint B.V.minorChannel Partner/ Reseller/ Distributor · 1 March 2022European collaboration agreement signed March 2022 for product licensing. Extends Pregene's geographic reach into European market.
• Dr. Reddy's LaboratoriescoreChannel Partner/ Reseller/ Distributor · 9 May 2021Exclusive license agreement for PRG1801 anti-BCMA CAR-T cell therapy in India. Dr. Reddy's responsible for clinical development and commercialization in India. Pregene is exclusive supplier of lentiviral vectors. Terms include $5M upfront, up to $7.5M milestones, and up to $150M in royalties on net sales.
• Guangdong Lewwin (莱恩医药)coreStrategic or Co-development Partner · 5 March 2020Joint construction of Guangdong Provincial Engineering Technology Research Center for Cell and Gene Therapy Innovative Drugs. Lewwin provides GLP-certified non-clinical evaluation services; Pregene provides cell therapy development expertise. Joint platform for drug discovery, process development, toxicology evaluation, IND application, clinical trials, and commercial production.
• Shenzhen Children's HospitalcoreStrategic or Co-development Partner · 5 March 2020Joint applicant for Guangdong Provincial Engineering Technology Research Center for Cell and Gene Therapy Innovative Drugs. Provides clinical research infrastructure and patient access for cell therapy trials.
• GalapagosminorOthersListed as partner on Pregene website; Galapagos is a comprehensive biopharmaceutical company with R&D, production, and sales capabilities. Gilead holds significant stake in Galapagos.
• Xianbo Biology (先博生物)minorOthersListed as partner on Pregene website; Xianbo Biological is committed to bringing innovative cell therapy products to cancer patients with rich R&D pipeline including clinical and preclinical projects.

Scale indicators10 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• JW Therapeutics (药明巨诺): JW Therapeutics is a leading Chinese CAR-T developer with NMPA-approved Carteyva (relmacabtagene autoleucel). Direct competitor to Pregene in autologous BCMA CAR-T for multiple myeloma and shares the same Chinese cell therapy market with similar GTM model targeting hematologic malignancies.
• Allogene Therapeutics: Allogene is a clinical-stage immuno-oncology company focused on allogeneic CAR-T therapies with pipeline targeting BCMA, CD19, and other antigens. Comparable allogeneic CAR-NK and cell therapy platform enabling technology approach similar to Pregene's CAR-NK focus.
• CARsgen Therapeutics (科济药业): CARsgen is a Chinese clinical-stage biotech developing autologous CAR-T therapies including BCMA-targeting zevorcabtagene autoleucel for multiple myeloma. Direct competitor operating in the same indication space with comparable licensing and partnership-driven business model.
• Legend Biotech (传奇生物): Legend Biotech developed Carvykti (cilta-cel), a BCMA-directed CAR-T partnered with Johnson & Johnson. Most direct global competitor in BCMA CAR-T space and validates the licensing-plus-milestones revenue model Pregene is pursuing with Kite.
• Gracell Biotechnologies (亘喜生物): Gracell developed allogeneic CAR-T platforms including FasTCAR and TruUCAR, targeting both hematologic malignancies and autoimmune diseases. Direct Chinese peer competing in the allogeneic CAR-T and autoimmune space with similar global partnership ambitions (acquired by AstraZeneca).
• Fosun Kite (复星凯特): Fosun Kite is the joint venture between Fosun Pharma and Kite Pharma that brought Yescarta to China. Direct Chinese CAR-T competitor sharing ecosystem with Pregene, with established commercial infrastructure in the same NMPA-regulated CAR-T market.
• Cellectis (via CALY Therapeutics portfolio): Cellectis develops gene-edited allogeneic CAR-T therapies using TALEN-based gene editing platform. Direct peer in the gene-edited cell therapy enabling technology space, with comparable multi-gene editing approach and allogeneic platform strategy overlapping with Pregene's iPSC multi-gene editing platform.

Emerging players

• Adicet Bio: Adicet Bio develops allogeneic gamma-delta CAR-T and CAR-NK cell therapies for oncology and autoimmune diseases. Emerging player with overlapping allogeneic NK-cell platform technology and autoimmune disease focus comparable to Pregene's CAR-NK program.

Broad incumbents

• Bristol-Myers Squibb (Breyanzi / Abecma): BMS markets Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T) following its Celgene/Juno acquisitions. Broad incumbent with multiple approved CAR-T franchises positioning against the same BCMA-indication space where Pregene competes.
• Novartis (Kymriah): Novartis commercializes Kymriah, the first FDA-approved CAR-T therapy. Broad incumbent in cell therapy across multiple hematologic malignancies with established global manufacturing footprint and commercialization scale that exceeds Pregene.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds2 records

Investors2 records

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 Pregene