What Zhenge Biotech does

Zhenge Biotech (臻格生物 / Zencore Biologics) is a Shanghai-based, privately held contract development and manufacturing organization (CDMO) founded in November 2017 that provides one-stop services for large-molecule biological drugs, including monoclonal antibodies, recombinant proteins, and antibody-drug conjugates (ADCs). The company's integrated platform spans six service modules: biologics CDMO (cell line development, process development, pilot and commercial manufacturing), ADC CDMO (conjugation, formulation, fill-finish, QC), cell culture media services anchored by the proprietary Zncore® CHO media line, analytical services (structural/biological/purity characterization compliant with Chinese, European, and US pharmacopeias), global CMC registration services (including FDA inspection support), and quality management systems. Operations are anchored by a 66,000 m² commercial production base in Lingang with 3x2,000L single-use and 3x5,000L stainless steel bioreactors, a dedicated ADC production base, a Zhangjiang R&D center, and a US Innovation Center in Germantown, Maryland. The company holds Shanghai's first ADC drug production license (C Certificate), EU QP audit clearance for both pilot and commercial bases, and multiple ISO certifications (9001/14001/45001/27001), positioning it for both domestic and European GMP-compliant supply.

Name

Zhenge Biotech

Legal name

Shanghai ZhenGe Bio-Technology Co., Ltd.

Website

https://zgbiotech.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Zhenge Biotech (Zencore Biologics) is a Shanghai-based, private biologics CDMO founded in 2017, providing one-stop services — cell line development, process development, commercial manufacturing, ADC CDMO, and proprietary cell culture media — for pharmaceutical and biotech clients across China, the US, and Europe.

Ownership category

akta.pro rank

Product category

Biopharmaceutical CDMO Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

Drug Substance–Drug Product Integrated CDMO (HLAGABAG), Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Biologics CDMO services
• Antibody-drug conjugate manufacturing
• Cell culture media products
• Large molecule pharmaceutical services
• GMP contract manufacturing

Headquarters

HQ city

Shanghai

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CDMO Service Fees: Contract development and manufacturing services for biological drugs including process development, cell line development, scale-up, and commercial manufacturing. Revenue generated through project-based contracts with pharmaceutical and biotech companies.
2. Cell Culture Media Products: Sale of proprietary cell culture media products for biopharmaceutical manufacturing. Products sold directly to biopharma companies for use in their drug development and production processes.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Zhenge Biotech is a one-stop biopharmaceutical CDMO providing integrated contract development and manufacturing services for large molecule biologics and antibody-drug conjugates (ADC). Its offering spans cell line development, process development and optimization, GMP pilot and commercial manufacturing, proprietary Zncore® CHO cell culture media, analytical and quality control services, and global CMC regulatory/registration services for pharmaceutical and biotech clients from preclinical through commercial stages.

Product overview

Zhenge Biotech (臻格生物/Zencore Biologics) is a one-stop CDMO (Contract Development and Manufacturing Organization) platform providing integrated services for large molecule biologics development and manufacturing. The core offering consists of five integrated service modules: (1) Biologics CDMO covering cell line development, process development, pilot and commercial manufacturing; (2) ADC CDMO for antibody-drug conjugate development and GMP production; (3) Cell Culture Media Services featuring the Zncore® CHO platform media product line; (4) Analytical Services with both R&D and GMP QC labs; and (5) Registration and Quality services supporting global CMC filings and GMP compliance. The company operates multiple manufacturing sites in Shanghai Lingang (commercial production base with 66,000m², pilot base with 10,000m²), Pudong Zhangjiang (R&D center with 4,500m²), and Germantown, Maryland, USA (4,000 sq ft innovation center), enabling end-to-end services from preclinical development to commercial manufacturing.

Differentiator

Problem solved

Functional benefit

Products and services

• Biologics CDMO (大分子CDMO服务) One-stop CDMO services for large molecule biological drugs, covering cell line development, process development and optimization, pilot production, clinical sample manufacturing, and commercial CMO services, as well as process characterization and validation studies. Targeted at pharmaceutical and biotechnology companies developing monoclonal antibodies and recombinant proteins.
• ADC CDMO (抗体偶联药物CDMO) One-stop ADC (antibody-drug conjugate) R&D and production services, including process development, analytical method development, GMP drug substance and drug product manufacturing, quality control, process characterization, stability studies, and regulatory filing support. Targeted at pharma/biotech companies developing ADC therapeutics.
• Cell Culture Media Services (细胞培养基服务) Cell culture media development services, Zncore® catalog media commercial production, and media testing services. Supports high-density CHO cell growth and protein expression for biopharmaceutical manufacturing. Includes chemically defined basal media, feed media, and perfusion media. Targeted at biopharma manufacturers requiring reliable, high-quality cell culture media supply.
• Zncore® CHO Platform Media Series (Zncore® CHO平台系列培养基) Chemically defined CHO cell culture media product portfolio, including basal media, feed media, and perfusion media, supporting CHO-K1, CHO-DG44, CHO-S, and CHOZN cell lines for high-density growth with average antibody titer of 5g/L. Targeted at biopharmaceutical manufacturers using CHO expression systems.
• Analytical Services (分析服务) Quality research services spanning drug discovery through regulatory filing stages, including structural characterization, biological activity characterization, purity analysis, process-related impurity and residual testing, compliant with Chinese Pharmacopoeia, European Pharmacopoeia, US Pharmacopoeia, and GMP/GLP standards. Includes both R&D and GMP QC lab capabilities. Targeted at pharma/biotech companies requiring comprehensive analytical support.
• Registration Services (注册服务) Global CMC registration and filing services, including FDA on-site inspection support, production and testing compliance with cGMP requirements, and registration strategy support. Targeted at biopharma companies seeking multi-region regulatory filing support (FDA, EMA, NMPA).
• Quality Services (质量服务) Quality management system establishment and quality control system execution, meeting FDA, EMA, and NMPA regulatory requirements. Targeted at biopharma companies requiring compliant quality infrastructure and oversight for their manufacturing operations.

Quantifiable outcome

• Over 80 pharmaceutical and biotech customers served
• +3 more outcomes

Named customers2 records

Segments1 record

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 core, major and standard.

• Apeloa Pharmaceutical (普洛药业)coreStrategic or Co-development PartnerApeloa Pharmaceutical and Zhenge Biotech established a strategic partnership for ADC CDMO services, combining Apeloa's pharmaceutical manufacturing expertise with Zhenge's ADC development capabilities.
• Maizhetai Biology (美赛生物)coreStrategic or Co-development PartnerMaizhetai Biology partnered with Zhenge Biotech for ADC CDMO strategic collaboration, leveraging combined expertise in biological drug development and manufacturing.
• Yantang Biology (岩唐生物)coreStrategic or Co-development PartnerYantang Biology and Zhenge Biotech entered into a strategic partnership for ADC drug development, utilizing Zhenge's integrated CDMO platform forADC therapeutics.
• Andu Biotechnology (安渡生物)majorGTM or Marketing PartnerAndu Biotechnology provides global strategic marketing services for Zhenge Biotech, supporting international market expansion and global business development efforts.
• VeritasstandardTechnology or IntegrationVeritas provides data integrity protection services for Zhenge Biotech, ensuring compliance and security for sensitive pharmaceutical manufacturing data.
• NNITstandardImplementation/ SI/ Consulting PartnerNNIT implemented LIMS (Laboratory Information Management System) for Zhenge Biotech, supporting digital transformation and operational efficiency in CDMO operations.
• Yuanpei Biology (源培生物)standardStrategic or Co-development PartnerYuanpei Biology maintains a strategic partnership with Zhenge Biotech, potentially related to biological reagents and materials supply for cell culture operations.

Scale indicators6 records

Recent moves16 records

Expansion highlights5 records

Direct peers

• WuXi Biologics: The largest biologics CDMO globally and Zhenge's primary domestic competitor, offering integrated discovery, development, and manufacturing services for monoclonal antibodies, recombinant proteins, and ADCs with substantially greater installed capacity and global customer reach.
• MabPlex International: A Chinese biologics CDMO specializing in monoclonal antibodies, recombinant proteins, and antibody-drug conjugates with both clinical and commercial GMP capacity, closely overlapping Zhenge's biologics-plus-ADC positioning.
• GenScript ProBio: The biologics CDMO arm of GenScript, providing cell line development, process development, GMP manufacturing, and analytical services for mAbs, recombinant proteins, and gene/cell therapies — a directly comparable integrated CDMO competitor.
• Porton Pharma: A major Chinese CDMO with growing biologics capabilities including cell culture, viral clearance, and GMP manufacturing, serving both small molecule and large molecule customers — a relevant peer as Porton scales into biologics.

Broad incumbents

• Asymchem Laboratories: A leading Chinese CDMO historically strong in small-molecule API manufacturing but actively expanding into biologics and peptide CDMO services, competing for adjacent outsourced development spend from biopharma customers.
• Pharmaron: A Chinese CRO/CDMO with a full spectrum of services from drug discovery through commercial manufacturing, including growing biologics CMC capability — an incumbent offering integrated services that overlap with Zhenge's scope.
• Lonza Group: The global market leader in biologics CDMO with extensive mammalian and microbial manufacturing capacity, ADC suite offerings, and cell therapy services — the international benchmark against which Chinese biologics CDMOs including Zhenge compete.
• Samsung Biologics: A South Korean biologics CDMO operating some of the world's largest single-site mammalian cell culture capacity, serving global biopharma with mAb, recombinant protein, and emerging modality services — a global peer Zhenge benchmarks against for large-molecule outsourcing.
• Catalent: A global CDMO with biologics, cell therapy, and ADC capabilities (including the recently expanded Bloomington facility) serving major biopharma clients — a relevant international incumbent competing for biologics outsourcing programs.

Emerging players

• ChemPartner: A Chinese CRO/CDMO offering discovery, preclinical, and biologics manufacturing services with growing integrated CDMO capabilities — a smaller-scale peer competing for similar Chinese and global biopharma outsourcing programs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors14 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 Zhenge Biotech