Nanjing Levena Biopharma

What Nanjing Levena Biopharma does

Nanjing Levena Biopharma is an antibody-drug conjugate (ADC) specialty contract research, development, and manufacturing organization (CRO/CMO) operating from facilities in Suzhou, Nanjing, and San Diego. Founded in 2013 and established as a wholly-owned subsidiary of NASDAQ-listed Sorrento Therapeutics in June 2016, the company serves global biopharmaceutical and biotechnology clients developing ADC therapeutics, with secondary reach into academic and research institutions. Its revenue is generated through five streams: catalog sales of proprietary linker-payload reagents and screening kits, custom ADC conjugation services, analytical and CMC development services, cGMP manufacturing of linker-toxins and ADC conjugates for clinical supply, and licensing of site-specific conjugation technologies to pharmaceutical partners.

The company's technological platform centers on two proprietary site-specific conjugation technologies, K-LOCK and C-LOCK, which enable controlled drug-to-antibody ratios and improved therapeutic indices compared to conventional random conjugation, with both technologies supporting INDs cleared in the US, China, and Korea. It maintains a broad linker portfolio (Val-Cit-PAB, Phe-Lys(Trt)-PAB, SMCC, MAL-EG, N3-EG and others), a payload library spanning tubulin inhibitors (MMAE, MMAF, DM1, DM4, Tubulysin M) and DNA-alkylating agents (Duocarmycin, Calicheamicin, PBD-dimer, α-Amanitin), and differentiated consumable product lines including SET™ ready-to-use linker-toxin kits, PSKA™/PSKG™ pre-screening kits, and anti-payload antibodies. The Suzhou facility (~5,000 sqm, Class C/D clean rooms) is designed for kilogram-scale cGMP production with SafeBridge Category 4 high-potency API handling, FDA aseptic processing compliance, and 100+ tumor cell line in-house pharmacology screening.

The business operates on a hybrid commercial model: project-based CRO/CMO services quoted on inquiry, catalog reagent sales at disclosed USD prices ranging from $360 to $2,640 per unit, and licensing arrangements with named partners including BioAtla (BA3011), Alteogen (ALT-P7), and Zhejiang NovoCodex (anti-HER2-ADC). The company has executed over 400 projects across more than 9 years of operation, secured lead-sponsor presence at World ADC summits across San Diego, Berlin, and Asia, and reports an in-house product portfolio that supports ADC discovery through clinical manufacturing on a single integrated platform.

Name

Nanjing Levena Biopharma

Legal name

联宁（苏州）生物制药有限公司

Website

https://levenabiopharma.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

51–100 employees

Short description

Nanjing Levena Biopharma is an ADC-focused CRO/CMO serving global biotech and pharmaceutical clients with proprietary site-specific conjugation technologies, linker-payload reagents, custom conjugation services, and kilogram-scale cGMP manufacturing from facilities in Suzhou, Nanjing, and San Diego.

Ownership category

akta.pro rank

Product category

ADC Contract Development and Manufacturing

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)

akta.pro secondary industries

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Antibody drug conjugates
• ADC CRO services
• Bioconjugation manufacturing
• Linker payload reagents
• GMP biologics production

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. ADC Research Reagents and Tools: Sale of proprietary linker-toxin products, SET™ kits, ADC screening kits (PSKA™, PSKG™), and anti-payload antibodies to biotechnology and pharmaceutical researchers for ADC discovery and development. Products available at catalog scale (mg to multi-gram quantities) with pricing from $360 to $2,640 per unit.
2. Custom ADC Conjugation Services (CRO): Proof-of-concept and custom ADC conjugation services for clients from 1mg to 200mg scale using combinations of payloads, linkers, and conjugation methods (cysteine-based Seattle Genetics method, lysine-based Immunogen method). Includes comprehensive ADC characterization report with full specifications. Conjugation turnaround in under three weeks.
3. cGMP Manufacturing (CMO): cGMP production of linker-toxins and ADC conjugates at Suzhou facility up to kilogram scale for clinical and commercial supply. Supports clients' IND filings and clinical programs with GMP-grade toxins and conjugates meeting FDA aseptic processing standards.
4. Analytical and CMC Development Services: Method development, concentration determination (UV), DAR analysis (HIC-HPLC), aggregate analysis (SEC-HPLC), residual drug analysis (RP-HPLC), endotoxin testing, cell killing assays, ELISA, stability studies, CMC development, and technical transfer services.
5. Licensing of Proprietary Technologies: Licensing of K-LOCK and C-LOCK site-specific conjugation technologies and proprietary linker-toxin combinations to pharmaceutical partners for use in their ADC development programs, as demonstrated with partnerships including BioAtla and Alteogen.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Nanjing Levena Biopharma is an ADC-focused contract research, development, and manufacturing organization (CRO/CMO) providing proprietary linker-toxin reagents, custom antibody-drug conjugation services, analytical and CMC development, and cGMP manufacturing from milligram to kilogram scale. The company supports pharmaceutical and biotechnology clients worldwide in advancing ADC programs from discovery through IND filing and clinical supply, leveraging proprietary site-specific conjugation technologies (K-LOCK and C-LOCK) and proprietary payloads such as Duostatin 5.

Product overview

Levena Biopharma operates as an ADC specialty company providing a one-stop-shop for antibody drug conjugates from discovery to clinic. The portfolio includes five core product categories: ADC Linkers (valine-citrulline and phenylalanine-lysine linkers), ADC Payloads (tubulin inhibitors including MMAE, MMAF, DM1, DM4, and DNA-alkylating agents such as duocarmycin and calicheamicin), Safe & Easy Toxin (SET™) ready-to-use kits, ADC Screening Kits (PSKA™/PSKG™) for antibody pre-screening, and Anti-payload Antibodies for research. These products are complemented by three service offerings: Antibody Drug Conjugation Services for custom ADC preparation, cGMP Production for manufacturing scale-up, and Analytical Services for comprehensive characterization and CMC development. The company leverages site-specific conjugation technologies (K-LOCK and C-LOCK) and serves pharmaceutical partners globally from facilities in Suzhou, Nanjing, and San Diego.

Differentiator

Problem solved

Functional benefit

Brands

• SET™ (Safe & Easy Toxin): A ready-to-use research tool for rapid antibody-drug conjugation experiments with pre-packaged linker-toxin vials
• PSKA™/PSKG™
• K-LOCK
• C-LOCK

Products and services

• ADC Linkers A portfolio of linker structures and functionalities (including Val-Cit-PAB, Phe-Lys(Trt)-PAB, Ala-Ala-Asn-PAB, SMCC, Py-ds-Prp, MAL-EG series, N3-EG series, ALD-BZ series, and PHA-EG series) designed for conjugation of a broad spectrum of antibodies and toxins, enabling precise and controlled drug-to-antibody ratios with consistent batch-to-batch manufacturing.
• ADC Payloads Comprehensive assortment of tubulin inhibitors (MMAE, MMAF, Dolastatin 10, Tubulysin M, Maytansinoid AP-3, DM1, DM4) and DNA-alkylating agents (Duocarmycin SA/TM/MA/DM, Calicheamicin g1, Nemorubicin, PNU-159682, PBD-dimer, a-Amanitin) available in API-quality purity, with cGMP production capability up to 100 gram quantities.
• Safe & Easy Toxin (SET™) Ready-to-use linker-toxin research tool in pre-packaged vials equipped with septum. Each SET™ vial contains approximately 200nmol of linker-toxin, sufficient to conjugate up to 5mg antibody at a DAR of 3-4. Available in Amine Reactive, Thiol Reactive, Click Reactive, and Sortase Reactive formats; minimizes hazardous toxin exposure in lab settings.
• ADC Pre-screening Kits (PSKA™ and PSKG™) Pre-screening kits using Protein A (PSKA™) and Protein G (PSKG™) that expedite identification of antibodies suitable for ADC candidates without requiring individual conjugation to cytotoxic agents. Includes industry-standard toxins: MMAE, MMAF, DM1, and duocarmycin.
• Anti-payload Antibodies Monoclonal and polyclonal antibodies with specificity against cytotoxic drug categories including MMAE/MMAF, DM1/DM4, Calicheamicin, Duocarmycin, PNU, and Amanitin for research use in ADC development and analytics.
• Antibody Drug Conjugation Service Custom ADC conjugation service providing small and large-scale proof-of-concept ADCs and PR&D support. Combines payloads, linkers, and conjugation methods (cysteine-based Seattle Genetics method, lysine-based Immunogen method) to deliver custom ADCs from 1mg to 200mg scale with comprehensive characterization reports, with turnaround in under three weeks.
• cGMP Production

Quantifiable outcome

• Over 400 projects executed for customers and partners, demonstrating established market presence and execution track record
• +5 more outcomes

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Three partnerships are on record, tiered core.

• Zhejiang NovoCodex Biopharmaceuticals (浙江新码生物医药)coreStrategic or Co-development Partner · 15 October 2018Strategic cooperation agreement signed October 15, 2018 in Shanghai for ADC collaboration. Levena provides process development, quality research, and GMP manufacturing of small molecule components for Zhejiang NovoCodex's anti-HER2-ADC product for breast cancer treatment. Levena will support the partner from clinical evaluation through commercialization. Zhejiang NovoCodex Biopharmaceuticals is a subsidiary of Zhejiang Medicine Co., Ltd. (浙江医药股份有限公司).
• BioAtla LLCcoreStrategic or Co-development Partner · 24 January 2018Multi-year strategic partnership for ADC product development and GMP linker-toxin production to support BA3011 (CAB-AXL-ADC) program. Levena provided process development and GMP manufacturing services supporting BioAtla's FDA IND filing, which was approved January 24, 2018 for first-in-human clinical trials in solid tumors. Levena's GMP facility in Suzhou has supported multiple IND filings in US, China, and Korea. BioAtla is a global biotech with operations in San Diego and Beijing.
• Alteogen Inc.coreStrategic or Co-development Partner · 30 November 2017GMP supply agreement signed November 30, 2017 between Levena Biopharma and Alteogen Inc. (Korean listed biotech). Levena provides GMP-grade linker-toxin for Alteogen's ALT-P7 Her-2 ADC product using Alteogen's proprietary NextMab™ ADC technology. ALT-P7 entered Phase I clinical trial in HER-2 positive breast cancer patients in August 2017. This was Levena's first GMP supply agreement with a Korean partner.

Scale indicators7 records

Recent moves11 records

Expansion highlights5 records

Direct peers

• Synaffix: Synaffix develops and licenses proprietary site-specific ADC conjugation technologies (GlycoConnect, HydraSpace, toxSYN) and offers payload/linker platforms for licensing. It is the closest analog to Levena's K-LOCK/C-LOCK business model of pairing IP-protected conjugation chemistry with payload supplies and licensing partnerships.
• Heidelberg Pharma: Heidelberg Pharma licenses its proprietary amanitin-based payload platform (License-to-Drive model) combined with conjugation chemistry for partner ADC programs. Levena's payload catalog (including amanitin products) and licensing of K-LOCK/C-LOCK mirror this technology-licensing CDMO model.
• WuXi STA (WuXi AppTec): WuXi STA is the leading Chinese CDMO with a published ADC platform spanning payload-linker manufacturing, conjugation, analytical, and cGMP production at gram-to-kilogram scales. It is the most direct on-shore competitor to Levena for both Chinese and global ADC programs.
• Pharmaron: Pharmaron provides integrated small-molecule and biologics CDMO services, including a dedicated ADC offering spanning antibody production, conjugation, payload-linker supply, and analytical. As another China-rooted CDMO with global reach, it competes with Levena for both Asian and US ADC clients.
• Carbogen Amcis: Carbogen Amcis specializes in highly potent APIs and ADC linker-payload development and GMP manufacturing with isolation technology for cytotoxic compounds. It is a direct peer in the high-potency payload and linker-toxin CDMO space.
• Kindeva Drug Delivery: Kindeva Drug Delivery offers commercial-scale high-potency API manufacturing, ADC conjugation, and fill-finish services from its St. Paul, Minnesota facility. It competes for the same ADC outsource projects that Levena pursues, with comparable high-potency containment capabilities.
• Piramal Pharma Solutions: Piramal Pharma Solutions operates dedicated ADC suites including high-potency payload manufacturing, conjugation, and analytical services across its US, UK, and India sites. It is a frequently selected CDMO for ADC programs overlapping directly with Levena's CRO/CMO scope.

Broad incumbents

• Lonza Group: Lonza operates the largest global biologics CDMO network with established ADC conjugation and GMP capabilities across multiple sites. While broader than a pure-play ADC CDMO, it competes for every kilogram-scale ADC manufacturing award that Levena targets.
• AbbVie (ImmunoGen): ImmunoGen — now part of AbbVie — pioneered ADC conjugation chemistry (DM1/DM4 payload and linker systems) and developed marketed ADCs (Kadcyla, Elahere). Its large-pharma R&D platform and broader oncology pipeline make it an incumbent ADC technology stack against which specialists like Levena differentiate.
• Catalent: Catalent provides comprehensive biologics and ADC development and manufacturing services, including SMARTag site-specific conjugation. Its broad service portfolio, global GMP footprint, and US-centric manufacturing offer an alternative to Levena for sponsors prioritizing Western CMC capacity.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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

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