Claudin 18.2-Targeted Immunotherapy: a landscape analysis of stakeholders, drug modalities, pipeline and business opportunities from an industry perspective

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Publisher: La Merie Publishing
Pages: 267
Format: PDF
Product Line: Full Report
Product Code: LMFR0039
Release Date: August of 2023

Claudin 18.2-Targeted Immunotherapy: a landscape analysis of stakeholders, drug modalities, pipeline and business opportunities from an industry perspective

This report provides you with a landscape description and analysis of discovery and development of claudin 18.2 (CLDN18.2)-targeted antibody and cell therapy candidates from an industry perspective as of August 2023. CLDN18.2 is transmembrane protein selectively expressed on the cancer cell surface of gastric epithelial cells.

The report brings you up-to-date with information about and analysis of

  • Claudin 18.2 target identification and validation;
  • Differential expression profile of claudin 18.2 in health and tumor tissues;
  • Incidence of cancers with significant expression of claudin 18.2 in major countries;
  • Scope and economic terms of licensing agreements for anti-CLDN18.2 immunotherapy candidates and discovery technologies;
  • Stakeholders in the field: major pharma and biotech, ex-China biotech companies; Chinese major pharma and Chinese emerging biopharma companies;
  • Specific company profiles, especially of Chinese, including financial situation;
  • Pipeline description and analysis regarding drug modalities, indications, territories (global vs regional), R&D stage;
  • Preclinical and clinical experience with CLDN18.2 immunotherapy candidates;
  • Specific profiles of anti-CLDN18.2 immunotherapy candidates.

The naked monoclonal antibody zolbetuximab has become the current gold standard and benchmark for all follow-on anti-CLDN18.2 immunotherapy candidates as zolbetuximab is the only candidate that has been evaluated in controlled pivotal clinical studies. Regulatory agencies in the US, the European Union, Japan and China have accepted license applications for zolbetuximab in June/July 2023 and potential approvals and market launches are expected during the course of 2024.

The clinical profile of zolbetuximab showed statistically significant and clinically relevant improvements in progression free survival by 1.94 or 1.41 months and in overall survival of 2.69 or 2.23 in the SPOTLIGHT or GLOW phase III trials, respectively. Major adverse events were gastrointestinal symptoms nausea, vomiting and decreased appetite. Furthermore, only 39.1% of gastric cancer patients were eligible to treatment with zolbetuximab. One of the inclusion criteria was expression of CLDN18.2 in tumor tissue defined by moderate to strong staining in ≥75% of cancer cells.

This product profile leaves sufficient space for improvements in efficacy, safety and patient eligibility by next generation anti-CLDN18.2 immunotherapy candidates. To generate more effective and safe CLDN18.2-targeted antibody and cell therapy candidates, several drug modalities with potential for enhanced effector function, increased safety and broader patient population have applied:

  • Naked monoclonal antibodies (mAbs) with enhanced target affinity and increased ADCC, CDC & ADCP;
  • Antibody-drug conjugates (ADCs) with improved linker & conjugation technology and payloads;
  • Chimeric antigen receptor (CAR) T-Cells (CAR-T) with improved constructs (signalling domains, armored, modular design);
  • Anti-CLDN18.2 Bispecific T-Cell Engaging (BiTE or TCE) Antibodies for recruitment of cytotoxic T-cells;
  • 2-Targeted Bispecific Immuno-Oncology (I-O) Antibodies for checkpoint blockade or immune stimulation.

This report evaluates the industry landscape of claudin18.2-targeted novel antibody and cell therapy candidates. The report is based on the identification and description of 48 companies with research and development activities in the field and 68 distinct product candidates.

For each company, a profile has been elaborated providing information about the company background/history, the financial situation, relevant technology, partnering deals and CLDN18.2-specific pipeline overview.

Specific profiles of 56 anti-CLDN18.2 immunotherapy candidates have been prepared to describe design and construct of the candidate, applied technologies, the preclinical in vitro and in vivo profile and clinical experience, if available. All information is fully referenced, either with 107 scientific references (conference abstracts, Posters, presentations, full paper) or hyperlinks leading to the source of corporate information, such as press releases, corporate presentations, annual reports, SEC disclosures and homepage content.

What will you find in the report?

  • Profiles of R&D companies active in the field;
  • Description of Big Pharma’s role in the field (in-house R&D, partnering and investing);
  • Comprehensive description and analysis of established and emerging drug modality technologies;
  • Competitor and pipeline analysis for each drug modality applied in anti-CLDN18 immunotherapy candidates;
  • Territories of major competition;
  • Preclinical and clinical profiles of anti-CLDN18.2 immunotherapy candidates;
  • Drug modality preferences of major pharma;
  • Scope and economic terms of collaboration and licensing deals.

Who will benefit from the report?

  • Venture capital, private equity and investment managers;
  • Managers of Big Pharma venture capital firms;
  • Financial analysts;
  • Business development and licensing (BDL) specialists;
  • Patent attorneys and specialists;
  • CEO, COO and managing directors;
  • Corporate strategy analysts and managers;
  • Chief Technology & Scientific Officer;
  • R&D portfolio, technology and strategy managers;
  • Clinical and preclinical development specialists

Table of Contents

Frequent Abbreviations


1          Executive Summary


2          Overview and Methodology


3          Discovery, Structure and Function of Claudin 18.2


3.1       Discovery of Claudin 18.2 as a highly lineage-specific cancer target

3.2       Structure and Function of Claudin 18.2


4          Expression Profile of Claudin 18.2 in Cancer


4.1       CLDN18.2 expression in gastric and gastro-esophageal junction (GEJ) cancer

4.2       CLDN18.2 expression in gastric, GEJ, pancreatic and other cancers

4.3       Summary of CLDN18.2 Expression in Cancer


5          Incidence of gastric, esophageal and pancreatic cancer


5.1       Gastric cancer

5.2       Esophageal cancer

5.3       Pancreatic cancer


6          CLDN18.2 Licensing Agreements


7          Analysis of Claudin 18.2 Stakeholders


7.1       Major Biopharmaceutical Companies outside of China with CLDN18.2 Programs

7.2       Other Biopharmaceutical Companies outside of China with CLDN18.2 Programs

7.3       Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs outside of China

7.4       Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs inside of China

7.5       Chinese Biopharmaceutical Companies with Non-Clinical & Preclinical R&D of CLDN18.2 Programs


8          Pipeline Analysis of CLDN18.2-Targeted Immunotherapy Candidates


8.1       CLDN18.2 Drug Modalities and Development Stage

8.2       Discontinued CLDN18.2 R&D Programs

8.3       Zolbetuximab as Benchmark for CLDN18.2-Targeted Immunotherapies

8.4       CLDN18.2-Targeted Naked Monoclonal Antibodies

8.4.1    Clinical Experience with Anti-CLDN18.2 Naked Monoclonal Antibodies

8.5       CLDN18.2 Targeted Antibody-Drug Conjugates (ADCs)

8.5.1    Clinical Experience with Anti-CLDN18.2 Antibody-Drug Conjugates

8.6       CLDN18.2 Targeted Chimeric Antigen Receptor T-cells (CAR-T)

8.6.1    Clinical Experience with Anti-CLDN18.2 CAR T-Cells

8.7       CLDN18.2 Targeted Bispecific T-Cell Engaging Antibodies

8.8       CLDN18.2 Targeted Bispecific Immuno-Oncology (I-O) Antibodies

8.8.1    CLDN18.2 x 4-1BB Bispecific Antibodies

8.8.2    CLDN18.2 x CD47 / SIRPα Bispecific Antibodies

8.8.3    CLDN18.2 x PD-L1 Bispecific Antibodies

8.8.4    CLDN18.2 x CD8 Bispecific Antibodies


9          Company Profiles


9.1       Major Biopharmaceutical Companies outside of China

9.1.1    Astellas Pharma

9.1.2    AstraZeneca

9.1.3    BioNTech

9.1.4    Bristol Myers Squibb

9.1.5    Merck

9.1.6    Roche


9.2       Other Biopharmaceutical Companies outside of China

9.2.1    ABL Bio

9.2.2    Abpro

9.2.3    CARTEXEL

9.2.4    Elevation Oncology

9.2.5    Integral Molecular

9.2.6    Leap Therapeutics

9.2.7    Phanes Therapeutics

9.2.8    SOTIO Biotech

9.2.9    TORL BioTherapeutics

9.2.10  Triumvira Immunologcics


9.3       Chinese Biopharmaceutical Companies with Clinical Development outside of China

9.3.1    Antengene

9.3.2    CARsgen Therapeutics

9.3.3    I-Mab Biopharma

9.3.4    Innovent Biologics

9.3.5    Jiangsu Hengrui Pharmaceuticals

9.3.6    La Nova Medicines

9.3.7    RemeGen

9.3.8    SparX Group

9.3.9    Transcenta Holding

9.3.10  Zai Lab


9.4       Chinese Biopharmaceutical Companies with Clinical Development inside China

9.4.1    Beijing Mabworks Biotech

9.4.2    Biotheus

9.4.3    CSPC Pharmaceutical Group

9.4.4    Gracell Biotechnologies

9.4.5    Jiangsu Aosaikang Pharmaceutical

9.4.6    L&L Biopharma

9.4.7    Legend Biotech

9.4.8    Nanjing Kaedi Biotherapeutics

9.4.9    Qilu Pharmaceutical

9.4.10  QureBio

9.4.11  Shandong Boan Biotechnology

9.4.12  Shanghai Junshi Biosciences

9.4.13  Shanghai Longyao Biotechnology

9.4.14  Sichuan Kelun-Biotech Biopharmaceutical

9.4.15  Suzhou Immunofoco Biotechnology

9.4.16  Zhejiang Doer Biologics


9.5       Chinese Biopharmaceutical Companies with Non-Clinical and Preclinical R&D

9.5.1    Akeso

9.5.2    Dragon Boat Biopharmaceutical

9.5.3    Elpiscience Biopharmaceutical

9.5.4    Genor Biopharma

9.5.5    OriCell Therapeutics

9.5.6    Shanghai Genbase Biotechnology


10        Anti-CLDN18.2 Drug Candidate Profiles


10.1     Naked Monoclonal Antibodies

10.1.1              AB011

10.1.2              ASKB589

10.1.3              BA1105

10.1.4              BC008

10.1.5              BNT141

10.1.6              DR30303

10.1.7              GB7004

10.1.8              IBI360

10.1.9              JS012

10.1.10            LM-102

10.1.11            MIL93

10.1.12            NBL-015; FL-301

10.1.13            Osemitamab; TST001

10.1.14            SPX-101

10.1.15            TORL-2-307-MAB

10.1.16            ZL-1211

10.1.17            Zolbetuximab


10.2     Antibody-Drug Conjugates

10.2.1              ATG-022

10.2.2              BA1301

10.2.3              CMG901

10.2.4              IBI343

10.2.5              JS107

10.2.6              LM-302; BMS-986476; TPX-4589

10.2.7              RC118

10.2.8              SHR-A1904

10.2.9              SKB315

10.2.10            SOT102

10.2.11            SYSA1801; EO-3021

10.2.12            TORL-2-307-ADC


10.3     Chimeric Antigen Receptor T-Cells

10.3.1              BNT212

10.3.2              CT041

10.3.3              CT048

10.3.4              GC506

10.3.5              IBI345

10.3.6              IMC002

10.3.7              KD-496

10.3.8              LB1908

10.3.9              LY011

10.3.10            PM3023

10.3.11            TAC01-CLDN18.2


10.4     Bispecific T-Cell Engaging Antibodies

10.4.1              ABP-150

10.4.2              ASP2138

10.4.3              GB264

10.4.4              Gresonitamab; AMG 910

10.4.5              HBM7022; AZD5863

10.4.6              IBI389

10.4.7              QLS31905

10.4.8              WB67


10.5     CLDN18.2 Targeted Bispecific Immuno-Oncology (I-O) Antibodies

10.5.1  CLDN18.2 x 4-1BB Bispecific Antibodies           FL-302; NBL-016           Givastomig           PM1032

10.5.2  CLDN18.2 x CD47 / SIRPα Bispecific Antibodies           BC007           ES028           PT886

10.5.3  CLDN18.2 x PD-L1 Bispecific Antibodies           Q-1802           TST006


11        References




Tables in the Text

Figures & Tables

Tables in the Text


Table 1            CLDN18.2 Tissue Expression in Cancer – Summary of Study Results

Table 2            Rights and Economic Terms of Licensing Agreements for CLDN18.2-Targeted Drug Candidates

Table 3            Overview of Major Biopharmaceutical Companies outside of China with CLDN18.2 Programs

Table 4            Overview of Other Biopharmaceutical Companies outside of China with CLDN18.2 Programs

Table 5            Overview of Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs outside of China

Table 6            Overview of Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs inside of China

Table 7            Overview of Chinese Biopharmaceutical Companies with Non-Clinical & Preclinical R&D of CLDN18.2 Programs

Table 8            Overview of Drug Modalities and R&D Stage of CLDN18.2-Targeted Immunotherapeutics in Active Development

Table 9            Discontinud CLDN18.2-Targeted Immunotherapeutics

Table 10          Naked Monoclonal Antibodies and their Fc Function

Table 11          Composition of Anti-CLDN18.2 Antibody-Drug Conjugates (ADCs)

Table 12          Autologous Anti-CLDN18.2 Chimeric Antigen Receptor T-cells

Table 13          CLDN18.2-Targeted Bispecific T-Cell Engaging Antibodies via CD3

Table 14          CLDN18.2-Targeted Immuno-Oncology (I-O) Bispecific Antibodies

Table 15          Astellas Pharma’s Pipeline of Claudin 18.2-Targeted Drug Candidates

Table 16          AstraZeneca’s CLDN18.2-Targeted Immunotherapy Franchise

Table 17          Claudin 18.2 Immunotherapy Franchise of BioNTech

Table 18          Integral Molecular’s Pipeline of CLDN18.2-Targeted Antibodies

Table 19          Integral Molecular’s Pipeline of CLDN18.2-Targeted Antibodies

Table 20          TORL Biotherapeutics’ Pipeline of CLDN18.2-Targeted Antibodies

Table 21          Pipeline of CARsgen Therapeutics’ Claudin 18.2 Franchise

Table 22          CLDN18.2-Targeted Immunotherapy Franchise of Innovent Biologics

Table 23          CLDN18.2-Targeted Immunotherapy Pipeline of Transcenta Holding

Table 24          CLDN18.2-Targeted Immunotherapy Pipeline of Biotheus

Table 25          CLDN18.2-Targeted Antibodies from CSPC Pharmaceutical Group

Table 26          CLDN18.2-Targeted Immunotherapy Pipeline of Nanjing Kaedi Biotherapeutics

Table 27          CLDN18.2-Targeted Immunotherapy Pipeline of Junshi Biosciences

Table 28          Zhejiang Biologics Pipeline of CLDN18.2-Targeted Antibodies

Table 29          CLDN18.2-Targeted Antibody Franchise of Dragon Boat Biopharmaceutical

Table 30          OriCell Therapeutic’s Pipeline of CLDN18.2-Targeted Bispecific Antibodies

Table 31          CLDN18.2-Targeted Immunotherapy Pipeline of Shanghai Genbase Biotechnology

Table 32          Clinical Development Program of Zolbetuximab in First-Line GC/GEJ Cancer

Companies mentioned in the report



AB Therapeutics





Astellas Pharma


Beijing Immunoah Pharma Tech Co.

Beijing Mabworks Biotech



Bristol Myers Squibb

CARsgen Therapeutics


CSPC Pharmaceutical Group

Dragon Boat Biopharmaceutical Co

Elevation Oncology

Elpiscience Biopharmaceuticals

Flame Biosciences

Genor Biopharma

Gracell Biotechnologies

Harbour BioMed

I-Mab Biopharma

Innovent Biologics

Integral Molecular

Jiangsu Aosaikang Pharmaceutical

Jiangsu Hengrui Pharmaceuticals

Keymed Biosciences

KPC Pharmaceutical

L&L Biopharma

LaNova Medicines Zhejiang

Leap Therapeutics

Legend Biotech

Luzsana Biotechnology


Nanjing Kaedi Biotherapeutics

NBE Therapeutics

Novarock Biotherapeutics

OriCell Therapeutics

Phanes Therapeutics

Qilu Pharmaceuticals




Shandong Boan Biotechnology

Shanghai Genbase Biotechnology

Shanghai Junshi Biosciences

Shanghai Longyao Biotechnology

Shanghai Novarock Biopharmaceutical Co.

Sichuan Kelun-Biotech Biopharmaceutical

SOTIO Biotech

SparX Group

Suzhou Immunofoco Biotechnology


TORL Biotherapeutics

Transcenta Holding

Turning Point Therapeutics


Zai Lab

Zhejiang Doer Biologics

Triumvira Immunologics

Zhejiang Doer Biologics

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