Polatuzumab Vedotin-Piiq

Media ReleaseCOPENHAGEN, Denmark; May 14, 2025 Data from 14 abstracts highlight the depth, breadth, and strength of Genmab’s comprehensive epcoritamab development program across multiple patient populations and treatment settings Genmab A/S (Nasdaq: GMAB) announced today that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30th European Hematology Association (EHA) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025. Two oral presentations will feature data from the Phase 1/2 EPCORE® NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritamab plus polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster. All abstracts accepted for presentation have been published and may be accessed online via the EHA Open Access Library. “Together with AbbVie, we have made tremendous progress advancing our broad epcoritamab development program and we are pleased to share important results at EHA 2025 evaluating epcoritamab in a variety of treatment settings and patient populations,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The data presented at EHA further reinforce our commitment to epcoritamab and its potential to become a core therapy across B-cell malignancies.” Several abstracts evaluating epcoritamab will also be presented at the 18th International Conference on Malignant Lymphoma (ICML), taking place June 17-21, 2025, in Lugano, Switzerland. Abstracts accepted for presentation at EHA include: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation S245First Disclosure of Epcoritamab + R-ICE in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT): EPCORE NHL-2OralSunday, June 1511:00-12:15 CESTS247Durable Efficacy with Fixed-Duration Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for 1L Diffuse Large B-cell Lymphoma (EPCORE NHL-5)OralSunday, June 1511:00-12:15 CESTPF881Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at Three-Year follow-up in Patients with Relapsed/Refractory Follicular LymphomaPosterFriday, June 13 18:30-19:30 CESTPF885Epcoritamab Plus Lenalidomide and Rituximab Achieves High Response Rates and Survival Benefits Compared with Usual Care in Relapsed/Refractory Follicular Lymphoma: A Comparative AnalysisPosterFriday, June 13 18:30-19:30 CESTPF920Sustained Remission in R/R DLBCL with Epcoritamab Monotherapy: EPCORE NHL-1 3y Results and Novel Subgroup Analyses in Patients with Complete Response at 2yPosterFriday, June 13 18:30-19:30 CESTPS1886Matching-Adjusted Indirect Comparison of Epcoritamab with Rituximab + Lenalidomide vs Tafasitamab with Rituximab + Lenalidomide in Second-Line+ Follicular LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1898Patient-Reported Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Epcoritamab within the Entire Study Cohort and in Patients with Symptoms at BaselinePosterSaturday, June 14 18:30-19:30 CESTPS1968Match-Adjusted Comparative Analysis of Epcoritamab + R-DHAX/C or R-ICE vs R-DHAX/C or R-ICE In 2L+ Transplant-Eligible Patients with Diffuse Large B-Cell LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1942Match-Adjusted Comparative Analysis of the Efficacy Of Epcoritamab + R-Mini-CHOP vs R-Mini-CHOP in Previously Untreated Diffuse Large B-Cell LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1932Treatment Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with High Cardiovascular Risk, and Treated with Non-Anthracycline Containing RegimensPosterSaturday, June 14 18:30-19:30 CESTPS1944Patient Preferences for Attributes of Bispecific Antibodies Indicated for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United StatesPosterSaturday, June 14 18:30-19:30 CESTPS1912Circulating Tumour DNA-Directed Intervention with Epcoritamab Alone or in Combination with Lenalidomide and Rituximab is Feasible in the Early Post-CAR-T Population at High Risk of Relapse: Preliminary Data from EpLCARTPosterSaturday, June 14 18:30-19:30 CESTPS1979Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (Epco-GDP) in Relapsed, Refractory Large B-cell Lymphoma – An Interim Analysis of Phase II Multicenter Investigator-initiated TrialPosterSaturday, June 1415:30-16:00 CESTPS1892Phase II Investigator-initiated Trial of Epcoritamab-Lenalidomide in Treatment Naïve Follicular LymphomaPosterSaturday, June 14 18:30-19:30 CEST The safety and efficacy of these investigational uses have not been established. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemoimmunotherapy in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®.  Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Contact: David Freundel, Senior Director, Product CommunicationsT: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.comThis Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. i Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. Media Release no. i08CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 140525_MRi08_EHA Curtain Raiser

In 2024, the field of cancer therapeutics has witnessed remarkable progress in targeting Claudin 18.2 (CLDN18.2). As a protein highly expressed in several malignancies—particularly gastrointestinal cancers such as gastric and pancreatic cancer—CLDN18.2 has emerged as a highly promising therapeutic target. Antibody-drug conjugates (ADCs) developed against this target, including Zolbetuximab, IBI-343, LM-302, and SHR-A1904, have shown encouraging preclinical and clinical results. These innovations not only improve patient survival but also pave the way for more personalized treatment approaches. By selectively recognizing and attacking tumor cells while minimizing damage to normal tissues, these agents are redefining the landscape of cancer therapy. CLDN18.2 is an isoform of Claudin-18, which belongs to the Claudin family of proteins. This family comprises transmembrane proteins that play crucial roles in maintaining tight junctions between epithelial and endothelial cells. Tight junctions function as both physical barriers, preventing the free passage of substances through the paracellular space, and as regulators of ion and small molecule permeability. The depiction of Claudin protein structures1 Structurally, Claudins share common features, including four transmembrane domains, two extracellular loops (ECL1 and ECL2), and intracellular N- and C-termini. CLDN18.2 is predominantly expressed in differentiated epithelial cells of the gastric mucosa, exhibiting highly specific expression under normal physiological conditions. However, during malignant transformation, the disruption of tight junctions caused by uncontrolled tumor proliferation can expose CLDN18.2 epitopes, making them accessible for targeted therapeutic intervention. Main characteristics of claudins2 From a proliferation perspective, evidence suggests that CLDN18.2 may interfere with intercellular communication and signal transduction pathways, influencing the cell cycle and promoting tumor growth. High expression of CLDN18.2 has been associated with increased tumor cell proliferation in several studies, likely due to its role in maintaining cell polarity and regulating cell growth. In terms of invasion and metastasis, abnormal activation of the CLDN18.2 gene may alter cell membrane functionality and enhance tissue permeability. This disruption facilitates tumor cells in breaching the basement membrane and invading surrounding tissues, thus promoting both local and distant metastases. Aberrant CLDN18.2 expression also impairs normal cell polarity and structural integrity, further weakening tissue barriers and enabling cancer cell dissemination. While CLDN18.2 expression is typically confined to gastric mucosal cells under normal conditions, it is significantly upregulated in various cancers, including gastric and pancreatic cancers. This persistent expression even after malignant transformation, combined with exposure of the epitope due to tight junction disruption, makes CLDN18.2 an attractive target for antibody-based therapies, particularly in cancers with limited treatment options. ADC Therapies Targeting CLDN18.2Zolbetuximab: The First Approved CLDN18.2-Targeted Monoclonal AntibodyZolbetuximab is the first globally approved therapeutic specifically targeting CLDN18.2. It is a chimeric IgG1 monoclonal antibody designed for the treatment of gastric and gastroesophageal junction (GEJ) adenocarcinomas. By binding selectively to CLDN18.2, a transmembrane protein highly expressed on certain gastric cancer cells, Zolbetuximab induces direct cancer cell death. Moreover, it activates two major immune-mediated mechanisms: antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). ADCC involves the recruitment of immune effector cells, such as natural killer (NK) cells, to the tumor site, leading to targeted destruction of cancer cells.CDC triggers the complement system to form membrane attack complexes (MACs) that lyse tumor cells.The development of Zolbetuximab was underpinned by its successful performance in two pivotal Phase III clinical trials—SPOTLIGHT and GLOW. In the SPOTLIGHT trial, Zolbetuximab combined with mFOLFOX6 chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone: Median PFS: 10.61 months vs. 8.67 monthsMedian OS: 18.23 months vs. 15.54 monthsSimilarly, the GLOW trial demonstrated that Zolbetuximab combined with CAPOX chemotherapy also yielded superior outcomes compared to CAPOX alone. Based on these positive results, Zolbetuximab has received regulatory approval in multiple countries and regions, including Japan, the United States, and the European Union, for the treatment of specific subtypes of gastric cancer. It remains the first and only approved CLDN18.2-targeted therapy to date. Although initially developed for gastric and GEJ adenocarcinomas, Zolbetuximab’s therapeutic potential could extend to other malignancies, such as pancreatic, biliary tract, esophageal, and lung cancers, where CLDN18.2 expression is also elevated. Expression testing is typically required to identify patients who are most likely to benefit from Zolbetuximab therapy. As understanding of CLDN18.2 biology deepens, it is anticipated that Zolbetuximab could be explored in combination strategies, such as with immune checkpoint inhibitors or other targeted therapies, to further enhance efficacy and reduce adverse effects. Additionally, the success of Zolbetuximab has catalyzed the development of next-generation CLDN18.2-targeted agents, promising new hope for patients with limited treatment options. These advances are expected to significantly contribute to the evolution of personalized cancer care, enabling more precise, effective, and individualized therapeutic strategies. Bispecific Antibody LB-4330LB-4330 is a bispecific antibody developed by L&L Biopharma, designed to leverage its dual-targeting capability to activate CD8+ T cells within the tumor microenvironment, thereby enhancing the body's immune response against cancer. By doing so, LB-4330 not only directly attacks cancer cells but also mobilizes the patient’s immune system for a more effective and sustained anti-tumor response. The mechanism of action of LB-4330 relies on its unique structural design, which enables simultaneous binding to CLDN18.2 and specific receptors on the surface of CD8+ T cells. This dual specificity allows LB-4330 to accumulate at tumor sites and activate T cells, triggering the release of cytotoxic substances to kill cancer cells. Moreover, LB-4330 may also enhance anti-tumor immunity through additional, less well-characterized mechanisms, such as modifying the tumor microenvironment or improving dendritic cell function. These features position LB-4330 as a promising therapeutic candidate, particularly for patients with advanced or metastatic cancers that are resistant to conventional treatments. The major CD8+ T cell states in human tumors3 Currently, LB-4330 is in Phase II clinical development, focusing on evaluating its safety and efficacy in patients with advanced or metastatic solid tumors. According to information released by L&L Biopharma, LB-4330 has shown encouraging potential in an open-label, Phase Ib/II dose-escalation and expansion study. This study aims to explore the drug’s effects at various doses to identify an optimal dosing range that maximizes therapeutic benefit while minimizing adverse events. Although detailed clinical results have yet to be fully disclosed, preliminary data indicate that LB-4330 is well-tolerated and has demonstrated meaningful clinical activity in certain patient populations. Beyond its established indications in gastric cancer, pancreatic cancer, and ovarian cancer, researchers are investigating the potential of LB-4330 in other tumor types. Given the widespread expression of CLDN18.2 across multiple malignancies, LB-4330 could emerge as a broad-spectrum anti-cancer agent. Furthermore, as understanding of CLDN18.2 biology deepens and combination strategies with other therapies (such as chemotherapy, radiotherapy, or immunotherapy) are explored, the application prospects for LB-4330 appear increasingly expansive. Despite its promising profile, several challenges must be addressed before LB-4330 can be widely adopted. These include the need to accurately identify patients most likely to benefit from the therapy—often requiring precise measurement of CLDN18.2 expression—and the necessity for long-term safety evaluations. Additionally, further mechanistic studies, optimization of dosing strategies, and identification of ideal combination regimens with existing therapies will be critical to fully unlocking LB-4330’s therapeutic potential. CLDN18.2-Targeting ADCsSeveral antibody-drug conjugates (ADCs) have been developed to target Claudin 18.2 (CLDN18.2), including IBI-343, LM-302, SHR-A1904, ATG-022, Sonestatug vedotin, and SKB-315. These agents utilize a specific antibody to recognize and bind to CLDN18.2 antigens on the surface of cancer cells, delivering a potent cytotoxic payload intracellularly to induce tumor cell death. Developed by companies such as Innovent Biologics, LaNova Medicines, Hengrui Medicine, Antengene Corporation, and Kelun-Biotech, these ADCs span various stages of clinical development (from Phase II to Phase III) and show promise in treating gastric cancer, esophageal cancer, and other CLDN18.2-positive solid tumors. 1) IBI-343IBI-343 is an innovative ADC developed by Innovent Biologics. It combines a highly specific anti-CLDN18.2 antibody with a cytotoxic small-molecule drug. This design enables precise targeting of CLDN18.2-expressing tumor cells, facilitating selective delivery of the cytotoxic agent and minimizing damage to normal tissues, thus improving both safety and efficacy. In preclinical studies, a single administration of IBI-343 significantly inhibited tumor growth in xenograft models with low antigen expression, maintaining low tumor volumes for up to 21 days. This finding suggests that IBI-343 is not only effective against tumors with high CLDN18.2 expression but also shows robust activity in tumors with lower antigen levels. This bystander effect enhances IBI-343’s appeal as a cancer therapeutic, particularly in tumors with heterogeneous antigen expression within the tumor microenvironment. IBI-343 has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for two indications: (1) advanced gastric/gastroesophageal junction adenocarcinoma patients with positive CLDN18.2 expression who have received at least two prior systemic therapies, and (2) advanced pancreatic ductal adenocarcinoma patients with positive CLDN18.2 expression who have received at least one prior systemic therapy. This designation accelerates the development timeline and underscores the potential importance of IBI-343 as a novel treatment option, particularly for patients with difficult-to-treat cancers. 2) LM-302LM-302 is an antibody-drug conjugate (ADC) developed by Lanpu Biopharmaceuticals (also known as Lansion Biotechnology). This investigational therapy combines a highly specific anti-CLDN18.2 monoclonal antibody with a cytotoxic payload, monomethyl auristatin E (MMAE). The design enables the antibody to selectively bind to the CLDN18.2 antigen expressed on tumor cell surfaces and deliver the cytotoxic agent directly into cancer cells, thereby achieving targeted tumor cell killing. As of the latest updates, LM-302 has been granted three Orphan Drug Designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer, gastric cancer, and gastroesophageal junction (GEJ) cancer. In China, LM-302 has advanced into Phase III clinical trials, indicating that the drug has demonstrated sufficient safety and preliminary efficacy in earlier studies and is now undergoing larger, more diverse patient evaluations to confirm its therapeutic potential. Moreover, LM-302 has been proposed for inclusion under China’s National Medical Products Administration (NMPA)/Center for Drug Evaluation (CDE) Breakthrough Therapy designation. The targeted indication is for patients with locally advanced or metastatic gastric or GEJ adenocarcinoma who are CLDN18.2-positive and have received at least two prior lines of systemic therapy. A Phase II clinical trial is also underway to evaluate the efficacy, safety, and tolerability of LM-302 in combination with toripalimab (an anti-PD-1 antibody) in patients with CLDN18.2-positive advanced gastrointestinal tumors. The primary endpoint of this study is to assess the efficacy of the LM-302 and toripalimab combination, with secondary objectives including safety, pharmacokinetics, immunogenicity, and the correlation between CLDN18.2/PD-L1 expression and antitumor activity. It is worth noting that Lanpu Biopharmaceuticals had previously entered into an exclusive licensing agreement with Turning Point Therapeutics, granting Turning Point rights to develop and commercialize LM-302 outside of Greater China and South Korea. However, following Bristol Myers Squibb’s acquisition of Turning Point, the licensing status of LM-302 has shifted, and the asset is now listed as "global" in ownership. 3) SHR-A1904SHR-A1904 is an ADC independently developed by Hengrui Medicine. It consists of a highly specific anti-CLDN18.2 antibody linked to a cytotoxic payload—a topoisomerase inhibitor (TOPOi). This design enables the ADC to selectively bind to CLDN18.2-expressing tumor cells and deliver its potent payload intracellularly, resulting in targeted cancer cell death. At the 2024 European Society for Medical Oncology (ESMO) Congress, early clinical data on SHR-A1904 were presented for the treatment of patients with CLDN18.2-positive gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJC). The results demonstrated manageable safety and promising antitumor activity, with an objective response rate (ORR) of 55.6% and a disease control rate (DCR) of 88.9%. Beyond gastric cancer, SHR-A1904 is also being investigated for other CLDN18.2-expressing solid tumors, highlighting its broad therapeutic potential. Notably, Hengrui Medicine entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, valued at up to €1.4 billion. Under this agreement, Merck has secured global exclusive development, manufacturing, and commercialization rights for SHR-A1904 outside of mainland China. This strategic partnership reflects strong international recognition of SHR-A1904's potential and positions it for global success. SHR-A1904 has been evaluated across multiple dose levels. The 6.0 mg/kg cohort demonstrated the best efficacy, achieving an ORR of 55.6% and a DCR of 88.9%. The safety profile was considered manageable, although some dose-limiting toxicities (DLTs) were observed at higher doses. With ongoing Phase III clinical trials, SHR-A1904 is poised to become a promising new treatment option for patients with CLDN18.2-positive cancers. Furthermore, through its international collaborations, SHR-A1904 is expected to benefit a broader patient population worldwide. ConclusionAs a member of the Claudin family, Claudin 18.2 (CLDN18.2) plays a vital role in maintaining tight junctions between epithelial and endothelial cells and is aberrantly overexpressed in various cancer types. This unique biological characteristic makes CLDN18.2 an ideal target for cancer therapy. Several CLDN18.2-targeted antibody-drug conjugates (ADCs)—including Zolbetuximab, IBI-343, LM-302, and SHR-A1904—have demonstrated significant antitumor activity with favorable safety profiles. Particularly, Zolbetuximab has achieved groundbreaking clinical success as the first approved therapy targeting CLDN18.2 for the treatment of gastric and gastroesophageal junction adenocarcinoma. Additionally, bispecific antibodies such as LB-4330, which enhance antitumor immune responses, are further expanding the therapeutic landscape of CLDN18.2 targeting. Globally, research on CLDN18.2-targeted therapies has become a major area of focus. More than 90 candidate therapies targeting CLDN18.2—including monoclonal antibodies, bispecific antibodies, CAR-T cells, and ADCs—are currently under development. The success of programs such as IBI-343 not only highlights the innovation capacity of Chinese biopharmaceutical companies but also provides valuable models for future drug development. As clinical trials progress and technologies advance, CLDN18.2-targeted therapies are expected to offer new hope for a broader range of cancer patients, driving forward the era of personalized medicine and precision oncology. These developments mark a deeper understanding of cancer biology and herald the arrival of more CLDN18.2-based therapies, ultimately benefiting patients worldwide. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery! Reference 1. Cao W, Xing H, Li Y, Tian W, Song Y, Jiang Z, Yu J. Claudin18.2 is a novel molecular biomarker for tumor-targeted immunotherapy. Biomark Res. 2022 May 31;10(1):38. doi: 10.1186/s40364-022-00385-1. PMID: 35642043; PMCID: PMC9153115.2. Kubota Y, Shitara K. Zolbetuximab for Claudin18.2-positive gastric or gastroesophageal junction cancer. Ther Adv Med Oncol. 2024 Jan 3;16:17588359231217967. doi: 10.1177/17588359231217967. PMID: 38188462; PMCID: PMC10768589.3. van der Leun AM, Thommen DS, Schumacher TN. CD8+ T cell states in human cancer: insights from single-cell analysis. Nat Rev Cancer. 2020 Apr;20(4):218-232. doi: 10.1038/s41568-019-0235-4. Epub 2020 Feb 5. PMID: 32024970; PMCID: PMC7115982.