On November 19, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that at the R&D Day taking place today, it will present the latest data and future plans for three mid/late-stage clinical programs, including ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]), ATG-037 (oral CD73 small molecule inhibitor), and ATG-101 (PD-L1/4-1BB bispecific antibody). The company will also share the latest progress on ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring "IO + ADC" dual-effect molecules for the treatment of solid tumors and its AnTenGager T-cell engager (TCE) technology platform which incorporates steric hindrance masking, along with updates on several key preclinical programs. In addition, guest expert Prof. Xin Wang, Chief Physician, Drug Clinical Trial Center, National Cancer Center / Cancer Hospital of the Chinese Academy of Medical Sciences, will deliver a keynote session sharing her insights on ATG-022.
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The event will be held today at 14:00 (Beijing Time), both in-person at the Antengene Shanghai office and online via webcast. For further information on how to join the event, please refer to: View Source
1. Building a pipeline of first/best-in-class innovative therapies with strategic focus on four areas
To address major unmet medical needs in the APAC region and globally amid the rapidly evolving innovative drug landscape, Antengene has adopted a forward-looking strategy to build a diverse portfolio covering four major areas – ADCs, immuno-oncology (IO), autoimmune diseases, and TCEs.
ADCs: ATG-022 (CLDN18.2 ADC) is advancing smoothly through clinical development and has generated a steady stream of promising data. In addition, two "IO + ADC" dual-mechanism candidates targeting B7-H3 x PD-L1 and CD24 are progressing well in preclinical development.
IO: ATG-037 (oral CD73 small molecule inhibitor) and ATG-101 (PD-L1/4-1BB bispecific antibody) are progressing smoothly through clinical studies.
Autoimmune diseases: ATG-201 (CD19×CD3 TCE), which is advancing toward clinical studies for the treatment of autoimmune diseases, can mediate complete B cell depletion with reduced risk of cytokine release syndrome (CRS). ATG-207 (undisclosed bifunctional biologics), is a first-in-class preclinical program being developed for T-cell driven autoimmune diseases.
TCEs: Antengene has built a robust portfolio of first/best-in-class programs targeting CD19×CD3, CDH6×CD3, ALPPL2×CD3, LY6G6D×CD3, GPRC5D×CD3, LILRB4×CD3, and FLT3×CD3, offering a wide therapeutic window for addressing unmet clinical needs across autoimmune diseases, solid tumors, and hematologic malignancies.
2. Encouraging data set a solid foundation for further advancement in clinical development
▶ ATG-022 (CLDN18.2 ADC)
Latest data from the Phase I/II CLINCH study: As of November 10, 2025, in patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 40% (12/30), a disease control rate (DCR) of 90% (27/30), and a median overall survival (mOS) of 14.72 months; while the 1.8 mg/kg dose cohort achieved an ORR of 40% (12/30), a DCR of 86.7% (26/30), and a median progression-free survival (mPFS) of 5.45 months. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%), those treated at the efficacious dose range of 1.8-2.4 mg/kg achieved an ORR of 28.6% (6/21) and a DCR of 52.4% (11/21). In these results, ATG-022 demonstrated potent antitumor activity in patients with a broad range of CLDN18.2 expression levels.
Broad combinatory potential for front-line treatment: the 1.8 mg/kg cohort demonstrated promising efficacy with only 16.1% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs). This differentiated safety profile uniquely positions ATG-022 as an ADC with best-in-class safety profile and potential to transform first-line standard of care in combination with both immune checkpoint inhibitors (CPIs) and chemotherapy.
Three clinical development pathways: To fully realize the therapeutic potential of its CLDN18.2-targeted therapy ATG-022, Antengene has outlined a clear clinical development roadmap designed to achieve regulatory approval, maximize therapeutic reach, and broaden tumor-type coverage. The strategy includes a near-term approval path through a pivotal Phase III in third and later line gastric cancer patients with moderate to high CLDN18.2 expression; a front-line proof-of-concept Phase II study evaluating ATG-022 in combination with a CPI and the CAPOX regimen, which, if supported by positive results, is expected to advance into a Phase III trial; and A broad indication-expansion effort through the ongoing Phase II study that builds on encouraging activity signals, extending beyond gynecologic tumors to further assess ATG-022 across a wider range of solid tumor types.
▶ ATG-037 (oral CD73 small molecule inhibitor)
Latest data from the Phase I/Ib STAMINA-01 study: As of October 24, 2025, in the subgroup of patients with CPI-resistant melanoma who received the combination regimen (12 patients), the ORR was 33.3%, the DCR was 100%, including 1 complete response (CR) and 3 partial responses (PRs). One of these patients had maintained CR and reported no safety issues despite having been on the treatment for more than two years. In the subgroup of patients with CPI-resistant non-small cell lung cancer (14 patients), the ORR was 21.4%, the DCR was 71.4%, including 3 PRs. These findings suggest that ATG-037 has clinically meaningful therapeutic potential in multiple tumor types, particularly in patients who are CPI-resistant.
Clinical development pathways: existing data show that ATG-037 holds enormous therapeutic potential for the treatment of first-line or CPI-resistant melanoma, with promising potential for expansion into other tumor types. Antengene’s clinical development roadmap for ATG-037 has four main components: 1. combination with CPI for the treatment of CPI-resistant unresectable and metastatic melanoma (second-line treatment); 2. combination with CPI for the first-line treatment of unresectable or metastatic melanoma; 3. active expansion into other tumor types supported by the encouraging proof-of-concept data in CPI-resistant non-small cell lung cancer; 4. explore potential combinations with next-generation CPIs such as PD-1×VEGF bispecific antibody.
▶ ATG-101 (PD-L1/4-1BB bispecific antibody): dose-escalation study of ATG-101 is currently underway in China, the U.S., and Australia, and has already observed favorable safety in varies dosing regimens, thus laying a solid foundation for the future clinical development. One study evaluating ATG-101 in extrapulmonary neuroendocrine carcinoma (EP-NEC) patients will be initiated soon.
3. AnTenGager technology platform: a key driver of innovation
▶ A TCE platform featuring steric hindrance masking: AnTenGager is a proprietary "2+1" second-generation TCE technology platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize CRS and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:
ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGagerTM TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer.
ATG-110（LY6G6D x CD3 TCE): A potential global best-in-class LY6G6D x CD3 targeted TCE being developed for the treatment of microsatellite stable colorectal cancer.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumors and lung cancer.
ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring "IO + ADC" dual-effect molecules for the treatment of solid tumors.
ATG-207 (undisclosed bifunctional biologics): a global first-in-class bifunctional biologic agent being developed for the treatment of T-cell driven autoimmune diseases, a therapeutic area representing a huge unmet clinical need.
Antengene will strive to further accelerate these highly promising clinical and preclinical programs. The company plans to report additional progress of these innovative programs and update the medical community, patients, and investors on future developmental milestones at a series of upcoming top international conferences.
(Press release, Antengene, NOV 19, 2025, View Source [SID1234660099])