• Registrational Phase 3 G-HOPE-001 Study Met Both Primary Endpoints, Demonstrating Statistically Significant and Clinically Meaningful Overall Survival and Progression-Free Survival Benefits in Previously Treated, CLDN18.2-positive Gastric Cancer
• Arcotatug Tavatecan Demonstrated a Favorable Safety Profile, with a Low Incidence of Gastrointestinal Adverse Events
• Arcotatug tavatecan is the First CLDN18.2-ADC to have a New Drug Application Accepted for Regulatory Review Globally

SAN FRANCISCO and SUZHOU, China, Oct. 23, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company committed to the discovery, development, manufacturing and commercialization of innovative medicines for the treatment of major diseases including oncology, cardiovascular and metabolic diseases, autoimmune diseases, and ophthalmic diseases, announced positive topline results from the Phase 3 (G-HOPE-001) study (NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D Code:TAK-921) in patients with Claudin (CLDN)18.2-positive, previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA). The data were orally presented as a Late-Breaking Abstract at the 2026 European Society for Medical Oncology (ESMO) Congress.

Gastric cancer is a leading cause of cancer-related death worldwide, and outcomes are particularly poor once the disease is advanced.^[1] Because treatment options are limited for people whose cancer continues to progress after multiple therapies, there is a significant need for new targeted therapies.^[2] CLDN18.2, a protein found at abnormally high levels on the surface of certain cancer cells, has emerged as a key biomarker for some gastrointestinal cancers, including gastric cancer.^[3] Arcotatug tavatecan is a novel, potential best-in-class Claudin 18.2-targeted antibody-drug conjugate (ADC) with an exatecan payload and an Fc-silenced backbone designed to reduce risk of Fc-mediated effects. Innovent entered into a license and collaboration agreement with Takeda in which Takeda will develop, manufacture and commercialize arcotatug tavatecan worldwide outside of Greater China.

Arcotatug Tavatecan Significantly Prolonged OS and PFS in Later-Line CLDN18.2-Positive G/GEJA

G-HOPE-001 is an international, multicenter, randomized, open-label study being conducted in China and Japan to evaluate arcotatug tavatecan monotherapy versus the treatment of physician's choice (TPC, irinotecan, paclitaxel or trifluridine/tipiracil) in patients with previously treated, unresectable locally advanced or metastatic CLDN18.2-positive G/GEJA.

The data reported at this ESMO were from two protocol-prespecified interim analyses: the first interim analysis (IA1) evaluated PFS, and the second interim analysis (IA2) evaluated OS, with data cutoff dates of February 13, 2026, and September 3, 2026, respectively. Compared with the TPC group, the arcotatug tavatecan group achieved statistically significant and clinically meaningful improvements in OS, PFS, and objective response rate (ORR).

• A significant improvement in OS. The median OS was 10.2 months in the arcotatug tavatecan group versus 6.9 months in the TPC group, representing a 43% reduction in the risk of death (HR=0.57, 95% CI: 0.45–0.73; P<0.0001).
• A substantial prolonged PFS. The IA1 showed that median PFS met the protocol-prespecified statistical criteria, demonstrating a statistically significant and clinically meaningful improvement. The IA2 showed that, by Independent Radiology Review Committee (IRRC) assessment, the arcotatug tavatecan group continued to demonstrate a substantial benefit in median PFS versus the TPC group (7.1 months versus 3.1 months (HR=0.45, 95% CI: 0.35–0.58).
• A remarkably higher ORR. The confirmed ORR per IRRC assessment in the arcotatug tavatecan group was 37.4%, significantly higher than 7.7% in the TPC group.

Arcotatug Tavatecan Demonstrated a Favorable Safety Profile with Incidences of Grade≥3 Nausea and Vomiting of only 0.9% and 2.6%

• Among patients receiving arcotatug tavatecan monotherapy, the overall safety profile was manageable, with a Grade ≥3 treatment-related adverse event (TRAE) rate of 47.4% versus 55.9% with TPC.
• The most common Grade ≥3 treatment-emergent adverse events (TEAEs) with arcotatug tavatecan versus TPC included anemia (20.4% vs. 13.1%), decreased neutrophil count (17.4% vs. 32.0%) and decreased white blood cell count (11.7% vs. 22.5%).
• There was a low incidence of severe gastrointestinal events with Grade ≥3 nausea, vomiting and diarrhea occurring in 0.9%, 2.6% and 1.3% of patients receiving arcotatug tavatecan, respectively, compared with 1.8%, 3.2% and 4.1% with TPC. This characteristic of the safety profile differentiates arcotatug tavatecan and may ease this aspect of treatment burden for patients in the future.
• TEAEs leading to dose interruption were reported in 47.4% of patients treated with arcotatug tavatecan versus 51.4% with TPC. Treatment-related drug discontinuations were uncommon and comparable between treatment arms, occurring in 1.7% of patients receiving arcotatug tavatecan.

Additional pos-hoc analyses data from the ongoing study will be shared at a future medical congress or published in a peer-reviewed journal.

Professor Lin Shen, Director of Department of Gastrointestinal Oncology, Beijing Cancer Hospital, said, "Gastric cancer remains a malignancy with a substantial disease burden in China and globally. For patients with advanced gastric cancer, treatment options become increasingly limited as the disease progresses to later lines of therapy, and overall prognosis remains poor, highlighting a substantial unmet medical need. As a notable therapeutic target in gastric cancer, CLDN18.2 has emerged as an important focus of precision treatment in gastrointestinal oncology. As a novel ADC targeting CLDN18.2, arcotatug tavatecan not only demonstrated promising antitumor activity in G-HOPE-001 study, but also showed clear clinical benefits in both PFS and OS. We look forward to arcotatug tavatecan potentially providing a new treatment option for more patients with CLDN18.2-positive advanced gastric cancer and further advancing precision treatment in gastric cancer."

Professor Kohei Shitara, Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Japan, said," Arcotatug tavatecan is a novel ADC targeting CLDN18.2. Given the relatively high expression of CLDN18.2 in G/GEJA, precision treatment targeting CLDN18.2 has important clinical significance. The data from the G-HOPE-001 study demonstrate encouraging antitumor activity of arcotatug tavatecan in patients with CLDN18.2-positive G/GEJ adenocarcinoma who had received multiple prior lines of therapy. Of note, interim results showed that arcotatug tavatecan demonstrated clear clinical benefits in both PFS and OS, further supporting its potential as a later-line treatment option. The results of G-HOPE-001 provide important Phase 3 clinical evidence for CLDN18.2-targeted ADC therapy and establish a foundation for further exploration of precision treatment strategies targeting CLDN18.2."

Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, said, "Arcotatug tavatecan was discovered by Innovent's research team, leveraging a novel Fc-silencing technology., Owing to its differentiated profile, Phase 3 clinical development was accelerated, positioning it as the first CLDN18.2 ADC to be accepted for regulatory review by a health authority globally. Arcotatug tavatecan is also Innovent's first ADC to achieve positive results in both PFS and OS, marking the validation of the SyntecanE® ADC platform based on an exatecan payload. We continue to deliver more innovative oncology therapies to benefit patients worldwide. "

About Arcotatug Tavatecan

Arcotatug tavatecan is a biomarker-directed, CLDN18.2-targeted ADC being developed as a precision medicine for the treatment of multiple CLDN18.2-expressing tumors. Through a cleavable linker, arcotatug tavatecan selectively delivers a highly potent exatecan payload, a topoisomerase I inhibitor, to tumor cells. It also incorporates an Fc-silenced structural design intended to minimize off-tumor, on-target toxicity.

Arcotatug tavatecan is the first CLDN18.2-directed ADC to have a new drug application accepted for regulatory review globally. Following positive results from the first interim analysis of the global Phase 3 G-HOPE-001 study, a new drug application (NDA) was submitted to China's National Medical Products Administration (NMPA) for the treatment of patients with CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received prior systemic therapy. The application is currently under priority review. AT is also being evaluated in an ongoing Phase 3 study in China for CLDN18.2-positive advanced pancreatic cancer, while its potential in first-line treatment of gastric and pancreatic cancer is being explored in Phase 1 clinical studies. Building on the progress of PoC studies, Takeda plans to initiate global Phase 3 trials in gastric and pancreatic cancer.

In addition, AT has received two Breakthrough Therapy Designations from the NMPA's Center for Drug Evaluation (CDE) for specified patient populations with advanced gastric and pancreatic cancer, respectively, and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with CLDN18.2-positive, locally advanced or metastatic pancreatic cancer who have received two prior systemic therapies.

About the G-HOPE-001 Study

The Phase 3 G-HOPE-001 study (NCT06238843) is an ongoing, international, multicenter, randomized, open-label study evaluating arcotatug tavatecan monotherapy versus treatment of physician's choice (TPC) (irinotecan, paclitaxel or trifluridine/tipiracil) in patients with previously treated, unresectable locally advanced or metastatic Claudin (CLDN)18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA). Eligible patients had CLDN18.2-positive tumors, defined as IHC ≥2+ in ≥75% of tumor cells as measured by the VENTANA CLDN18 (43-14A) Assay, and had progressed on two to four prior systemic regimens. Patients were randomized 1:1 to receive arcotatug tavatecan 6 mg/kg once every three weeks or TPC, stratified by region, primary tumor site and prior gastrectomy. The study's dual primary endpoints are progression-free survival (PFS) per RECIST v1.1 and overall survival (OS). Secondary endpoints include objective response rate (ORR), disease control rate, duration of response, time to response and safety. The study enrolled 464 participants across China and Japan.

About Gastric and Gastroesophageal Junction Adenocarcinoma (G/GEJA)

Gastric cancer is the fifth most common cancer and fifth leading cause of cancer-related deaths worldwide with Japan and China among the highest-incidence regions globally.^[1],[4] Five-year net survival rates vary globally but are approximately 20 to 40%, with markedly poorer rates in patients with advanced disease.^[5] Treatment options become increasingly limited as the disease progresses, and median overall survival remains less than 10 months for patients receiving later lines of therapy.^[6] Claudin 18.2, a tight junction protein typically found in healthy gastric tissue but abnormally expressed on the surface of tumor cells in a significant proportion of gastric and gastroesophageal junction cancers, has emerged as an important biomarker-driven target for the development of novel precision therapies in this disease.^[3]

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage.

Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the high quality outbound internationalization of China's innovative drug industry.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

References

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