信达生物ESMO首次口头报告IBI3001（EGFR/B7H3双抗ADC）国际I期数据：ORR 30.2%、安全性可控，但关键数字已随摘要提前披露且处极早期

SAN FRANCISCO and SUZHOU, China ,  Oct. 25, 2026  -- Innovent Biologics, Inc. (HKEX Stock Code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases including oncology, autoimmune, metabolic, and ophthalmic diseases, presented for the first time the international Phase 1 clinical data of IBI3001, a first-in-class EGFR/B7H3 ADC, in a Proffered Paper session at the 2026 European Society for Medical Oncology (ESMO) Congress.

Safety and Efficacy of the Anti-EGFR/B7H3 Bispecific ADC IBI3001 in Patients with Advanced Solid Tumors: Results from a Multi-Regional Phase 1 Study

Abstract number: 1001O

The data presented were from an international multicenter Phase 1 clinical study conducted in China, Australia, and the United States, designed to evaluate the safety, tolerability, and preliminary efficacy of IBI3001 in patients with advanced solid tumors. As of the data cutoff date, a total of 57 patients with advanced solid tumors had received IBI3001 monotherapy (1 mg/kg–10 mg/kg), including 21 with non-small cell lung cancer (NSCLC), 15 with pancreatic cancer, 8 with small cell lung cancer (SCLC), and 13 with other tumors. Of these, 78.9% had received ≥2 prior treatment.

IBI3001 monotherapy demonstrated a manageable safety profile.

During dose escalation, only one dose-limiting toxicity (DLT) event occurred in each of the 8 mg/kg and 10 mg/kg cohorts, and all DLTs were well managed.

The Grade ≥3 treatment-related adverse events (TRAEs) was 47.4%. The most common TRAEs were hematologic toxicities, and all adverse events were clinically manageable.

Only 1 participant (1.8%) discontinued treatment permanently due to a TRAE and did not occur in 6mg/kg or 8mg/kg cohorts. No TRAE-related deaths occurred, indicating a favorable overall safety profile.

IBI3001 showed encouraging efficacy signals across multiple solid tumors in later-line setting.

Among 53 efficacy-evaluable patients, the overall objective response rate (ORR) was 30.2% and the disease control rate (DCR) was 88.7%; in the 8 mg/kg dose cohort, the ORR reached 45.0% and the DCR was 100%.

By tumor type,

In 16 patients with EGFR-mutant NSCLC, the ORR was 31.3%, the DCR was 93.8%, and median progression-free survival (PFS) reached 7.7 months;

In 15 patients with pancreatic cancer (93.3% (14/15) had received prior irinotecan treatment, 86.7% (13/15) were in the third-line or later setting), the ORR was 15.4%, the DCR reached 92.3%, with median PFS reaching 6.9 months;

In 8 patients with SCLC, the ORR was 62.5% and the DCR was 100%;

In 5 patients with head and neck squamous cell carcinoma/esophageal squamous cell carcinoma, the ORR was 60.0% and the DCR was 100%.

As a first-in-class EGFR/B7H3 bispecific ADC, IBI3001 has demonstrated positive antitumor efficacy and an excellent safety profile across multiple solid tumors. It is expected to bring a next-generation ADC treatment option with high efficacy and low toxicity for tumor types such as EGFR-mutant NSCLC, pancreatic cancer, and esophageal cancer, further validating the differentiated advantages and development capabilities of Innovent's ADC technology platform. Currently, IBI3001 has advanced to the dose-optimization stage of a Phase 1b proof-of-concept (PoC) study, with plans to further validate its efficacy and safety in the above-mentioned later-line refractory cancer patient populations.

Professor Yi Hu of the Chinese PLA General Hospital  stated: "Patients with advanced solid tumors have limited options after multiple lines of treatment, and EGFR-targeted therapy-resistant NSCLC, SCLC, and pancreatic cancer are particularly challenging refractory tumor types in clinical practice. IBI3001 is a first-in-class bispecific ADC targeting EGFR and B7H3. It leverages dual targets to enhance tumor recognition specificity and carries a topoisomerase I inhibitor payload to exert potent antitumor activity. The Phase 1 data presented here shows manageable safety and impressive efficacy across multiple refractory tumor types, especially in pancreatic cancer, with a DCR of 92.3% and a median PFS of nearly 7 months; in EGFR-targeted therapy-resistant advanced EGFR-mutant NSCLC, the ORR was 31.3%, the DCR was 93.8%, and median PFS was 7.7 months; it also showed positive efficacy in SCLC and squamous cell carcinoma. These findings support further dose optimization and expansion to explore IBI3001's potential for those patients with limited treatment options."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent Biologics,  stated: "IBI3001 is a leading bispecific ADC program in our oncology portfolio. The Phase 1 clinical data presented at ESMO support the potential of our bispecific ADC platform. By targeting two tumor-associated antigens, this approach is designed to improve tumor-targeting specificity and reduce off-target toxicity, while covering a broader population of patients who may benefit. We will advance IBI3001's Phase 1b dose-optimization and subsequent cohort-expansion studies while continue to develop differentiated ADCs on our platforms to address unmet clinical needs."

About IBI3001

IBI3001 is a first-in-class anti-EGFR/B7H3 bispecific antibody-drug conjugate developed by Innovent. It simultaneously targets two targets closely associated with tumor initiation and progression: EGFR is a classic receptor tyrosine kinase that drives tumor cell proliferation and is abnormally expressed in multiple solid tumors, including lung cancer, colorectal cancer, and pancreatic cancer; B7H3 is a tumor-enriched immunomodulatory protein that is highly expressed in various solid tumors and is closely associated with tumor invasion and immunosuppression.

IBI3001 carries a topoisomerase I inhibitor as its payload, with a drug-to-antibody ratio (DAR) of 4, and combines high affinity with good stability. Preclinical studies showed that IBI3001 has a potent bystander effect and demonstrated excellent antitumor activity in both in vitro and in vivo tumor models with different EGFR and B7H3 expression levels, along with a favorable safety profile. Currently, the Phase 1b dose-optimization study of IBI3001 is ongoing, and subsequent clinical exploration will be conducted in multiple highly prevalent and refractory tumor types.

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 .

Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s).

(2) Ramucirumab Injection (Cyramza ® ), Selpercatinib Capsules (Retsevmo ® ), Pirtobrutinib Tablets (Jaypirca ® ) and abemaciclib (Verzenios ® ) are products discovered and developed by Eli Lilly.

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