On April 23, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S (Press release, Innovent Biologics, APR 23, 2025, View Source [SID1234652067]).

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Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO (Free ESMO Whitepaper) Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO (Free ASCO Whitepaper), further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options."

Details on the abstracts are listed below:

Oral Presentation

1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma

Abstract Number: 2502
Session Type: Oral Abstract
Session Title: Developmental Therapeutics-Immunotherapy
Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT
Presenter: Jun Guo, MD, Beijing Cancer Hospital

2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer

Abstract Number: 104
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot"
Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT
Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC)

Abstract Number: 8509
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT
Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine

4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343

Abstract Number: 4017
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT
Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center

5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21)

Abstract Number: 7007
Session Type: Oral Abstract
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT
Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences

6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01)

Abstract Number: 3519
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer-Colorectal and Anal
Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT
Presenter：Changqing Jing, MD, Shandong Provincial Hospital

7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in nasopharyngeal carcinoma: The EP-STAR trial

Abstract Number: 6010
Session Type: Oral Abstract
Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer
Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT
Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center

Poster Presentation

1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress

Abstract Number: TPS9594
Session Type: Poster
Session Title: Melanoma/Skin Cancers
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute

2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial

Abstract Number: 5565
Session Type: Poster
Session Title: Gynecologic Cancer
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Jin Shu, MD, Chongqing University Cancer Hospital

3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study

Abstract Number: 1029
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research

4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study

Abstract Number: 1102
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Fan Wu, MD, Fujian Cancer Hospital

5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress

Abstract Number: TPS4201
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Lin Shen, MD, Beijing Cancer Hospital

6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases.

Abstract Number: 4050
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Dan Sha, MD, Shandong Provincial Hospital

*Abstracts of TYVYT (sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007.