Company Announcements

SAN FRANCISCO and SUZHOU,China, April 23, 2025 /PRNewswire/ -- 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, announces that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2^α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S.

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO 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 Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO, 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-2^α-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: 5/31/20253:00 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: 6/1/20259:45 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-2^α-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: 6/3/20259:45 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: 6/2/202511:30 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: 5/30/20252:45 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: 6/1/202511:30 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 n as opharyngeal 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: 6/2/20253:00 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-2^α-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: 6/1/20259:00 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: 6/1/20259:00 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: 6/2/20259:00 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: 6/2/20259:00 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: 5/31/20259:00 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: 5/31/20259:00 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.

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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

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 (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.

Forward-looking statement

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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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