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Innovent to Present New Clinical Data of IBI363(PD-1/IL-2α-biased bispecific fusion protein) at the 2026 ASCO Annual Meeting


News provided by

Innovent Biologics

Apr 21, 2026, 20:00 ET

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SAN FRANCISCO and SUZHOU, China, April 21, 2026 /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 first-in-class IBI363 (PD-1/IL-2α-biased bispecific fusion protein) * as well as TYVYT® (sintilimab injection)** will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 to June 2, 2026, in Chicago, Illinois, U.S.

Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "We are excited to announce that at the 2026 ASCO Annual Meeting, we will present new PoC data of IBI363 in NSCLC, across both IO-resistant and first-line settings. With robust PoC data for IO-resistant NSCLC now in hand, we are moving IBI363 into MRCT pivotal development, an important step toward tackling a major global unmet medical need. At the same time, we are encouraged by the promising dose optimization data in first-line NSCLC, and we look forward to continued maturation of PoC full data to inform our next steps. Innovent will continue to push the boundaries of cancer care, as we are dedicated to delivering physicians and patients more innovative, effective, and life-saving treatment options."

Abstracts of IBI363(PD-1/IL-2α-biased bispecific fusion protein)

1.  Presentation Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC).
Abstract Number: 8586
Session Type: Poster
Session Title: Lung Cancer/Non-Small Cell Metastatic
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Haiyan Tu, Guangdong Provincial People's Hospital

2.  Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody IBI363 (TAK-928) in patients (pts) with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC): updated results from a phase I study.
Abstract Number: 2618
Session Type: Poster
Session Title: Developmental Therapeutics/Immunotherapy
Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Jianya Zhou, First Affiliated Hospital of Zhejiang University School of Medicine

3.  Presentation Title: Randomized phase 3 study (MarsLight-11) evaluating IBI363 (TAK-928) versus docetaxel in patients (pts) with squamous non-small cell lung cancer (sqNSCLC) after prior chemotherapy (chemo) and immunotherapy (IO).
Abstract Number: TPS8673
Session Type: Poster
Session Title: Lung Cancer/Non-Small Cell Metastatic
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Roy S. Herbst, Yale School of Medicine

Abstracts of TYVYT®(sintilimab)

1.  Presentation Title: Adjuvant sintilimab plus bevacizumab following curative resection of spontaneously ruptured hepatocellular carcinoma: A prospective exploratory phase II study (CLEAR-2)
Abstract Number: TPS4254
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Yongjun Chen, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

2.  Presentation Title: Neoadjuvant chemoradiotherapy with or without PD-1 blockade in pMMR/MSS low rectal cancer patients (CHOICE II): A multi-center, open-label, randomized controlled trial.
Abstract Number: 3640
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Wei Zhang, Changhai Hospital

3.  Presentation Title: Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC): A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study 
Abstract Number: 4148
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Jia Fan, Zhongshan Hospital, Fudan University

4.  Presentation Title: CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer.
Abstract Number: TPS3680
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Yue Liu, The Second Affiliated Hospital of Zhejiang University School of Medicine.

5.  Presentation Title: Long-term survival and biomarker analysis of neoadjuvant chemoradiotherapy with or without PD-1 antibody sintilimab in pMMR locally advanced rectal cancer: A randomized clinical trial. 
Abstract Number: 3610
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Xiao Weiwei, Sun Yat-sen University Cancer Center

6.  Presentation Title: Larynx preservation via chemotherapy-free neoadjuvant sintilimab-cetuximab-SBRT and response-adapted treatment in locally advanced laryngeal cancer: A phase II, single-arm clinical trial (The NeoVOICE study).
Abstract Number: 6095
Session Type: Poster
Session Title: Head and Neck Cancer
Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Song Ming, Sun Yat-sen University Cancer Center

7.  Presentation Title: Pathological complete response and ctDNA analyses in SCIENCE: Results from a randomized, phase III trial of neoadjuvant chemotherapy plus sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy in resectable locally advanced esophageal squamous cell carcinoma.
Abstract Number: LBA4082
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Xuefeng Leng, Sichuan Cancer Hospital

8.  Presentation Title: Sintilimab (PD-1 antibody) Plus Gemcitabine and Docetaxel (GT) as First-line or Later-line Therapy in Patients with Advanced Epithelioid Sarcoma: A Prospective, Multicenter, Single-arm, Phase II Clinical Study.
Abstract Number: 11574
Session Type: Poster
Session Title: Sarcoma
Session Date & Time: June 1, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Xiaowei Zhang, Fudan University Shanghai Cancer Center

9.  Presentation Title: Sintilimab plus Anlotinib and Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma: A Prospective, Phase II Clinical Trial.
Abstract Number: 8050
Session Type: Poster
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Jianchun Duan, Cancer Hospital, Chinese Academy of Medical Sciences

*Innovent entered into a license and collaboration agreement with Takeda for co-development and co-commercialization of IBI363 (Takeda R&D code: TAK-928). Please refer to the announcement for more information.

**Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT), except for abstract #4148.

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 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, 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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