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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

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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-2 α-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-2 α -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-2 α-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.

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SOURCE Innovent Biologics