San Francisco, USA and Suzhou, ChinaMay 22, 2026 /PRNewswire/ — Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, cardiovascular and metabolic diseases, autoimmune diseases, and ophthalmology, announced updated Phase I PoC clinical data for IBI363 (Takeda development code: TAK-928), a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, in the treatment of advanced immune-resistant non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. A summary of the abstract is provided below, with more detailed research results to be formally presented during the conference.
After long-term follow-up, IBI363 demonstrated favorable long-term safety in subjects with immunotherapy-resistant NSCLC. Particularly encouraging, long-term follow-up data suggest that IBI363 showed excellent overall survival (OS) in both squamous and non-squamous NSCLC, validating the long-term survival benefit derived from IBI363’s unique dual mechanism of “immune checkpoint blockade + cytokine agonism.”
Based on this clinical study data, IBI363 has entered a global Phase III clinical study (Marslight-11) for immunotherapy-resistant squamous NSCLC, and its clinical trial design will also be presented at this ASCO. Following regulatory discussions, IBI363 is also planned to initiate a global Phase III clinical study for immunotherapy-resistant non-squamous NSCLC.
Updated PoC Clinical Data for IBI363 in Immunotherapy-Resistant Advanced NSCLC
IBI363 Demonstrates Robust Survival Benefit with Clear Long-Tail Effect in Immunotherapy-Resistant Squamous NSCLC
- Previously, in the TROPION-Lung01 study targeting similarly immunotherapy-treated NSCLC patients, the docetaxel (standard of care) control arm showed a median overall survival (OS) of 9.4 months and a 24-month OS rate of 14.8% in squamous NSCLC. IBI363’s long-term follow-up data demonstrate a highly competitive survival advantage.
IBI363 Shows Strong Long-Term Survival Benefit in Immunotherapy-Resistant Non-Squamous NSCLC, Particularly Notable in Subjects with a History of Smoking; Clear Long-Term Survival Tail Effect
- Previously, in the TROPION-Lung01 study targeting similarly immunotherapy-treated NSCLC patients, the docetaxel (standard of care) control arm showed a median overall survival (OS) of 12.3 months and a 24-month OS rate of 21.7% in non-squamous NSCLC. IBI363’s long-term follow-up data demonstrate a highly competitive survival advantage.
Favorable Long-Term Follow-Up Safety Profile for IBI363
- In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favorable safety profile: Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 48.5% of subjects. Common adverse events primarily included arthralgia (52.2%, Grade ≥3 3.7%), anemia (46.3%, Grade ≥3 4.4%), and rash (39.0%, Grade ≥3 8.8%), mostly mild to moderate in severity, controllable and manageable, with no new safety signals observed.
Dr. Hui Zhou, Senior Vice President of Research and Development (Oncology Pipeline) at Innovent Biologics, stated: “Lung cancer remains the most common malignancy worldwide. Although immunotherapy has significantly improved survival for some patients, treatment options remain very limited for NSCLC patients who do not respond to immunotherapy and lack driver gene mutations, with overall survival typically less than 12 months. The PoC study data presented at this ASCO conference are encouraging. Under long-term follow-up, IBI363 demonstrated excellent overall survival (OS) in both immunotherapy-resistant squamous and non-squamous NSCLC, validating the long-term survival benefit derived from its unique dual mechanism of action. This potentially offers a novel therapeutic pathway for this large patient population.”
About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)
IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein independently developed by Innovent, possessing dual functions of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 has been engineered to retain its affinity for IL-2Rα while reducing binding affinity to IL-2Rβ and IL-2Rγ, thereby mitigating toxicity. The PD-1 binding arm enables simultaneous PD-1 blockade and selective IL-2 delivery. This differentiated strategy allows for more precise and effective targeting and activation of tumor-specific T cell subsets.
Currently, IBI363 is being evaluated in a series of clinical trials globally, including a global multi-regional Phase III trial for immunotherapy-resistant squamous non-small cell lung cancer and a pivotal Phase II study in China for untreated acral and mucosal melanoma. Additionally, multiple Phase Ib/II trials are ongoing to evaluate IBI363 in non-small cell lung cancer and colorectal cancer (including first-line and later-line treatments), as well as other tumor types. To date, IBI363 has received three Breakthrough Therapy Designations (BTD) from China’s NMPA and two Fast Track Designations (FTD) from the U.S. FDA.
In October 2025, Innovent entered into a strategic collaboration with Takeda Pharmaceutical Company. The parties will jointly develop and co-commercialize IBI363 (Takeda development code: TAK-928) in the United States. Additionally, Innovent granted Takeda commercialization rights for IBI363 in regions outside of Greater China and the United States.
About Innovent Biologics
“Start with Integrity, Succeed through Action” – Innovent’s mission and goal is to develop high-quality biologics that are affordable for the people. Founded in 2011, Innovent is dedicated to researching, developing, manufacturing, and commercializing innovative drugs for major diseases such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology, to benefit more lives. The company has 18 approved products on the market: sintilimab injection (Tyvyt®), bevacizumab injection (Byvasda®), adalimumab injection (Sulinno®), rituximab injection (Dabohua®), pemigatinib tablets (Pemazyre®), olverembatinib tablets (Nerlynx®), ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), equecabtagene autoleucel injection (Fucaso®), tafolecimab injection (Sintbilo®), fulzerasib tablets (Dabote®), pirtobrutinib tablets (Jaypirca®), taletrectinib adipate capsules (Dabole®), lietinib tablets (Aoyixin®), tifcemalimab N01 injection (Sintbimin®), mazdutide injection (Xinerme®), picankibart injection (Xinmeiyue®), and ipilimumab N01 injection (Daboxin®). Currently, 5 new drug molecules are in Phase III or pivotal clinical studies, and an additional 14 new drug candidates have entered clinical research.
The company has established over 30 strategic collaborations with international partners including Eli Lilly, Roche, Takeda, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously innovating and developing its own drugs and pursuing growth, Innovent adheres to the people-centered development philosophy of economic construction. Over the years, always guided by scientific goodwill and committed to a “patient-centered” approach, the company cares for patients and their families and actively fulfills its social responsibilities. The company has initiated and participated in numerous patient assistance programs, enabling more patients to benefit from advances in life sciences and to access and afford high-quality biologics. To date, Innovent’s patient assistance programs have benefited over 200,000 ordinary patients, with the total value of drug donations reaching RMB 4 billion. Innovent hopes to work together with everyone to improve the development level of China’s biopharmaceutical industry, to meet the people’s accessibility to medication and their aspirations for a healthy life.
For more information, please visit the company’s website: www.innoventbio.com or the company’s LinkedIn account: www.linkedin.com/
Disclaimer: 1. Innovent does not recommend the use of unapproved drugs/indications.
2. Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) are developed by Eli Lilly.
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