- Long-term follow-up data show that IBI363 monotherapy demonstrates promising overall survival (OS) benefits in both immune-resistant lung squamous cell carcinoma and lung adenocarcinoma, with a notable long-tail effect.
- A global Phase III clinical study of IBI363 for immune-resistant squamous non-small cell lung cancer is ongoing; based on regulatory discussions, plans are underway to initiate a global Phase III clinical study for immune-resistant non-squamous non-small cell lung cancer.
- Innovent Biologics and Takeda Pharmaceutical are jointly developing IBI363 globally (Takeda development code: TAK-928).
San Francisco, USA, and Suzhou, ChinaJune 1, 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 disorders, autoimmune diseases, and ophthalmology, announced detailed updated data from the proof-of-concept (PoC) study of IBI363, 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.
IBI363 demonstrates robust survival benefits with a pronounced long-tail effect in immune-resistant lung squamous cell carcinoma
IBI363 shows robust long-term survival benefits in immune-resistant lung adenocarcinoma, particularly prominent in subjects with a history of smoking; the long-term survival tail effect is evident
IBI363 demonstrates favorable long-term follow-up safety data
- In the overall population (n = 136) during long-term follow-up, IBI363 exhibited a favorable safety profile: in the 1 mg/kg and 1.5 mg/kg dose groups, the incidence of treatment-emergent adverse events (TEAEs) of Grade 3 or higher was 30.6%; in the 3 mg/kg dose group, this rate was 64.9%.
- Common adverse events across all patients included arthralgia (52.2%, ≥Grade 3: 3.7%), anemia (46.3%, ≥Grade 3: 4.4%), and rash (39.0%, ≥Grade 3: 8.8%). These adverse events were mostly mild to moderate, controllable, and manageable, with no new safety signals observed.
Professor Jianya Zhou from the First Affiliated Hospital, Zhejiang University School of Medicine stated: “Lung cancer is the malignant tumor with the highest incidence and mortality rates globally and in China, posing a major public health issue. Although immunotherapy has revolutionized the treatment landscape for non-small cell lung cancer, the current standard of care, docetaxel, offers limited efficacy for wild-type NSCLC patients who have failed immunotherapy. In recent years, while explorations of novel therapies such as combination immunotherapy and antibody-drug conjugates (ADCs) have brought new hope, several large Phase III clinical studies targeting NSCLC patients who have failed platinum-based chemotherapy and immunotherapy have not yielded satisfactory results. Therefore, there is a significant and urgent unmet clinical need in immunotherapy-failed NSCLC. As a PD-1/IL-2α-bias bispecific molecule, IBI363 has shown clinical benefits in terms of ORR and PFS in immune-resistant NSCLC, particularly in the 3 mg/kg Q3W dose group, where over 40% of subjects, regardless of lung squamous cell carcinoma or lung adenocarcinoma, have survived beyond 24 months, highlighting the potential of the immunotherapy tail effect to bring long-term survival benefits to patients.“
Dr. Hui Zhou, Chief Medical Officer (Oncology) of Innovent Biologics stated: “Lung cancer remains the most common malignant tumor globally. Although immunotherapy has significantly improved the survival status of some patients, treatment options for NSCLC patients who do not respond to immunotherapy and lack driver gene mutations remain very limited, making long-term survival difficult to achieve. The PoC study data presented at this ASCO meeting are encouraging. IBI363 not only provides short-term disease control, but the long-term follow-up data further validate the unique long-term survival benefits of its dual mechanism of ‘immune checkpoint blockade plus cytokine agonism.’ We look forward to this drug offering a new treatment option for a broad range of patients, ultimately helping them achieve long-term survival benefits.”
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 Biologics. It possesses 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 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 immune-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 assess 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 Biologics entered into a strategic collaboration with Takeda Pharmaceutical. The parties will jointly develop IBI363 (Takeda development code: TAK-928) globally and co-commercialize it in the United States. Additionally, Innovent has 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 general public. Founded in 2011, Innovent is dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology, aiming to benefit more lives through our work. The company has 18 approved products: 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®), tebotelimab N01 injection (Sintbimin®), mazdutide injection (Xinerme®), picankibart injection (Xinmeiyue®), and ipilimumab N01 injection (Daboxin®). Currently, 5 new drug molecules have entered Phase III or pivotal clinical studies, and an additional 14 new drug candidates are in clinical development.
The company has entered into over 30 strategic collaborations with international partners such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously innovating and developing new drugs for its own growth, Innovent adheres to the people-centered development philosophy in economic construction. Over the years, it has always been guided by scientific goodwill, steadfastly committed to a “patient-centered” approach, caring for patients and their families, and actively fulfilling its social responsibilities. The company has initiated and participated in numerous drug assistance and donation 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 a total value of donated drugs reaching RMB 4 billion. Innovent hopes to work together with everyone to improve the development level of China’s biopharmaceutical industry, to meet the accessibility of medications for the people and the pursuit of 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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