SAN FRANCISCO and SUZHOU, China, May 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 updated data from the Phase 1 PoC clinical study of its first-in-class PD-1/IL-2^α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the treatment of advanced immunotherapy(IO)-resistant non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. An overview of the abstract information is provided below, and the full abstract is available here. More detailed results will be presented during the conference.

Updated data from this PoC study conducted in China, showed that after extended follow-up, IBI363 continued to demonstrate a manageable long-term safety profile in IO-resistant NSCLC. Notably, the long-term follow-up data showed strong overall survival (OS) in both squamous NSCLC and adenoNSCLC, supporting the durable benefits driven by IBI363's unique dual mechanism of immune checkpoint blockade plus cytokine agonism.

Based on the data from this study, IBI363 has entered a global Phase 3 clinical study (MarsLight-11) for IO-resistant squamous NSCLC, the clinical trial design of which will also be presented at this ASCO. Pending regulatory communications, initiation of a global Phase 3 clinical study of IBI363 for IO-resistant non-squamous NSCLC is also planned.

Updated PoC Clinical Data of IBI363 in Immunotherapy-Resistant Advanced NSCLC

The abstract at this conference reported updated data on IBI363 monotherapy in subjects with advanced NSCLC (ClinicalTrials.gov, NCT05460767). As of the follow-up cutoff date of November 20, 2025, a total of 136 subjects with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W).

IBI363 Showed Robust Survival Benefits with a Long Tail Effect in IO-Resistant Squamous NSCLC

• All 67 squamous NSCLC patients had no known EGFR mutations. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7).
• Previously, in the TROPION – Lung01 study that also enrolled NSCLC patients previously treated with immunotherapy, the docetaxel (standard of care) control group achieved a median overall survival (OS) of 9.4 months and a 24 – month OS rate of 14.8% in patients with squamous NSCLC. The long – term follow – up data of IBI363 demonstrate a highly competitive survival advantage.

IBI363 Showed Potential for Long-Term Survival Benefits with a Long Tail Effect in IO-Resistant Wild-type AdenoNSCLC, Especially in Patients with a Smoking History

• Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0).
• Smoking history may be an important influencing factor for the efficacy in immuno-resistant adenoNSCLC. In adenoNSCLC subjects with a smoking history, better survival benefits were observed. The median OS for smokers across all dose groups (n=31) reached 23.4 (95%CI 11.3, NE, maturity 48.4%) months.
• Previously, in the TROPION – Lung01 study that also enrolled NSCLC patients previously treated with immunotherapy, the docetaxel (standard of care) control group achieved a median overall survival (OS) of 12.3 months and a 24 – month OS rate of 21.7% in patients with non-squamous NSCLC. The long – term follow – up data of IBI363 demonstrate a highly competitive survival advantage.

IBI363 Showed a Favorable Safety Profile in Long-Term Follow-up

• In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favorable safety profile: treatment-emergent adverse events (TEAEs) of grade 3 or above were present in 48.5% of patients. The most common adverse events were mainly arthralgia (52.2%, ≥grade 3 3.7%), anemia (46.3%, ≥grade 3 4.4%), and rash (39.0%, ≥grade 3 8.8%), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "Lung cancer remains the most common malignant tumor worldwide. Although immunotherapy has transformed the treatment landscape of NSCLC, therapeutic options are still very limited for patients without driver gene mutations who have failed immunotherapy, with overall survival typically less than 12 months. With longer follow-up, we are encouraged to see outstanding survival outcomes with IBI363 in IO-resistant NSCLC across both squamous and adenoNSCLC. These results further underscore the novel mechanism of IBI363 and its 'tailing effect' driven by dual immune checkpoint blockade and cytokine agonism. We hope it will offer a new treatment option for this large patient population and ultimately deliver long-term survival benefits."

About IBI363 (PD-1/IL-2^α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2^α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

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.

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