On May 31, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that ivonescimab, the Company’s first-in-class PD-1/VEGF bispecific antibody, has achieved a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment for patients with advanced squamous non-small cell lung cancer (sq-NSCLC) in the Phase III HARMONi-6 (AK112-306) study. These landmark findings will be featured in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Professor Shun Lu, Director of the Lung Cancer Center at Shanghai Chest Hospital and Principal Investigator of HARMONi-6, presented the data in an oral Plenary Session presentation.

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This marks the first time a China-originated investigational oncology drug has been selected for the ASCO (Free ASCO Whitepaper) Plenary Session in the society’s 61-year history. This moment is a definitive testament to the ivonescimab regimen’s role in ushering cancer immunotherapy into the ‘2.0 Era’.

The HARMONi-6 study results were simultaneously published in The Lancet.

The HARMONi-6 study enrolled a total of 532 patients. Among them, approximately 63% had centrally located squamous tumors, 39.0% had PD-L1 TPS <1%, and 33.8% had multi-site metastases, liver metastases, or brain metastases. At the pre-specified interim analysis, as assessed by the Independent Data Monitoring Committee (IDMC), the study met its key secondary endpoint of overall survival (OS), demonstrating both clinically a meaningful and statistically significant benefit.

As of the data cutoff date of February 27, 2026, with a median follow-up of 21.36 months:

34% reduction in the risk of death – ivonescimab plus chemotherapy significantly prolonged OS

In the intent-to-treat (ITT) population, ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (HR=0.66 [95% CI: 0.50–0.87], P=0.0017(＜0.0049). Median OS was 27.9 months in the ivonescimab arm (the final death event in this arm caused the Kaplan-Meier curve to drop sharply to the median, thereby producing the mOS estimate) versus 23.7 months in the control arm.
The 12-month OS rate was 78.9% with ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively. The survival benefit continued to widen over time, reflecting a more durable and clinically meaningful long-term survival advantage.
Consistent OS benefit across all prespecified subgroups

OS benefit with ivonescimab was observed consistently regardless of PD-L1 expression status: HR=0.68 in the PD-L1 TPS ≥1% subgroup and HR=0.64 in the TPS <1% subgroup; HR=0.67 in the PD-L1 TPS 1–49% subgroup and HR=0.64 in the TPS ≥50% subgroup.
The OS benefit was also consistent across subgroups defined by metastatic burden: HR=0.47 in patients with ≥3 metastatic sites and HR=0.69 in those with liver metastases.
Comparable subsequent anticancer therapy between the two arms

Proportions of patients in the two groups who subsequently received immunotherapy: 13.9% in the treatment group vs 19.2% in the control group; proportions receiving targeted therapy: 12.4% vs 17.3%; proportions receiving ADC therapy: 4.5% vs 5.6%; proportions participating in other clinical trials: 0.8% vs 2.3%.

Favorable safety profile comparable to tislelizumab plus chemotherapy

Grade ≥3 treatment-related adverse events (TRAEs) occurred in 69.2% of patients in the ivonescimab arm and 58.9% in the control arm.
Rates of adverse events leading to treatment discontinuation or death were similar between arms.
At the prespecified interim analysis for progression-free survival (PFS), ivonescimab plus chemotherapy had already demonstrated a clinically meaningful and statistically significant improvement in PFS compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months versus 6.9 months (HR=0.60 [95% CI: 0.46–0.78], P＜0.0001).

Professor Shun Lu, Principal Investigator of HARMONi-6, Director of the Lung Cancer Center at Shanghai Chest Hospital and Tenured Professor:

"HARMONi-6 is the first global Phase III study in lung cancer to show statistically significant improvements in both OS and PFS compared with PD-1 plus chemotherapy. It is also the first in sq-NSCLC to achieve dual OS and PFS success through a pre-specified hypothesis test. The results significantly reduced the risk of death and disease progression, with consistent benefits across all subgroups, while enabling patients to maintain better quality of life for longer.

These strong head-to-head data redefine the gold standard for first-line sq-NSCLC treatment and fill a major clinical gap for anti-angiogenic therapy in this setting. We look forward to ivonescimab delivering broader benefits to patients worldwide as a next-generation immuno-oncology therapy."

Dr. Yu Xia, Founder, Chairwoman, President and CEO of Akeso:

"Today, we are thrilled to announce that ivonescimab plus chemotherapy has successfully challenged PD-1 plus chemotherapy, achieving both clinically meaningful and statistically significant improvements in overall survival (OS) and progression-free survival (PFS). We extend our sincere gratitude to all investigators, clinical teams, and patients who participated in this study. Thanks to their efforts, Chinese patients with advanced sq-NSCLC are the first to benefit from this innovative, safe, and highly effective global therapy.

Prior to ivonescimab, no therapy had successfully challenged the dominance of PD-1-based regimens in a head-to-head Phase III trial. Ivonescimab has already demonstrated dual OS and PFS benefits in EGFR-mutant non-squamous NSCLC after TKI failure, becoming the first immunotherapy approved in this setting. It has also shown superior PFS versus pembrolizumab monotherapy in first-line PD-L1-positive NSCLC. These results have generated strong global anticipation for next-generation therapies. Since its launch, ivonescimab has been widely adopted by clinicians and patients.

PD-1 plus chemotherapy is currently the most broadly used first-line regimen in oncology. Following our previous success versus pembrolizumab monotherapy, the HARMONi-6 study now demonstrates for the first time that ivonescimab plus chemotherapy can achieve dual superiority in both OS and PFS over PD-1 plus chemotherapy. This landmark result solidifies ivonescimab’s position as a next-generation cornerstone of cancer immunotherapy.

The success of HARMONi-6 gives us even greater confidence to leverage global resources, fully unlock ivonescimab’s potential, reshape treatment paradigms, and deliver more effective and safer solutions to patients worldwide."

Ivonescimab is currently being evaluated in more than 30 clinical settings across a wide range of tumors, including 15 Phase III trials, seven of which are head-to-head studies versus PD-1/PD-L1 therapies. The positive results from HARMONi-6 further strengthen its differentiated clinical profile. In partnership with Summit Therapeutics, Akeso remains fully committed to advancing the global development of ivonescimab to maximize its therapeutic benefit for patients worldwide.

(Press release, Akeso Biopharma, MAY 31, 2026, View Source [SID1234666269])

On May 31, 2026 Servier reported updated efficacy and safety results from more than three years of follow-up in the Phase 3 INDIGO trial evaluating VORANIGO (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (IDH1/2) glioma following surgical intervention and who are not in immediate need of chemoradiotherapy. These data, which will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 at 4:36 p.m. CDT in Chicago, strengthen the previous findings from the INDIGO pivotal trial and demonstrate the clinical benefits of VORANIGO continue to improve over time.

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The extended analysis includes 21.3 months of additional unblinded data collected between the March 7, 2023, trial unblinding and the January 17, 2025, data cutoff. As of data cutoff, all 163 patients enrolled in the placebo arm discontinued treatment and 144 crossed over to the VORANIGO treatment arm. Median follow-up was 41.6 months. These results build upon the placebo-controlled, double-blind data previously published in The Lancet Oncology.

"The extended Phase 3 INDIGO trial analysis significantly improves our understanding of the clinical benefits of VORANIGO," said Islam Hassan, M.D., MSc., Global Head of Development-Neuro-Oncology at Servier. "With more than three years of follow-up data, these results validate the durable and sustained benefits of long-term treatment with VORANIGO and demonstrate a steady improvement in patient responses over time. We are proud to share these results and remain committed to expanding our understanding of the long-term impact of VORANIGO for the glioma community."

A global, randomized, double-blinded, Phase 3 trial of vorasidenib vs placebo in patients with grade 2 glioma with an IDH1/2 mutation (INDIGO): updated efficacy and safety – Sunday, May 31, 4:36 – 4:42 p.m. CDT

Key findings, which were presented by Timothy Cloughesy, M.D., David Geffen School of Medicine, Department of Neurology, University of California, Los Angeles, an investigator for the INDIGO trial, include:

Median progression-free survival (PFS) per blinded independent review committee (BIRC) was 44.1 months (95% CI, 27.7-not estimable [NE]) in patients treated with VORANIGO. PFS was the primary endpoint of the trial.
The median time to next intervention (TTNI) per BIRC for patients treated with VORANIGO was NE (95% CI, 52-NE). The number of next-intervention events remained low among VORANIGO patients (23.8%), indicating that VORANIGO is effectively delaying the need for subsequent treatment. TTNI was a key secondary endpoint of the trial.
Patients treated with VORANIGO experienced an objective response rate (ORR) per BIRC of 20.8% (95% CI, 15%-27.8%). ORR improved with longer follow-up, reflecting durable and gradual responses with VORANIGO. An additional 72.6% of patients experienced stable disease.
Median duration of treatment among VORANIGO patients was 38.3 months (95% CI, 19.98-43.76).
A 72% reduction in the rate of on-treatment seizures was observed in patients treated with VORANIGO.
The safety profile of VORANIGO was tolerable with mainly low-grade adverse events (AEs) and consistent with previously reported data. The most commonly reported Grade ≥3 or worse treatment-emergent adverse events (TEAEs) were increased alanine aminotransferase (10.8%), increased aspartate aminotransferase (4.8%), seizures (4.8%), increased gamma-glutamyltransferase (3%) and syncope (1.8%). No new safety signals were detected and fewer than 5% of patients discontinued treatment due to an AE. There were no treatment-related deaths.
"Historically, many patients with Grade 2 IDH-mutant gliomas faced a poor long-term prognosis and managed their disease with a ‘watch and wait’ strategy due to the limited availability of targeted treatment options," said Dr. Timothy Cloughesy. "The latest results from the Phase 3 INDIGO trial—the largest dataset in IDH-mutant glioma to date—provide valuable evidence on how long-term IDH inhibition can delay disease progression and extend the time to next intervention."

Impact of vorasidenib vs placebo on seizure rates and quality of life: exploratory analysis from Phase 3 INDIGO study – Monday, June 1, 1:30 – 4:30 p.m. CDT

Findings from an exploratory analysis of the INDIGO study evaluating the impact of VORANIGO on seizure rates and quality of life will be shared in a separate presentation. As of data cut off in January 2025, results show:

The rate of seizures per person per year in the VORANIGO arm (15.9 seizures per person-year [95% CI, 9.1-27.7]; p=0.0002) demonstrated the sustained, positive, long-term effect of VORANIGO on seizure control.
The effects of VORANIGO were more pronounced among people with oligodendrogliomas (6.9 seizures per person-year [95% CI, 2.7-17.7]; p<0.0001) than those with astrocytoma (17.5 seizures per person-year [95% CI, 9.4-32.3]; p=0.6448).
VORANIGO had an acceptable safety profile with no new safety signals during extended follow-up.

(Press release, Servier, MAY 31, 2026, View Source [SID1234666268])

On May 31, 2026 TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics, reported clinical data for Tosposertib (TU2218), an oral dual inhibitor targeting transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), in first-line (1L) recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026.

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The data presented during the poster session included the latest results and follow-up data from the Phase 2a trial evaluating the combination of Tosposertib and Keytruda (Pembrolizumab) as. In addition to the 75% response rate in the first-line (1L) patient group (including 1 CR and 8 PR), which drew attention upon abstract release on May 22, the presentation also disclosed progression-free survival (mPFS) and overall survival (mOS) data for the first time.

According to the research poster presented by Tiumbio at ASCO (Free ASCO Whitepaper) 2026, as of the data cutoff date of March 31, 2026, the median progression-free survival (mPFS*) in a total of 12 first-line (1L) patients was 10.9 months. While cross-trial comparisons are inherently limited, this result compares favorably with historically reported PFS outcomes for standard-of-care pembrolizumab monotherapy and pembrolizumab plus chemotherapy. In addition, an 83% response rate was observed in the high CPS (>20) subgroup (n=6), while a 67% response rate was also observed in the low CPS 1–19 subgroup (n=6), a patient population that may derive relatively limited benefit from immuno-oncology therapies.

The median overall survival (mOS*) had not yet been reached (NR), with a substantial proportion of patients remaining alive and continuing on treatment or follow-up at the time of analysis.

(*) mPFS (Median Progression-Free Survival): the median length of time during which 50% of patients enrolled in the clinical trial experienced neither disease progression nor death.
(*) mOS (Median Overall Survival): the median length of time from initiation of treatment in the clinical trial until death from any cause, regardless of disease progression.

The dataset included 14 patients receiving 2nd-line or later treatment after relapse following prior standard therapy. In this subgroup, the combination achieved a response rate of 42.9% (including 1CR and 5 PR). The mPFS was 2.9 months, while mOS had not yet been reached (NR). By comparison, currently available standard treatment options in 2nd-line or later settings for R/M HNSCC typically show response rates of approximately 10% to 15%, with mPFS of 2.1 months. These findings suggest that Tosposertib and Keytruda combination may offer meaningful clinical advantage even in later-line patients who have limited treatment options after failure of existing therapies.

In addition, the combination was generally manageable, and safety findings were generally consistent with the known profiles of the agents and the underlying patient population. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) observed with the combination of Tosposertib and Keytruda was 48.3%. No Grade 5 treatment-related adverse events leading to patient death or cardiovascular toxicities were reported.

Professor Hye Ryun Kim of the Division of Medical Oncology at Yonsei University Severance Hospital, one of Korea’s leading experts in head and neck cancer treatment and the first author who personally presented the poster at ASCO (Free ASCO Whitepaper), commented, "The interim data presented at ASCO (Free ASCO Whitepaper) 2026 represents a differentiated clinical outcome that highlights the potential therapeutic benefit of Tosposertib in recurrent or metastatic head and neck cancer. In this disease setting, where treatment remains challenging and patient prognosis is often poor, we believe Tosposertib has significant potential to emerge as a new treatment option capable of addressing the limitations of existing therapies."

Hun-taek Kim, CEO of Tiumbio, stated, "We believe these interim data presented at ASCO (Free ASCO Whitepaper) 2026 demonstrated a compelling clinical profile compared with outcomes historically observed with current standard of care. Based on these data, we plan to evaluate potential regulatory pathways, including the possibility of seeking Breakthrough Therapy Designation, as we continue to advance Tosposertib toward its potential to become a new standard of care in R/M HNSCC."

About Tosposertib (TU2218)
Tosposertib (TU2218) is a highly potent, oral dual inhibitor designed to block the signaling pathways of transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), two critical mediators of tumor growth and metastasis. This novel drug candidate was discovered and developed by Tiumbio to enhance the therapeutic efficacy of immune-oncology agents such as Keytruda.

(Press release, TiumBio, MAY 31, 2026, View Source [SID1234666267])

On May 31, 2026 ImmVira Group ("ImmVira") reported that preliminary Phase IIa clinical data for MVR-T3011, its lead oncolytic immunotherapy candidate, was presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. As of the data cut-off on January 31, 2026, the optimized dose of MVR-T3011 achieved a 100% complete response rate (CRR) in BCG-unresponsive carcinoma in situ (CIS) and a durable 90% recurrence-free survival (RFS) in papillary (Ta/T1) tumors[1].

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While intravesical instillation of Bacillus Calmette-Guérin (BCG) remains the standard of care for high-risk NMIBC-representing 75% of all newly diagnosed bladder cancer cases, a global BCG shortage and high rates of non-response leave a significant patient population without effective options. MVR-T3011 was developed with the goal of delivering potent local and systemic anti-tumor immunity directly within the bladder, offering a potential organ-preserving treatment option for this high-need population.

The ongoing trial enrolled 46 patients in total with pathologically confirmed BCG-unresponsive high-risk NMIBC. Patients received intravesical MVR-T3011 at one of two dose levels:

Lower-dose group (2×109 PFU): Induction course followed by maintenance dosing over two years (n=25).
Higher-dose group (1×1010 PFU): Induction course followed by maintenance dosing over two years (n=21).
The results demonstrate that MVR-T3011 achieved meaningful clinical efficacy and a favorable safety profile across both carcinoma in situ (CIS) and papillary (Ta/T1) disease settings：

In the CIS cohort, the higher-dose 1×1010 PFU regimen achieved a 100% complete response rate (CRR) at 3 months, 6 months, and 9 months, as well as at any assessed timepoint— a marked step up from the lower-dose 2×109 PFU cohort, which achieved a 66.7% CR rate at any timepoint (with timepoint-specific CRRs of 55.6% at 3 months and 75.0% at 6 months). The 12-month CRR for the 1×1010 PFU cohort has not yet been reached, with follow-up ongoing.
In the papillary (Ta/T1) cohort, the 2×109 PFU dose delivered a durable 12-month recurrence-free survival (RFS) of 74.0%, an already strong outcome; at the higher 1×1010 PFU dose, 9-month RFS reached 90.0%, with longer-duration follow-up ongoing.
Across all 46 patients treated, MVR-T3011 demonstrated a manageable safety profile consistent with prior observations. Importantly, the higher-dose 1×1010 PFU cohort showed a safety profile consistent with the lower-dose 2×109 PFU cohort, with no Grade 4 or 5 TEAEs reported across either dose level, or no deaths attributable to treatment.

"The presentation of these Phase IIa results at ASCO (Free ASCO Whitepaper) 2026 marks a meaningful milestone for ImmVira and for the broader NMIBC community," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "MVR-T3011 has demonstrated great therapeutic potential through both direct anti-tumor activity in CIS and immune suppression in papillary (Ta/T1) disease. This represents a synergy of direct oncolysis and immune activation, further enhanced by the integrated effects of exogenous IL-12 and PD-1 antibody expressions within tumor cells. We are committed to rapidly advancing our clinical program to reach broader bladder cancer patient populations and provide meaningful treatment alternatives for those in need.

[1] Due to the small sample size and the early, interim nature of the data, the observed CRR and RFS are subject to statistical uncertainty and are inherently susceptible to change as patient enrollment continues and follow-up matures. These preliminary results should not be construed as an indication of the final outcomes of the current study, nor should they be regarded as predictive of results that may be achieved in a future confirmatory phase III clinical trial or in connection with any regulatory review or approval.

About MVR-T3011

MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations.

(Press release, Immvira, MAY 31, 2026, View Source [SID1234666266])

On May 31, 2026 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, reported updated data from the Phase 1 PoC clinical study of its first-in-class PD-1/IL-2α-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) The detailed data was presented today at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The updated data is from a PoC clinical study conducted in China to evaluate the safety and efficacy of 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 once every 3 weeks, 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).
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 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.
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 occurred in 30.6% of patients treated with 1/1.5 mg/kg and 64.9% of patients treated with 3mg/kg.
The most common adverse events among all patients were arthralgia (52.2%, 3.7% ≥grade 3), anemia (46.3%, 4.4% ≥grade 3), and rash (39.0%, 8.8% ≥grade 3), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.
Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, commented: "Lung cancer remains the most commonly diagnosed and deadliest malignancy worldwide, representing a major public health challenge. Despite the transformative impact of immunotherapy on the treatment landscape of NSCLC, patients with wild-type NSCLC who experience disease progression following immunotherapy continue to face limited treatment options, with docetaxel-based standard-of-care therapy offering only modest efficacy.

In recent years, emerging approaches such as immunotherapy-based combinations and ADCs have brought new hope. However, multiple large-scale Phase III clinical trials in NSCLC patients who had failed both platinum-based chemotherapy and immunotherapy have not yet delivered satisfactory outcomes. Therefore, there remains a substantial and urgent unmet medical need in the post-immunotherapy setting for NSCLC.

As a PD-1/IL-2α-bias bispecific molecule, IBI363 has demonstrated encouraging clinical benefit in immunotherapy-resistant NSCLC, with both objective response rate (ORR) and progression-free survival (PFS) showing meaningful improvement. Notably, in the 3 mg/kg Q3W cohort, more than 40% of patients with either squamous or adenocarcinoma histology survived beyond 24 months. These findings highlight the potential of IBI363 to generate a durable immunotherapy tail effect and deliver long-term survival benefits for patients."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "While immunotherapy has significantly improved survival outcomes for certain patients, treatment options remain extremely limited for patients with NSCLC who do not respond to immunotherapy and lack actionable driver gene mutations, making long-term survival difficult to achieve.The proof-of-concept (PoC) data presented at this year’s ASCO (Free ASCO Whitepaper) meeting are highly encouraging. IBI363 has demonstrated not only meaningful short-term disease control, but also, through extended follow-up, validated the unique long-term survival benefits of its dual mechanism of action, combining immune checkpoint blockade with cytokine agonism. We are excited about the potential of IBI363 to provide a novel treatment option for a broad population of patients and ultimately help deliver durable, 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 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 not only blocks PD-1 but also selectively delivers IL-2 to the tumor through binding to IL-2 receptor alpha.

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.

(Press release, Innovent Biologics, MAY 31, 2026, View Source;innovent-presents-long-term-follow-up-results-from-the-poc-study-of-ibi363-tak-928-pd-1il-2-bias-bispecific-fusion-protein-showing-robust-survival-benefits-in-advanced-immunotherapy-resistant-non-small-cell-lung-302786450.html [SID1234666265])