Delving into the Latest Updates on IBI-363 with Synapse

Overview

Basic Info

Drug Type

Antibody fusion proteins

Synonyms

IBI 363, IBI-363, IBI363

+ [1]

Target

IL2RA x PD-1

Action

agonists, inhibitors

Mechanism

IL2RA agonists(Interleukin-2 receptor alpha chain agonists), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [7]

Active Indication

Advanced Lung Squamous Cell CarcinomaMetastatic Non-Squamous Non-Small Cell Lung CarcinomaSquamous non-small cell lung cancer+ [16]

Inactive Indication-

Originator Organization

Innovent Biologics (Suzhou) Co. Ltd.

Active Organization

Innovent Biologics (Suzhou) Co. Ltd.Fortvita Biologics (USA) Inc.

Inactive Organization-

License Organization

Takeda Pharmaceutical Co., Ltd.

Innovent Biologics, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (United States), Breakthrough Therapy (China)

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To compare the overall survival (OS) of participants with unresectable locally advanced or metastatic squamous non-small cell lung cancer who progressed during or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy, treated with IBI363 (experimental group) and docetaxel (control group).

Start Date19 Nov 2025

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT07217301

/ Not yet recruitingPhase 3

A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Phase: 3 Type: Randomized, open-label, multi-regional, multi-center Population: Adults with advanced/metastatic squamous Non Small Cell Lung Cancer (NSCLC), post-progression on platinum chemo + PD-1/PD-L1 immunotherapy Enrollment:
600 participants Randomization: 1:1 (IBI363 vs. docetaxel)
Stratification factors:
1. Primary vs. acquired IO resistance
2. Concurrent vs. sequential prior chemo-immunotherapy
3. Region (Asia vs. non-Asia)
Treatment Arms:
1. IBI363 Arm (Investigational Drug):
Priming dose: 0.1 mg/kg on Day 1 of Cycle 1 (C1D1) Intended dose: 3 mg/kg every 3 weeks (Q3W) starting Day 8 of Cycle 1 (C1D8) Cycle duration: 28 days for Cycle 1, then 21 days from Cycle 2 onward Dose adjustments: Up to 2 reductions (1.5 mg/kg or 1 mg/kg Q3W) allowed for adverse events (AEs) Re-priming protocol: Required if delays in dosing exceed defined thresholds (e.g., >10 days post-priming or ≥5 weeks since last dose)
2. Control Arm (Docetaxel):
75 mg/m² every 3 weeks (Q3W), starting from C1D1 21-day cycle duration Dose Reduction: as per label

Start Date30 Oct 2025

Sponsor / Collaborator

Fortvita Biologics (USA) Inc.

[+1]

NCT07124793

/ Not yet recruitingPhase 2

Phase II Study to Evaluate the Efficacy and Safety of IBI363 in Combination With IBI305 in Participants With Advanced Solid Tumors

CIBI363A203, a Phase 2 study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with IBI305 (a bevacizumab biosimilar) in participants with advanced malignancies conducted in China. Primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include DoR, DCR, TTR, PFS, per RECIST v1.1, and OS; the incidence and severity of AEs, irAEs, SAEs, AESIs and their relationship to the investigational drug, and changes in vital signs, physical examination, and laboratory values before and after study treatment; PK, and immunogenicity of IBI363. The cohorts include: IBI363 and IBI305 combination therapy in participants with advanced EGFRmut NSCLC progressed after EGFR TKI and Platinum-based chemotherapy, and advanced platinum-resistant ovarian cancer (PROC). The anticipated enrollment for this study is approximately 60 participants with each cohort 30 participants, and actual enrollment may change with future amendments as cohorts are opened and closed based on evolving data.

Start Date31 Aug 2025

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with IBI-363

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100 Translational Medicine associated with IBI-363

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100 Patents (Medical) associated with IBI-363

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1

Literatures (Medical) associated with IBI-363

Nature cancer

IL-2Rα-biased agonist enhances antitumor immunity by invigorating tumor-infiltrating CD25+CD8+ T cells

Article

Author: Chia, Tiongsun ; He, Kaijie ; Lu, Jia ; Liang, Xue ; Guan, Jian ; Chen, Bingliang ; Sun, Jiya ; Liu, Huisi ; Yao, Ying ; Wang, Feifei ; Wu, Zhihai ; Li, Yaning ; Li, Xue ; Xu, Jinling ; Zou, Jia ; Wu, Weiwei ; Feng, Ye ; Wu, Min ; Ling, Xiaomin ; Fu, Fenggen ; Zhou, Shuaixiang ; Deng, Junjie ; Zhang, Ying

To avoid regulatory T cell promotion and vascular toxicity, the interleukin-2 receptor-β/interleukin-2 receptor-γ (IL-2Rβγ)-biased approach is used by most IL-2 analogs in immuno-oncology. However, recent clinical disappointments in these IL-2 agonists have questioned this strategy. Here we show that both wild-type (IL-2^wt) and IL-2Rβγ-attenuated (IL-2^α-bias) agonists that preserve IL-2Rα (CD25) activities can effectively expand tumor-specific CD8⁺ T cells (TSTs) and exhibit better antitumor efficacy and safety than the 'non-α' counterpart (IL-2^nα). Mechanistically, TSTs coexpress elevated CD25 and PD-1 and are more susceptible to stimulation by IL-2Rα-proficient agonists. Moreover, the antitumor efficacy of anti-PD-1 depends on activation of PD-1⁺CD25⁺ TSTs through autocrine IL-2-CD25 signaling. In individuals with cancer, a low IL-2 signature correlates with non-responsiveness to anti-PD-1 treatment. In mouse models, IL-2^α-bias, but not IL-2^nα, restores the IL-2 signature and synergizes with anti-PD-1 to eradicate large established tumors. These findings underscore the indispensable function of CD25 in IL-2-based immunotherapy and provide rationales for evaluating IL-2Rα-biased agonists in individuals with cancer.

43

News (Medical) associated with IBI-363

04 Dec 2025

·www.prnewswire.com

Innovent Biologics Announces Closing of Global Strategic Partnership with Takeda for Next-Generation IO and ADC Therapies

SAN FRANCISCO and SUZHOU, China, Dec. 4, 2025 /PRNewswire/ -- Innovent Biologics (HKEX: 01801) today announced that the global strategic collaboration with Takeda (TSE: 4502, NYSE: TAK) has closed and become effective following the satisfaction of all closing conditions. The collaboration, initially announced on October 22, 2025, aims to accelerate the global development and commercialization of Innovent's next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) therapies, including the global partnership on IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), and an option for an early-stage program IBI3001 (EGFR/B7H3 ADC). Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent, stated, "IBI363 and IBI343 represent our next-generation therapies designed to address critical unmet needs in global cancer treatment. With clear, aligned development plans, Innovent's deep understanding of these assets, combined with Takeda's extensive experience and strong development and commercialization capabilities, we are poised to maximize the clinical potential of these assets across multiple indications. We look forward to the collaboration with our partner going forward." Under the agreement: Innovent and Takeda will co-develop IBI363 globally, and co-commercialize IBI363 in the U.S., with Takeda leading the co-development and co-commercialization efforts under joint governance and aligned development plan. In addition, Innovent has granted Takeda exclusive commercialization rights for IBI363 outside Greater China and the U.S. Takeda has global manufacturing rights to supply IBI363 outside of Greater China, with such rights being co-exclusive with Innovent for commercial supply in the U.S. Innovent has also granted Takeda exclusive global rights to develop, manufacture and commercialize IBI343 outside of Greater China. Additionally, Takeda receives an exclusive option to license global rights for IBI3001, a first-in-class EGFR/B7H3 bispecific ADC in Phase 1 stage, outside Greater China. Takeda will pay Innovent an upfront payment of US$1.2 billion, including a US$100 million equity investment in Innovent through new share issuance at premium, i.e., HK$112.56 per share. Furthermore, Innovent is eligible for development and sales milestone payments for IBI363, IBI343, and IBI3001 (if option exercised) totaling up to approximately $10.2 billion, for a total deal value of up to $11.4 billion. Innovent is also eligible to receive potential royalty payments for each molecule outside Greater China, except with respect to IBI363 in the U.S., where the parties will share profits or losses (40/60 Innovent/Takeda). Detailed information about the collaboration can be found at the official website of Innovent Biologics. About Innovent Biologics 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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 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 , or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo

License out/inADCPhase 1

22 Oct 2025

·www.fiercebiotech.com

Takeda pays Innovent $1.2B upfront, offers whopping $10B-plus in biobucks for cancer assets

Takeda has identified Innovent Biologics assets as an answer to the question of which products will drive growth in the 2030s.\n Takeda is paying Innovent Biologics $1.2 billion upfront for rights to two cancer candidates. The deal, which includes (PDF) $10.2 billion in milestones, puts the biologics at the center of Takeda’s efforts to establish growth drivers for the post-Entyvio era.Inflammatory bowel disease drug Entyvio is central to Takeda’s commercial operations. With a series of patents set to expire through 2032, the drugmaker is preparing for rivals to try to launch biosimilar copies of Entyvio in the coming years. It is unclear exactly when biosimilars will start eroding the drug\'s sales, but Takeda knows the threat is coming. An attempt to make cell therapy a growth area failed. Takeda has identified Innovent assets as an answer to the question of which products will drive growth in the 2030s, continuing a string of major deals between global and Chinese drugmakers. The deal gives Takeda rights to two candidates, IBI363 and IBI343, that have shown promise in the treatment of patients with certain solid tumors. IBI363 is designed to unleash antitumor immune responses by blocking PD-1 signaling while also acting on IL-2 to activate and expand tumor-specific T cells. Multiple companies have bet on IL-2, most notably Bristol Myers Squibb through its huge, ill-fated Nektar Therapeutics deal, without realizing the potential of the cytokine to make cancer immunotherapies more broadly effective.Innovent is running phase 2 trials to test IBI363 in patients with types of lung and colorectal cancers. A global phase 3 trial in non-small cell lung cancer is expected to start in the coming months. The studies build on data in more than 1,200 patients that have persuaded Innovent IBI363 could become the backbone immuno-oncology treatment.Takeda will pay 60% of the cost of developing the candidate and pocket 60% of any profits. The Japanese company will lead co-commercialization efforts in the U.S. and have the exclusive right to commercialize the drug outside of the U.S. and China. IBI343 is a Claudin 18.2-directed antibody-drug conjugate. In a competitive field, Innovent has identified gastrointestinal toxicity as a way to differentiate its ADC from rival assets such as AstraZeneca’s AZD0901. Innovent is running a phase 3 gastric cancer trial in Japan and China and has completed a global phase 1/2 study. Takeda plans to expand into the first-line gastric and pancreatic cancer settings. The deal gives Takeda the right to develop and commercialize IBI343 outside China. Takeda has also landed an option on IBI3001, an ADC targeting EGFR and B7H3. Innovent is running a phase 1 solid tumor trial for that asset.

ImmunotherapyPhase 1ADCLicense out/inPhase 2

22 Oct 2025

·firstwordpharma.com

Takeda pays $1.2B upfront to transform oncology pipeline with two Innovent drugs

Takeda will pay Innovent Biologics $1.2 billion upfront for rights outside of China to two late-stage cancer drugs, one a PD-1/IL-2α-bias bispecific antibody fusion protein and the other a Claudin 18.2-targeting antibody-drug conjugate (ADC). "These two programmes have the potential to be transformative for our oncology portfolio," remarked Teresa Bitetti, president of Takeda's global oncology business unit.Along with an option on another earlier-stage ADC targeting both EGFR and B7H3, the deal announced Wednesday has a total value to Innovent of up to $11.4 billion, including a strategic equity investment of $100 million, plus sales royalties.The agreement marks another validation of Chinese-derived assets and follows hot on the heels of Dianthus Therapeutics, Gilead Sciences and Roche turning to the country for experimental drugs, with the latter two also in the oncology space. For more on the continuing trend, see ViewPoints: Cross-border deals still worth the risk despite rising US-China tensions.Phase III studies ongoingHeading up the transaction is the bispecific antibody fusion protein IBI363, which is being studied in an ongoing Phase I/II trial and three Phase II studies across patient segments and lines of therapy in non–small-cell lung cancer (NSCLC) and microsatellite stable colorectal cancer. Meanwhile, a global Phase III study in second-line squamous NSCLC is expected to begin in the coming months.The second key drug is an ADC dubbed IBI343, which is currently being evaluated in a Phase III study in previously treated gastric cancer. Takeda said that it plans to advance the development of IBI343 and expand into the first-line gastric and pancreatic cancer settings. "We are encouraged by the clinical results these investigational medicines have shown," said Andy Plump, Takeda's president of R&D. "We are uniquely positioned to partner with Innovent to accelerate and expand the potential of these investigational medicines in a range of solid tumours."The agreement also gives Takeda an option on IBI3001. The ADC is being studied in an ongoing Phase I trial in patients with locally advanced or metastatic solid tumours. Takeda indicated that it plans to establish manufacturing for all three investigational medicines in the US.

License out/inADCPhase 1Phase 2Phase 3

100 Deals associated with IBI-363

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Squamous Cell Carcinoma	Phase 3	United States	Fortvita Biologics (USA) Inc.	30 Oct 2025
Advanced Lung Squamous Cell Carcinoma	Phase 3	China	Fortvita Biologics (USA) Inc.	30 Oct 2025
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	United States	Fortvita Biologics (USA) Inc.	30 Oct 2025
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	China	Fortvita Biologics (USA) Inc.	30 Oct 2025
Squamous non-small cell lung cancer	Phase 3	United States	Innovent Biologics (Suzhou) Co. Ltd.	25 Aug 2025
Locally Advanced Malignant Solid Neoplasm	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	31 Aug 2025
Platinum-Resistant Ovarian Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	31 Aug 2025
Resectable Lung Non-Small Cell Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	26 Aug 2025
Non-squamous non-small cell lung cancer	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	04 Aug 2025
Acral Lentiginous Malignant Melanoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Feb 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05460767 (ASCO2025) Manual	Phase 1	Advanced Lung Non-Small Cell Carcinoma	136	IBI363	ofcdfprgwg(ggtssuquni) = fygeuxaoda pumkcypbml (kbncgfdjmi ) View more	Positive	30 May 2025
				IBI363 3 mg/kg Q3WIBI363 3 mg/kg Q3W	zttfhernkt(riyudmgzak) = dtfrrcbnre tpowmiqbyz (miurvikkoq ) View more
NCT05460767 \| NCT06081920 (ASCO2025) Manual	Not Applicable	Mucosal Melanoma \| Melanoma	91	IBI363 (pts with at least one post-baseline tumor assessment)	noinmfcfoh(qebpktxifh) = orwttssmyt dmjctwuzfp (jacvvihyij, 53.4 - 74.4) View more	Positive	30 May 2025
				IBI363 (pts treated at 1mg/kg and above)	noinmfcfoh(qebpktxifh) = xyvpajxltj dmjctwuzfp (jacvvihyij, 57.1 - 79.2) View more
NCT05460767 (ASCO2025) Manual	Phase 1	Colorectal Cancer KRAS Mutation \| Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	141	IBI363	mzvcigroxq(gkzcqxajsm) = tryxlvzrip pwwumyvnyl (qhljaszfso ) View more	Positive	30 May 2025
				IBI363 + bevacizumab	mzvcigroxq(gkzcqxajsm) = ililpxyidb pwwumyvnyl (qhljaszfso ) View more
NCT05460767 \| NCT06081920 (SITC2024) Manual	Phase 1/2	Melanoma	40	IBI363	amtqeygmzj(uteunjwahj) = cbnjjtegtf aywgkeqymo (hwhyklvmmf, 50.1 - 81.4) View more	Positive	05 Nov 2024
				IBI363 (mucosal melanoma)	amtqeygmzj(uteunjwahj) = lwggfwamoq aywgkeqymo (hwhyklvmmf, 38.7–78.1) View more
NCT05460767 (ESMO2024) Manual	Phase 1	Colorectal Cancer Last line	35	IBI363 + beva	dpkgxiqosb(bhaemcciev) = ujmekrwjwu avvsejcyan (njolfrwyfj ) View more	Positive	16 Sep 2024
NCT05460767 (WCLC2024) Manual	Phase 1	Non-Small Cell Lung Cancer Third line	89	IBI363 0.6 mg/kg Q2W	vioqpvqrnz(syhnqhmbgr) = gtvwwmvnjd nqavauothv (grdyozcysd ) View more	Positive	10 Sep 2024
				IBI363 3 mg/kg Q3W	wulrifsygn(srsajfnoxt) = znntlgjpkv actkwxckxt (ykbyzsdbtc, 15.1 - 35.7) View more
NCT05460767 (PRNewswire) Manual	Phase 1	Melanoma	45	IBI363 1mg/kg (既往接受过免疫治疗)	chzanrsani(supytkgzuz) = uolfsbvvlt xovisuqcmy (scbzgdawre ) View more	Positive	14 Jun 2024
				IBI363 1mg/kg (既往未经过免疫治疗的黏膜型黑色素瘤)	chzanrsani(supytkgzuz) = ffxsjnwoft xovisuqcmy (scbzgdawre ) View more
NCT05460767 (phase I study of IBI363, ASCO2024)	Phase 1	Solid tumor	24	IBI363 600 μg/kg QW	glxwnefpuh(uemygjfrfp) = ophfguyolx otrojfwixs (gzcsiffbqk ) View more	Positive	24 May 2024
				IBI363 600 μg/kg Q2W	glxwnefpuh(uemygjfrfp) = qfjlyuxipi otrojfwixs (gzcsiffbqk ) View more
NCT05460767 (phase I study, ASCO2024)	Phase 1	Melanoma	67	IBI363 100-2000 μg/kg QW/Q2W/Q3W	gdiabunmaz(pbskwhoosy) = gojzqrusoi yfaddktrep (opfcdqmlso ) View more	Positive	24 May 2024
				IBI363 (In pts had prior IO)	cwiatvqgtp(owhtnxtdkx) = rykklclijx blcswomhen (cjqqasjews, 11.1 - 34.7) View more
NCT05460767 (phase I, ASCO2024)	Phase 1	Colorectal Cancer	68	IBI363 600 ug/kg Q2W	ffhmdmgwgw(deengnudle) = lhlpbriqnd kjlwtwyyla (cijcboawpw, 46.2 - 95.0) View more	Positive	24 May 2024
				IBI363 1 mg/kg Q2W	ffhmdmgwgw(deengnudle) = jovgksbdeb kjlwtwyyla (cijcboawpw, 46.2 - 95.0) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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