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.

NCT07122687

/ RecruitingPhase 2

A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.

Start Date26 Aug 2025

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with IBI-363

100 Translational Medicine associated with IBI-363

100 Patents (Medical) associated with IBI-363

Literatures (Medical) associated with IBI-363

01 Sep 2023·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 ; Wu, Weiwei ; Zou, Jia ; 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.

News (Medical) associated with IBI-363

27 Aug 2025

·www.prnewswire.com

Innovent Announces 2025 Interim Results and Business Updates

Robust revenue growth and substantial profit improvement Continued exceptional executions under a clear roadmap of dual-driven growth and global innovation SAN FRANCISCO and SUZHOU, China, Aug. 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2025 interim results and major business updates. Continue Reading Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum. On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent's innovation capabilities and lays a solid foundation for globalization. We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent's growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company." Dual-driven revenue growth with execution excellence Robust revenue growth and substantial profit improvement[1] Total revenue: RMB 5.95 billion, up 50.6% year-on-year Product revenue: RMB 5.23 billion, up 37.3% year-on-year Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion Gross margin: 86.8%, up 2.7 percentage points year-on-year Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year R&D investment: RMB 903 million Cash on hand: approximately USD 2 billion[2] Dual-engine growth supported by comprehensive and diversified product portfolio Expansion of oncology product portfolio with three new launches Dovbleron® (taletrectinib) : Potentially best-in-class ROS1 inhibitor Limertinib : Third-generation EGFR TKI Jaypirca®(pirtobrutinib) : First non-covalent BTK inhibitor Strengthening general biomedicine portfolio with innovative pipeline SINTBILO® (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025 SYCUME ® ( teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review Innovative commercial strategy with multi-channel coverage Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence Enhancing brand strength through the establishment of a lifecycle management system TYVYT ® : NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway SYCUME ® ( teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc. Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics Emerging value from globalization strategy, prioritizing novel pipeline's global R&D Flagship pipeline showcased at top-tier conferences, entering global registration studies IBI363 (PD-1/IL-2 α -bias ): Unleashing potential as a next-generation IO therapy with global first-in-class design Three oral presentations at ASCO highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC First MRCT Phase 3 study of GC has been initiated in China and Japan First Phase 3 study of PDAC has been initiated Global MRCT of PDAC is in plan NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted Over 10 next-generation programs advancing into global development Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc A uto immune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc Hybrid models to accelerate innovation IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide Enhance global presence with broader market access Six products (TYVYT®, BYVASDA®, Pemazyre®, Dupert®, SINTBILO®, SYCUME®) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia More launches planned Brazil, Mexico, Columbia, India, etc Research innovation showcased at medical conferences Oncology pipeline: AACR, ASCO, Nature Medicine General biomedicine pipeline: ADA, NEJM Facilities and manufacturing capacity adhering to high-quality standards 7,500 employees globally Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China's total biopharmaceutical production capacity First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations Committed to responsible business practices and enhancing ESG management practices Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent's innovative drugs Innovent has been graded 'AAA' rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise" Provided over 2,200 job opportunities for recent graduates To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees 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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. Forward-Looking Statements 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBreakthrough TherapyPhase 3Phase 2Fast Track

25 Aug 2025

·www.prnewswire.com

Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, Aug. 24, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major therapeutic areas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lung cancer (NSCLC). IBI363 is Innovent's self-discovered novel PD-1/IL-2α-bias bispecific antibody fusion protein. The upcoming study will be the first global Phase 3 trial of IBI363 and represents a significant milestone in advancing a first-in-class, dual-immune activation immunotherapy for this large patient population. Besides, the pivotal trial of IBI363 head-to-head against pembrolizumab (Keytruda®) in the treatment of melanoma is underway in China. IBI363 as a Next-generation IO therapy Set for First Global Phase 3 Lung Cancer Trial This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting. Major alignments of the Phase 3 program were reached regarding the dose selection, study design, and other critical considerations. Innovent has also received IND approval from China's National Medical Products Administration (NMPA) for this program. In parallel, Innovent has initiated communications and submissions to other major Health authorities. IBI363 has also received Fast Track Designation (FTD) from the FDA and Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China for this indication. The multi-regional, randomized, controlled Phase 3 trial will enroll approximately 600 patients globally including China, U.S., Canada, EU, UK, and Japan, etc. The study will evaluate the efficacy and safety of IBI363 3 mg/kg monotherapy compared with docetaxel in patients with unresectable, locally advanced or metastatic squamous NSCLC who have experienced disease progression following platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. The primary endpoint is overall survival. IBI363's Breakthrough Data Validates its Dual-immune Activation Mechanism, Stepwise Development in Multiple Tumor Types At ASCO 2025, Phase 1b/2 results demonstrated meaningful and durable clinical activity in areas of high unmet need, including IO-resistant lung cancer, traditionally "cold tumors" such as acral and mucosal melanoma, and microsatellite stable (MSS) colorectal cancer. These promising data position IBI363 as a potential first-in-class dual-immune activation therapy with broad applicability across difficult-to-treat cancers. Innovent is rapidly progressing IBI363 into registrational studies, with a pivotal program in melanoma already ongoing, a global Phase 3 trial in squamous NSCLC expected to start shortly, and a registration strategy in colorectal cancer in planning. In parallel, multiple Phase 1b/2 trials are evaluating IBI363 both as monotherapy and in combinations in first-line NSCLC, first-line CRC, and additional tumor types, including platinum-resistant ovarian cancer (PROC), EGFR+ NSCLC, and neoadjuvant therapy for non-squamous NSCLC. This comprehensive development strategy is designed to maximize the value of IBI363 and expand its potential to address multiple large global oncology markets and improve patient outcomes. Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology and Hematology for Yale Cancer Center and Smilow Cancer Hospital, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology at Yale School of Medicine, shared, "Lung cancer remains the most prevalent malignant tumor worldwide, with particularly high incidence and mortality rates globally. Non-small cell lung cancer constitutes the majority of these cases. Although immunotherapy has significantly improved survival outcomes for some patients, those who do not respond to such treatments and lack driver gene mutations have limited therapeutic options, underscoring the urgent need for enhanced clinical interventions. Clinical research of the PD-1/IL-2α-biased bispecific molecule IBI363 has revealed encouraging findings. Preliminary trials have demonstrated that IBI363 not only induces tumor remission in a subset of patients but also achieves disease stability in the majority of patients, indicating durable anti-tumor activity. In comparison to traditional chemotherapy, IBI363 appears to offer potential advantages in both objective response rate (ORR) and progression-free survival (PFS), providing new hope for patients diagnosed with lung cancer." Professor Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated: "As a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein, IBI363 acts by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is engineered to retain 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. This dual mechanism targets and activates tumor-specific T cells co-expressing PD-1 and IL-2α, enabling more precise and effective stimulation of this T-cell subpopulation. IBI363 has demonstrated robust antitumor activity across multiple tumor models and has shown remarkable efficacy in IO-resistant, PD-L1 low expression, and cold tumor settings. The promising data associated with IBI363 offers a novel treatment avenue for patients with non-small cell lung cancer who have not responded to immunotherapy. As research progresses, this innovative therapy holds the potential to bridge clinical gaps and provide the possibility of long-term survival for a greater number of patients." Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, said, "Today's IND clearance marks a significant milestone as we initiate the first global Phase 3 trial of our next-generation IO therapy, IBI363 (PD-1/IL-2α-bias). If successful, this trial could bring a potentially transformative treatment to patients with squamous NSCLC worldwide, who currently have limited options after checkpoint inhibitor therapy. Concurrently, we are exploring IBI363 in a broad global clinical program and look forward to more data and continued development in the future. This achievement also signifies a milestone for Innovent's global innovation strategy, rooted in our mission to 'empower patients worldwide with affordable, high-quality biopharmaceuticals' and our vision to 'build a global premier biopharmaceutical leader.' Having developed a highly competitive pipeline aligned with our globalization strategy, we have prioritized the global R&D of our assets, alongside expanding our international team and footprint to accelerate the development and access of innovative therapies worldwide. In addition to IBI363, Innovent is advancing a broader pipeline for global development, including next-generation ADC programs such as bispecific and dual-payload ADCs. We believe our robust pipeline and ongoing R&D efforts will continue to expand our impact in oncology on a global scale." 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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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 Statements 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 Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyFast TrackINDBreakthrough TherapyPhase 2

30 Jun 2025

·pipelinereview.com

Innovent Biologics Showcases "Dual Innovations" at Oncology R&D Day, Pioneering the Future of Cancer Treatment with Next-Generation IO and ADC Platforms

SAN FRANCISCO, CA, USA and SUZHOU, China I June 30, 2025 I Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, held its Oncology R&D Day, unveiling its forward-looking strategy centered on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies. This strategic focus aims to redefine the standards of cancer treatment and propel Innovent toward becoming a global, premier biopharmaceutical leader. The event drew over 500 participants, including leading oncology key opinion leaders (KOLs), principal investigators, analysts, and global investors, signaling strong engagement with Innovent’s transformative vision for the future of oncology. Dual Innovations of IO+ADC Development Strategy Global Innovation Next-gen IO IBI363 Development Strategy Near-term Catalyst Keynote speech R&D Strategy “Over the past decade, Innovent has been at the forefront of China’s biopharmaceutical evolution—pioneering the PD-1 immunotherapy era and building China’s leading oncology brand, with over 3 million cancer patients treated with our therapies,” said Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent . “We are entering a new chapter focused on global innovation, powered by a robust pipeline and dual innovation of next-generation IO and next-generation ADC. Our recent presence at the 2025 ASCO with eight oral presentations highlights the strength and global competitiveness of our R&D. But this is only the beginning. With a clear vision to advance at least five pipeline assets into MRCT Phase 3 by 2030, we are committed to delivering innovative, high-quality, and accessible cancer treatments to patients worldwide.” Dual Innovation to Unlock the Future of Oncology: Next-gen IO + Next-gen ADC At the core of Innovent’s oncology strategy lies the dual engines of next-generation immunotherapy (IO) and next-generation antibody-drug conjugates (ADC), supported by deep insights in cancer biology and differentiated technology platforms. “We are harnessing deep cancer biology insights, advanced antibody and protein engineering, and differentiated ADC linker-payload technologies to develop broader-spectrum, more potent, and less toxic therapies aimed at transforming the oncology treatment paradigm,” said Dr. Zhou Hui, SVP of Innovent Oncology R&D . “Our strategy is designed to target some of the toughest challenges in cancer care, including drug resistance, cold tumors, and improve the efficacy of current IO treatment, while bringing new hope to patients worldwide.” Global R&D Roadmap: a Clear, Stepwise Development Strategy Innovent’s pipeline is guided by a rational, phased IO+ADC combination strategy designed to address tumor heterogeneity and immune escape, evolving through three stages: Currently its oncology pipeline features nearly 10 next-generation molecules in global development, with multi-regional trials actively underway in the U.S., EU, and Asia. The company also continues to invest in global R&D infrastructure, supported by R&D hubs in Shanghai and San Francisco and antibody and ADC manufacturing capacity exceeding 140,000L. Innovent is rapidly expanding its global innovation footprint, with a 2030 goal to advance at least five pipeline assets into global MRCT Phase 3 trials. Key potential candidates includes: IBI363: Next-Gen IO Redefining Cancer Immunotherapy IBI363 is a global first-in-class PD-1/IL-2 α -bias fusion protein, featuring a differentiated molecular design and a dual immune activation mechanism. Emerging clinical data strongly support its mechanism of action in reinvigorating and expanding tumor-specific T cells (TSTs). At ASCO 2025, IBI363 demonstrated breakthrough potential in three hard-to-treat tumor types, with a long tailing effect in prolonged survival benefits: With two Breakthrough Therapy Designations from the NMPA CDE, two Fast Track Designations from the FDA, IBI363 is advancing rapidly toward registrational development. The first head-to-head trial vs. pembrolizumab in mucosal and acral melanoma was initiated. Meanwhile, IBI363 is in preparation for registrational trails in IO-treated squamous NSCLC, and third-line MSS colorectal cancer. Additional trails for first-line and other solid tumors also under exploration in ongoing PoC studies. High-Potency, Low-toxicity ADC Platforms Synergizing with IO for Broad Indication Coverage Innovent is rapidly advancing its next-gen ADC pipeline, including: These programs leverage proprietary payloads and linkers, optimized for lower toxicity and high potency, and are poised to synergize with Innovent’s IO agents to address broader and deeper indications. Innovent Academy: R&D Engine to Drive Global Innovation Innovent Academy is the company’s discovery engine for driving global innovation. The Academy continues to expand its platforms in IO, ADC, T-cell engagers, and cytokines, firmly establishing its leadership in next-gen oncology discovery and translational science to generate 6–8 novel molecules per year. Specifically, for next-gen IO and next-gen ADC dual upgradation, Innovent Academy focuses on: This framework allows Innovent to systematically escalate efficacy and broaden tumor applicability, laying the foundation for first-in-class and best-in-class combination regimens for cancer treatments. Catalyzing China’s Role in Global Oncology Innovation Leading oncology KOLs and principal investigators (PIs) delivered keynote speeches, reflecting on a pivotal moment for China’s biotech industry. They emphasized that China’s innovation, which is driven by rising translational capabilities, expanding global talent pools, and patient-centric trial execution, has entered a “Deepseek” moment, one where Chinese-discovered drugs can lead global standards, not just follow them. “What we’re witnessing is a profound shift,” said one keynote speaker. “Innovent’s next-generation IO programs like IBI363, with a clear global-first design, and ADC platforms targeting previously untreatable populations, show that Chinese biotech is poised to influence—not just participate in—the next global oncology paradigm.” The enthusiastic response from investors and KOLs underscores growing confidence in China-originated oncology innovation and reaffirms Innovent’s position as it enters a new era of global innovation with a vision to become a global premier biopharmaceutical leader. 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 16 products in the market. It has 2 new drug applications (NDA) under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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. SOURCE: Innovent Biologics

Fast TrackImmunotherapy

100 Deals associated with IBI-363

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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05460767 \| NCT06081920 (ASCO2025) Manual	Not Applicable	Mucosal Melanoma \| Melanoma	91	IBI363 (pts with at least one post-baseline tumor assessment)	ndlutohwoj(ijyvuztmlg) = csvtqizpdd acmkjpvqar (hstdsxpklc, 53.4 - 74.4) View more	Positive	30 May 2025
				IBI363 (pts treated at 1mg/kg and above)	ndlutohwoj(ijyvuztmlg) = atntastxxr acmkjpvqar (hstdsxpklc, 57.1 - 79.2) View more
NCT05460767 (ASCO2025) Manual	Phase 1	Advanced Lung Non-Small Cell Carcinoma	136	IBI363	iccucvmefb(uksfuxkkcg) = qbrobcluon wauvqjvkmq (ithalebqbe ) View more	Positive	30 May 2025
				IBI363 3 mg/kg Q3WIBI363 3 mg/kg Q3W	whvmcqvyfr(bbqixrokuq) = qidwtwxvhp vtwzslmuev (szhhhotogx ) View more
NCT05460767 (ASCO2025) Manual	Phase 1	Colorectal Cancer KRAS Mutation \| Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	141	IBI363	pqbnzszovi(itlvmreyub) = ophbnoxjjb ggcmonqplk (jvtjpuwidv ) View more	Positive	30 May 2025
				IBI363 + bevacizumab	pqbnzszovi(itlvmreyub) = hkgmwrvdoj ggcmonqplk (jvtjpuwidv ) View more
NCT05460767 \| NCT06081920 (SITC2024) Manual	Phase 1/2	Melanoma	40	IBI363	dgxmvkgqpn(xppuabsiyt) = tzdqsoviyv woeztgzlgu (wkbnyqpcme, 50.1 - 81.4) View more	Positive	05 Nov 2024
				IBI363 (mucosal melanoma)	dgxmvkgqpn(xppuabsiyt) = ktyphryiqq woeztgzlgu (wkbnyqpcme, 38.7–78.1) View more
NCT05460767 (ESMO2024) Manual	Phase 1	Colorectal Cancer Last line	35	IBI363 + beva	djgjasxbcq(uqmvzlfhzm) = lcxdaepntr ftrjbwwvkp (rxdcaolfex ) 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	iulwaiiaeh(xunjbffqxf) = dwvtakbsdu smhsolwhwl (vbkgdudtbl ) View more	Positive	10 Sep 2024
				IBI363 3 mg/kg Q3W	mneaobmbif(vnztazwgjs) = pnogifpmtr gyyftimzpy (ecphprycpi, 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)	fbriyvavqo(fwakwfyfva) = bietgpsvih wukhsvkwgc (qyjcquftuv ) 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)	fbriyvavqo(fwakwfyfva) = sxdkymvvlg wukhsvkwgc (qyjcquftuv ) View more
NCT05460767 (phase I study, ASCO2024)	Phase 1	Melanoma	67	IBI363 100-2000 μg/kg QW/Q2W/Q3W	xiotuppota(cfzcxsfxeh) = wygfeedrch csfcoimwyb (hamlcbmpte ) View more	Positive	24 May 2024
				IBI363 (In pts had prior IO)	mlzxarfihk(hvjtnxruqb) = qdtefvmdfw sdbkmyqrkb (oeiigowzly, 11.1 - 34.7) View more
NCT05460767 (phase I, ASCO2024)	Phase 1	Colorectal Cancer	68	IBI363 600 ug/kg Q2W	tbswwramhr(tzoyepdehw) = qypjfxmvis irdvjynzen (mgbnnayedk, 46.2 - 95.0) View more	Positive	24 May 2024
				IBI363 1 mg/kg Q2W	tbswwramhr(tzoyepdehw) = firahffjkt irdvjynzen (mgbnnayedk, 46.2 - 95.0) View more
NCT05460767 (phase I study of IBI363, ASCO2024)	Phase 1	Solid tumor	24	IBI363 600 μg/kg QW	bojllaways(lmkkiemgrt) = mlxkgqkucg iuvlqywykm (xbeyugxbwz ) View more	Positive	24 May 2024
				IBI363 600 μg/kg Q2W	bojllaways(lmkkiemgrt) = wzxgburlbr iuvlqywykm (xbeyugxbwz ) View more

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