Innovent Biologics Showcases "Dual Innovations" at Oncology R&D Day, Pioneering the Future of Cancer Treatment with Next-Generation IO and ADC Platforms
Innovent Biologics (IVBIY) hosted its Oncology R&D Day, unveiling its strategic focus on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies. The event, which attracted over 500 participants, showcased the company's ambitious plans to advance at least five pipeline assets into MRCT Phase 3 by 2030.
The company highlighted its flagship product IBI363, a first-in-class PD-1/IL-2α-bias fusion protein, which demonstrated breakthrough potential in three hard-to-treat tumors with significant survival benefits: median overall survival up to 17.5 months in NSCLC, 16.1 months in later-line CRC, and 14.7 months in immune-resistant melanoma. IBI363 has received two Breakthrough Therapy Designations from NMPA CDE and two Fast Track Designations from FDA.
Innovent's pipeline includes nearly 10 next-generation molecules in global development, supported by R&D hubs in Shanghai and San Francisco, with antibody and ADC manufacturing capacity exceeding 140,000L. Key candidates include IBI343 (CLDN18.2 ADC), IBI3009 (DLL3 ADC), IBI3003 (tri-specific T-cell engager), IBI3001 (EGFR/B7H3 ADC), and IBI3020 (CEACAM5 dual-payload ADC).
Innovent Biologics (IVBIY) ha organizzato il suo Oncology R&D Day, presentando il suo focus strategico sull'innovazione duale nelle tecnologie di immuno-oncologia (IO) di nuova generazione e nei coniugati anticorpo-farmaco (ADC). L'evento, che ha attirato oltre 500 partecipanti, ha mostrato i piani ambiziosi dell'azienda di far avanzare almeno cinque asset in pipeline alla Fase 3 MRCT entro il 2030.
L'azienda ha messo in evidenza il suo prodotto di punta IBI363, una proteina di fusione PD-1/IL-2α-bias di prima classe, che ha dimostrato un potenziale rivoluzionario in tre tumori difficili da trattare con benefici significativi sulla sopravvivenza: sopravvivenza mediana complessiva fino a 17,5 mesi nel NSCLC, 16,1 mesi nel CRC in linee avanzate e 14,7 mesi nel melanoma immune-resistente. IBI363 ha ricevuto due Designazioni di Terapia Sperimentale (Breakthrough Therapy Designations) da NMPA CDE e due Fast Track Designations dalla FDA.
La pipeline di Innovent comprende quasi 10 molecole di nuova generazione in sviluppo globale, supportate da centri di R&S a Shanghai e San Francisco, con una capacità produttiva di anticorpi e ADC superiore a 140.000L. I candidati chiave includono IBI343 (ADC CLDN18.2), IBI3009 (ADC DLL3), IBI3003 (engager tri-specifico per cellule T), IBI3001 (ADC EGFR/B7H3) e IBI3020 (ADC a doppio payload CEACAM5).
Innovent Biologics (IVBIY) celebró su Oncology R&D Day, revelando su enfoque estratégico en la innovación dual en tecnologías de inmuno-oncología (IO) de próxima generación y conjugados anticuerpo-fármaco (ADC). El evento, que atrajo a más de 500 participantes, mostró los ambiciosos planes de la compañía para avanzar al menos cinco activos en pipeline a la Fase 3 MRCT para 2030.
La empresa destacó su producto estrella IBI363, una proteína de fusión PD-1/IL-2α-bias de primera clase, que demostró un potencial revolucionario en tres tumores difíciles de tratar con beneficios significativos en la supervivencia: supervivencia global mediana de hasta 17,5 meses en NSCLC, 16,1 meses en CRC en líneas avanzadas y 14,7 meses en melanoma resistente al sistema inmunológico. IBI363 ha recibido dos Designaciones de Terapia Revolucionaria (Breakthrough Therapy Designations) de NMPA CDE y dos Designaciones de Vía Rápida (Fast Track) de la FDA.
La pipeline de Innovent incluye casi 10 moléculas de próxima generación en desarrollo global, apoyadas por centros de I+D en Shanghái y San Francisco, con una capacidad de fabricación de anticuerpos y ADC que supera los 140,000L. Los candidatos clave incluyen IBI343 (ADC CLDN18.2), IBI3009 (ADC DLL3), IBI3003 (engager tri-específico para células T), IBI3001 (ADC EGFR/B7H3) e IBI3020 (ADC de doble carga útil CEACAM5).
Innovent Biologics (IVBIY)는 Oncology R&D Day를 개최하여 차세대 면역항암제(IO) 및 항체-약물 접합체(ADC) 기술의 이중 혁신에 대한 전략적 집중을 공개했습니다. 500명 이상의 참가자가 참석한 이번 행사에서는 2030년까지 최소 5개의 파이프라인 자산을 MRCT 3상으로 진입시키겠다는 회사의 야심찬 계획이 소개되었습니다.
회사는 주력 제품인 IBI363을 강조했으며, 이는 최초의 PD-1/IL-2α-바이어스 융합 단백질로, 치료가 어려운 3가지 암종에서 획기적인 잠재력을 보여주었으며 생존 혜택이 크게 나타났습니다: 비소세포폐암(NSCLC)에서 중앙 생존 기간 최대 17.5개월, 후기 CRC에서 16.1개월, 면역 저항성 흑색종에서 14.7개월입니다. IBI363은 NMPA CDE로부터 두 차례의 혁신 치료제 지정(Breakthrough Therapy Designations)과 FDA로부터 두 차례의 신속 심사 지정(Fast Track Designations)을 받았습니다.
Innovent의 파이프라인에는 전 세계 개발 중인 거의 10개의 차세대 분자가 포함되어 있으며, 상하이와 샌프란시스코의 연구개발 허브의 지원을 받고 있습니다. 항체 및 ADC 제조 능력은 140,000L를 초과합니다. 주요 후보 물질로는 IBI343 (CLDN18.2 ADC), IBI3009 (DLL3 ADC), IBI3003 (삼중 특이 T세포 인게이저), IBI3001 (EGFR/B7H3 ADC), IBI3020 (CEACAM5 이중 페이로드 ADC)가 있습니다.
Innovent Biologics (IVBIY) a organisé sa Journée R&D en oncologie, dévoilant son orientation stratégique vers une double innovation dans les technologies d'immuno-oncologie (IO) de nouvelle génération et les conjugués anticorps-médicament (ADC). L'événement, qui a attiré plus de 500 participants, a mis en lumière les plans ambitieux de l'entreprise visant à faire progresser au moins cinq actifs en phase MRCT 3 d'ici 2030.
L'entreprise a mis en avant son produit phare IBI363, une protéine de fusion PD-1/IL-2α-biais de première classe, qui a démontré un potentiel révolutionnaire dans trois tumeurs difficiles à traiter avec des bénéfices significatifs sur la survie : survie globale médiane allant jusqu'à 17,5 mois dans le NSCLC, 16,1 mois dans le CRC en ligne avancée, et 14,7 mois dans le mélanome résistant à l'immunothérapie. IBI363 a reçu deux désignations de thérapie révolutionnaire (Breakthrough Therapy Designations) de la NMPA CDE et deux désignations de voie rapide (Fast Track Designations) de la FDA.
Le pipeline d'Innovent comprend près de 10 molécules de nouvelle génération en développement mondial, soutenu par des centres de R&D à Shanghai et San Francisco, avec une capacité de fabrication d'anticorps et d'ADC dépassant 140 000L. Les candidats clés incluent IBI343 (ADC CLDN18.2), IBI3009 (ADC DLL3), IBI3003 (engageur tri-spécifique des cellules T), IBI3001 (ADC EGFR/B7H3) et IBI3020 (ADC à double charge utile CEACAM5).
Innovent Biologics (IVBIY) veranstaltete seinen Oncology R&D Day und stellte seinen strategischen Fokus auf duale Innovationen in der nächsten Generation der Immunonkologie (IO) und Antikörper-Wirkstoff-Konjugat (ADC)-Technologien vor. Die Veranstaltung, an der über 500 Teilnehmer teilnahmen, präsentierte die ehrgeizigen Pläne des Unternehmens, bis 2030 mindestens fünf Pipeline-Kandidaten in die MRCT Phase 3 zu bringen.
Das Unternehmen hob sein Flaggschiff-Produkt IBI363 hervor, ein neuartiges PD-1/IL-2α-Bias Fusionsprotein, das in drei schwer behandelbaren Tumorarten bahnbrechendes Potenzial mit signifikanten Überlebensvorteilen zeigte: medianes Gesamtüberleben bis zu 17,5 Monate bei NSCLC, 16,1 Monate bei späteren CRC-Linien und 14,7 Monate bei immunresistentem Melanom. IBI363 erhielt zwei Breakthrough Therapy Designations von NMPA CDE sowie zwei Fast Track Designations von der FDA.
Die Pipeline von Innovent umfasst fast 10 Moleküle der nächsten Generation in globaler Entwicklung, unterstützt durch F&E-Zentren in Shanghai und San Francisco, mit einer Antikörper- und ADC-Produktionskapazität von über 140.000L. Wichtige Kandidaten sind IBI343 (CLDN18.2 ADC), IBI3009 (DLL3 ADC), IBI3003 (tri-spezifischer T-Zell-Engager), IBI3001 (EGFR/B7H3 ADC) und IBI3020 (CEACAM5 Dual-Payload ADC).
- First-in-class PD-1/IL-2α-bias fusion protein IBI363 showed strong survival benefits across multiple cancer types
- Received multiple regulatory designations: 2 Breakthrough Therapy Designations (NMPA CDE) and 2 Fast Track Designations (FDA)
- Large manufacturing capacity exceeding 140,000L for antibody and ADC production
- Robust pipeline with 10 next-generation molecules in global development
- Clear development roadmap with goal to advance 5 pipeline assets into global MRCT Phase 3 by 2030
- Strong R&D infrastructure with hubs in Shanghai and San Francisco
- None.
"Over the past decade, Innovent has been at the forefront of
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:
- Next-gen IO + Chemotherapy: to redefine the IO cornerstone
- Next-gen IO + mAb-ADC / bispecific ADC: to cover expansive tumor types and treatment lines
- Next-gen IO + Dual-Payload ADC (dpADC): to unlock full potential of IO+ ADC synergy, and reshape cancer treatment
Currently its oncology pipeline features nearly 10 next-generation molecules in global development, with multi-regional trials actively underway in the
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:
- IBI343: innovative CLDN18.2 ADC with site-specific conjugation and a TOPO1 inhibitor payload, demonstrating significant survival benefits in both GC and PDAC
- IBI363: PD-1/IL-2α-bias fusion protein as next-gen IO to redefine cancer treatment and expand the boundaries of IO responsiveness
- IBI3009: DLL3 ADC in collaboration with Roche
- IBI3003: tri-specific T-cell engager targeting BCMA/GPRC5D/CD3 for multiple myeloma
- IBI3001: EGFR/B7H3 ADC with two synergetic targets covering multiple potential indications
- IBI3020: CEACAM5 dual-payload ADC as globally the first to enter clinical phase
IBI363: Next-Gen IO Redefining Cancer Immunotherapy
IBI363 is a global first-in-class PD-1/IL-2α-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:
- Immune-resistant NSCLC (squamous & Adeno): boosted response rate and extended PFS reflects strong immune activation; median overall survival (mOS) up to 17.5 months in 1.5 mg dose cohorts, 12-month OS rate exceeding
70% for 3 mg dose cohorts, and benefit observed even in PD-L1 low expressers - Later-line CRC (3L+): mOS of 16.1 months in monotherapy and only
17.8% OS events occurred in combination with bevacizumab with 9.4 months follow-up, outperforming historical benchmarks - Immune-resistant melanoma (mucosal/acral subtypes): confirmed overall response rate (cORR)
23% , median duration of response (mDoR) 14 months, and median OS 14.7 months, showing unprecedented positive response and a long-lasting immunologic tailing effect
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:
- IBI343 (CLDN18.2 ADC): first in PDAC to demonstrate long-term survival benefits (mOS 12.1 months in 2L)
- IBI3001 (EGFR/B7H3 ADC): dual-targeted ADC with broad potential in solid tumors
- IBI3020 (CEACAM5 dual payload ADC): designed for high efficacy and low toxicity in treatment-resistant tumors
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:
- diversified antitumor mechanisms to integrate TME modulation and optimize IO efficacy;
- dual targeting approaches to overcome tumor heterogeneity and drug resistance.
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
"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
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.
Statement: |
1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). |
2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. |
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