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Innovent Biologics
Innovent makes sintilimab, China's best-selling PD-1 antibody, and has become a source of next-generation assets for Roche and Takeda.
Also called: 信达生物Innovent Biologics (Suzhou)Innovent Biopharmaceutical Technology (Hangzhou)Innovent Biologics
Overview
Founded by Michael Yu in Suzhou BioBay; sintilimab (Tyvyt) approved 2018 and now in six indications, four biosimilars (bevacizumab, rituximab, adalimumab, trastuzumab), fulzerasib (with GenFleet), equecabtagene autoleucel (with IASO), and the Claudin 18.2 ADC IBI343. Out-licensing: the DLL3 ADC IBI3009 to Roche (January 2025) and the PD-1/IL-2 alpha-bias bispecific IBI363 plus IBI343 to Takeda (October 2025, $1.2 billion upfront, up to $11.4 billion). Also the GLP-1 mazdutide outside oncology. Lilly co-markets Tyvyt in China.
Headquarters
Suzhou, CN
Scorecard
All companies#33of 1244 companies, score 89
- approved products +24
- phase 3 +9
- phase 1/2 +1
- targets +12
- modalities +10
- regions +3
- registry trials +30
4 approved, 3 in phase 3, 1 earlier, 6 targets, 644 registry studies. Formula on the scorecards page.
Deals
Deal map| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2025-10-22 | Innovent Biologics to Takeda IBI363, PD-1 x IL-2 alpha-bias bispecific antibody-cytokine fusion, and IBI343, Claudin 18.2 ADC; option on IBI3001 (EGFR x B7-H3 ADC) | Co-development | $1.2bn (including a $100m equity investment premium) | up to $11.4bn | source |
| 2025-01-02 | Innovent Biologics to Roche / Genentech IBI3009, DLL3 ADC for small cell lung cancer | Licence | $80m | up to $1.0bn | source |
Type
Biotech · 1801.HK
Stage
Public
Website
Founded
2011
ApprovedMonoclonal antibody (anti-PD-1, IgG4)
Sintilimab · Tyvyt
Sintilimab is Innovent's PD-1 antibody, approved in China since 2018 for Hodgkin lymphoma and then, on the ORIENT trials, for first-line lung, liver, oesophageal and stomach cancer. In 2022 the FDA rejected its lung cancer application because a China-only trial against chemotherapy did not fit US practice, defining the agency's stance on single-country data.
ApprovedSmall-molecule covalent KRAS G12C inhibitor
Fulzerasib · Dupert
Fulzerasib was the first KRAS G12C-blocking pill approved in China, for lung cancers carrying that mutation after earlier treatment.
ApprovedCell therapy (autologous BCMA CAR-T, fully human binder)
Equecabtagene autoleucel · Fucaso
Equecabtagene autoleucel is a BCMA CAR-T from IASO Bio and Innovent, approved in China in June 2023 for multiple myeloma that has returned after at least three lines of treatment. In the FUMANBA-1 trial about 96% of infused patients responded, most with deep minimal-residual-disease-negative remissions and few severe cytokine release reactions; it competes with cilta-cel and zevor-cel in China.
Phase 3ADC
IBI354 is an experimental antibody-drug conjugate from Innovent Biologics (Suzhou) in phase 3 trials for HER2-positive breast cancer and ovarian cancer, aimed at HER2.
Phase 3antibody-drug conjugate (ADC), per the sponsor's pipeline page; form not stated in the registry record
IBI343 is an experimental investigational agent whose form is not stated in the registry from Innovent Biologics (Suzhou) in phase 3 trials for pancreatic ductal adenocarcinoma, aimed at Claudin 18.2.
Phase 3monoclonal antibody (anti-CTLA-4, per the sponsor's pipeline page; form not stated in the registry record)
IBI310 is an experimental investigational agent whose form is not stated in the registry from Innovent Biopharmaceutical Technology (Hangzhou) in phase 3 trials for hepatocellular carcinoma, with its target not yet stated publicly.
Phase 2fusion protein
IBI363 is an experimental fusion protein from Innovent Biologics (Suzhou) in phase 2 trials for melanoma, non-small-cell lung cancer and colorectal cancer, aimed at PD-1.
ApprovedSmall-molecule ROS1 TKI (next generation, CNS-penetrant)
Taletrectinib · Ibtrozi
A ROS1 lung-cancer pill approved in 2025 that works in the brain and after crizotinib, with fewer dizziness-type side effects than repotrectinib.
Similar pages
- PersonJianming Xu
Shares ORIENT-16, Sintilimab and the tag china.
- TrialRELIANCE
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation and the tag china.
- InstitutionNational Healthcare Security Administration
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- TreatmentRelmacabtagene autoleucel
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- InstitutionTongji Hospital, Huazhong University of Science and Technology
Shares IASO Biotherapeutics, FUMANBA-1, Equecabtagene autoleucel.
cancers
fronts
drugs
ApprovedCell therapy (autologous BCMA CAR-T, fully human binder)
Equecabtagene autoleucel · Fucaso
ApprovedSmall-molecule covalent KRAS G12C inhibitor
Fulzerasib · Dupert
Phase 3monoclonal antibody (anti-CTLA-4, per the sponsor's pipeline page; form not stated in the registry record)
Phase 3antibody-drug conjugate (ADC), per the sponsor's pipeline page; form not stated in the registry record
Phase 3ADC
Phase 2fusion protein
ApprovedMonoclonal antibody (anti-PD-1, IgG4)
Sintilimab · Tyvyt
ApprovedSmall-molecule ROS1 TKI (next generation, CNS-penetrant)
Taletrectinib · Ibtrozi
companies
trials
A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid TumorsA Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon CancerA First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid TumorsA Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple MyelomaA Study of IBI363 in Subjects With Advanced MelanomaA Study of IBI363 in Subjects with Advanced Solid MalignanciesA Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line TreatmentA Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or MetastatCONTINUUMFulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLCFUMANBA-1IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid TumorsIBI343 in Combination Therapy for Advanced Malignant Solid TumorsIBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C MutationIBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast CancerIBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung CancerIBI363 Combined With Bevacizumab for Advanced Colorectal CancerIBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-SmallNeoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung CancerORIENT-11ORIENT-16ORIENT-32Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung CancerSBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal CancerStudy of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer