# Sintilimab

Source: https://onco.cc/drugs/sintilimab/  
OnCo record `sintilimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

First approved by the NMPA in December 2018 for relapsed or refractory classical Hodgkin lymphoma, then added by the ORIENT programme: first-line non-squamous NSCLC with pemetrexed-platinum (ORIENT-11), squamous NSCLC (ORIENT-12), first-line hepatocellular carcinoma with the bevacizumab biosimilar IBI305 (ORIENT-32), first-line oesophageal squamous cell carcinoma (ORIENT-15) and first-line gastric or gastro-oesophageal junction adenocarcinoma (ORIENT-16). Co-commercialised in China with Eli Lilly. In March 2022 the FDA issued a complete response letter for the ORIENT-11 indication after an advisory committee voted 14 to 1 that a single-country trial with a chemotherapy comparator did not fit US practice, the case that defined the agency's stance on China-only data. Listed on the National Reimbursement Drug List since 2019 after a steep negotiated price cut.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: china
- Brand: Tyvyt
- Code: IBI308
- Modality: Monoclonal antibody (anti-PD-1, IgG4)
- Mechanism: Fully human IgG4 antibody that blocks PD-1 binding to PD-L1 and PD-L2, restoring T-cell activity against the tumour.
- Approvals: China 2018: Relapsed or refractory classical Hodgkin lymphoma after two or more lines; China 2021: First-line non-squamous NSCLC with pemetrexed and platinum (ORIENT-11); first-line squamous NSCLC with gemcitabine and platinum (ORIENT-12); first-line unresectable hepatocellular carcinoma with IBI305 (ORIENT-32); China 2022: First-line oesophageal squamous cell carcinoma with chemotherapy (ORIENT-15); China 2023: First-line gastric or gastro-oesophageal junction adenocarcinoma with chemotherapy (ORIENT-16)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Sintilimab
- Innovent: Tyvyt: https://www.innoventbio.com/
- ORIENT-11 (J Thorac Oncol 2020): https://doi.org/10.1016/j.jtho.2020.07.014
- ORIENT-32 (Lancet Oncol 2021): https://doi.org/10.1016/S1470-2045(21)00252-7
- ORIENT-16 (JAMA 2023): https://doi.org/10.1001/jama.2023.19918
- NMPA (National Medical Products Administration): https://www.nmpa.gov.cn

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Hodgkin lymphoma](https://onco.cc/cancers/hodgkin-lymphoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [PD-1](https://onco.cc/targets/pd1/), [PDCD1LG2](https://onco.cc/targets/pdcd1lg2/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/), [Innovent Biologics](https://onco.cc/companies/innovent/), [TaiRx](https://onco.cc/companies/tairx/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- trials: [A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal C](https://onco.cc/trials/nct06979908/), [A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer](https://onco.cc/trials/nct05890742/), [A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colo](https://onco.cc/trials/nct07506109/), [A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and PK of CVM-1118 in Combination With Sintilimab and TACE in Part](https://onco.cc/trials/nct07521852/), [A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peri](https://onco.cc/trials/nct07268677/), [A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)](https://onco.cc/trials/nct06530251/), [A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients](https://onco.cc/trials/nct06497985/), [A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untr](https://onco.cc/trials/nct07005336/), [Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer](https://onco.cc/trials/nct07398326/), [Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A P](https://onco.cc/trials/nct07686796/), [ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.](https://onco.cc/trials/nct05632939/), [Assessment of the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct06220318/), [Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial](https://onco.cc/trials/nct07722754/), [Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer](https://onco.cc/trials/nct06572813/), [CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC](https://onco.cc/trials/nct06652412/), [Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer](https://onco.cc/trials/nct05757336/), [Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer](https://onco.cc/trials/nct05171660/), [Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC)](https://onco.cc/trials/nct06502080/), [CONTINUUM](https://onco.cc/trials/continuum/), [Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis](https://onco.cc/trials/nct05057052/), [Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer](https://onco.cc/trials/nct06698757/), [Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer](https://onco.cc/trials/nct07638501/), [Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies）](https://onco.cc/trials/nct07007767/), [Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)](https://onco.cc/trials/nct06198907/), [Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07797816/), [mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer](https://onco.cc/trials/nct06761027/), [Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer](https://onco.cc/trials/nct05116462/), [Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer](https://onco.cc/trials/nct05450029/), [Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)](https://onco.cc/trials/nct07351487/), [Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.](https://onco.cc/trials/nct07394387/), [Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE II）](https://onco.cc/trials/nct05429463/), [Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer](https://onco.cc/trials/nct05562297/), [Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer](https://onco.cc/trials/nct06204094/), [Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct07040098/), [ORIENT-11](https://onco.cc/trials/orient-11/), [ORIENT-16](https://onco.cc/trials/orient-16/), [ORIENT-32](https://onco.cc/trials/orient-32/), [PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer](https://onco.cc/trials/nct05236972/), [Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.](https://onco.cc/trials/nct06888674/), [Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.](https://onco.cc/trials/nct06888648/), [Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Can](https://onco.cc/trials/nct06841159/), [Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer](https://onco.cc/trials/nct06121505/), [PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM](https://onco.cc/trials/nct06788171/), [Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial](https://onco.cc/trials/nct07774754/), [Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer](https://onco.cc/trials/nct06685276/), [Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer](https://onco.cc/trials/nct07745790/), [SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer](https://onco.cc/trials/nct07683221/), [SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer](https://onco.cc/trials/nct07535632/), [Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct05484024/), [Short-Course Radiotherapy Followed by Immunotherapy Combined With Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer: A Prospective, Randomiz](https://onco.cc/trials/nct07594925/), [Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC.](https://onco.cc/trials/nct07654530/), [Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer](https://onco.cc/trials/nct07656766/), [Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer](https://onco.cc/trials/nct07831993/), [Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer](https://onco.cc/trials/nct06584032/), [Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma](https://onco.cc/trials/nct06558227/), [Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma](https://onco.cc/trials/nct07468630/), [Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy](https://onco.cc/trials/nct06523049/)
- people: [Jianming Xu](https://onco.cc/people/xu-jianming/), [Michael Yu (Yu De-Chao)](https://onco.cc/people/yu-michael/)
- key papers: [CONTINUUM: induction-concurrent chemoradiotherapy with or without sintilimab in locoregionally advanced nasopharyngeal carcinoma](https://onco.cc/key-papers/paper-continuum-sintilimab-nasopharyngeal-liu-lancet-2024/), [Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study](https://onco.cc/key-papers/paper-ren-lancet-oncol/), [Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial](https://onco.cc/key-papers/paper-xu-jama/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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