Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 72 |
| INN | Sintilimab |
| Status | Approved |
| Drug code(s) | IBI308 |
| Brand name | Tyvyt |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Adimab technology (yeast display) |
| Target(s) | PD-1 |
| Indications of clinical studies | Liver cancer, gastric cancer, solid tumors, non-small cell lung cancer, Esophageal cancer, Hodgkin's lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2016 |
| Start of Phase 2 | |
| Start of Phase 3 | September 01, 2017 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2018 |
| Date of first US approval | |
| INN, US product name | Sintilimab |
| US or EU approved indications | None |
| Company | Innovent Biologics |
| Licensee/Partner | Eli Lilly |
| Comments about company or candidate | June 2022: Approved in China for esophageal squamous cell carcinoma; In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, and recently approved for one additional indication. Two submissions are under review in China. As of June 2022 Lilly SEC filing, In 2020, we obtained an exclusive license for sintilimab injection from Innovent for geographies outside of China. Innovent, with collaboration from us, filed the initial registration of sintilimab injection in the U.S. that the FDA did not approve in its current form and recommended an additional multiregional clinical study be performed. Lilly does not plan to further pursue submission. (https://investor.lilly.com/node/47571/html) March 2022: FDA issues Complete Response Letter (https://investor.lilly.com/news-releases/news-release-details/lilly-announces-complete-response-letter-sintilimab-combination) BLA for approval in NSCLC submitted in March 2021; PDUFA date is March 2022 NCT03794440 Phase 2/3 in liver cancer recruiting as of Feb 2019. Jan 17, 2019: Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-16) that is to evaluate Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma Dec. 27, 2018: Innovent Biologics, Inc. and Eli Lilly and Company ("Lilly") jointly announce today that the co-developed Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).Sep 2018: Innovent initiated ORIENT-11, a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with pemetrexed (Alimta®) and platinum-based chemotherapy as first-line treatment for advanced or recurrent ns-NSCLC in China. This study is currently under recruitment and Innovent plans to enroll 378 patients. May 18, 2018: Innovent Biologics Inc. (Suzhou, China) said the State Drug Administration (formerly CFDA) accepted and granted Priority Review to an NDA for sintilimab (IBI308) in April to treat relapsed or refractory classical Hodgkin's lymphoma. The new drug application (NDA) for IBI308 for the treatment of r/r cHL was officially accepted by the Center of Drug Evaluation of the China Food and Drug Administration (CFDA) on April 19, 2018 and was granted the “Priority Review Status” on April 23, 2018. The company also reported preliminary data from the Phase II ORIENT-1 trial evaluating the anti-PD-1 mAb in the indication. Among 96 patients, sintilimab led to an overall response rate (ORR) of 79.2% and a disease control rate (DCR) of 97.9%. According to the company, the results meet the preset statistical criteria. Median duration of response has not yet been reached. Final data will be presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Phase 3 NCT03150875 in NSCLC recruiting as of Sep 1, 2017. September, 12, 2016 – Innovent biologics announced today that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with its investigational agent IBI308, a fully human anti-PD-1 antibody, for the treatment of advanced solid tumors. IBI308 has some distinct features that may differentiate it from other commercially available and clinical stage anti-PD1 antibodies. Adimab and Innovent initiated a partnership in 2013 to discover antibodies against multiple targets selected by Innovent. The PD-1 program, which Innovent has partnered with Lilly, was initiated in the spring of 2013. |
| Full address of company | 9900 Belward Campus Drive, Rockville, MD 20850 North America United States of America https://www.innoventbio.com/AboutUs/ContactUs |
Immune checkpoint inhibitor
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |