Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 33 |
| INN | Tislelizumab |
| Status | Approved |
| Drug code(s) | BGB-A317 |
| Brand name | Tizveni, Tevimbra |
| mAb sequence source | mAb humanized |
| 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 | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Bladder cancer, esophageal Squamous Cell Carcinoma, Hepatocellular Carcinoma, Non-small cell lung cancer, Hodgkin lymphoma, liver cancer, Advanced Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, China, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 01, 2015 |
| Start of Phase 2 | April 15, 2017 |
| Start of Phase 3 | November 07, 2017 |
| Date BLA/NDA submitted to FDA | July 10, 2021 |
| Year of first approval (global) | 2019 |
| Date of first US approval | March 13, 2024 |
| INN, US product name | Tislelizumab, Tislelizumab-jsgr |
| US or EU approved indications | Treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Tislelizumab’s initial approval was in classical Hodgkin’s lymphoma. US approval: Tislelizumab-jsgr is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. |
| Company | BeiGene Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | Apr 2024: European Commission also approves tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use. March 14, 2024 I BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) as orphan drug Feb 2024: BeiGene has announced the acceptance of a biologics licence application (BLA) by the US Food and Drug Administration (FDA) for TEVIMBRA (tislelizumab) to treat advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Sep 19, 2023: BeiGene announces European Commission approves TEVIMBRA for previously treated advanced or metastatic esophageal squamous cell carcinoma. The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma; FDA decision expected in July 2024. July 14, 2022 press release: FDA has deferred action until required inspections can be completed; however, no US submission planned at this time for monotherapy in NSCLC following FDA feedback. H2 BLA submission for tislelizumab 1L Nasopharyngeal cancer (US) (https://www.novartis.com/sites/novartis_com/files/q2-2022-investor-presentation.pdf). June 13, 2022: The China National Medical Products Administration has granted approval for BeiGene’s tislelizumab along with chemotherapy as a first-line treatment to treat recurrent or metastatic nasopharyngeal cancer. April 15, 2022: IBeiGene, Ltd. announced that the China National Medical Products Administration (NMPA) has granted approval to BeiGene’s anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. April 6 2022 press release: European Medicines Agency validated MAAs for tislelizumab in multiple non-small cell lung cancer and esophageal squamous cell carcinoma indications Sep 13, 2021: BLA accepted; PDUFA date July 12, 2022. January 11, 2021: Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field. Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of USD 650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. April 10, 2020 I BeiGene, Ltd., a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 12/27/2019: BeiGene announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies. The new drug application (NDA) was previously granted priority review by the NMPA. July 2019: China National Medical Products Administration (NMPA, formerly known as the CFDA) has granted priority review status to the supplemental new drug application (sNDA) for tislelizumab, an investigational Fc-engineered anti-PD-1 antibody, for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC). An NDA for tislelizumab as a potential treatment for patients with relapsed / refractory (R/R) classic Hodgkin’s lymphoma (cHL) was accepted by the NMPA in August 2018 and granted priority review status in November 2018. New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with locally advanced or metastatic UC have been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and the R/R cHL filing has been granted priority review. Celgene will return the global rights of BeiGene's anti-PD-1 antibody candidate tislelizumab as a result of its merger deal with Bristol-Myers Squibb NCT03957590 Phase 3 study in Esophageal Squamous Cell Carcinoma not yet recruiting as of May 21, 2019. NCT03924986 Phase 3 study in nasopharyngeal cancer not yet recruiting as of April 23, 2019. Nov 2018: Marketing application submitted in China has priority review. Aug 2018: BeiGene announced that the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA) has accepted the new drug application (NDA) for tislelizumab, an investigational anti-PD-1 antibody, as a potential treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL). Phase 3 studies in HCC, ESCC and NSCLC recruiting as of July 2018. July 2018: Data on the pivotal Phase II trial for PD-1/L1 checkpoint inhibitor candidate tislelizumab as a treatment for classical Hodgkin lymphoma in patients who are ineligible for autologous stem cell transplantation was announced by BeiGene and its partner Celgene. Results indicated an objective response rate of 73% and a 50% complete response rate. April 10, 2018: BeiGene, Ltd. announced that the first patient was dosed in a global Phase 2 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, in patients with previously treated advanced hepatocellular carcinoma (HCC or liver cancer). Jan. 09, 2018: BeiGene, Ltd. and Boehringer Ingelheim Biopharmaceuticals (China) Ltd. today announced that the two companies have entered into a commercial supply agreement for tislelizumab, BeiGene’s investigational anti-PD-1 antibody. Tislelizumab will be manufactured in Boehringer Ingelheim’s world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim. NCT03358875 Phase 3 in NSCLC started in Nov 2017. April 21, 2017: BeiGene, Ltd. announced that the first patient was dosed in a pivotal clinical trial of BGB-A317, an investigational anti-PD-1 antibody, in Chinese patients with relapsed or refractory classical Hodgkin lymphoma. NCT02407990 Phase 1 study; Phase 1 in China started in Dec 2016 |
| Full address of company | 30 Science Park Road, Zhongguancun Life Science Park
Changping District, Beijing 102206 Asia China https://www.beigene.com/ |
Immune checkpoint inhibitor. BGB-A317 has high affinity and specificity for PD-1 and differs from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |