Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is intended for the treatment of mature lymphocytic tumors in combination with CHOP/CHOEP or CD20 monoclonal antibodies.
SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, is currently the subject of multiple clinical studies for conditions including vitiligo, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and alopecia areata. In 2018, Hengrui entered into a licensing agreement with Arcutis (NASDAQ: ARQT), granting the US company exclusive rights to the drug in the US, European Union, and Japan. Currently, there are no domestic JAK1 inhibitors on the market in China, with products such as Pfizer’s abrocitinib, Novartis’s (NYSE: NVS) Jakavi (ruxolitinib), Eli Lilly’s (NYSE: LLY) Olumiant (baricitinib), and AbbVie’s (NYSE: ABBV) upadacitinib being examples of commercially available JAK1 inhibitors globally.
SHR2554, an enhancer of zeste homolog 2 (EZH2) inhibitor discovered by Hengrui, was first approved for a Phase I clinical trial in China in May 2018 for the treatment of recurrent/refractory mature lymphocytic tumors. In January 2023, the molecule was awarded breakthrough therapy designation (BTD) status in China for use in recurrent or refractory peripheral T-cell lymphoma. Other EZH2 inhibitors in the market include Epizyme’s Tazverik (tazemetostat), which received marketing approval for the treatment of metastatic or locally advanced epithelioid sarcoma (ES) in adults and adolescents aged 16 and above in 2020, and for adult recurrent/refractory follicular lymphoma (r/r FL) in June of the same year. Other similar products in the space are Pfizer’s PF-06821497, Daiichi Sankyo’s (TYO: 4568) valemetostat, and Constellation’s CPI-0209, which was acquired by Morphosys.- Fineline.com
