2023年11月1日,赛诺菲和烨辉医药共同宣布,赛诺菲已与BK PHARMACEUTICALS、烨辉医药达成协议,赛诺菲收回在中国大陆对甲磺酸贝舒地尔片进行开发和商业化的独家权利。
BioNova Pharmaceuticals Limited (BioNova) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to BN104 for the treatment of relapsed/refractory (R/R) acute leukemia.
SHANGHAI, China, Sep. 21, 2023 - BioNova today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BN104 for the treatment of relapsed/refractory (R/R) acute leukemia.
BioNova today announced that Center of Drug Evaluation (CDE) had approved its investigational new drug (IND) application for BN104 for the treatment of relapsed/refractory (R/R) acute leukemia in China.
Shanghai, China and Summit, NJ, August 1 2023 - BioNova announces 乐舒克® (Belumosudil Mesylate Tablets) has been approved by the China NMPA for the treatment of patients with cGVHD who have an inadequate response to corticosteroids or other systemic treatments.
SHANGHAI, China, May. 24, 2023 - BioNova today announced that it has submitted an investigational new drug (IND) application for BN104 for the treatment of relapsed/refractory (R/R) acute leukemia to the China National Medical Products Administration (NMPA).
SHANGHAI, China, April. 20, 2023 - BioNova Pharmaceuticals Limited (BioNova), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to BN104 for the treatment of acute myeloid leukemia (AML).
SHANGHAI, China, February. 9, 2023 - BioNova today announced that the first patient has been dosed in the phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin's Lymphoma (NHL).
SHANGHAI, China, September. 5, 2022 - BioNova today announced that Center of Drug Evaluation (CDE) of National Medical Products Administration (NMPA) had approved its investigational new drug (IND) application for BN301 (STRO-001) to conduct clinical trials in patients with hematologic malignancies in China.
BioNova Pharmaceuticals Limited(烨辉医药)今日宣布,该公司在中国大陆拥有独家商业化权益用于治疗慢性移植物抗宿主病(cGVHD)的Belumosudil(REZUROCK™)已于近日获准在海南乐城国际医疗旅游先行区特定医疗机构瑞金海南医院应用于患者的临床治疗。