BioNova Pharmaceuticals Limited (BioNova) today announced that Center of Drug Evaluation (CDE) of National Medical Products Administration (NMPA) had approved its investigational new drug (IND) application for BN102 to conduct clinical trials in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin Lymphoma (NHL) in China.
BioNova today announced that it has submitted an investigational new drug (IND) application for BN102 for the treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin Lymphoma (NHL) to the China National Medical Products Administration (NMPA).
Shanghai and Hong Kong, PRC, Nov. 22, 2021 - BioNova Pharmaceuticals Limited (BioNova) together with its joint venture subsidiary BK Pharmaceuticals Limited, today announced that it has filed a New Drug Application (NDA) for belumosudil for the treatment of chronic graft-versus-host disease (cGVHD) to the China National Medical Products Administration (NMPA).
Sutro Biopharma, Inc. and BioNova Pharmaceuticals Limited today jointly announced an option agreement for BioNova to develop and commercialize STRO-001, a CD74-targeting Antibody-Drug Conjugate (ADC), for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan.
On Sep 8, Sanofi S.A. (NYSE: SNY) announced to acquire Kadmon Holdings, Inc. (NASDAQ: KDMN) in $1.9 billion deal, adding Rezurock™(belumosudil) to its transplant portfolio. Currently, BioNova is conducting a Phase 2 belumosudil (BN101) clinical trial for cGVHD in seven clinical centers in China and expecting to file NDA submission by the end of 2021.
SHANGHAI, August 20, 2021 -- BioNova Pharmaceuticals (Shanghai) Ltd. (BioNova) and Insilico Medicine (Insilico), today announced entry into a collaboration agreement to jointly discover small molecule inhibitors by targeting oncogenic pathways, which are believed to be dominant drivers of specific hematologic malignancies.
BioNova Pharmaceuticals (Shanghai) Ltd. (BioNova) and WuXi STA, a subsidiary of WuXi AppTec recently announced the signing of a collaboration agreement to jointly accelerate the development and manufacture processes for BioNova’s innovative oncology medicines.
NEW YORK, NY / ACCESSWIRE / July 16, 2021 - Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved REZUROCK™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.
SHANGHAI, CHINA, February 22, 2021 – BioNova today announced a global strategic collaboration with Ardeagen Corporation (Ardeagen), a company focused on discovery and development of Antibody Drug Conjugates (ADCs), for the discovery, development and commercialization of up to three ADCs for the treatment of oncology/hematology malignancies.
KOBE March 16, 2020 - Carna Biosciences Inc. (JASDAQ: 4572) today announced that it has entered into a license agreement with BioNova Pharmaceuticals Limited (BioNova) to develop and commercialize AS-1763, a novel next-generation non-covalent Bruton's tyrosine kinase (BTK) inhibitor for the Greater China territory.