Alphamab Oncology Co. Ltd. has won conditional marketing approval from China’s NMPA for KN-035 (envafolimab), the world’s first PD-1/PD-L1 antibody to be administered by subcutaneous injection. The drug was cleared for use in treating adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high phenotype/mismatch-repair deficiency. That includes patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan. Read More
Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19 and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19. Read More
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity. Read More
Ascentage Pharma Group International’s olverembatinib has received marketing approval from China’s NMPA for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CMP-AP) harboring a T315I mutation. The Suzhou, China-based firm said the decision marks the country’s first approved third-generation BCR-ABL inhibitor for the treatment of TKI-resistant CML. Read More
Zenas Biopharma LLC in-licensed the global right to develop, manufacture, and commercialize the antibody obexelimab from Xencor Inc. to treat autoimmune diseases in a deal worth up to $480 million. Under the agreement, Monrovia, Calif.-based Xencor gained the rights to acquire additional shares in U.S. and China-based Zenas, which will bring its total equity up to 15%. Read More
Bright Peak Therapeutics Inc. has licensed rights to use Livzon Mabpharm Inc.’s anti-PD-1 candidate, LZM-009, to develop its own PD-1 targeted immunocytokines (PD-1 ICs). Bertolt Kreft, chief scientific officer for Bright Peak, told BioWorld that Livzon’s phase II anti-PD-1 “exhibits a promising initial safety and efficacy profile, making it well-suited to the task. Read More
Biopharmas in Asia-Pacific raising money in public or private financings: Ablaze, Beigene, Bionomics, Greenlight, Help, Incannex Healthcare, Neurophth, Serum Institute of India. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Akston, Arctic Vision, Astrazeneca, Beigene, Biontech, Daiichi Sankyo, Hutchmed, Innovent, Oncotelic, Pfizer, Pulmonem, Syneurx, Tennor. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Biotron, Bone, Ix, Link Health, Merck, NLC, Pfizer, Qurient, Ranok, RDIF, Seelos, Shenzhen Pregene, Simcere, Sosei-Heptares, Todos Medical, Tonix, Valneva. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Alphamab Oncology, Ascentage, Beigene, Biontech, Carsgen, Glaxosmithkline, Janssen-Cilag, Johnson & Johnson, Kintor, Merck, Moderna, Novavax, Pfizer, RDIF, Relief, Seqirus, Takeda. Read More
