Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Actimed, Aptose, Austrianova, Avant, Celltrion, Cytomed, Hanmi, Kazia, Klothea, Klothonova, Mankind Pharma, Microbiotix, Nxera, TC Biopharm, Trioar.
Immunotherapy-focused biotech company LTZ Therapetics Inc. and GSK plc are partnering to develop up to four potential first-in-class myeloid cell engagers using LTZ’s immune-engager platform to target blood cancers and solid tumors.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Celltrion, Henlius, Obi Pharma.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Actimed, Aptose, Austrianova, Avant, Celltrion, Cytomed, Hanmi, Kazia, Klothea, Klothonova, Mankind Pharma, Microbiotix, Nxera, TC Biopharm, Trioar.
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
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