Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024.
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs).
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.
Lotte Biologics Co. Ltd. said it partnered with domestic bioventure Kanaph Therapeutics Inc. to develop an antibody-drug conjugate (ADC) technology platform in hopes of rounding out a full, in-house ADC value-chain.
Kelun-Biotech Biopharmaceutical Co. Ltd. raised HK$1.36 billion (US$174 million) in an IPO in Hong Kong to support its push into the increasingly competitive antibody-drug conjugate (ADC) market in China.
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
The trophoblast cell surface antigen 2 (TROP2) class chalked mix news by way of Astrazeneca plc and Daiichi Sankyo Co. Ltd. as the pair disclosed phase III data from the closely watched Tropion-Lung 1 trial with datopotamab deruxtecan (dato-dxd) against non-small-cell lung cancer.
Privately held F-star Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. have completed their third license agreement, one that could bring F-star about $1 billion. The new collaboration is focused on R&D against undisclosed cancer targets.
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
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