China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Genfleet Therapeutics (Shanghai) Co. Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to advance GFH-375 (VS-7375) into a phase I/II study in patients with advanced solid tumors with KRAS G12D mutation.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. has received IND clearance in China by the National Medical Products Administration (NMPA) to conduct a phase I trial of its antibody-drug conjugate (ADC) FZ-AD005 for advanced solid tumors.
Miami-headquartered Summit Therapeutics Inc. expanded rights to Akeso Inc.’s non-small-cell lung cancer (NSCLC) drug, ivonescimab (SMT-112; AK-112), June 3 while raising $200 million to advance the therapy.
Although details are scant, Akeso Pharmaceuticals Inc. reported that its PD-1/VEGF bispecific antibody, ivonescimab (AK-112), demonstrated statistically significant superiority as a first-line therapy for PD-L1-positive non-small-cell lung cancer (NSCLC) compared to Merck and Co. Inc.’s Keytruda (pembrolizumab).
Although details are scant, Akeso Pharmaceuticals Inc. reported that its PD-1/VEGF bispecific antibody, ivonescimab (AK-112), demonstrated statistically significant superiority as a first-line therapy for PD-L1-positive non-small-cell lung cancer (NSCLC) compared to Merck and Co. Inc.’s Keytruda (pembrolizumab).
Gyre Therapeutics Inc. has announced IND clearance for Gyre Pharmaceuticals’ F-230 tablets by China’s National Medical Products Administration (NMPA). F-230 is a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH).
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
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