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BioWorld - Wednesday, December 17, 2025
Home » Topics » Regulatory » NMPA

NMPA
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Fosun Pharma to buy out Henlius in $691.7M merger deal

June 25, 2024
By Tamra Sami
Shanghai Fosun Pharmaceutical Co. Ltd announced it will buy out partner Shanghai Henlius Biotech Inc. for up to HKD$5.4 billion (US$691.7 million), according to a joint announcement on the Hong Kong Stock Exchange.
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Non-Hodgkin lymphoma cells in the blood flow

China’s NMPA clears Dizal’s golidocitinib in T-cell lymphoma

June 20, 2024
By Tamra Sami
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.
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Microscope with laptop displaying histology image.
Cancer

Genfleet’s KRAS G12D inhibitor GFH-375 receives NMPA clearance to enter clinic in China

June 20, 2024
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.
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Handshake behind digital globe

Takeda, Ascentage in $1.2B option agreement for olverembatinib

June 18, 2024
By Tamra Sami
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.
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Handshake behind digital globe

Takeda, Ascentage in $1.2B option agreement for olverembatinib

June 17, 2024
By Tamra Sami
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.
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Immuno-oncology

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical’s FZ-AD005 receives IND clearance in China

June 5, 2024
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.
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Gold dollar sign inside gold cog

Summit expands rights, cash for Akeso’s China-approved NSCLC drug

June 4, 2024
By Marian (YoonJee) Chu
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.
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Lung cancer illustration

Akeso’s ivonescimab bests Keytruda in PD-L1-positive NSCLC trial

June 4, 2024
By Tamra Sami
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).
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Lung cancer illustration

Akeso’s ivonescimab bests Keytruda in PD-L1-positive NSCLC trial

May 31, 2024
By Tamra Sami
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).
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Cardiovascular

China’s NMPA clears IND for Gyre’s F-230 for pulmonary arterial hypertension

May 31, 2024
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).
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