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BioWorld - Thursday, December 25, 2025
Home » Topics » Regulatory » NMPA

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Multiple myeloma illustration
Immuno-oncology

CSPC’s mRNA-LNP-based CAR T-cell therapy cleared to enter clinic in China for multiple myeloma

June 26, 2024
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with the first mRNA-lipid nanoparticles (LNP)-based CAR T-cell injection, SYS-6020.
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Non-Hodgkin lymphoma cells in the blood flow

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

June 25, 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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Liver disease

Innovent’s mazdutide reduces liver fat content in obese patients

June 25, 2024
By Tamra Sami
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, saw 80% reduction in liver fat content in patients with more than 10% liver fat content in the phase III Glory-1 obesity trial.
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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.
Read More
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.
Read More
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