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BioWorld - Wednesday, May 13, 2026
Home » Topics » Regulatory » NMPA

NMPA
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3D rendering of antibody drug conjugated with cytotoxic payload
Immuno-oncology

Mabwell's antibody-drug conjugate 7MW-3711 cleared to enter clinic in China for solid tumors

July 24, 2023
Mabwell (Shanghai) Bioscience Co. has received approval from China's National Medical Products Administration (NMPA) for its clinical trial application for 7MW-3711 for advanced malignant solid tumors.
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3D representation of tumor
Immuno-oncology

Mabwell’s TROP2-targeting ADC cleared to enter clinic in China for solid tumors

July 19, 2023
Mabwell (Shanghai) Bioscience Co. Ltd. has received clearance by China’s National Medical Products Administration (NMPA) for its clinical trial application for 9MW-2921 for advanced solid tumors.
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Immuno-oncology

Qihan’s gene-edited iPSC-derived cell therapy product QN-019a allowed to enter clinic in China

July 19, 2023
Hangzhou Qihan Biotech Co. Ltd. has received clinical trial clearance from China’s National Medical Products Administration (NMPA) for QN-019a for CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.
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Viiv Healthcare’s HIV treatment cabotegravir approved in China

July 18, 2023
By Doris Yu
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
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China approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer

July 18, 2023
By Tamra Sami
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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Viiv Healthcare’s HIV treatment cabotegravir approved in China

July 14, 2023
By Doris Yu
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
Read More

China approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer

July 13, 2023
By Tamra Sami
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Read More
Multiple myeloma illustration

Innovent-Iaso first to finish line in China for multiple myeloma CAR T therapy

July 11, 2023
By Marian (YoonJee) Chu
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
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Multiple myeloma illustration

Innovent-Iaso first to finish line in China for multiple myeloma CAR T therapy

July 3, 2023
By Marian (YoonJee) Chu
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
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Endocrine/Metabolic

China’s NMPA clears anti-GFRAL monoclonal antibody JMT-203 to enter clinic for cancer cachexia

June 27, 2023
CSPC Pharmaceutical Group Ltd. has announced clinical trial approval by China’s National Medical Products Administration (NMPA) for the antibody drug JMT-203, being developed by the company’s Shanghai JMT-Bio Technology Co. Ltd. subsidiary for cancer cachexia.
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