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BioWorld - Sunday, May 10, 2026
Home » Topics » Regulatory » NMPA

NMPA
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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.
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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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Hand holding elbow

China Medical System obtains second psoriasis drug approval in 2023

June 13, 2023
By Doris Yu
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
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3D representation of tumor
Cancer

CSPC Pharmaceutical’s selective ATM inhibitor SYH-2051 cleared to enter clinic in China for solid tumors

June 13, 2023
CSPC Pharmaceutical Group Ltd. has received clinical trial clearance by China’s National Medical Products Administration (NMPA) for SYH-2051 for solid tumors.
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