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BioWorld - Tuesday, June 9, 2026
Home » Topics » Regulatory » NMPA

NMPA
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China's NMPA approves INDs for IASO's CD19/CD22 CAR-T therapy

Aug. 3, 2021
Red blood cells

Sinocelltech’s SCT-800 wins NMPA approval; first homegrown drug for hemophilia A

July 27, 2021
By Doris Yu
Sinocelltech Group Ltd. won market approval from China’s NMPA for SCT-800, a B-domain deleted recombinant human coagulation factor VIII, for the prophylactic treatment of severe hemophilia A in adolescent and adult patients. This marks the first homegrown drug for treating hemophilia A in China.
Read More

China approves Sincere Biotech’s oral HIV-1 drug azvudine

July 27, 2021
By Elise Mak
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection.
Read More
Red blood cells

Sinocelltech’s SCT-800 wins NMPA approval; first homegrown drug for hemophilia A

July 26, 2021
By Doris Yu
Sinocelltech Group Ltd. won market approval from China’s NMPA for SCT-800, a B-domain deleted recombinant human coagulation factor VIII, for the prophylactic treatment of severe hemophilia A in adolescent and adult patients. This marks the first homegrown drug for treating hemophilia A in China.
Read More

China's NMPA clears initiation of clinical trials with ESG-401 for solid tumors

July 23, 2021

China approves Sincere Biotech’s oral HIV-1 drug azvudine

July 22, 2021
By Elise Mak
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection.
Read More
Chinese flag and microscopes

China now wants quality, not just quantity

July 20, 2021
By Doris Yu
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
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Lepu’s NDA for anti-PD-1 antibody accepted ahead of Hong Kong IPO

July 20, 2021
By Doris Yu
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
Read More
Chinese flag and microscopes

China now wants quality, not just quantity

July 16, 2021
By Doris Yu
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
Read More

Lepu’s NDA for anti-PD-1 antibody accepted ahead of Hong Kong IPO

July 15, 2021
By Doris Yu
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
Read More
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