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BioWorld - Friday, February 20, 2026
Home » Topics » Regulatory » NMPA

NMPA
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China's NMPA approves IND for phase I/II study of BBM-H901

Aug. 11, 2021

Akeso’s PD-1 drug wins China approval for Hodgkin’s lymphoma

Aug. 10, 2021
By Elise Mak
Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL).
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Phase II study of ASC-40 for the treatment of acne vulgaris approved in China

Aug. 9, 2021

ImmVira receives NMPA approval for clinical testing of intravenous MVR-T3011

Aug. 9, 2021

Akeso’s PD-1 drug wins China approval for Hodgkin’s lymphoma

Aug. 6, 2021
By Elise Mak
Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space.
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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.
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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.
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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
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