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

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Lung cancer illustration

Cstone scores approval for Blueprint Medicines’ Gavreto in China

March 30, 2021
By Elise Mak
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
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FDA and China NMPA clear INDs for JMT-601 in NHL

March 30, 2021
Lung cancer illustration

Cstone scores approval for Blueprint Medicines’ Gavreto in China

March 26, 2021
By Elise Mak
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
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CanSino reports China NMPA clearance of clinical trial application for inhaled COVID-19 vaccine

March 23, 2021

China NMPA clears start of phase III trial of Endostar for malignant thoracoabdominal effusions

March 22, 2021

China's NMPA approves emergency use of recombinant protein subunit vaccine against COVID-19

March 19, 2021

CSPC cleared to begin clinical trials in China with SYHX-1901 for rheumatoid arthritis and SLE

March 19, 2021
Green approved stamp

Remegen wins China approval for lupus drug telitacicept

March 16, 2021
By Elise Mak
Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year. A self-developed dual targeted TACI-Fc fusion protein, telitacicept is the second innovative biologic to treat SLE approved in China.
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Green approved stamp

Remegen wins China approval for lupus drug telitacicept

March 12, 2021
By Elise Mak
Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year.
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China's NMPA clears initiation of phase III trial of socazolimab for ES-SCLC

March 9, 2021
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