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BioWorld - Thursday, February 19, 2026
Home » Topics » Regulatory » NMPA

NMPA
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NMPA of China approved IND application for HLX-26

April 19, 2021

Toripalimab approved in China for locally advanced or metastatic urothelial carcinoma

April 13, 2021
Gastric cancer

Zai Lab wins China approval for Qinlock to treat fourth-line GIST

April 6, 2021
By Elise Mak
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
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Gastric cancer

Zai Lab wins China approval for Qinlock to treat fourth-line GIST

April 1, 2021
By Elise Mak
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
Read More

China's NMPA approves Ayvakit for GIST with PDGFRA exon 18 mutation

April 1, 2021

Qinlock approved in China for advanced GIST

April 1, 2021

China NMPA clears CTA for basket trial of Trodelvy for cancers with high TROP-2 expression

March 31, 2021
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.
Read More
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