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BioWorld - Monday, May 11, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Health professional pointing stethoscope at Clinical Trial words, icons

Luoxin’s PIK3α inhibitor receives trial nod in China after Novartis’ alpelisib

May 19, 2020
By Elise Mak
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
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Approved stamp

Zai Lab and Novocure score the first China approval for glioblastoma in 15 years

May 19, 2020
By David Ho
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma.
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Approved stamp

Zai Lab and Novocure score the first China approval for glioblastoma in 15 years

May 15, 2020
By David Ho
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.
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Health professional pointing stethoscope at Clinical Trial words, icons

Luoxin’s PIK3α inhibitor receives trial nod in China after Novartis’ alpelisib

May 13, 2020
By Elise Mak
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
Read More
Flag of China and masks

China tightens grip on med-tech exports to plug loopholes after complaints

April 21, 2020
By Elise Mak
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
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Chinese regulatory approval granted to initiate phase II/III study of HBM-9161 in ITP

April 16, 2020
Flag of China and masks

China tightens grip on med-tech exports to plug loopholes after complaints

April 2, 2020
By Elise Mak
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
Read More

China NMPA approves Tecentriq with chemotherapy for extensive-stage SCLC

Feb. 14, 2020
Opportunity compass with Chinese flag

China brings multinational med tech to local hospitals, accelerates regulation and digital

Feb. 3, 2020
By Stacy Lawrence
The market for multinational medical device companies in China has largely been driven by use only in major public hospitals for patients who pay mostly or entirely out-of-pocket. But that’s continuing to change in ways that could offer a window onto medical device trends in the region over the coming decades.
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China's NMPA clears ASC-22 to begin trials for HBV in China

Jan. 23, 2020
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