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BioWorld - Friday, December 26, 2025
Home » Topics » Regulatory » NMPA

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Ascletis’ all-oral HCV treatment approved for marketing in China

Aug. 11, 2020
By Bryan Wong
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
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Digital heart illustration

NMPA approves the first AI ECG diagnostic machine

Aug. 7, 2020
By Bryan Wong
HONG KONG – A Chinese med-tech company plans to take to market what it claims is the first electrocardiography (ECG) diagnostic machine powered by AI, but as it moves to markets beyond China, it could face significant competition.
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Ascletis’ all-oral HCV treatment approved for marketing in China

Aug. 5, 2020
By Bryan Wong
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
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Beigene’s FDA-cleared BTK inhibitor Brukinsa approved in China

June 9, 2020
By Elise Mak
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
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Beigene’s FDA-cleared BTK inhibitor Brukinsa approved in China

June 4, 2020
By Elise Mak
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
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Brukinsa receives approval in China for patients with CLL/SLL and MCL

June 4, 2020

China NMPA gives clearance for phase II study of TJ-107/HyLeukin-7 in GBM

May 22, 2020
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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