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BioWorld - Tuesday, June 9, 2026
Home » Topics » Regulatory » NMPA

NMPA
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China's NMPA approves initiation of clinical trials of anti-Claudin 18.2 ADC SYSA-1801

June 17, 2021
Green approved stamp

Remegen wins first China approval for domestic ADC product

June 15, 2021
By Elise Mak
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).
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Zelgen wins China approval for hepatocellular carcinoma therapy

June 15, 2021
By Doris Yu
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment.
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China's NMPA approves clinical trial application for sirolimus for injection (albumin-bound)

June 11, 2021

Zelgen wins approval in China for its donafenib

June 10, 2021
By Doris Yu
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment. The small-molecule drug, independently developed by Zelgen, is a multitarget kinase inhibitor.
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Green approved stamp

Remegen wins first China approval for domestic ADC product

June 9, 2021
By Elise Mak
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept). The news sent Remegen’s share price (HKEX:9995) up 12.8% in Hong Kong on June 9.
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Drug capsules in petri dish

Micurx wins China approval for antibacterial contezolid

June 8, 2021
By Elise Mak
Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
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China's NMPA clears IND for FXR agonist ASC-42 for chronic hepatitis B

June 7, 2021

China's NMPA accepts IND application for CT-120, a dual-antigen specific CAR-T therapy

June 4, 2021
Drug capsules in petri dish

Micurx wins China approval for antibacterial contezolid

June 3, 2021
By Elise Mak
Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
Read More
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