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

NMPA
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Antibody-drug conjugate
Immuno-oncology

Bioray receives IND clearance in China for BRY-812 ADC targeting LIV-1

May 24, 2023
Bioray Pharmaceutical Co. Ltd.’s IND application for BRY-812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors, has been accepted by the China National Medical Products Administration (NMPA).
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Hepatitis C virus

China's NMPA approves Sanhome’s alfosbuvir for HCV

May 23, 2023
By Zhang Mengying
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
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China's NMPA approves Sanhome’s alfosbuvir for HCV

May 22, 2023
By Zhang Mengying
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
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Immune

Westvac announces NMPA clearance for clinical trials of bivalent and trivalent COVID-19 protein vaccines

May 19, 2023
China's National Medical Products Administration (NMPA) has given drug clinical trial approval for two new COVID-19 vaccines against the current XBB variants developed by Westvac Biopharma Co. Ltd. and West China Medical Center at Sichuan University.
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Immuno-oncology

CSPC Pharmaceutical’s antibody-drug conjugate SYS-6010 cleared to enter clinic in China for advanced solid tumors

April 21, 2023
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6010 has obtained clinical trial approval from China’s National Medical Products...
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Infection

Grand Pharmaceutical’s APAD cleared to enter clinic in China for sepsis

April 6, 2023
Grand Pharmaceutical Group Ltd. has received...
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COVID-19 vaccine and syringe with flag of China

China greenlights CSPC’s mRNA COVID-19 vaccine for emergency use

March 28, 2023
By Zhang Mengying
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
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China greenlights CSPC’s mRNA COVID-19 vaccine for emergency use

March 23, 2023
By Zhang Mengying
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
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NMPA accepts enfortumab vedotin application from Astellas

March 21, 2023
By Doris Yu
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
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Immuno-oncology

Henlius’ agonistic anti-OX40 humanized monoclonal antibody HLX-51 cleared to enter clinic in China

March 16, 2023
Shanghai Henlius Biotech Inc. has received...
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