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BioWorld - Tuesday, May 12, 2026
Home » Topics » Regulatory » NMPA

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Hand holding elbow

China Medical System obtains second psoriasis drug approval in 2023

June 13, 2023
By Doris Yu
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
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3D representation of tumor
Cancer

CSPC Pharmaceutical’s selective ATM inhibitor SYH-2051 cleared to enter clinic in China for solid tumors

June 13, 2023
CSPC Pharmaceutical Group Ltd. has received clinical trial clearance by China’s National Medical Products Administration (NMPA) for SYH-2051 for solid tumors.
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Hand holding elbow

China Medical System obtains second psoriasis drug approval in 2023

June 8, 2023
By Doris Yu
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
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Canbridge obtains first approval for Alagille syndrome in China

June 6, 2023
By Doris Yu
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
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Canbridge obtains first approval for Alagille syndrome in China

June 6, 2023
By Doris Yu
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
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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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