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Home » Topics » Regulatory » NMPA

NMPA
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Vaccine vial and syringe

Aim seeks approval of first serum-free human rabies vaccine

March 18, 2025
By Marian (YoonJee) Chu
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
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China accepts NDA of influenza tablet, clears Tepezza biosimilar

March 18, 2025
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
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Vaccine vial and syringe

Aim seeks approval of first serum-free human rabies vaccine

March 12, 2025
By Marian (YoonJee) Chu
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
Read More
Cancer immunotherapy illustration
Immuno-oncology

CSPC’s bifunctional fusion protein cleared for trials in China

March 6, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with JMT-108 for advanced malignant tumors.
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Biocity’s SC-0062 hits phase II endpoints in diabetic kidney disease

March 4, 2025
By Tamra Sami
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
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Biocity’s SC-0062 hits phase II endpoints in diabetic kidney disease

Feb. 26, 2025
By Tamra Sami
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
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Globe showing Asia-Pacific region

Asia recap: Innocare, Akeso in phase III; Deepseek in Antengene

Feb. 25, 2025
By Marian (YoonJee) Chu
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
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3D illustration demonstrating antibody-drug conjugate.

Radiance wins ROR1 ADC rights from CSPC in potential $1B+ deal

Feb. 25, 2025
By Marian (YoonJee) Chu
Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
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3D illustration of transparent human torso with close up of spinal cord

Qyuns’ QX-002N hits endpoints in ankylosing spondylitis trial

Feb. 25, 2025
By Tamra Sami
Qyuns Therapeutics Co. Ltd.’s monoclonal antibody targeting IL-17A, QX-002N, met both primary and secondary endpoints in a phase III trial in ankylosing spondylitis.
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Globe showing Asia-Pacific region

Asia recap: Innocare, Akeso in phase III; Deepseek in Antengene

Feb. 21, 2025
By Marian (YoonJee) Chu
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
Read More
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