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Home » Topics » Regulatory » NMPA

NMPA
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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
3D illustration demonstrating antibody-drug conjugate.

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

Feb. 20, 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.
Read More
Wooden stamp with China flag

Microport’s laparoscopic surgical robot cleared in China

Feb. 14, 2025
By Marian (YoonJee) Chu
Shanghai Microport Medbot (Group) Co. Ltd. won China National Medical Products Administration approval of its self-developed Toumai single-arm and single-port laparoscopic surgical robot.
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Illustration of antibodies binding to human cell receptors
Respiratory

Akeso’s IL-4Rα/ST2 bispecific antibody gains IND clearance in China

Feb. 14, 2025
Akeso Inc. has received IND approval by China’s National Medical Products Administration (NMPA) for AK-139, an IL-4Rα/ST2 bispecific antibody under investigation for a number of indications, including respiratory and skin diseases.
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Vaccine vial and syringe
Immune

CSPC’s herpes zoster vaccine gains clinical trial clearance in China

Feb. 10, 2025
CSPC Pharmaceutical Group Ltd. has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6017, an mRNA vaccine to prevent herpes zoster infections.
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3D illustration of tumor
Immuno-oncology

Bioray’s BR-111 cleared to enter clinic in China for ROR1-positive cancers

Feb. 10, 2025
Bioray Pharmaceutical Co. Ltd. has announced clinical trial clearance in China by the National Medical Products Administration (NMPA) for BR-111 for injection for the treatment of ROR1-positive hematological malignancies and solid tumors.
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