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BioWorld - Sunday, December 14, 2025
Home » Topics » Regulatory » NMPA

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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.
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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.
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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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Eyebright Meiyue Tong TOPPOP Smart store

‘Little giant’ Eyebright’s phakic IOL cleared for myopia in China

Jan. 30, 2025
By Marian (YoonJee) Chu
Eyebright Medical Technology (Beijing) Co. Ltd. is expanding its position in China’s phakic intraocular lens (IOL) market, gaining the National Medical Products Administration (NMPA) approval of its Loong Crystal PR phakic IOL product for myopia in adults in January 2025.
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3d rendering of bispecific antibodies

Newco Prolium licenses antibody from Innocare, Keymed for $520M

Jan. 21, 2025
By Tamra Sami
In another Chinese newco out-licensing deal, Innocare Pharma Ltd. and Keymed Biosciences Co. Ltd. out-licensed their co-developed CD20×CD3 bispecific antibody (ICP-B02/CM355) to startup Prolium Bioscience Inc. in a deal worth up to $520 million.
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Gavel and block with Chinese flag

China deepens drug, device reforms, aims to be global powerhouse

Jan. 21, 2025
By Tamra Sami
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
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Gavel and block with Chinese flag

China deepens drug, device reforms, aims to be global powerhouse

Jan. 16, 2025
By Tamra Sami
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
Read More
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