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BioWorld - Thursday, December 18, 2025
Home » Topics » Regulatory » NMPA

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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.
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Green approved stamp

CSPC wins China clearance of new DPP-4 inhibitor

Jan. 14, 2025
By Marian (YoonJee) Chu
CSPC Pharmaceutical Group Ltd. on Jan. 13 gained the National Medical Products Administration’s approval of Shanzeping (prusogliptin tablets; DBPR-108) as a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor to treat adult patients with type 2 diabetes.
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Cornerstone Robotics Sentire

Cornerstone Robotics raises $70M to expand international footprint

Jan. 14, 2025
By Tamra Sami
Cornerstone Robotics Ltd. raised more than $70 million in a series C round to expand its international footprint and accelerate R&D efforts for its robotic surgery solutions. The funds will allow the Hong Kong-headquartered company to accelerate commercialization of new surgical robotic products, conduct clinical trials, obtain regulatory approvals and promote global adoption of advanced robotic surgical solutions.
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AI-generated image for cancer cells observed under a microscope
Immuno-oncology

CSPC’s SYS-6041 cleared to enter clinic in China

Jan. 13, 2025
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYS-6041, an antibody-drug conjugate, for advanced solid tumors.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 8, 2025
By Marian (YoonJee) Chu
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
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Immuno-oncology

SYS-6045 cleared for clinic in China for advanced solid tumors

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
Read More
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