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BioWorld - Saturday, January 17, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Hepatitis B virus rendering

Ausperbio bags $73M series B for hep B-targeting RNA therapy

Dec. 30, 2024
By Marian (YoonJee) Chu
Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide candidate as a functional cure for chronic hepatitis B.
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Antibody-drug conjugate

Ideaya, Hengrui join hands in $1B deal for phase I ADC targeting DLL3

Dec. 30, 2024
By Tamra Sami
In a deal worth up to $1 billion, Ideaya Biosciences Inc. is in-licensing Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s SHR-4849, a phase I DLL3-targeting opo-I-payload antibody-drug conjugate (ADC). Under terms of the deal, San Francisco-based Ideaya will develop and commercialize SHR-4849 worldwide outside of greater China, and Shanghai-based Hengrui is eligible to receive up to $1.04 billion that includes a $75 million up-front fee, $200 million in development and regulatory milestone payments, and commercial success-based milestone payments. Hengrui is also eligible to receive royalties on net sales outside of greater China.
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China gives thumbs up to Innovent’s taletrectinib for lung cancer

Dec. 24, 2024
By Tamra Sami
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
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Cardiovascular

SYH-2062 cleared for clinic in China for hypertension

Dec. 24, 2024
CSPC Pharmaceutical Group Ltd. has gained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2062 injection, a double-stranded small interfering RNA (siRNA) drug to treat hypertension.
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China gives thumbs up to Innovent’s taletrectinib for lung cancer

Dec. 23, 2024
By Tamra Sami
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
Read More
Illustration of monoclonal antibody hovering between doctor's hands
Cancer

Antibody-drug conjugates SYS-6005, SYS-6043 cleared to enter clinic in China

Dec. 23, 2024
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials of antibody-drug conjugates (ADCs) SYS-6005 and SYS-6043.
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Blue heart and data grid

China clears Stereotaxis/Microport’s robotic ablation catheter

Dec. 11, 2024
By Marian (YoonJee) Chu
Stereotaxis Inc. and Chinese partner Shanghai Microport EP Medtech Co. Ltd. gained the National Medical Products Administration’s approval of its Magbot magnetic navigation ablation catheter Dec. 9 for use with Stereotaxis’ robotic ablation system to treat drug-resistant cardiac arrhythmias in China.
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Sanbexin sublingual tablets

NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye

Dec. 10, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Read More
Natural killer cell attacking cancer cell
Immuno-oncology

NK-510 approved to enter clinic in US and China

Dec. 9, 2024
Base Therapeutics (Shanghai) Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical trials for advanced solid tumors.
Read More
Sanbexin sublingual tablets

NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye

Dec. 5, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Read More
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