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BioWorld - Monday, December 15, 2025
Home » Topics » Regulatory » NMPA

NMPA
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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.
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Lungs
Respiratory

SYH-2059 to enter trials in China for interstitial lung disease

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of SYH-2059 tablets for interstitial lung disease, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
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Wooden stamp with China flag

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

Jan. 7, 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

Simcere Zaiming’s CDH6-binding ADC to enter clinic in US, China

Jan. 7, 2025
Simcere Zaiming Pharmaceutical Co. Ltd. has announced clinical trial approvals in China and the U.S. for its CDH6-targeting antibody-drug conjugate (ADC), SIM-0505, for advanced solid tumors. A global clinical study will evaluate SIM-0505 in various malignant tumors, including ovarian cancer and renal cancer.
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Antibody-drug conjugate

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

Dec. 31, 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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Year in review 2024 - Asia deals and innovation

Major 2024 licensing deals confirm Asia’s ascent from copier to innovator

Dec. 31, 2024
By Tamra Sami and Marian (YoonJee) Chu
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
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