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Home » Topics » Regulatory » NMPA

NMPA
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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.
Read More
Hepatitis B virus rendering

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

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

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

Dec. 30, 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.
Read More
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.
Read More
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.
Read More

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.
Read More
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.
Read More
Previous 1 2 3 4 5 6 7 8 9 10 11 12 … 54 55 Next

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