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BioWorld - Thursday, December 25, 2025
Home » Topics » Regulatory » NMPA

NMPA
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Green approved stamp

Hutchmed earns NMPA approval for savolitinib amid IPO plan

June 29, 2021
By Elise Mak
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
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Globe showing Asia-Pacific region

China and Indonesia to collaborate on pharma regulatory matters

June 29, 2021
By David Ho
A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market.
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Lynk cleared to begin clinical trials in China with LNK-01003 for inflammatory bowel disease

June 28, 2021

China NMPA clears phase I trial of InnoCare's ICP-033 for solid tumors

June 28, 2021

I-Mab receives Chinese clearance to conduct phase Ib study of felzartamab in SLE

June 28, 2021
Globe showing Asia-Pacific region

China and Indonesia to collaborate on pharma regulatory matters

June 25, 2021
By David Ho
A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market.
Read More

Hutchmed earns NMPA approval for savolitinib amid IPO plan

June 23, 2021
By Elise Mak
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Read More
Green approved stamp

China grants first CAR T approval to Fosun Kite

June 23, 2021
By Elise Mak
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
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China's NMPA approves initiation of clinical trials of anti-Claudin 18.2 ADC SYSA-1801

June 17, 2021
Green approved stamp

Remegen wins first China approval for domestic ADC product

June 15, 2021
By Elise Mak
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).
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