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BioWorld - Wednesday, June 10, 2026
Home » Topics » Regulatory » NMPA

NMPA
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FDA Approved stamp

Henlius, Organon win US FDA approval of first Perjeta biosimilar

Nov. 18, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
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Amyloid plaques on nerve cell
Neurology/psychiatric

Akeso’s AK-152 gains IND clearance in China for Alzheimer’s

Nov. 17, 2025
No Comments
Akeso Inc. has received clearance from China’s National Medical Products Administration (NMPA) to initiate clinical trials with AK-152 for Alzheimer’s disease.
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Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

Nov. 12, 2025
By Marian (YoonJee) Chu
No Comments
Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
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Wooden stamp with China flag
Cancer

Evopoint’s XNW-34017 gains clinical trial clearance in China

Nov. 12, 2025
No Comments
Evopoint Biosciences Co. Ltd. has obtained clinical trial clearance in China for XNW-34017, an oral protein degrader that targets Aurora kinase A (AURKA) while simultaneously degrading MYC.
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Pacbio Revio sequencing plate

China lifts Illumina ban, clears Pacbio’s Sequel II CNDx

Nov. 6, 2025
By Marian (YoonJee) Chu
On Nov. 5, the Chinese Ministry of Commerce reported it would lift the export ban on Illumina Inc., which had been in place since March 4. While the ban will be lifted starting Nov. 10, Illumina remains on the unreliable entities list, requiring government approval for instrument purchases.
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Handshake with charts, maps, data

Qyuns and Roche partner in $1B+ bispecific antibody deal

Nov. 4, 2025
By Marian (YoonJee) Chu
No Comments
Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.
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Handshake with charts, maps, data

Qyuns and Roche partner in $1B+ bispecific antibody deal

Oct. 29, 2025
By Marian (YoonJee) Chu
No Comments
Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.
Read More
Chris Lai, cofounder and CEO, Metis at Nanoforge launch

Metis plans China NDA submission for orally dissolving PBA drug

Oct. 28, 2025
By Marian (YoonJee) Chu
No Comments
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
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Chris Lai, cofounder and CEO, Metis at Nanoforge launch

Metis plans China NDA submission for orally dissolving PBA drug

Oct. 27, 2025
By Marian (YoonJee) Chu
No Comments
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
Read More
Doctor with illustration of kidneys
Nephrology

CSPC’s SYH-2061 gains clinical trial clearance in China

Oct. 27, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYH-2061 injection for the treatment of IgA nephropathy and other complement-mediated diseases.
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