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BioWorld - Wednesday, February 18, 2026
Home » Topics » Regulatory » NMPA

NMPA
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China approves Innovent’s picankibart as first domestic IL-23p19

Dec. 1, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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Illustration of pink and blue antibodies
Endocrine/metabolic

CSPC’s JMT-206 cleared to enter clinic in China for obesity

Nov. 27, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for JMT-206 for weight management in individuals with obesity or overweight and at least one weight-related comorbidity.
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Red and blue bispecific antibodies

Phrontline raises $60M in pre-A+ round for bispecific ADCs

Nov. 25, 2025
By Marian (YoonJee) Chu
No Comments
Phrontline Biopharma Suzhou Co. Ltd. closed a $60 million pre-A+ financing round led by Lapam Investment, with participation from nine other investors. The funds raised will support Phrontline’s development of next-generation antibody-drug conjugate (ADC) candidates.
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Concept art for "unlocking the secrets of the mind"
Neurology/psychiatric

CSPC’s SYH-2056 cleared to enter clinic in China for depression

Nov. 24, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has obtained approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials with the company’s selective 5-HT2A receptor agonist, SYH-2056 tablets, for the treatment of depression.
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Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

Nov. 18, 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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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.
Read More
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.
Read More
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.
Read More
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