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National Medical Products Administration

Pharma & Biotech

Galderma wins China approval for Relfydess, but can its six-month wrinkle treatment challenge established Botox rivals?

Galderma wins China approval for Relfydess after positive Phase 3 frown line results. Competition and its pending US review remain crucial.

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Pharma & Biotech

China approves Foresee’s twice-yearly prostate cancer injection. Could it unlock a $123.85m milestone deal?

Foresee's CAMCEVI 42 mg wins China approval for advanced prostate cancer. Examine GeneScience's launch plans, clinical evidence and licensing economics.

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Pharma & Biotech

Can Chipscreen’s AI-discovered CS43158 overcome leukemia drug resistance? China clears human trials

Chipscreen secures China IND clearance for CS43158, targeting FLT3 mutations and resistance pathways in acute myeloid leukemia.

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Pharma & Biotech

Cadonilimab delivered 84.6% complete responses in an earlier study. Can Akeso prove lasting benefit?

Akeso starts Phase III cadonilimab testing in colon cancer, with 386 patients planned and recurrence outcomes central to its clinical strategy.

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Medical Devices & Diagnostics

Norroy starts 600-patient Phase 3 trial of 177Lu-NYM032 in metastatic prostate cancer

Norroy Bioscience has started pivotal Phase 3 development of 177Lu-NYM032 in PSMA-positive metastatic castration-resistant prostate cancer, with a registered target enrollment of about 600 patients and overall survival as the primary objective.

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Pharma & Biotech

Harbour BioMed takes HBICE platform into global clinical testing with B7H4×CD3 bispecific HBM7004

HBM7004 can now enter clinical development in both China and the United States after NMPA and FDA IND clearances, putting Harbour BioMed’s B7H4-dependent T-cell engager into its first human test.

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Pharma & Biotech

Akeso adds B7-H3 to its ADC strategy, but AK157D1 enters a field where a rival is already under FDA review

China has cleared Akeso’s AK157D1 for Phase 1 testing in advanced solid tumors, adding a DXd-class B7-H3 programme to a target already attracting late-stage ADC competition.

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Pharma & Biotech

Leads Biolabs moves PD-L1/4-1BB bispecific toward approval in rare aggressive neuroendocrine cancer

China’s Center for Drug Evaluation has accepted opamtistomig for previously treated advanced EP-NEC and placed the application under Priority Review, while detailed pivotal data await presentation.

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Pharma & Biotech

What do BEL512 Phase 2 results mean for Belenos Biosciences and CRSwNP treatment?

Belenos says BEL512 met all Phase 2 CRSwNP endpoints, but undisclosed effect sizes make the planned 2027 Phase 3 trial the critical test.

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Pharma & Biotech

NCX 470 moves toward China approval with U.S. review already underway

NCX 470 enters China regulatory review after two positive Phase 3 glaucoma trials. Read why U.S. and China decisions could reshape Nicox.

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