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Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption
Policy / Regulatory

Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption

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BRL Medicine’s Allogeneic CD19 CAR‑T Included in CDE’s “Care Program‑Extension” – Rare Disease Fast Track for Relapsed/Refractory Systemic Sclerosis

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Walvax’s Third‑Generation COVID‑19 mRNA Vaccine Wins NMPA Approval – JN.1‑Based Shot Clears Regulatory Bar for Adults in China

Policy / Regulatory

China’s Seventh National VBP Round for Medical Consumables Concludes in Tianjin – 517 Digestive Intervention Products Selected Across 23 Categories

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Ocumension’s OT‑301 NDA Accepted by China’s CDE – Dual‑Mechanism Glaucoma Therapy Advances Toward Approval in Open‑Angle Glaucoma and Ocular Hypertension

Allergan Aesthetics' JUVÉDERM VOLBELLA Wins NMPA Approval for Infraorbital Hollowing – Hyaluronic Acid Filler Expands China Label Beyond Lips
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Allergan Aesthetics’ JUVÉDERM VOLBELLA Wins NMPA Approval for Infraorbital Hollowing – Hyaluronic Acid Filler Expands China Label Beyond Lips

GSK's Shingrix Wins Japan Approval for Prefilled Syringe Presentation – Recombinant Zoster Vaccine Gains Administration Flexibility
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GSK’s Shingrix Wins Japan Approval for Prefilled Syringe Presentation – Recombinant Zoster Vaccine Gains Administration Flexibility

Hengrui's Hetrombopag Wins China Approval for CTIT and Pediatric ITP – Oral TPO‑RA Expands Across Thrombocytopenia Indications
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Hengrui’s Hetrombopag Wins China Approval for CTIT and Pediatric ITP – Oral TPO‑RA Expands Across Thrombocytopenia Indications

Bayer's Sevabertinib Granted FDA Accelerated Approval – First‑Line Oral TKI for HER2‑Mutant Non‑Small Cell Lung Cancer
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Bayer’s Sevabertinib Granted FDA Accelerated Approval – First‑Line Oral TKI for HER2‑Mutant Non‑Small Cell Lung Cancer

Roche's Enspryng Granted FDA Priority Review for MOGAD – First IL‑6 Inhibitor Poised to Expand Beyond NMOSD
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Roche’s Enspryng Granted FDA Priority Review for MOGAD – First IL‑6 Inhibitor Poised to Expand Beyond NMOSD

Boji Medical and Zhejiang Maiyata Sign Strategic Partnership – Leading China CRO Joins Microbiome Innovator to Advance Live Biotherapeutic Products
CompanyDeals

Boji Medical and Zhejiang Maiyata Sign Strategic Partnership – Leading China CRO Joins Microbiome Innovator to Advance Live Biotherapeutic Products

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AbbVie’s Atogepant Meets All Endpoints in Phase III LUNA Study – Oral CGRP Antagonist Shows Superior Efficacy in Menstrual Migraine Prevention