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Implantable Cardiac Pacing Lead Approved for Marketing
2025-02-19
Recently, the innovative product "Implantable Cardiac Pacing Lead" of MicroPort Sorin CRM (Shanghai) Co., Ltd. is approved for marketing by China NMPA.
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Management Requirements for Temporary Import and Use of Medical Devices in Urgent Clinical Need in Medical Institutions Issued and Implemented
2025-02-19
In order to fully implement the Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 739), and to further meet the demand for specific medical devices in urgent clinical need, the National Medical Products Administration (NMPA), in collaboration with the National Health Commission, has issued the Management Requirements for Temporary Import and Use of Medical Devices in Urgent Clinical Need in Medical Institutions (Announcement No. 97 of 2024, hereinafter referred to as the Management Requirements).
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Ciltacabtagene Autoleucel Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Ciltacabtagene Autoleucel Injection (trade name: 卡卫荻/Carvykti), of Nanjing Legend Biotech Co., Ltd. is approved for marketing with conditions by China NMPA.
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Vunakizumab Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Vunakizumab Injection (trade name: 安达静) of Suzhou Suncadia Biopharmaceuticals Co., Ltd. is approved by China NMPA. It is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis through systematic treatment or phototherapy.
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Xeligekimab Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Xeligekimab Injection (trade name: 金立希/Jin Li Xi) of Chongqing Genrix Biopharmaceutical Co., Ltd. is approved by China NMPA. It is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis through systematic treatment or phototherapy.
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Stapokibart Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Stapokibart Injection (trade name: 康悦达) of Chengdu Kangnuoxing Biopharma, Inc. is approved by China NMPA. It is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis in adults who are inadequately controlled by topical medications or for whom topical medications are not indicated.
