Tag Archives: NMPA

GSK Advances Hepatitis B Treatment Pipeline with China NDA Submission for Bepirovirsen Based on Phase III Trial Success

(IN BRIEF) GSK has announced that China’s National Medical Products Administration has accepted for review a New Drug Application for bepirovirsen, an investigational antisense oligonucleotide designed to treat adults with chronic hepatitis B. The submission is supported by Phase III … Read the full press release

GSK Expands Respiratory Portfolio with China Approval of Long-Acting Exdensur Therapy for Severe Asthma Patients

(IN BRIEF) GSK has secured approval in China for Exdensur (depemokimab), a first-of-its-kind ultra-long-acting biologic for treating severe eosinophilic asthma in patients aged 12 and above. Approved by China’s National Medical Products Administration, the therapy offers a novel treatment approach … Read the full press release

GSK Achieves Landmark NMPA Approval for Shingrix as First Shingles Vaccine for Immunosuppressed Patients in China

(IN BRIEF) GSK’s Shingrix vaccine has been approved by China’s NMPA for adults aged 18 and over who are immunocompromised or immunosuppressed, marking the first shingles vaccine available for this group in the country. Affecting about six million people annually … Read the full press release

Sanofi’s Sarclisa Receives Approval in China for Newly Diagnosed Multiple Myeloma Treatment

(IN BRIEF) Sarclisa (isatuximab) has been approved in China for use in combination with the VRd regimen to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. The approval is based on positive results from … Read the full press release

Sarclisa Receives First Approval in China for Treatment of Relapsed or Refractory Multiple Myeloma

(IN BRIEF) Sarclisa, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release

QIAGEN gibt neue Meilensteine für seinen Tuberkulose-Test QuantiFERON bekannt

HILDEN, Deutschland, GERMANTOWN, Maryland (USA), und SHANGHAI, China, 7-Feb-2022 — /EuropaWire/ — QIAGEN NV (NYSE: QGEN; Frankfurt Prime Standard: QIA), ein deutscher Anbieter von Sample-to-Insights-Lösungen, die es Kunden ermöglichen, Einblicke in die Bausteine des Lebens – DNA, RNA und Proteine … Read the full press release

QIAGEN annonce de nouvelles étapes pour son test de tuberculose QuantiFERON

(COMMUNIQUÉ DE PRESSE) HILDEN, Germany / GERMANTOWN, MD, United Staes / SHANGHAI, 7-Feb-2022 — /EuropaWire/ — QIAGEN NV (NYSE : QGEN ; Frankfurt Prime Standard : QIA), une société allemande fournisseur de solutions Sample to Insights qui permettent aux clients de débloquer des informations sur … Read the full press release

QIAGEN announces new milestones for its QuantiFERON tuberculosis test

(PRESS RELEASE) HILDEN, Germany / GERMANTOWN, MD, United Staes / SHANGHAI, 7-Feb-2022 — /EuropaWire/ — QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA), a German provider of Sample to Insights solutions that enable customers to unlock insights from the building … Read the full press release