This week, the second biological drug developed by SinoCellTech - ripertamab, a new anti-CD20 monoclonal antibody, was approved for marketing, which aroused the attention of the industry. The news review of this week is from August 29 to September 2, covering a total of 26 pieces of information in 4 sections, i.e., drug review, R&D, business, and listing.
Drug Review
NMPA – Marketing
[Approval]
1. On August 30, the NMPA official website revealed that ripertamab, a new anti-CD20 monoclonal antibody developed by SinoCellTech, had been put on the market. It is for the treatment of newly diagnosed adult patients with CD20 positive diffuse large B-cell non-Hodgkin's lymphoma (DLBCL) with the international prognosis index (IPI) of 0-2, combined with the standard CHOP chemotherapy (cyclophosphamide, adriamycin, vincristine, and prednisone). Ripertamab is the second biological drug of SinoCellTech that has been approved for marketing following the recombinant coagulation factor VIII.
2. On September 2, the NMPA official website revealed that AstraZeneca's application for new indications of the SGLT-2 inhibitor, Dapagliflozin tablets, had been approved. It is for the treatment of adult patients with chronic kidney disease (CKD) with a risk of disease progression. It can reduce the estimated risk of continuous decline of the glomerular filtration rate, progression to end-stage renal disease, death from cardiovascular diseases, and hospitalization with heart failure, regardless of whether these patients have type II diabetes or not. Previously, this indication had been approved by the FDA on April 30.
3. On September 2, the NMPA official website revealed that the new indication of the rivaroxaban tablets of Bayer had been approved for marketing. It is for the treatment of patients with the peripheral arterial disease (PAD) undergoing peripheral (lower limb) vascular reconstruction (surgical operation or intravascular treatment) to reduce the risk of major thrombotic vascular events (cardiovascular death, myocardial infarction, ischemic stroke, major amputation, and acute limb ischemia). Rivaroxaban is an oral drug with high selectivity and the direct inhibitory factor of Xa.
4. On September 2, the NMPA official website revealed that Novartis's Omalizumab Monoclonal Antibody Prefilled Injection/Home-use Preparation was approved. It is for the treatment of children aged 6 and above, ...
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