NMPA
1. On May 8, NMPA official website revealed that AstraZeneca's Selumetinib Hydrogen Sulfate Capsule had been approved for marketing for treating patients aged 3 years and above with symptomatic and/or progressive, inoperable NF1 related PN. Selumetinib, a MEK1/2 inhibitor developed by ArrayBioPharma (a subsidiary of Pfizer), was approved for marketing for the first time in April 2020.
2. On May 8, NMPA official website revealed that India Dr. Reddy's Laboratories' Class 5.2 chemical drug, Sevelamer Carbonate Tablet, had been approved for marketing for treating hyperphosphatemia in adult patients with CKD. Dr. Reddy's Laboratories is the fourth pharmaceutical company and the first foreign pharmaceutical company with generic drugs approved for marketing. Sevelamer carbonate, also known as cross-linked polyallylamine polymer, is a copolymer of polyacrylamide and epichlorohydrin by cross-linked polymerization.
3. On May 9, NMPA official website revealed that Efbemalenograstim Alfa Injection (R&D code: F-627) of Evive Biotech / Chiatai Tianqing had been approved for marketing for preventing and treating neutropenia caused by tumor patients during chemotherapy. Efbemalenograstim Alfa Injection is a rhG-CSF dimer expressed by CHO cells.
4. On May 17, NMPA official website revealed that BioRay's Zuberitamab Injection had been approved for marketing for treating adult patients with CD20-positive DLBCL and NOS, which should be combined with standard CHOP chemotherapy (cyclophosphamide, adriamycin, vincristine and prednisone). Zuberitamab (R&D code: HS006) is a human-mouse chimeric anti-CD20 monoclonal antibody.
5. On May 17, NMPA official website revealed that Sanhome's first-in-class Alfosbuvir Tablet had been approved for marketing for combining with daclatasvir dihydrochloride to treat adult patients with genes 1, 2, 3, and 6 chronic HCV infection who are newly treated or treated with interferon, with or without compensatory cirrhosis. Alfosbuvir is an HCV NS5B polymerase inhibitor.
6. On May 17, NMPA official website revealed that Bayer's Finerenone (brand name: Kerendia) had expanded indications for the early stage of chronic kidney disease related to T2D. Finerenone, a non-steroidal selective mineralocorticoid receptor antagonist, was approved by NMPA for the first time in June 2022 for treating the adult patients with chronic kidney disease related to T2D (25mL/min/1.73m2 ≤ eGFR < 75mL/min/1.73m2, with albuminuria), which can reduce the risk of eGFR continuous decline and end-stage renal disease.
7. On May 17, NMPA official website revealed that Eisai's Perampanel Oral Suspension had been approved for marketing for treating partial seizures of epilepsy (with or without secondary generalized seizures) in adults and children over 4 years old. Perampanel (brand name: Fycompa) is a selective and non-competitive AMPA (α - amino - 3 - hydroxy - 5 - methyl - 4 - isoxazole propionic acid) receptor antagonist.
8. On May 17, NMPA official website revealed that AB&B BIO-TECH's preventive biological product, Class 1 tetravalent influenza virus subunit vaccine, had been approved for marketing as an adjuvant-free tetravalent influenza virus subunit vaccine for people over 3 years old. The vaccine contains a new antigen form, with the characteristics of high purity, low inoculation side effects and good safety.
9. On May 23, NMPA official website revealed that Bayer's copanlisib for injection had been approved for marketing for treating adult patients with recurrence or refractory follicular lymphoma (FL) who have received at least two systemic treatments in the past. Copanlisib for injection is an intravenous PI3K inhibitor which can inhibit PI3K-α and PI3K-δ kinase subtypes mainly expressed in malignant B cells at the sub-nanomolar level.
10. On May 23, NMPA official website revealed that the eleventh indication of BeiGene's Tislelizumab (brand name: Baizean) had been approved for marketing for the first-line treatment of unresectable, locally advanced, recurrent or metastatic ES...
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