Several new drugs are to be included in the priority review!

According to the latest publicity on the website of the Drug Review Center of the State Drug Administration of China, a number of innovative drugs have been included in the list of priority reviews to be made.
source: CDE 1, AbbVie's JAK inhibitor upadacitinib two listing applications to be included in the priority review, the development of adaptive disorders for systemic treatment for adults and adolescents aged 12 years and over moderate severe specialty dermatitis patients.
according to CDE publicity, the two listing applications corresponding to 30mg and 15mg two different specifications.
Upateni, discovered and developed by AbbVie scientists, is a once-a-day oral, selective and reversible JAK1 inhibitor approved by the FDA in August 2019 to treat adult patients with moderate to severe active rheumatoid arthritis who are underreacted or insensitive to methotrexate.
addition, the drug was approved by the FDA in 2018 as a breakthrough therapy for adult patients with moderate to severe idiopathic dermatitis suitable for systemic treatment.
2, two listing applications for Luspatercept-aamt, Reblozyl, an injection company owned by Perpetual, were included in CDE's list of priority reviews for the treatment of adult β-thalassemia patients who require regular infusion of red blood cells (RBCs).
Reblozyl is a "first-in-class" red blood cell maturant developed globally by New Base in collaboration with Acceleron Pharmaceuticals, and was approved by the FDA in November 2019 under the trade name Reblozyl, becoming the first FDA-approved drug to treat β thremia-related anemia."
Rortsip has also been developed to treat patients with ERP progenitic stimulator (ESA) primary treatment, low-risk bone marrow prolific abnormal syndrome (MDS) (PHASE III COMMANDS study), non-transfusion β thrmostic anemia (phase II. BEYOND study) and bone marrow fibrosis.
3, Baiji Shenzhou Stoxi monoant is an IL-6 inhibitor, originally developed by Johnson and Johnson Corporation (JNJ. US) research and development, which is then licensed to EUSA Pharma.
2020, Baiji Shenzhou reached a partnership with EUSA Pharma to develop and commercialize two drugs in Greater China, including Stoic monoanti.
in China, Stoic single resistance has been included in the "first batch of clinically urgent need for new drugs abroad" list due to rare diseases.
this time, the adaptations to be included in the priority review are: treatment of adult patients with human immunodeficiency virus (HIV) negative and human herpes virus 8 (HHV-8) negative multi-center Castelman disease (multi-center Castleman disease).
4, GlaxoSmithKline's Dotera velipivirin tablets were included in the proposed priority review process and were suitable for treating adult human immunodeficiency virus 1 (HIV-1) patients who received stable antiretroviral therapy to achieve virological inhibition (HIV-1 RNA less than 50 copies/mL) for at least 6 months, had no history of virological failure, and had no known or suspected resistance to non-nucleotide retroviral inhibitors or integrated enzyme inhibitors.
dotiravelpiverin is a new two-in-one HIV compound, consisting of dotirave and lipivellin in 50 mg/25 mg specifications.
November 2017, Dotila Velipeverin was approved for listing by the FDA.
5, AstraZeneca Olapali tablet new adaptive drug listing application is to be included in the priority review, single drug for the treatment of adult patients with BRCA1/2 mutations (embryo and/or somatic cell line) and after the previous new hormone drug treatment, disease progression metastatic degenerative prostate cancer adults.
Olapali tablet is the FDA-approved first oral polyadenosine disphosphate keruclease (PARP) inhibitor that kills tumor cells by inhibiting PARP enzyme activity and preventing PARP from dissociating from DNA, in collaboration with DNA damage repair functional defects.
first approved for listing in the European Union and the United States in 2014.
Olapali was first approved for listing by the NMPA in August 2018 and has been approved for treatment in China so far: (1) Maintenance therapy in adult patients with platinum-sensitive relapsed epitheliotic ovarian cancer, fallopian tube cancer or primary peritina cancer after platinum-containing chemotherapy has reached full or partial remission.
maintenance treatment for advanced ovarian cancer with BRCA mutation (2).
(3) maintenance therapy for advanced epitheliotic ovarian, fallopian or primary peritiotic cancer with BRCA mutations.
6 and Thyda PD-1 combination therapies are to be included in the priority review.
Sinda BioPD-1 Xindili monoanti-injection and beva-bead monoantigen (Daju) combined for non-removable or metastatic hepatocellular carcinoma that has not been systematically treated in the past have been included in the CDE priority review.