This week, in terms of drug review, Toludesvenlafaxine Hydrochloride Extended-Release Tablets, a kind of first-in-class anti-depressant drug developed by Luye Pharma, was approved for marketing. In terms of R&D, the phase III clinical research of PCSK9 Monoclonal Antibody developed by Akeso, Inc. met the endpoints and was planned to apply for marketing. In terms of business, SonnetBio and Janssen reached a cooperation agreement on three candidate products: SON-1010, SON-1210, and SON-1410.
The news review of this week is from October 31 to November 4, covering a total of 25 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA – Marketing
[Approval]
1. On October 31st, the NMPA official website revealed that the new indication of PD-1 Monoclonal Antibody Serplulimab Injection developed by Henlius had been approved for marketing, intended for the combination chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). This is the second indication of Serplulimab approved after MSI-H solid tumor.
2. On November 1st, the NMPA official website revealed that Chiral-tech's generic drug of Eliglustat Tartrate Capsule had been approved for marketing for the long-term treatment of adult patients with Gaucher's disease whose cytochrome P4502D6 (CYP2D6) genotypes are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs) 1. The original product is a potent and highly specific oral ceramide analogue inhibitor.
3. On November 3rd, the NMPA official website revealed that Toludesvenlafaxine Hydrochloride Extended-Release Tablets (brand name: Ruoxinlin), a first-in-class drug developed by Luye Pharma, had been approved for marketing for the treatment of depression. The antidepressant effect of Toludesvenlafaxine Hydrochloride may be relevant to the enhancement of 5-hydroxytryptamine (5-HT) and norepinephrine (NE) in the central nervous system by inhibiting the reuptake of 5-HT and NE.
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