This week, in terms of Drug Review, the marketing application of a first-in-class of HAISCO, HSK16149 capsule was submitted, and Fosun Kite's CD19 CAR-T autologous product for new indications was declared for marketing. In terms of R&D, several clinical trials achieved positive results, while Alpine Immune terminated two clinical trials of davoceticept due to the death of patients. In terms of Business, JW Therapeutics and 2seventybio conditionally agreed to establish a strategic alliance; In terms of the Listing, Cwbio, a molecular testing company, was listed on the STAR.
The news review of this week is from October 24 to 28, covering a total of 23 pieces of information in 4 sections, i.e., drug review, R&D, business and listing.
Drug Review
NMPA – Marketing
[Application]
1. On October 25, the CDE official website revealed that the new indication of Axicabtagene Ciloleucel Injection from Fosun Kite was declared for marketing. It was intended for the treatment of adult large B-cell lymphoma (r/rLBCL) which failed to respond to first-line immunotherapy or recurred within 12 months after first-line immunotherapy. Axicabtagene Ciloleucel Injection is a targeted human CD19 autologous CAR-T cell therapy product that Fosun Kite imported Yescarta from Kite for technology transfer in China in early 2017 and was authorized to carry out localized production in China.
2. On October 25, the CDE official website revealed that a marketing application for Parsaclisib, the PI3Kδ inhibitor of Innovent, was submitted, and it was intended to be included in the priority review for use in adult patients with relapsed or refractory follicular lymphoma who had previously received at least two systemic treatments. Parsaclisib comes from Innovent's cooperation with Incyte in 2018.
3. On October 27, the CDE official website revealed that the marketing application of HAISCO's first-in-class HSK16149 Capsule was submitted, presumably for the treatment of diabetic peripheral neuralgia. HSK16149 is a novel voltage-gated calcium ion channel analgesic, belonging to me-better of pregabalin. Benefits from its high target selectivity, strong and long-acting analgesic effect, and small central side effects, it may have...
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