This week, there was nothing special in the drug review section, but BeiGene's new indication for Zanubrutinib was approved in the EU while TopAlliance's Toripalimab submitted a marketing application in the EU. In terms of R&D, the most noteworthy is Hengrui's JAK inhibitor Phase III clinical success, making it expected to be the first product made in China in the field of autoimmune system diseases. In the area of business, Hansoh Pharmaceutical Group introduced EGFR/cMet bispecific antibodies, which are expected to link up with Almonertinib in a deal valued at up to RMB1.468 billion.
The news review of this week is from November 14 to 18, covering a total of 23 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA – Marketing
[Application]
1. On November 15, the CDE official website revealed that Everest Medicines's Budesonide Sustained-release Capsule (Nefecon) was submitted and processed as a marketing application for the treatment of adult patients with primary IgA nephropathy (IgAN) at risk of progression. Nefecon is an innovative oral targeted sustained-release preparation of budesonide, which is now the world's first targeted therapeutic drug for IgA nephropathy.
2. On November 16, the CDE official website revealed that Novartis' new indication for Secukinumab was processed for submission of a marketing application. Secukinumab is a fully human IL-17A inhibitor, the first and only fully human interleukin inhibitor in the world. Approved in China as early as March 2019, it is currently approved for the treatment of adults with moderate to severe plaque psoriasis and pediatric patients aged 6 years and above weighing ≥50 kg who are eligible for systemic therapy or phototherapy" and "adult patients with ankylosing spondylitis who have failed to respond to conventional therapy.
NMPA – Clinical Trials
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