This week, in China, Humanwell Healthcare's Class 1.2 traditional Chinese medicine was approved for marketing. Pearl Bio's Bozitinib enteric capsule was planned to be included for priority approval. While globally, the terlipressin injection became the world's first FDA-approved therapy to improve renal function in adult patients with hepatorenal syndrome (HRS). Besides, several drugs have obtained Fast Track Designation (FTD), and many innovative drugs achieved positive clinical results, despite the fact that there were also a few drug failures. The news reviewed this week is from September 12 to 16, covering a total of 26 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA – Marketing
[Approval]
1. On September 15, the NMPA official website revealed that Humanwell Healthcare's Desmodium styracifolium total flavonoids capsule, a class 1.2 traditional Chinese medicine, had been approved for marketing. Used for the treatment of ureteral calculi syndrome diagnosed as pent-up dampness-heat in traditional Chinese medicine, it is the world's first new drug of traditional Chinese medicine for the prevention and treatment of urolithiasis. The drug adopts macroporous resin adsorption technology for purification, extracting Desmodium styracifolium total flavonoids from the single Chinese herbal medicine of Desmodium styracifolium.
NMPA – Marketing
[Application]
2. On September 13, the CDE official website revealed that an application had been submitted for the marketing of Liporaxel (RMX3001), jointly developed by Haihe Biopharma and Daehwa Pharmaceutical of South Korea. The drug is intended for second-line treatment of patients with advanced gastric cancer. RMX3001 is an oral paclitaxel preparation developed by Daehwa Pharmaceutical based on its innovative lipid self-emulsifying drug delivery technology, as well as the world's first oral paclitaxel product successfully developed and approved for marketing.
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