On June 16, Henlius announced that HLX04-O, its recombinant anti-VEGF humanized monoclonal antibody injection, has met the primary endpoint in an international multicenter Phase III clinical study in patients with wet age-related macular degeneration (wAMD). This study was an international…
On June 16, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that Qilu Pharmaceutical has initiated an open-label, multicenter Phase I clinical study (Registration No.: CTR20262372) to evaluate the safety, tolerability, pharmacokinetics, and preliminary…
On June 16, the CDE official website showed that the New Drug Application (NDA) for Mezigdomide capsules, developed by BMS, has been accepted. The drug is indicated for use in combination with carfilzomib and dexamethasone for the treatment of adult…
On June 15, the NMPA official website showed that the Category 5.1 drug Lidocaine and Prilocaine Aerosol Spray, jointly filed by Plethora Solutions and Fosun Pharma, has been approved for marketing in China for the treatment of primary premature ejaculation…
On June 15, the NMPA official website showed that Zelgen Pharmaceuticals’ Category 1 new drug Jicatinib has been approved for a new indication for the treatment of severe alopecia areata (Acceptance No.: CXHS2500046). Alopecia areata is a common inflammatory non-scarring…
On June 15, the NMPA official website announced that Hengrui Medicine’s self-developed CDK4/6 inhibitor, Dalpiciclib Hydrochloride Tablets, has been approved for a new indication. The new indication is for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor…
On June 15, the NMPA official website showed that Bristol Myers Squibb’s TYK2 inhibitor Deucravacitinib has been approved for a new indication in China for the treatment of psoriatic arthritis . Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor that…
On June 15, Daiichi Sankyo announced that its FLT3 inhibitor, Quizartinib Hydrochloride Tablets, has been approved for marketing in China. The drug is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have been…
On June 15, the Drug Clinical Trial Registration and Information Disclosure Platform showed that The United Laboratories (TUL) has registered a Phase III clinical trial (overweight/obesity) for UBT251 Injection. This is a randomized, double-blind, parallel, placebo-controlled Phase III study designed…
Recently, Merck announced that the U.S. FDA has approved the combination regimen of its HIF-2α inhibitor Welireg (belzutifan) and PD-1 inhibitor Keytruda (pembrolizumab) as adjuvant therapy for adult patients with renal cell carcinoma (ccRCC) containing a clear cell component who…