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Recently, the Category 1 innovative drug Anaprazole Sodium Enteric-coated Tablets of Xuanzhu (Beijing) Pharmaceutical Technology Co., Ltd. is approved by China NMPA. It is an innovative drug independently developed in China and has independent intellectual property rights, indicated for the treatment of duodenal ulcers.

To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&As documents and FAQs documents. The relevant items are hereby announced as follows:

Recently, the Category 1 innovative drug Retagliptin Phosphate Tablets of Jiangsu Hengrui Pharmaceuticals Co., Ltd. is approved by China NMPA. It is indicated for improving the blood glucose control for adult patients with type 2 diabetes

Recently, the Category 1 innovative drug Oteseconazole Capsules of eVENUS PHARMACEUTICAL LABORATORIES INC. is approved by China NMPA. It is indicated for the treatment of severe vulvovaginal candidiasis (VVC).

Recently, the innovative product Zirconium Niobium Alloy Femoral Head of Suzhou MicroPort Orthopedics Medical Technology Co., Ltd. is approved by China NMPA.

Recently, the innovative product Artificial Lens of Alcon Laboratories, Inc. is approved by China NMPA.