Naproxen sodium tablet of humanwell medicine was approved by FDA

On September 3, humanwell pharmaceutical announced that Yichang humanwell Pharmaceutical Co., Ltd (hereinafter referred to as "Yichang humanwell", the holding subsidiary of humanwell Pharmaceutical Co., Ltd (the company holds 67% of its equity) received the approval number of naproxen sodium tablet from the U.S Food and Drug Administration (FDA), which means that the applicant can produce and sell the product in the U.S market Naproxen sodium tablets are analgesic drugs, which are used to temporarily relieve slight pain, including arthritis slight pain, muscle ache, back pain, menstrual cramp, headache, toothache, common cold and temporary antipyretic Yichang humanwell submitted the Anda application for naproxen sodium tablets in 2018, with a total R & D investment of about 8 million yuan According to iqvia data statistics, from May 31, 2018 to May 31, 2019, the sales volume of naproxen sodium tablets in the U.S market is about US $44 million, and the main manufacturers include Bayer, majorpharm, etc According to the data statistics of minenet, in 2018, the sales volume of naproxen sodium in three terminal public hospitals and retail terminals in cities, counties and towns in China is about 100 million yuan, and the main manufacturers include Hunan Jinjian Pharmaceutical Co., Ltd and Hainan Huanglong Pharmaceutical Co., Ltd On the same day, humanwell received the notice of clinical trial of hydroxymorphine hydrochloride tablets approved and issued by the State Drug Administration Hydroxymorphone hydrochloride tablets are suitable for acute pain requiring opioid analgesics At present, hydromorphone hydrochloride tablets are not listed in China According to iqvia data statistics, from May 31, 2018 to May 31, 2019, the global sales volume of hydroxymorphone hydrochloride tablets is about 15 million US dollars On September 25, 2018, Yichang humanwell submitted the application for clinical registration of hydroxymorphone hydrochloride tablets and was accepted Up to now, it has invested about 14 million yuan According to the requirements of laws and regulations related to drug registration in China, Yichang humanwell will start the clinical research of drugs after receiving the approval documents for clinical trials of the above drugs After the completion of the clinical studies, it will submit the clinical trial data and relevant data to the State Drug Administration for production application.