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Highlights
A few days ago, according to the official website of the State Food and Drug Administration, Yichang Renfu Pharmaceutical Co., Ltd. was approved as a generic version of hydromorphone hydrochloride sustained-release tablets for Class 3 production, and won the first generic version of the product in China. According to data from Minenet, the terminal sales of painkillers in China's public medical institutions will exceed 18 billion yuan in 2022, a year-on-year increase of 14.52% in the first half of 2023. Up to now, Humanwell Pharma has 20 product production approvals in the field of painkiller chemical drugs.
Hydromorphone hydrochloride extended-release tablets are suitable for the treatment of severe pain in adults, and there is currently no similar product of the same dosage form approved for marketing in China.
Sales of terminal analgesics in China's public medical institutions in recent years (unit: 100 million yuan)
Source: Minenet's competitive landscape of drug terminals in China's public medical institutions
In recent years, the terminal sales scale of painkillers in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (hereinafter referred to as China's public medical institutions) has steadily increased, exceeding 18 billion yuan in 2022, a year-on-year increase of 14.52% in the first half of 2023. Hydromorphone sales exceeded 400 million yuan in 2022 and increased by more than 80% year-on-year in the first half of 2023.
Hydromorphone hydrochloride sustained-release tablets approval
Source: Minenet China Listed Drugs (MID) Database
According to the data of Minenet, hydromorphone products include hydromorphone hydrochloride injection and hydromorphone hydrochloride sustained-release tablets, and only Yichang Renfu Pharmaceutical has the production approval for the two products, and there is no enterprise production report under review.
Humanwell Pharma said that the approval of hydromorphone hydrochloride sustained-release tablets marks the company's qualification to sell the drug in the domestic market, further enriching the company's product line, and its marketing will have a positive impact on the company.
2022 Top 5 Terminal Oral Painkiller Products in China's Public Medical Institutions (Unit: 100 million yuan)
Source: Minenet's competitive landscape of drug terminals in China's public medical institutions
Not long ago, Humanwell Pharmaceutical announced that its holding subsidiary, Yichang Humanwell Pharmaceutical, was approved to imitate Class 3 aminophen oxycodone tablets, becoming the second domestic enterprise. In 2022, the terminal sales of aminophen oxycodone tablets in China's public medical institutions exceeded 300 million yuan, and they are the TOP5 products of internal painkillers.
Up to now, Humanwell Pharmaceutical has 20 product production approvals in the field of analgesic chemical drugs, and tapentadol hydrochloride tablets and buprohydrocodone tablets are all under review as generic Class 3 production reports, and are expected to win the first imitation.
Source: official website of the State Food and Drug Administration, Minenet database
Note: The statistical scope of "Drug Terminal Competition Pattern of China's Public Medical Institutions" by Minenet is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics, and the above sales are calculated based on the average retail price of products at the terminal. If there is any omission, please correct it!