Zhitong Finance App News, Kaishaoye Health (00876) announced that Qinghai Pharmaceutical Co., Ltd. (Qinghai Pharmaceuticals), a subsidiary of the Group, has successfully obtained the “Drug Registration Certificate” issued by the China National Drug Administration (China Drug Administration) on July 21, 2026, and has been approved for domestic production registration.
Hydromorphone hydrochloride injection is used for moderate to severe cancer pain, acute pain after surgery, and severe analgesia, and clinical rigidity requirements continue to be stable; this variety is an anesthetic drug with a very high entry threshold for R&D, approval, and production. It has been included in the “Medicinal Narcotics Catalogue (2025 Edition)” (jointly issued by the State Drug Administration, Ministry of Public Security, and the National Health Commission). It is a standard powerful analgesic for the clinical treatment of moderate to severe cancer pain and severe acute pain after surgery in domestic hospitals.
According to the “Notice of the State Drug Administration on Issuing Regulations on the Administration of Experimental Research on Narcotic Drugs and Psychotropic Drugs (No. 51 of 2025”), Annex 2 “Regulations on the Number of Narcotic Drugs and Psychotropic Drugs Manufacturers”, the number of designated manufacturers of narcotic drugs such as morphone hydrochloride injections is up to three, and the competitive pattern of the industry is highly concentrated. After successful registration, Qinghai Pharmaceutical became one of only three companies in the country with a valid production registration certificate for this product.
The approval of this product greatly enriches the Group's high-barrier narcotics pipeline, consolidates Qinghai Pharmaceutical's scarce competitive advantage in the domestic narcotics and analgesics circuit, and is expected to bring continuous revenue growth to the Group's business in the long run.