Sihuan Pharmaceutical Holdings Group Ltd., a leading pharmaceutical company with the largest cardio-cerebral vascular (CCV) drug franchise in China’s prescription market, has received the new drug certificate (H20120078) for new Category 3.1 drug, the Nalmefene hydrochloride injection (Nalmefene hydrochloride) and approval for production (2012S00818) from the State Food and Drug Administration.
Nalmefene hydrochloride is yet another generic drug for which the company has received approval for production following the Roxatidine acetate hydrochloridefor injection. It will be manufactured by Beijing Sihuan Pharmaceutical Co., Ltd., a wholly-owned manufacturing subsidiary of the company.
Nalmefene hydrochloride is a next generation opioid (opium) receptor inhibitor following Naloxone and Naltrexone. The injection formulation of Naloxone hydrochloride was invented by Ohmeda Pharmaceuticals and was approved by the US Food and Drug Administration (FDA) in 1995. The clinical uses of Nalmefene hydrochloride include anti-shock, neuroprotection, treatment for acute morphine poisoning, drug relapse prevention, recovery from the after-effects of anesthesia such as respiratory and nerve center depression and the treatment of unconsciousness persons. The drug is also effective for treating heart failure and spinal cord injuries, for cerebral protection, etc. Multi-centre, randomized, blind, and positive-controlled clinical research of Nalmefene hydrochloride of Sihuan Pharmaceutical were performed by the Peking University First Hospital, the First Affiliated Hospital of China Medical University, Xijing Hospital (The First Affiliated Hospital of the Fourth Military Medical College) and Qingdao Municipal Hospital.
Compared to Naloxone, Nalmefene demonstrates longer curative effects and fewer adverse reactions. With its high bioavailability, biological activities and biofilm penetration ability, it helps to regulate respiration, circulation, digestion, and the endocrine and nervous systems. It is becoming a substitute for Naloxone, and has been included in Part B of the National Medicine Catalogue. At present, the size of the Nalmefene hydrochloride market in China is approximately RMB1 billion. As a substitution for Naloxone hydrochloride, Nalmefene hydrochloride has enormous market potential.
Diseases of the central nervous system (CNS) are common in China, which has an immense patient base. Due to the rapid pace of modern life, accelerated urbanisation and mental stress, the demand for CNS medicines has seen rapid growth in recent years given the rising number of patients. According to IMS, the size of the CNS drug market now exceeds RMB 23 billion. With the CNS drug market expected to reach RMB 100 billion in 2020, the Group sees great potential and strong growth prospects in the market.
Dr Che Fengsheng, chairman and CEO of Sihuan Pharmaceutical, said, “Nalmefene Hydrochloride has shown better characteristics for treatment and higher clinical value than Naloxone. Its market demonstrates great potential to expand. Leveraging Sihuan Pharmaceutical’s strong marketing capabilities and extensive sales and distribution network, we believe that our market share for Nalmefene Hydrochloride will see rapid growth, which will strengthen our position in drugs for the treatment of major diseases of the central nervous system. Together with other new products, this will in turn enhance the continuous development and growth of Sihuan Pharmaceutical in China’s prescription drug market and create value for the shareholders and the Company.”