Sihuan Pharmaceutical: Production Approval Granted For Rivastigmine Hydrogen Tartrate Capsule, The First Drug Passing Consistency Evaluation And Levetiracetam Tablet And The First Registration Approval Granted For Midazolam Oromucosal…

HONG KONG, Feb. 18, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that rivastigmine hydrogen tartrate capsule and levetiracetam tablet developed by the Group have been granted the drug production approval by the National Medical Products Administration (the "NMPA") of the People's Republic of China (the "PRC") and midazolam oromucosal solution has been granted the drug registration approval. Sihuan Pharmaceutical is the first company in the PRC which has been granted registration approval for midazolam oromucosal solution.

The approved dosage forms of rivastigmine hydrogen tartrate capsule are 1.5 mg and 3.0 mg and is used for the treatment of mild to moderate Alzheimer's dementia. The major symptom of dementia is cognitive impairment. According to epidemiological data published in the PRC in 2018, the prevalence of dementia among people aged 60 or above was 5.3% in the PRC, of which 50% to 70% (i.e. nearly 5.0 million to 6.5 million) of dementia patients suffer from Alzheimer's disease, and this situation has caused an enormous burden on the society and families. The pathological changes of Alzheimer 's disease mainly involve the choline neural pathway from basal forebrain to cerebral cortex and hippocampus. Rivastigmine hydrogen tartrate, a carbamate selective acetylcholinesterase inhibitor, promotes cholinergic nerve conduction by delaying the degradation of acetylcholine released by intact cholinergic neurons. The effectiveness of rivastigmine hydrogen tartrate has been widely clinically verified, and it is recommended as a first-line treatment in domestic and foreign guidelines. The Group obtained production approval for rivastigmine hydrogen tartrate capsule under Class 4 of new chemical drug, being the first company in the PRC that have passed the consistency evaluation. According to IQVIA's China Hospital Pharmaceutical Audit Report (CHPA, sales data of hospitals with 100 or more beds), the total market size of Alzheimer 's disease treatment in the PRC was approximately RMB760 million in 2019.

The approved dosage forms of levetiracetam tablet are 0.25 g and 0.5 g. Levetiracetam tablet is mainly used for treatment of partial seizures in adults and children aged over 4 with epilepsy. As a new generation of broad-spectrum antiepileptic drugs, the mechanism of action of levetiracetam tablet is different from that of other existing antiepileptic drugs. It exerts its efficacy against epilepsy by affecting the synaptic vesicle proteins SV2A, potassium channels and N-type calcium channels and has many advantages such as high bioavailability, linear pharmacokinetic curve, low protein binding rate, no liver enzyme induction and less drug interactions, thereby improving patients ' long-term medication compliance and reducing the frequency of seizures. It is also recommended as a first-line treatment in domestic and foreign guidelines. According to IQVIA's China Hospital Pharmaceutical Audit Report (CHPA, sales data of hospitals with 100 or more beds), the total market size of epilepsy drugs and oral products in the PRC were approximately RMB4.37 billion and approximately RMB2.83 billion in 2019, respectively, in which, the total market size of levetiracetam tablet ranked first and amounted to approximately RMB650 million.

In addition, the Group 's midazolam oromucosal solution, which has been granted registration recently, is the first mucosal drug developed in the PRC specifically for treating acute persistent seizures caused by high fever or epilepsy in infants, children and adolescents. Midazolam exerts a therapeutic effect by stimulating benzodiazepine receptors and enhancing the effect of the gamma-aminobutyric acid (GABA) inhibitory neurotransmitter. It is also effective for epileptic seizures and febrile seizures. Midazolam is a recommended drug in the guidelines for epilepsy treatment and febrile seizures. Midazolam, which is currently in clinical use, is mainly administered orally or intravenously, causing significant impediment to the medication administration for infants and children during persistent seizures. Compared with other formulations, oromucosal solution is convenient to administer and has a fast onset of effect. It can also be used for out-of-hospital and home emergency first-aid treatment. The Group believes that this product will greatly fill the existing market gaps after its launch and will provide a safe and effective new family treatment option for infants, children and adolescents.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical said, "All of the above products address the diseases in the central nervous system area and are applicable to a wide range of patients. Together with products of the Group currently on the market, such as oxcarbazepine tablets, and other neurology drug which will be successively launched, Sihuan Pharmaceutical provides patients with more and better treatment options with synergy to further consolidate its leading market position in this field."

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has formed a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.