HONG KONG, June 1, 2019 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) the largest cardio-cerebral vascular ("CCV") drug manufacturer in China's prescription drug market, announced that the Group has completed the post-launch clinical trials of "Cinepazide Maleate Injection (Kelinao)" for the treatment of acute ischemic stroke. By the completion of the Studies, the Product has obtained post-launch large clinical trials verification, which could demonstrate that the Product can improve the prognosis of stroke patients, lower disability rate and improve cerebral circulation for stroke patients.
The Group responded proactively to the injection re-evaluation requirement of the China Food and Drug Administration (the "CFDA") and commenced post-launch large clinical trials verification in 2016. The Studies took three years to complete and the Group has invested nearly RMB100 million on the Studies and successfully completed the supplementary application prior to the specified time limit, so that the Product can be continually available for sale on the market, thus ensuring the persistent treatment for patients using the Product.
The Studies were led by Professor Cui Liying, who is the chairman of committee of the neurology branch in Chinese Medical Association and works in the department of neurology in Peking Union Medical College Hospital. The Studies involve multiple top hospitals nationwide, including nationally renowned Class III hospitals. The Studies was a high standard of evidence-based research and was designed as a randomized, double-blinded and randomized control trial (RCT) clinical trial, aiming at evaluating the efficacy and safety of the Product for the treatment of acute ischemic stroke. A total of 1,301 patients (between age of 18 to 80) suffering from moderate to severe acute ischemic stroke with acute onset within 48 hours have been enrolled in the Studies. The subjects were arranged to receive a 14-day study medication therapy and to complete a follow-up visit and evaluation on the 90th day thereafter.
Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Acute stroke is a disease with high incidence, high disability rate, high mortality rate and multiple complications. It has become a major threat to the health of Chinese residents. Results of the Studies showed that the Product is effective in promoting the function recovery after 90 days in stroke patients. The effective treatment with this Product, greatly decreases the disability rate of stroke patients, thus enabling more patients returning to society. The Studies verified the efficacy and safety of the Product for the treatment of acute ischemic stroke through scientific design and strict management. The Product will also reshape the landscape for stroke treatment while benefiting more patients, families and society with its proven therapeutic efficacy."
The results demonstrated that the Cinepazide Maleate group significantly outperformed the control group in terms of mRS on the 90th day of the primary efficacy endpoint. The endpoint reflects a patient's disability and prognosis, and is the globally common-used standard in assessing the prognosis of stroke patients. The results suggested that the Product significantly decreases disability rate, thus greatly reduces the economic burden of patients' families and the society. The assessment results based on Barthel index – the secondary efficacy endpoint, also showed that the Cinepazide Maleate group significantly performed better than the control group. This endpoint, which reflects a patient's self-care ability, suggested that the Product is able to significantly restore the patients' social abilities. Based on the NIHSS, another secondary efficacy endpoint of the Studies suggested that there is no statistically significant difference between the Cinepazide Maleate group and the control group. Researchers analyzed the cause and concluded that the NIHSS score is applied mainly to assess the degree of neurological impairment at the time of onset, and its objectivity is not as good as mRS index in reflecting the prognosis of a patient, resulting in inconsistent results between NIHSS and mRS indexes.
In addition, in terms of safety, no new adverse events were found in the Studies, and the incidence of adverse events of the Product was not significantly different from that of the control group. In 2016, Professor Guo Daihong, from the Adverse Drug Reaction Monitoring Center of the People's Liberation Army, was authorized by the Center of Drug Evaluation to conduct an automated safety monitoring study on the Product. The research data from 11,665 patients also showed that the Product has good safety profile. The results of the Studies are expected to be published on authoritative international journals in the area of stroke.
According to the Summary of Health Statistics in China in 2018, patients deaths due to cerebrovascular diseases accounted for 23.18% of the Chinese residents deaths in rural areas in 2017 and the rate in urban area was 20.52%, which means that at least one out of every five deaths was caused by stroke. Besides, the mortality/disability rates of acute stroke at 3 months and 1 year were 37.1% and 33.8%, respectively. In the United States, the mortality rate of heart diseases is 4 to 5 times that of stroke, while the case is the opposite in China, where the incidence of stroke has increased year-on-year over the past 20 years, with its mortality rate 2 to 3 times that of heart diseases. Currently, there is a shortage of drugs for the treatment of acute ischemic stroke in the domestic market and abroad, and existing drugs are lack of clinical evidence-based verification. "Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke in China in 2018" also suggested that conducting further clinical studies could help to discover drugs or treatment methods that are constructive to improve cerebral blood circulation. Results of the Studies showed that the Product is effective in promoting the function recovery after 90 days in stroke patients. The effective treatment with this Product, greatly decreases the disability rate of stroke patients, thus enabling more patients returning to society.