Sihuan Pharm Post-launching Large-scale Clinical Trials of Cinepazide Maleate Injection were Completed With Efficacy Verified

Reshaping the Landscape for Stroke Treatment

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."