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Sihuan Pharmaceutical Holdings Group Ltd.

四 環 醫 藥 控 股 集 團 有 限 公 司

(incorporated in Bermuda with limited liability)

(Stock code: 0460)

VOLUNTARY ANNOUNCEMENT

OFFICIAL RELEASE OF THE RESULT OF LARGE-SCALE CLINICAL TRIALS

AFTER THE LAUNCH OF CINEPAZIDE MALEATE INJECTION THE DRUG TAKES STROKE TREATMENT INTO A NEW ERA WITH ITS VERIFIED EFFICACY

The board of directors (the ''Board'') of Sihuan Pharmaceutical Holdings Group Ltd. (the ''Company'' or ''Sihuan Pharmaceutical'', together with its subsidiaries, the ''Group'') is pleased to announce that the principal findings of Group's completed post-launch clinical trials (the ''Studies'') on ''Cinepazide Maleate Injection (Kelinao)'' (''Cinepazide Maleate Injection'' or the ''Drug'') for the treatment of acute ischemic stroke have recently been published in BMC Neurology, a journal of neurology under the BMC Journal Group in the United Kingdom. Reference is made to the announcement of the Company dated 31 May 2019 in respect of post-launchinglarge-scale clinical verification trials of the Drug. The successful publication of the results of the Studies confirms the Drug being so far the first among all the acute ischemic stroke treatment drugs available nationwide to have completed large-scalepost-launch randomized controlled trial (RCT) verification studies and taken the lead to disclose, in an international SCI journal, its efficacy of improving the prognosis and lowering the disability rate of stroke patients.

BMC Neurology is a journal of neurology under the BMC Group, one of the top 10 international journal groups. It mainly reports on the latest research progress in the field of neurology around the world. The article was published only 6 months after its submission. The publication of the results of the Studies in the international SCI journal proves that international peer experts highly recognize and value the findings of the results, which are expected to become a reference for the guidelines for diagnosis and treatment of stroke.

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The Studies have enrolled patients aged between 18 to 80 suffering from moderate to severe acute ischemic stroke within 48 hours of the onset. 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. The design of the Studies was highly consistent with the current diagnosis and treatment status of clinical stroke patients. The results demonstrated that the Cinepazide Maleate Injection group significantly out-performed the control group in terms of Modified Rankin Scale (mRS) on the 90th day of the primary efficacy endpoint. The endpoint reflects a patient's disability and prognosis, and is currently the globally accepted gold standard in assessing the prognosis of stroke patients. The results suggested that the Cinepazide Maleate Injection significantly decreases disability rate, thus greatly relieving the economic burden of the patients' families and the society. The assessment results based on the Barthel index, the secondary efficacy endpoint, also showed that the Cinepazide Maleate Injection group significantly out-performed the control group. This endpoint, which reflects a patient's self-care ability, suggested that Cinepazide Maleate Injection is able to significantly restore patients' social abilities. In terms of safety, no new adverse events were found in the Studies, and the incidence of adverse events of the Drug was not significantly different from that of the control group.

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. 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 in China is quite the opposite, 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 lack 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 identify drugs or treatment methods that are conducive to improving cerebral blood circulation. Results of the Studies showed that the Drug is effective in promoting recovery of function in stroke patients of treatment after 90 days. The effective treatment with the Drug, greatly decreases the disability rate of stroke patients, thus enabling hundreds of thousands of patients to return to society.

The Drug is a weak calcium ion antagonist, which can effectively improve the blood supply in the cerebral ischemic area and avoid the hypoperfusion in the ischemic area caused by low blood pressure as a result of other calcium antagonists. The Drug was successfully developed by the Chinese Academy of Medical Sciences, and was registered and launched in 2002. Over the past 18 years, clinical experience of the Drug has been accumulated with approximately 6 million patients. The Studies were led by Professor Cui Liying, who is the former 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 involved 68 top hospitals from dozens of provinces, cities and municipalities across the country, including nationally renowned Class III hospitals such as Beijing Union Medical College Hospital, XuanWu Hospital, Beijing Hospital, The General Hospital of the People's Liberation Army, Beijing University First Hospital, Jilin University First Hospital

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and People's Liberation Army General Hospital, with a final enrollment of 1,301 subjects. The Studies are the clinical trial with the largest number of participating organizations and the largest sample size among studies on the self-developed drugs for the treatment of stroke in China, providing an important guarantee for the credibility and reproducibility of the study results.

The Group believes that, following the official release of the results of the Studies, the Drug will also reshape the landscape for stroke treatment while benefiting more patients, families and society with its proven therapeutic efficacy.

This announcement is being made by the Group on a voluntary basis to update the investing public on the Group's latest business development, and does not constitute, and is not intended to be, an advertisement regarding the use of any medicine, surgical appliance, treatment or orally consumed product.

By order of the Board

Sihuan Pharmaceutical Holdings Group Ltd.

Dr. Che Fengsheng

Chairman and Executive Director

Hong Kong, 21 August 2020

As at the date of this announcement, the executive directors of the Company are Dr. Che Fengsheng (Chairman), Dr. Guo Weicheng (Deputy Chairman and Chief Executive Officer), Dr. Zhang Jionglong, Mr. Choi Yiau Chong and Ms. Chen Yanling; the non-executive director of the Company is Mr. Kim Jin Ha; and the independent non-executive directors of the Company are Mr. Patrick Sun, Mr. Tsang Wah Kwong and Dr. Zhu Xun.

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Sihuan Pharmaceutical Holdings Group Ltd. published this content on 21 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 August 2020 04:26:01 UTC