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E200069A Sihuan Pharm 1..2 Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. 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 ACQUISITION OF ALL INTERESTS AND INTELLECTUAL PROPERTY RIGHTS OF PLAZOMICIN, A NEW GENERATION OF AMINOGLYCOSIDE ANTIBIOTICS IN THE GREATER CHINA REGION 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 Xuanzhu (HK) Biopharmaceutical Limited (‘‘Xuanzhu’’), a wholly-owned subsidiary of the Group, acquired all interests and intellectual property rights of plazomicin, a new generation of aminoglycoside antibiotics, in the Greater China Region (including the People’s Republic of China (the ‘‘PRC’’), Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan) from Achaogen, Inc. (‘‘Achaogen’’), a company incorporated in Delaware, the United States of America. Plazomicin is a new generation of semisynthetic aminoglycoside antibiotics developed by Achaogen. It produces antibacterial effect mainly through binding to bacterial 30S ribosomal subunits and is used to treat severe infections caused by multi-drug resistance (‘‘MDR’’) gram-negative bacteria and enterobacteriaceae, including the carbapenem-resistant enterobacteriaceae. In the PRC, MDR bacterial infections are mainly acquired in hospital and most of the infected individuals are immunocompromised due to various reasons. Viral infection, such as novel coronavirus infection, can cause invasion of lymphocytes and damage to immune system. A person with reduced immunity might develop secondary bacterial infections, which increase the risk of acquiring further infections in hospital. – 1 – There are very limited choices of drugs for the clinical treatment of MDR bacteria, however, the only few treatment options have limited clinical application due to issues such as severe renal toxicity. Plazomicin injection was launched in June 2018 with the approval of the U.S. Food and Drug Administration (FDA) for the treatment of complex urinary tract infections and acute pyelonephritis in adults. Currently, clinical application confirms that plazomicin significantly reduces the risk of renal toxicity than previous generations of aminoglycosides. As bacteria are becoming increasingly resistant to existing antibacterial drugs, super bacteria have posed the most serious threat to human health. The World Health Organization (WHO) has predicted that 10 million people will die as a result of super bacterial infections each year by 2050. EvaluatePharma, a pharmaceutical market research agency, has predicted that the annual sales of plazomicin will reach US$313 million in 2022. The Group expects that plazomicin will generate significant economic benefits after its launch in the Greater China Region. In addition, benapenem, a Category 1 innovative carbapenem antibiotic developed by the Group, has commenced Phase II clinical trials for complex urinary tract infections in various clinical trial units in the PRC with smooth progress. Phase III clinical trials are expected to commence in the second half of this year. Azithromycin capsule, another anti-infective product of the Group, is being selected in the second batch of the National Centralized Medicine Procurement (全國藥品集中採購). The specification of this drug is 0.25g* 6 capsules/box, and the procurement price is RMB5.46/ box. Eight provinces, namely Jiangsu, Shandong, Fujian, Liaoning, Heilongjiang, Gansu, Guangxi and Tibet, have been selected for supply of the drug and will provide a minimum of 30 million capsules. The selection of azithromycin capsule in this centralized procurement will help the Group to quickly enter the PRC domestic sales market of azithromycin capsule, increase market presence and further accelerate its development in the field of anti-infective drugs. This announcement is being made by the Company on a voluntary basis to let the investing public understand 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. Chairman and Executive Director Dr. Che Fengsheng Hong Kong, 20 February 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), Mr. Choi Yiau Chong, Dr. Zhang Jionglong 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. – 2 –.
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  • Plazomicin Sulfate ASHP INJECTABLE DRUG INFORMATION
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