Sihuan Pharmaceutical Announces Acquisition of All Interests and Intellectual Property Rights of Plazomicin, A New Generation of Aminoglycoside Antibiotics in the Greater China Region

HONG KONG, Feb. 20, 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 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.

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.

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. 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.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical said, "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, the selection of azithromycin capsule in the second batch of the National Centralized Medicine 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."

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.

Source: Sihuan Pharmaceutical Holdings Group Ltd.
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