Business
Sihuan Pharmaceutical : has been Granted the Drug Registration Approval for Another Solid-Liquid Double Chamber Bag, and is the First Company in China that Obtained Drug Registration Approval for "Non-PVC Solid-Liquid Double Chamber Bag for Cefuroxime Sodium/Sodium Chloride Injection"
Sihuan Pharmaceutical : has been Granted the Drug Registration Approval for Another Solid-Liquid Double Chamber Bag, and is the First Company in China that

About this update from Sihuan Pharmaceutical Holdings Group Ltd.
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) Sihuan Pharmaceutical has been Granted the Drug Registration Approval for Another Solid-Liquid Double Chamber Bag, and is the First Company in China that obtained Drug Registration Approval for "Non-PVCSolid-Liquid Double Chamber Bag for Cefuroxime Sodium/Sodium Chloride Injection" 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 "non-PVCsolid-liquid double chamber bag for cefuroxime sodium/sodium chloride injection" (the " Drug ") jointly developed by the Group and its associated company Beijing Ruiye Drugs Manufacture Co. Ltd. (" Beijing Ruiye ") has been granted drug registration approval by the National Medical Products Administration (the " NMPA ") of the People's Republic of China (" China "). The specification of the Drug is 0.75g solid chamber, 100ml liquid chamber and 0.9g sodium chloride. Following the announcements dated 26 May 2019 and 17 June 2019 in relation to the Group having obtained the drug registration approvals for "non-PVCsolid-liquid double chamber bag for ceftazidime/sodium chloride injection","non-PVCsolid-liquid double chamber bag for cefodizime sodium/5% glucose injection" and "non-PVCsolid-liquid double chamber bag for cefodizime sodium/sodium chloride injection" (the " Series Drugs "), Beijing Ruiye further obtained the drug registration approval for non-PVCsolid-liquid double chamber infusion soft bag (the " Solid-liquid Double Chamber Bag ") formulation, and was the first and only drug manufacturer in China that has been granted drug registration approval for the Solid-liquid Double Chamber Bag of the Drug by the NMPA. - 1 - The Solid-liquid Double Chamber Bag is safe, reliable and convenient, and is one of the most promising new formulations in the pharmaceutical industry. Relying on the special virtual welding technology which enables instant dissolution of antibiotic drug powder in menstruum in a closed system, the Solid-liquid Double Chamber Bag products used in clinical application can avoid secondary pollution that may exist in the conventional dispensing process, facilitates the operations of medical staff, and shortens the dispensing process and time, thus guaranteeing the medication safety of patients in a more effective way. The Group's approved Solid-liquid Double Chamber Bags are exclusive formulations for cephalosporin products. Riding on the formulation advantages, it is expected that Solid-liquid Double Chamber Bag will substitute for certain existing products and has a good market prospect. Therefore, the Group expects that the Drug together with the Series Drugs can gradually change the existing antibiotic drug market pattern. Beijing Ruiye possesses a number of patents for the production technologies of Solid-liquid Double Chamber Bag, and a number of other types of cephalosporin Solid-liquid Double Chamber Bag are currently being reviewed for approval. It is expected that the Group will have a comprehensive product portfolio of cephalosporin Solid-liquid Double Chamber Bag varieties after obtaining the approvals. In addition, the Group is preparing to build a manufacturing plant and is expected to continue to increase its investment to expand the production capacity of Solid-liquid Double Chamber Bag products. Therefore, riding on the all-round advantages in terms of technology, variety and production capacity, it is expected that the Group will enjoy a first-mover advantage in the market of cephalosporin Solid-liquid Double Chamber Bag varieties and seize the initiative in respect of market access. Cefuroxime is a second-generationbroad-spectrumsemi-synthetic cephalosporin antibiotic that is mainly applied for infections caused by sensitive bacteria, including acute and chronic bronchitis, pneumonia, lung abscess, urinary tract infection, eye, nose and throat infection, bone and joint infection, gynecological infection, meningitis, sepsis and penicillin-resistant gonorrhea. According to MENET database, the sales of cefuroxime in 2017 was RMB4.63 billion in China, ranking second among all cephalosporin antibiotics, among which the sales of injectable cefuroxime was RMB3.77 billion, representing 6.63% of the sales of injectable cephalosporin antibiotics. The approval of the Drug will further enrich the Group's product line in the area of anti- infective drugs, as well as firmly establish the Group's leading position in the area of Solid- liquid Double Chamber Bag. The Group expects that the Drug will form synergistic effects with the Group's other approved Series Drugs, thus contributing to Sihuan Pharmaceutical's development in the therapeutic antibiotic intravenous solution market. Relying on the advantage in respect of production capacity, the Group is expected to gradually become a leading company in the therapeutic Solid-liquid Double Chamber Bag industry in China. - 2 - This announcement is made by the Group on a voluntary basis with the purpose of allowing the investing public to 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. Dr. Che Fengsheng Chairman and Executive Director Hong Kong, 19 June 2019 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. - 3 -
View stock analysis, news, and events for Sihuan Pharmaceutical Holdings Group Ltd.
More from Sihuan Pharmaceutical Holdings Group Ltd.
Sihuan Pharmaceutical : VOLUNTARY ANNOUNCEMENT - INSULIN ASPART 30 INJECTION DEVELOPED BY SIHUAN PHARMACEUTICAL ACHIEVED EQUIVALENT CLINI...
July 30, 2021
Sihuan Pharmaceutical : VOLUNTARY ANNOUNCEMENT-ENTERING INTO STRATEGIC COOPERATION AGREEMENT BETWEEN JILIN HUISHENG BIOPHARMACEUTICAL AND...
April 28, 2021