Xuanzhu Biopharm, a subsidiary of Sihuan Pharmaceutical, Its Innovative Drug Anaprozole Sodium Enteric-coated Tablets Obtains Drug Registration Approval From NMPA

HONG KONG, June 27, 2023 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd together with its subsidiaries, is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu Biopharm"), a non-wholly owned subsidiary of Company, has received a drug registration approval from the National Medical Products Administration (the "NMPA") of China of Anaprozole Sodium Enteric-coated Tablet for the treatment of duodenal ulcer. It is the first drug approved for marketing by Xuanzhu Biopharm, which marks a new milestone for Xuanzhu Biopharm from R&D to commercialization.

Anaprozole Sodium Enteric-coated Tablet is currently the first and only proton pump inhibitor (PPI) fully independently developed in China. Its Phase I-III clinical studies are all based on the Chinese population, so it is more suitable for Chinese patients. Anaprozole tablets can effectively inhibit the secretion of gastric acid and has the characteristics of fast onset, stable therapeutic effect, less individual variation, and long half-life. Clinical data shows that Anaprozole is metabolized through multiple CYP enzymes and non-enzymes, so the risk of drug to drug interactions is low when it is used in combination with other drugs. The drug and its metabolites are excreted through the gut and kidney, which provides safer medication options for patients with renal insufficiency.

In addition, Anaprozole Sodium Enteric-coated Tablet is not only used to treat duodenal ulcer, but also is expanding its new indication for the treatment of adult reflux esophagitis (RE). Its Phase II clinical trial has completed the enrollment of subjects, and its Phase III clinical trial is planned to initiate by the end of 2023.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, "We are an innovative pharmaceutical company with roots in China and a global perspective. Our group is committed to the continuous research and development, production and commercialization of class 1 drugs with core proprietary intellectual property rights to address unmet clinical medical needs. PPI is the preferred drug choice for the treatment of peptic ulcer. The approval of Xuanzhu Biopharm's Anerazole Sodium Enteric-Coated Tablets will bring more treatment options for patients. It is also a shot in the arm for injecting billions of dollars into the acid suppressant market. According to statistics, the number of patients with peptic ulcer in China reached over 70 million in 2021, and the total market sales size of proton pump inhibitors in China is nearly RMB30 billion, of which the oral proton pump inhibitor market is nearly RMB13 billion, which reflects that the market is relatively large. Meanwhile, based on their excellent clinical performance, Anaprozole Sodium Enteric-coated Tablet will be gladly accepted by doctors and patients and will have huge commercial potential and clinical value in the future."

About Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical Holdings Group Ltd. is an international medical aesthetic and biopharmaceutical company led and driven by innovation, with a leading independent production, and R&D technology platform, a rich global product pipeline and a mature and excellent sales system. Focusing on high-growth therapeutic areas such as medical aesthetics, oncology, metabolism, diabetes, cardiovascular and cerebrovascular, modern Chinese medicine and industrial hemp, it adheres to its overall strategic objective of "Adhering to the full-speed promotion of a two-wheeled strategy of Sihuan medical aesthetics and biopharmaceuticals" to build a leading medical aesthetics and biopharmaceutical company in China.

About Xuanzhu Biopharmaceutical Co., Ltd.
Xuanzhu Biopharmaceutical is the innovative drug subsidiary of Sihuan Pharmaceutical. It is an innovative pharmaceutical company with roots in China and a global perspective, focusing on major diseases such as digestion, oncology and non-alcoholic steatohepatitis, and is committed to the continuous research and development, production and commercialization of class 1 drugs with core proprietary intellectual property rights to address unmet clinical medical needs. The company has a team with extensive experience in the development and industrialisation of innovative drugs. Having been involved in the research of digestion, oncology and non-alcoholic steatohepatitis for many years, the company has a deep understanding and international vision of the development of new drugs in related fields and their future development direction. The company has two R&D platforms: small molecule chemistry and large molecule biologics. The dual engines drive the company's innovation and development, forming a product pipeline that covers small molecule, monoclonal antibodies, bispecific antibodies, antibody-drug conjugate (ADC) and other types of products. The company adheres to the strategic concept of "innovation driven, promoting the development of new drugs in China and serving human health", and the values of "open innovation, courageous commitment, overcoming difficulties and scientific rigor". With a focus on unmet clinical needs, the company continues to develop new class 1 drugs with international competitiveness, and is committed to developing into a first-class innovative pharmaceutical company with independent research and development, production, and sales capabilities.

For more information about Sihuan Pharm, please visit the company website https://www.sihuanpharm.com/
For further information, please contact: ir@sihuanpharm.com

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