Sihuan Pharm's Innovative Digestive System Drug Anaprazole Sodium Achieved Early Completion of Patient Recruitment for Phase II Clinical Trial in China

HONG KONG, April 25, 2019 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), the largest cardio-cerebral vascular drug manufacturer in China's prescription drug market, announced the early completion of patient recruitment for Phase II clinical trial in China for Anaprazole Sodium, a patented innovative digestive system drug researched and developed by the Group. The new drug is a Class 1 innovative drug researched and developed by the Group.

Anaprazole is a new generation of proton pump inhibitor ("PPI"), being the only PPI researched and developed in China, and has both China and international patents. The new drug is going through a multi-centered, randomized, double-blinded, double-simulation, positive drug parallel controlled Phase II clinical trial study to assess its effectiveness and safety in therapeutic effects for duodenal ulcer, with a sample size of 150, mainly for the purpose of exploring the best dosage of the new drug. The Study is being conducted in nearly 20 clinical trial centers in China, and now has early completed patient recruitment. The new drug is expected to enter Phase III clinical trial within the current year.

Currently, the new drug has already completed a series of Phase I clinical studies in China. Existing clinical information shows that common adverse reactions (which are mainly gastrointestinal reactions) are similar to drugs of the same category, pharmacokinetics are basically consistent with the linear features, pharmacodynamics show a clear dosage/effect relationship, and its acid suppression effect is comparable to pharmacodynamics of similar drugs in the market.

Anaprazole's intended indications include peptic ulcer (PUD), gastroesophageal reflux disease (GERD), and helping PUD patients to eliminate Helicobacter pylori. The new drug is in the form of enteric-coated tablets with single isomer composition for clinical oral dosage through no-enzyme or multi-enzyme metabolic pathways, which mitigates the risk of drug-drug interactions.

According to MENET database, the market for peptic ulcer drugs in China is huge with continuous growth, the sales turnover in 2017 reached approximately RMB35.8 billion. Of which, PPI drugs had dominating market share, among the top 10 anti-ulcer drugs in terms of market share, six were PPI drugs. The sales of Rabeprazole, a drug similar to Anaprazole, recorded continuous growth since it was launched in the market, and was ranked No. 1 in terms of market share in 2017 among oral anti-ulcer drugs of public hospitals in China with sales of approximately RMB3.87 billion. It is expected that the new drug will have huge market potential if it can be launched successfully in the market in future.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Sihuan Pharmaceutical possesses a well-established and international innovative R&D platform, XuanZhu Pharma Co., Ltd. ("Xuanzhu Pharma"), attributable to our 10 years of continuous dedication of substantial resources and efforts. Recently announced breakthroughs of multiple projects including Anaprazole indicate that Sihuan Pharmaceutical's R&D efforts have begun to reap fruit. Sihuan Pharmaceutical is expanding its product portfolio in the area of digestive system products, of which Jie'ao (Roxatidine Acetate Hydrochloride for Injection), a digestive system product which has been launched in the market, is a new generation of histamine H2 receptor antagonist that has recorded good market performance. In addition, other generic drugs also form a part of the network in the area of digestive system. The clinical development of the new drug has been making smooth progress, laying a good foundation for the market network of multi-level product portfolio of the Group in the area of digestive system."

Dr. Che Fengsheng continued, "With the aim to 'strengthen R&D capabilities, optimize product resources and accelerate market expansion', Sihuan Pharmaceutical is entering the next stage of development, with view to create better and sustainable return for its shareholders."

Sihuan Pharmaceutical has been dedicating substantial resources and efforts in innovative drug R&D since as early as 2008. Sihuan Pharmaceutical now possesses a well-developed innovative drug R&D platform, with a strong product pipeline focusing on therapeutic areas with considerable unmet clinical demand, including oncology, diabetes, non-alcoholic liver diseases and diabetes. XuanZhu Pharma is the Group's small molecule innovative drug development center. It focuses on major disease areas with significant clinical needs, including diabetes, oncology, anti-infective and non-alcoholic hepatitis, with approximately 200 experienced personnel with over 10 years of experiences working in multinational pharmaceutical companies. The Group's Clinical Development Center is responsible for clinical procedures including project management, clinical testing, data  management, biostatistics, medical science, registration, quality assessment and quality control. In 2017, the Group's expenditure for R&D and relevant activities increased by 48.3% to RMB533.2 million, accounting for 18.3% of the revenue.

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