Navigation Links
Sihuan Pharmaceutical Secures SFDA Approval for Anaprazole Sodium Category 1.1 New Drug Clinical Studies

HONG KONG, July 17, 2013 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) ("Sihuan Pharmaceutical" or the "Company"), a leading pharmaceutical company with the largest cardio-cerebral vascular ("CCV") drug franchise in China's prescription market, today announced that Anaprazole Sodium, a Category 1.1 new drug received the Approval for Clinical Studies from the State Food and Drug Administration ("SFDA") of the People's Republic of China. Anaprazole Sodium is the fifth Category 1 innovative drug in respect of which the Company has received approval for Clinical Studies, applications for patents have been made in China, the United States, Japan and Europe. 

Anaprazole Sodium is a new generation of proton pump inhibitors ("PPIs") which treats ulcers quickly and efficiently by inhibiting gastric acid secretion and eradicating Helicobacter pylori. Preclinical studies have shown that the new drug covalently binds to proton pump, thus providing substantially stronger and longer inhibitory effects when compared to other PPI drugs, traditional H2-receptor antagonists and antacids currently available in the market. Therefore, it can effectively treat various gastric acid diseases.

According to MENET figures, PPIs, with a sales of RMB21.9 billion as at the end of 2012, is the best-selling drug category for treating gastrointestinal ulcers. By inhibiting H+-K+exchange conducted by the proton pump located on the membrane of parietal cell lining stomach wall, PPIs blocks the last step in the synthesis of gastric acid and inhibits the secretion of gastric acid.

Preclinical data showed that Anaprazole Sodium is safer and possess the properties of rapid onset, stronger and longer duration of acid inhibition. Its metabolism is achieved through various enzymes, with minimal or no drug-drug interactions as well as less side-effects on gastrointestinal, cardiovascular and respiratory systems than drugs currently available in the market. In addition, its single isomer regiment provides additional quality and predictability. The above advantages will provide a favourable market potential for Anaprazole Sodium. 

Gastrointestinal ulcers and gastric motility disorders are common in China and have a significant patient base. With the fast-paced living environment, accelerated urbanisation and the persistently high stress level in China, the incidence rates of such diseases have been increasing each year. The overall incidences of digestive disease afflict 10%-20% of the total population, and the recurrence rate of gastrointestinal ulcers is above 75%. According to MENET figures, the size of the market has exceeded RMB$27.0 billion as at the end of 2012. This brings promising market potential and prospects.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Further to getting clinical trial approval for Benapenem and Imigliptin Hydrochloride, the Company has once again succeeded in having clinical approval for Anaprazole Sodium, another innovative drug, demonstrating the continuous enhancement of its R&D capabilities. Anaprazole Sodium will offer physicians and patients better treatment options after its launch, and will vigorously drive the development of the Company in the field of digestive system. This follows the launch of Roxatidine, an exclusive first-to-market generic drug this year. This will further consolidate the diversified product lines of the Company and drive its sustainable growth. Looking into the future, we will continue to bring our strong research and development capabilities into full play by developing more innovative drugs, so as to further inject new momentum into the Company's development. "

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical Holdings Group Ltd. is a leading pharmaceutical company and the largest cardio-cerebral vascular drug franchise in China's prescription drug market by market share. The success of the Company can be attributed to its differentiated and proven sales and marketing model, diversified portfolio of market leading drugs, extensive nationwide distribution network, and strong research and development capabilities. Sihuan Pharmaceutical major products such as Kelinao, Anjieli, Chuanqing, Qu'Ao, GM1 and Oudimei are widely used in the treatment of various cardio-cerebral vascular diseases.

SOURCE Sihuan Pharmaceutical Holdings Group Ltd.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sihuan Pharmaceutical Announces 2012 Annual Results
2. State Food and Drug Administration Grants Approval to Sihuan Pharmaceutical for Clinical Trial of Innovative Drug -- Pinoxacin Hydrochloride
3. Sihuan Pharmaceutical Collaborates with NeuroVive to Develop Two Innovative Cardio-cerebral Vascular Products in China
4. Sihuans First-to-market Generic Drug Roxatidine Receives New Drug Certificate and Approval for Production
5. Sihuan Pharmaceutical Announces 2012 Interim Results
6. Sihuans First-to-market Generic Drug Roxatidine Passes On-site Inspection for Drug Registration Conducted by the Chinese State Food and Drug Administration
7. Cree, Intuitive Surgical, Alexion Pharmaceuticals, Roche and Onyx Pharmaceuticals highlighted as Zacks Bull and Bear of the Day
8. Abuse-Deterrent Formulations of Purdues OxyContin and Endo Pharmaceuticals Opana ER Have Not Increased PCPs Comfort When Prescribing These Products for Chronic Pain
9. Valeant Pharmaceuticals To Announce 2013 Second Quarter Results On August 7, 2013
10. GW Pharmaceuticals to Report Q3 2013 Results and Host Conference Call on 5 August, 2013
11. RXi Pharmaceuticals Announces Positive Data in Second Phase 1 Multi-Dose Study
Post Your Comments:
(Date:11/25/2015)... 2015 Research and Markets ( ) ... - Global Forecast to 2020" report to their ... for 37.21% of the total market share in 2014. ... region is projected to growth at the highest CAGR ... primarily to the fast growing water, industrial gas treatment, ...
(Date:11/24/2015)... 25, 2015 WuXi PharmaTech (Cayman) Inc. ("WuXi" ... open-access R&D capability and technology platform company serving the ... China and the ... extraordinary general meeting of shareholders held today, the Company,s ... and approve the previously announced agreement and plan of ...
(Date:11/24/2015)... N.C. , Nov. 24, 2015  In the ... projects in an effort to quickly uncover new insights, ... --> --> However, ... a market research project and ensure that all rules ... and industry standards. Another major barrier to efficiently launching ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... , ... Beddit® has launched a new Android app for use ... a more intuitive SleepScore™ that rates sleep quality on a 100-point scale and makes ... by a proprietary algorithm. Beddit analyzes the data to provide an easy to understand ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... provide scholarships for people struggling with eating disorders as a result of the ... second annual event, held at Fox Run Golf Club in Eureka, will help ...
(Date:11/25/2015)... ... 2015 , ... Many people know of the common symptoms of low thyroid ... skin. But many people who find their cholesterol levels and weight are creeping up ... especially if they don’t have any of the other symptoms. , Thyroid hormone plays ...
(Date:11/24/2015)... ... 2015 , ... Genesis Chiropractic Software helps practice owners automate ... between the practice owner and the patient that automatically manages all five aspects ... Click here to learn more. , According to Dr. Brian ...
(Date:11/24/2015)... Dallas, Texas (PRWEB) , ... November 24, 2015 , ... ... of all charitable donations are made in the last five weeks of the year ... #GivingTuesday was created in 2012 to connect the nation’s charities with those individuals who ...
Breaking Medicine News(10 mins):