Navigation Links
Sihuan Pharmaceutical Secures SFDA Approval for Anaprazole Sodium Category 1.1 New Drug Clinical Studies
Date:7/17/2013

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:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... 10, 2016  Rich Pharmaceuticals, Inc. (OTC Markets: RCHA) ... reverse split of its issued and outstanding shares of ... Thursday, February 11, 2016. The Company,s common stock will ... 76303T308 and temporary ticker symbol "RCHAD". After 20 trading ... ticker symbol (RCHA).  --> ...
(Date:2/10/2016)... 2016  Oxis International Inc. (OTC/QB: OXIS) announced today ... as a "clinical trial triumph" after one of the ... cancer remission. Daniel Vallera , a ... Center. --> Daniel Vallera , a ... Center. --> An article on the ...
(Date:2/10/2016)... Feb. 10, 2016  The ALS Association, in partnership with ... Challenge to generate a biomarker to track TDP43 aggregation. The ... to a $1 million investment. --> ... that affects nerve cells in the brain and the spinal ... and control muscle movement, which often leads to total paralysis ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... 10, 2016 , ... Early this week, Team Iconic at J. Walter Thompson ... as the first global confectionery brand sourced from 100% sustainable cocoa. , The Nestlé ... their product, through activities that focus on better farming, better lives and better cocoa. ...
(Date:2/10/2016)... ... ... As part of its ongoing series of aquatic therapy related webinars, HydroWorx ... dynamic expert and thoughtful presentation to give attendees a better sense of how to ... free to attend, but registration is required. , Rehabilitation of Offensive Lineman ...
(Date:2/10/2016)... ... February 10, 2016 , ... Emergency rooms provide emergency ... find. Unfortunately, this can leave patients with dental emergencies at risk of losing a ... offering emergency dental care. , Common dental emergencies include:, , ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... will bring together more than 200 of the country’s top healthcare executives to ... , “The true benefit of the Forum is the provider-centric perspective, experience, expertise ...
(Date:2/10/2016)... ... February 10, 2016 , ... AHRA: ... winner and inspirational speaker Jan Fox will serve as keynote speaker at the ... provide participants with tools to more effectively communicate with their own organizational staff ...
Breaking Medicine News(10 mins):