Tillotts and Menarini Receive Regulatory Approval for Asacol® 400 and 800 mg Tablets in the People's Republic of China
RHEINFELDEN, Switzerland, June 4th, 2020 – Tillotts Pharma AG ("Tillotts"), part of the Japanese Zeria Group, and A. Menarini International Trading (Wuhan) Co. Ltd. ("Menarini"), a member of the Italian A. Menarini Group, are pleased to announce the regulatory approval for Asacol® 400 and 800 mg tablets in the People’s Republic of China (“China”).
After announcing the successful partnership of Tillotts and Menarini in October 2019, the regulatory approval was the next important milestone for both parties in order to work towards a successful launch of Asacol® 800 mg. The approval process for Asacol® 400 and 800 mg began a number of years ago with the initial submission of the regulatory dossiers and the conduct of two Phase III studies in the local population.
Mattias Norrman, Chief Operations Officer at Tillotts, says, "We are very pleased to finally have received the approval of our Asacol® 400 and 800 mg tablets in China. It has been a long way coming, where we have faced a number of challenges throughout the assessment. Therefore, I am extremely proud of the team behind this achievement for their hard work and continued dedication during the past years. We are now looking forward to working towards the final launch and making the Asacol® tablets available to the Chinese IBD patients. It is always a great satisfaction to ensure that IBD patients around the world receive first -line treatment opportunities."
Adds Mr. Dong Minsheng, General Manager of Menarini China, "We thank the National Medic al Products Administration (NMPA) for their approval of Asacol® and availability for patient access in the Chinese market. According to statistics from the Chinese Center for Disease Control and Prevention, it is estimated that by 2025, the number of patients with IBD in China will reach 1.5 million1. We believe that the commercial launch of Asacol® will bring new treatment options to clinicians and enable IBD patients in China to return to living a normal life. Upholding Menarini's brand promise of 'Invigorating Lives,' Menarini will continue to focus on the development of cutting-edge drugs and improve drug access in China to contribute to 'Healthy China 2030.'"
For more information, please contact:
Julie Delin Fosdal
Senior Manager Corporate Communications
Phone: +41 61 935 2761
Email: Julie Fosdal@tillotts.com
Menarini Asia Pacific
Regional Senior Manager, Branding and Communications
Phone: +65 64943427
Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with over 300 employees in Switzerland and abroad. Tillotts is dedicated to the development, in/out-licensing and commercialisation of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products for the treatment of IBD as well as in-licensed products, in around 65 countries through its affiliates within Europe and a network of gastroenterology-focused partners throughout the world.
All trademarks used or mentioned here are protected by law. The rights to Asacol®, including the rights to the trademark, are owned by Tillotts in various countries except for the following: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands and Luxembourg.
Copyright © 2020 Tillotts Pharma AG. All rights reserved.
For more information, please visit www.tillotts.com.
Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focuses on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internat ionally through a number of subsidiaries. For more information about Zeria, please visit www.zeria.co.jp.
About Menarini China
Menarini China group of companies is a member of the Menarini Group, the world’s largest Italian biopharmaceutical company with a heritage of over 130 years and over 17,000 employees in more than 136 countries. Menarini China operates across the entire commercial value chain, from clinical development, regulatory approval and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Consumer Health, Dermatology, Allergy/Respiratory, Cardiovascular, Oncology/Spec ialty Care and Men’s Health.
For more info about Menarini, please visit www.menariniapac.com.
1Kaplan, Gilaad. (2015). The global burden of IBD: From 2015 to 2025. Nature reviews. Gastroenterology & hepatology. 12. 10.1038/nrgastro.2015.150.