NANJING, China, Sept. 14, 2024 /PRNewswire/ -- On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). Sanbexin sublingual tablets is the first innovative drug in the world to be designated with the Breakthrough Therapy by the FDA for the treatment of stroke.
The Breakthrough Therapy designation stems from the provisions of 《Food and Drug Administration Safety and Innovation Act》. It is designed to expedite the development and regulatory review of drugs for treating serious diseases and addressing significant unmet medical needs. The designation will be beneficial for the drugs to obtain the FDA's guidance in the clinical development, accelerate the overseas clinical development process, and is also expected to significantly shorten the time for marketing review through the priority review designation.
The Breakthrough Therapy designation is based on the significant improvement in efficacy metrics demonstrated by the sublingual tablets in a previous clinical study. The data from a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study in China for the treatment of AIS demonstrated that Sanbexin sublingual tablets significantly improved neurological recovery and independent living ability in patients with AIS compared to placebo, meeting the expected efficacy endpoints with a favorable safety profile. JAMA Neurology published the study's key findings online.
The designation will be beneficial for Simcere to obtain the FDA's guidance in the clinical development of Sanbexin sublingual tablets, accelerate the overseas clinical development process, and is also expected to significantly shorten the time for marketing review through the priority review designation.
According to a recent article in The Lancet, stroke is the second leading cause of death and disability worldwide, with 12 million new cases and 6.6 million deaths each year. Among them, acute ischemic stroke is the most common type of stroke, accounting for about 70% of all strokes, and constituting a heavy disease burden for all countries around the world. The efficacy of acute ischemic stroke treatment is highly time-dependent. Receiving treatment as early as possible will help patients to improve their disease outcome and avoid disability.
Sanbexin sublingual tablets is a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell injury or impairment caused by AIS. Such unique sublingual formulation can quickly disintegrate once in contact with the saliva once place under the tongue and can be absorbed into the blood through the sublingual venous plexus, which is expected to increase the flexibility of stroke treatment. Sequential therapy consisting of the marketed Sanbexin concentrated solution for Injection. These two formulae enable patients to receive a complete course of treatment in and outside of the hospital.
On June 28, 2023, the new drug application (NDA) for Sanbexin sublingual tablets in China is accepted by the National Medical Products Administration. The first indication is for the improvement of neurological symptoms, daily activities, and functional impairment due to AIS. Phase I clinical trials for Sanbexin sublingual tablets on healthy volunteers have been completed in the United States.
CONTACT: Haoyun Huang, huanghaoyun@simcere.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration
XIAMEN, China, Oct. 4, 2024 /PRNewswire/ -- On September 30th, the 13th Gulangyu Piano Art Week commenced with great fanfare on the enchanting island of Gulangyu in Xiamen. It captivated global musical elites and piano enthusiasts alike, once again showcased the island's enduring allure and brilliance as the "Island of Pianos" and the "Island of Music."
Under the stars and moonlight, with piano melodies resonating throughout, the festival's opening night on September 30th was highlighted by a performance from Dang Thai Son, a Vietnamese-Canadian pianist and Gulangyu resident artist hailed as "Asia's first Chopin." He performed solo piano pieces including Adagio, BWV 564 and Images, Book I, followed by collaborative performances with his student Wang Zitong and the Fuzhou Strait Symphony Orchestra, delivering timeless concertos such as Concerto for Two Pianos, K.365 and Piano Concerto No. 2 in F minor, Op. 21. The opening concert set the tone for the week-long festivities with a flourish of extraordinary music. Each note played on the black-and-white keys pulsed with Gulangyu's unique rhythm and emotions, while Dang Thai Son's masterful artistry led the audience through a captivating musical journey, earning enthusiastic applause and acclaim. Additionally, French national honoree and fellow Gulangyu resident artist Michel Dalberto hosted a masterclass, sharing his insights with the public, further strengthening Gulangyu's bridge to the world of music and uniting music lovers across the globe.
As a key highlight of this year's Gulangyu Piano Art Week, the premium concerts not only feature Gulangyu resident artists Dang Thai Son and Michel Dalberto, but also welcome distinguished guests including Sofia Gulyak, the first female pianist to win First Prize and the Princess Mary Gold Medal in the history of the Leeds International Piano Competition, Andrei Pisarev, Russian Honored Artist and head of the piano department at Moscow Tchaikovsky Conservatory, Lin Shuobin, organ instructor at the Chinese University of Hong Kong and organ education series tutor at the Hong Kong Cultural Centre, and Caroline Robinson, organist and assistant choral conductor at Atlanta's Cathedral of St. Philip. These top-tier artists delivered exceptional performances that align with international standards, creating a world-class musical feast. In addition, seven high-level academic activities, combining experience and knowledge-sharing, invited music lovers and professionals from various fields to engage in the artistic journey together.
Moreover, diverse music events such as courtyard concerts, beach concerts, and piano classes offered citizens and visitors a glimpse into the boundless possibilities of music, enriching the cultural lives of the public. Throughout the event, publicly accessible pianos across the island, starlit markets, art film screenings, and interactive art installations were open to all, encouraging the public to explore Gulangyu on foot and experience the pure essence and power of music, fostering a deeper passion for music and contributing to the transmission and development of musical culture. On October 1st, all the pianos on the island played 《My Motherland and Me》 to celebrate the 75th anniversary of the founding of the People's Republic of China, with beautiful melodies commemorating this significant occasion.
The Gulangyu Piano Art Week, one of the most important piano art brands in China and the broader Asian region, continues to serve as a prestigious public music event, enhancing Gulangyu's reputation as a cultural hub. The music culture of Gulangyu blends the elegance of grand concert halls with the vibrancy of community life. From intimate family concerts to lively street performances, music has become an integral part of island life, attracting music enthusiasts and professionals from all over the world. This, in turn, injects a steady stream of vitality into the island and contributes to Xiamen's reputation as a "Cultural Center, City of Arts, and Island of Music."
As the 13th Gulangyu Piano Art Week sets sail, the World Cultural Heritage site of Gulangyu once again shines with a dazzling musical celebration, leveraging its unique cultural charm and deep musical heritage to contribute to the protection and preservation of world heritage, while opening a new chapter in global music culture. With the theme "Romantic World Heritage, Enjoy the Piano Island: OUR ISLAND, OUR PIANO," this year's piano art week is jointly organized by the Xiamen Municipal People's Government, the Fujian Provincial Department of Culture and Tourism, and the Fujian Federation of Literary and Art Circles. The event is hosted by the Xiamen Gulangyu-Wanshishan Scenic Area Management Committee, the Xiamen Municipal Bureau of Culture and Tourism, the Xiamen Federation of Literary and Art Circles, the Siming District People's Government, and Xiamen Media Group. The event was running from September 30 to October 6 and featured over 50 exciting events under eight key themes.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
The 13th Gulangyu Piano Art Week Grandly Opens
