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Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration

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NANJING, China, Sept. 5, 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 the “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.

 

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SINEXCEL and FastCharge.me Forge Partnership for EV Charging Solutions

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September 14, 2024

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ANAHEIM, Calif., Sept. 14, 2024 /PRNewswire/ — SINEXCEL, a well-established global supplier of energy storage and EV charging solutions, has signed a strategic partnership with FastCharge.me Inc. (“FCME”) at RE+ 2024. This collaboration aims to expand the deployment of innovative EV charging solutions to the growing EV market in America.

Under the agreement, SINEXCEL will supply a range of EV charging products and solutions to FCME upon request, enhancing FCME’s charging infrastructure and expanding its network across America.

“We chose to partner with SINEXCEL for their EV charging solutions because of their strong, nearly 20-year, foundation in power electronics and their deep expertise in the EV charging and Energy Storage sectors,” said Moshe Becker, CEO and Co-Founder of FCME. “We have full confidence in their robust and enduring technologies, capabilities and capacities in the global EV charging market. We are excited about the high performance and reliability of charging experiences these charging solutions will offer to our customers, and we look forward to introducing more innovative solutions through this collaboration.”

Derek Leng, General Manager of SINEXCEL North America, added, “We are thrilled to partner with FCME and all the related parties. FCME has a very in-depth market understanding and insights, strong technical capabilities and visionary foresight. This collaboration aligns perfectly with our goals and visions of bringing exceptional EV charging solutions and customer experiences to the North American EV charging market.”

This partnership marks a significant step forward in the mission to advance EV infrastructure, ensuring that SINEXCEL and FCME are at the forefront of delivering superior charging solutions that meet the evolving needs of American customers and end-users.

Since 2007, SINEXCEL has been dedicated to power electronics, Energy Storage and EV charging solutions. Expanding its reach to over 60 countries, SINEXCEL invests over 10% of its revenue into R&D, driving innovation and the development of reliable, high-quality products and solutions. As a trusted partner of global EV charging market leaders like Shell and BP, SINEXCEL is set to make a significant impact in the U.S. market through its collaboration with FCME and other business partners, paving the way for a more sustainable and greener future.

Contact:
FastCharge.me
Stephanie McGreevy, COO
stephanie@fastcharge.me

SINEXCEL 
Melody Yu, Marketing Manager
hongxia_yu@sinexcel.com 

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2024 China-MENA Intelligent Transportation Development and Cooperation Conference (Dubai) Will Be Held Soon

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September 14, 2024

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DUBAI, UAE, Sept. 14, 2024 /PRNewswire/ — The year 2024 marks the 40th anniversary of the establishment of diplomatic relations between China and Arab states. It is an important node for China-Arab relations to continue with the past and open up the future. In order to continuously strengthen the alignment of the development strategies of the transportation industry between China and the MENA region, and promote innovative cooperation in science, technology, finance and industries in the field of intelligent transportation, China Intelligent Transportation Association (ITS China), as the only national level social organization representing Chinas intelligent transportation industry and facing the world, will organize and hold the 2024 China-MENA Intelligent Transportation Development and Cooperation Conference (hereinafter referred to as the “Conference”) in Dubai on 18th September 2024.

With the theme of “Sharing and Matchmaking”, the Conference will set up sessions such as keynote speeches, cooperation and exchanges, matchmaking negotiations and technical product display around the three major building blocks including urban intelligent transportation construction, intelligent networked new energy vehicles, smart logistics and public travel, so as to provide participants with market development consultation and resource matchmaking services and the opportunities for in-depth exchanges and matchmaking with relevant institutions in the MENA region, and promote practical project cooperation and implementation.

The Conference has received strong support from relevant departments of China, United Arab Emirates, Oman, Saudi Arabia, Iran and other countries. More than 1,000 representatives from enterprises and institutions such as Shenzhen Urban Transport Planning Center Co., Ltd. ( SUTPC) , Sunland Technology Co. Ltd., CATARC, Zhong’anlianke Technology and Beijing ICE TECH will be invited to actively participate in the Conference.

As the only nationwide non-profit social organization specializing in intelligent transportation in China, ITS China is committed to establishing communication channels in the field of intelligent transportation at home and abroad, and promoting the exchange of technologies and industries in the field of intelligent transportation. The 2024 China-MENA Intelligent Transportation Development and Cooperation Conference will certainly build a professional platform for dialogue and cooperation among relevant institutions in the transportation industry of China and MENA. The Conference will become an annual grand event for precise matchmaking of scientific and technological innovation needs and sharing of successful experiences. We will share the scientific and technological innovation achievements of intelligent transportation with relevant institutions of the countries along Belt and Road Initiative (BRI) routes to jointly promote the rapid development of intelligent transportation and create a better future for transportation!

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Global AI Summit Calls for Global Action to Guarantee AI Innovation is for the “Good of Humanity”

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September 14, 2024

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RIYADH, Saudi Arabia, Sept. 14, 2024 /PRNewswire/ — The Global AI Summit (GAIN) in Riyadh concluded on a high, after the summit welcomed more than 30,000 delegates from across the globe over three days. The live stream of the summit, organized by the Saudi Data and AI Authority (SDAIA), received 3.7m views.

Building on the success of previous editions, GAIN 2024 featured more than 450 speakers from 100 countries, participating in 150 sessions. It also witnessed over 25 launches and announcements, and facilitated the signing of over 80 agreements and Memoranda of Understanding (MoUs).

The summit has grown exponentially since its inception in 2020. Its growing prominence reflects the Kingdom of Saudi Arabia’s role in advancing AI capabilities as it positions itself as a global leader in this space.

The key output from the summit was the need for governments and policy makers to take global action to ensure that AI technology evolves for the good of humanity. Central to responsible evolution is an ethical framework and robust governance.

To support the advancement of AI ethics and governance, SDAIA announced the Riyadh Charter of Artificial Intelligence for the Islamic World in collaboration with the Islamic World Educational, Scientific, and Cultural Organization (ICESCO). This promotes ethical AI grounded in Islamic values and principles, as well as sustainable development through international cooperation.

SDAIA has played a pivotal role in forging key collaborations to strengthen local and regional AI solutions, signing MoUs with Microsoft Arabia to develop Arabic language models, IBM for a Center of Excellence in Generative AI technologies, and NVIDIA to scale AI infrastructure across the Kingdom.

The summit also marked several major milestones. Alongside the unveiling of ALLaM, the world’s most advanced Arabic Language Model, other diverse initiatives such as the Global AI Community, the THAKAI Platform, and guidelines for addressing deepfake technology.

Furthermore, the launch of the Generative AI Center of Excellence by the Digital Cooperation Organization (DCO), the agreement to open an International Center for AI Research and Ethics (ICAIRE) as a UNESCO Category 2 Center, further underscored the impact of GAIN 2024.

The summit itself provided the platform for companies from all over the world to showcase the latest AI technologies and innovations, including AI generated avatars, AI generated artwork, and even Robotic bar staff serving beverages.

The summit closed with an inspirational speech from the Director of Saudi Arabia’s National Information Center, His Excellency Dr. Esam Alwagait, in which he thanked participants:

“Your candid perspectives have not only inspired us with the vision of what lies ahead, but have also grounded us in the realities we must face. Together, we have not only imagined the future of AI, but have also made it real by addressing the challenges and identifying the enablers needed to truly unlock its potential.”

He added:

“It has been incredibly inspiring to see the world come together here in Riyadh, united by momentum to make AI work for everyone. The commitment to collaborative action has been evident throughout the summit.” 

The success of GAIN 2024 ensures that the Kingdom’s AI infrastructure will be significantly strengthened and has cemented Saudi Arabia position at the center of global AI.

Media@GlobalAISummit.org

Photo – https://mma.prnewswire.com/media/2505796/SDAIA.jpg

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SOURCE The Saudi Data & Artificial Intelligence Authority (SDAIA)

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