Edaravone

NANJING, China, Dec. 4, 2024 /PRNewswire/ -- On November 2, 2024, Simcere Pharmaceutical announced that Sanbexin® sublingual tablets (generic name: edaravone and dexborneol sublingual tablets), an innovative drug for stroke, has been approved for marketing by the National Medical Products Administration. This product is indicated for the improvement of neurological symptoms, daily activities, and functional impairment due to acute ischemic stroke. Continue Reading Packaging of Sanbexin® sublingual tablets Sanbexin® sublingual tablets is a dual-target brain cytoprotective agent composed of edaravone and dexborneol. These two active ingredients exert synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell damage caused by acute ischemic stroke. The sublingual tablets are designed for quick disintegration once in contact with saliva under the tongue. This facilitates the active ingredients' rapid absorption into the blood and brain through the sublingual venous plexus. Compared to conventional oral formulations, sublingual tablets bypass the first-pass hepatic metabolism, which is conducive to higher drug bioavailability and faster onset of action. Previously, Sanbexin® injection was approved for marketing in China in 2020. As the world's only innovative drug approved for stroke since 2015, it has helped over 3 million patients in the past 4 years. The phase III clinical trial led by Professor Fan Dongsheng of Peking University Third Hospital showed that the patients in the Sanbexin® sublingual tablets group after 14 consecutive days of drug administration, obtained a significantly higher proportion of functional independence outcome at 90 days post-treatment than those in the placebo group (64.4% vs. 54.7%,). The latest data was published in JAMA Neurology on February 19, 2024. Professor Fan Dongsheng, Principal Investigator of TASTE-SL and Professor at Peking University Third Hospital mentioned:"Sanbexin® sublingual tablets has shown significant effects and good safety in improving recovery of cerebral cells and independent living ability during the acute phase in patients with acute ischemic stroke. The more convenient administration allows for sequential therapy with Sanbexin® injection, facilitating stroke patients to receive a complete course of brain cytoprotection in and outside of the hospital during the acute phase of stroke." Professor Wang Yongjun, Director of Beijing Tiantan Hospital, Capital Medical University "The average length of hospital stay for stroke patients in China is about one week, while clinical studies suggest that brain cytoprotective drugs need to be used for 14 consecutive days. Sanbexin® sublingual tablets is easy to take, allowing patients to receive treatment at home. This can better reduce disability among patients and is also expected to lower medical costs." In August 2024, Sanbexin® sublingual tablets was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for AIS, making it the world's first innovative drug in the field of stroke treatment to have received such acknowledgment. Currently, a global multi-centered clinical trial of Sanbexin® sublingual tablets is under preparation. "The approval of Sanbexin® sublingual tablets in China is believed to significantly reduce the number of stroke-related disabilities in China." Professor Gregory W. Albers, Director of the Stroke Center and the Medical Center at Stanford University commented, " We are planning to conduct a large-scale Phase III clinical trial of Sanbexin® sublingual tablets in the United States, hoping to replicate the success of the trial in China and help reduce the global burden of stroke-related disabilities." Dr. Marc Fisher, former President of the World Stroke Organization and Professor at Harvard Medical School, commented on this new approval:"Sanbexin® has gradually gained popularity in China and is now available in a sublingual tablets formulation, with clinical data confirming its safety and efficacy. We are hoping to see trials of Sanbexin® sublingual tablets conducted outside China. If the trial results are positive and it receives approval in other countries, such as the U.S., it will have a huge impact globally on the treatment of acute ischemic stroke." The Sanbexin® sublingual tablets, with its convenient delivery method, will make stroke prevention and treatment more comprehensive and accessible. Its therapeutic area is expected to be expanded to pre-hospital emergency treatment for the acute phase of stroke, as well as to the treatment for the sub-acute and chronic phases of cerebrovascular diseases, to further promote the recovery of neurological functions and to improve the functional prognosis of stroke patients. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Dewpoint Therapeutics, a young biotechnology company, could receive nearly half a billion dollars if all goes to plan in a new partnership focused on its experimental medicine for ALS.Through a deal announced Wednesday, Dewpoint has given Mitsubishi Tanabe Pharma the exclusive right to license the medicine once it hits certain near-term research and development goals. Should Mitsubishi Tanabe choose to license the program, the Japan-based company would then be responsible for its clinical development and commercialization.In exchange, Dewpoint has received an undisclosed upfront sum of money and could take home more through milestone and tiered royalty payments. The total value of the deal could reach as high as $480 million.Mitsubishi Tanabe a distant corporate cousin of the car manufacturer already sells Radicava, one of the few drugs approved in the U.S. to treat amyotrophic lateral sclerosis. Radicava is available as an infusion or, since 2022, a mixture taken orally. Doctors have said the drug offers only modest effects and its administration, at least with the infused version, can be so cumbersome that patients often dont find it worthwhile.With limited treatment options, people with ALS currently live an average of two to five years after they are diagnosed. Roughly 90% of cases are classified as sporadic, meaning experts dont know the root cause.ALS remains a critical area of unmet medical needs and [Mitsubishi Tanabe] is committed to addressing it, said Masao Nawano, head of the companys research division, in a statement. Together with Dewpoint, we have the potential to deliver meaningful innovations to patients and families affected by this devastating condition.Launched in 2019, Dewpoint believes that mysterious clusters of molecules may be a path to new drugs for cancer, heart conditions and nerve-destroying disorders like ALS. Studies have suggested these clusters, known as biomolecular condensates, are important in cell regulation and may causes diseases if they malfunction.The idea has intrigued venture capitalists, giving rise to a few startups that debuted shortly after Dewpoint. Nereid Therapeutics launched in the middle of November 2020 with $50 million in funding from Apple Tree Partners. Two weeks later, Transition Bio unveiled itself and announced the closing of a seed funding round led by Lifeforce Capital.Faze Medicines also emerged in late 2020, backed by powerful investment firms like Third Rock Ventures and Alexandria Venture Investments as well as large pharmaceutical companies like Novartis, AbbVie and Eli Lilly. Yet less than two years later, Faze abruptly shut down. The companys science did not progress sufficiently to meet our bar for further investment, a Third Rock spokesperson said at the time.Dewpoint, meanwhile, has continued to draw in money since its launch. The company inked collaborations with Bayer, Merck & Co., Pfizer and Novo Nordisk that collectively could be worth well over $1 billion.Some of that money hasn't materialized, though. The company reportedly lost its alliances with Merck and Pfizer, and laid off staff earlier this year.Ameet Nathwani, Dewpoints CEO and a former Sanofi executive, said in a statement that Mitsubishi Tanabe is the ideal partner for the ALS program, given the companys knowledge of the disease and its global clinical capability and expansive patient network.Dewpoints drug is meant to treat ALS by breaking up abnormal accumulations of a protein called TDP-43. This protein is essential for processing RNA, and some scientists believe that when it stops functioning correctly, or when there isnt enough of it in the core of nerve cells, diseases like ALS can develop. '