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China Medical System: Innovative Drug Methylthioninium Chloride Enteric-coated Sustained-release Tablets Approved for Marketing in China

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  • Innovative drug Methylthioninium Chloride Enteric-coated Sustained-release Tablets (Lumeblue®) is an oral diagnostic drug, approved by China’s NMPA for enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.
  • The results of the Phase III clinical trial in China show that the Product can significantly improve the detection rate of non-polypoid colorectal lesions (the primary endpoint of the study), leading to an improved detection rate of dangerous lesions such as non-polypoid adenomas (the secondary endpoint).
  • The Product can be taken during the bowel preparation step, ensuring that colorectal staining is completed by the time colonoscopy is conducted. This not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving the screening benefits.
  • As of now, CMS’s newly launched innovative portfolio has been expanded to 5 products, continuously generating driving force to the Group’s sustainable and healthy development.

 

SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or CMS) is pleased to announce that on 11 June 2024, the New Drug Application (NDA) of the Group’s innovative drug methylthioninium chloride enteric-coated sustained-release tablets (Lumeblue®) (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The drug registration certificate was obtained on 18 June 2024. The Product is indicated to enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, and it is the first oral methylthioninium chloride enteric-coated sustained-release tablets in China. The Group will synergize with existing gastroenterology products and resources to advance the commercialization and academic promotion related works of the Product in an orderly manner, aiming to achieve nationwide large-scale clinical application as soon as possible so as to benefit patients with colorectal disease.

 

Lumeblue® is an oral diagnostic drug that uses patented multi-matrix (MMX) technology to deliver active substances directly to the colon and release them locally in a controlled manner. As an enhancer dye, the Product increases the contrast between colorectal lesions and healthy mucosa. The results of the Phase III clinical trial in China show that the Product can significantly improve the detection rate of non-polypoid colorectal lesions(the primary endpoint of the study), leading to an improved detection rate of dangerous lesions such as non-polypoid adenomas (the secondary endpoint)[1]. In addition, the Product can be taken during the bowel preparation step, ensuring that colorectal staining is completed by the time colonoscopy is conducted. This not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving the screening benefits.

 

According to the diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association, approximately a total of 28 million gastroenteroscopies were completed nationwide in 2012, including 5.83 million colonoscopies. In 2019, approximately 38.73 million gastroenteroscopies were completed nationwide, an increase of 34.62% compared with 2012[2]. The Chinese consensus of early colorectal cancer screening recommends that people aged 50 to 75 years old should be screened for colorectal cancer regardless of whether they have alarm symptoms[3]. There are approximately 400 million people aged 50 to 75 in China in 2020[4]. With the popularity of early screening for colorectal cancer in China, it is expected to witness a considerable growth of the number of colonoscopies in China in the future.

 

The Product has been approved by the European Medicines Agency (EMA) to be commercialized in the European Union under the trade name Lumeblue™ in August 2020. The Group obtained an exclusive license for the Product from Cosmo Technologies Ltd, a fully owned subsidiary of Cosmo Pharmaceuticals NV, on 3 December 2020.

 

Driven by the twin-wheel of “Collaborative R&D and Independent R&D”, CMS has continuously deployed global first-in-class (FIC) and best-in-class (BIC) innovative products guided by patient and clinical demands. With enhancing R&D capabilities in developing differentiated innovative products, CMS has empowered the continuous transformation of scientific research outcomes into clinical application, continuously releasing the value of innovation. As of now, CMS’s newly launched innovative portfolio has been expanded to 5 products, continuously generating driving force to the Group’s sustainable and healthy development. Desidustat Tablets and Methotrexate Injection (rheumatoid arthritis), CMS’s innovative pipeline products, are currently under NDA review in China. Meanwhile, over 10 innovative pipeline products are undergoing clinical trials in China, mainly randomized controlled trials (RCT). CMS is expected to launch differentiated innovative products every year in the future with higher efficiency and more controllable costs, continuing to optimize its product portfolio and build fresh driving forces for the mid- to long-term development of the Company.

 

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

 

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

 

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

 

Reference:

  1. The results of the Phase III clinical trial in China was published and can be found at: https://web.cms.net.cn/en/2022/12/positive-results-for-china-phase-iii-clinical-trial-of-methylthioninium-chloride-enteric-coated-sustained-release-tablets/
  2. The diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association
  3. Chinese consensus of early colorectal cancer screening (2019, Shanghai)Chinese Journal of Internal MedicineDOI 10.3760/cma.j.issn.0578-1426.2019.10.004
  4. CHINA POPULATION CENSUS YEARBOOK 2020, can be found at https://www.stats.gov.cn/sj/pcsj/rkpc/7rp/zk/indexch.htm

 

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

 

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

 

Media Contact

Brand: China Medical System Holdings Ltd.

Contact: CMS Investor Relations

Email: ir@cms.net.cn

Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

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Press Release

Thunderball Results: Your Ultimate Destination for Real-Time Updates and Insights

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Thunderball is proud to announce itself as the ultimate online destination for thunder ball enthusiasts, offering the latest and most accurate results immediately after every draw. Whether you’re a regular follower or an occasional visitor. At thunderball results, we have a singular mission to ensure that Thunderball enthusiasts have easy access to the most recent and comprehensive results. It is designed with you in mind. We understand that the thrill of the game doesn’t just come from playing, it comes from waiting with bated breath for the results, and we make sure that wait is as short and stress-free as possible.

With the growing number of websites providing information on the internet, what sets us apart is our dedication to delivering accurate, timely, and accessible updates. We know how frustrating it can be to scour the web for reliable information or to miss out due to delays. That’s why our team works diligently to update results immediately, ensuring you have access to the latest information in real-time. 

Moreover, our platform offers more than just the most recent numbers. We provide a comprehensive archive of past Thunderball draws, allowing users to track patterns, revisit results, and strategize their future plays. 

What You Can Expect from us;

1. Timely Updates: One of the standout features of our platform is our commitment to offering timely updates immediately after each Thunderball draw. Our team stays on top of every draw, ensuring the winning numbers are posted on the site as soon as they are available. Say goodbye to long waits and misinformation—we deliver accurate results, fast.

2. Expert Analysis: We believe that informed players are better players. That’s why Thunderball results goes beyond the numbers to offer detailed analysis and valuable insights. Our expert team provides in-depth statistical breakdowns, offering users a chance to understand trends, hot numbers, and other factors that could impact future games.

A User-Friendly Experience

Our website has been designed with simplicity and efficiency at its core, so players of all levels can find what they need quickly and without hassle.  

We’ve also optimized the platform for mobile use, so whether you’re at home, commuting, or out with friends, you can check the latest results and never miss a moment of the action. As part of our commitment to accessibility, Thunderball Result is compatible with all devices, ensuring you can stay connected wherever you are.

About Thunderball 

Founded with the mission of creating an online hub for thunderball enthusiasts, Thunderball results has rapidly become the go-to destination for lottery players across the UK. We recognize that the key to a satisfying lottery experience is reliability, and our platform reflects that commitment through real-time updates, comprehensive data archives, and in-depth insights.

Our team is made up of passionate lottery fans and tech experts who understand the importance of providing quick and accurate information. Since launching, Thunderball Results has garnered a loyal following by consistently delivering results in a timely and efficient manner, making it a trusted resource for thousands of players every day.

At Thunderball Results, we’re more than just a results platform—we’re a community built around the excitement of the thunderball game. Whether you participate regularly or just enjoy checking the results, we invite you to join us to stay up to date with the latest thunderball draws and immerse yourself in a supportive and engaging community. For more information, visit https://thunderballresults.uk and follow us on social media for the latest news, updates, and winning numbers.

Contact details 

Company name: Thunderball Results 

Website link: https://thunderballresults.uk  

Contact email: info@thunderballresults.uk  

Country: United Kingdom 

City: London 

Contact person name: Thomas Ferguson

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Press Release

Champ, America’s Loch Ness Monster ‘spotted’ in drone footage from filmmakers

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Champ, is that you?

Since the 1600’s, tales of a mysterious sea serpent named Champ, named after explorer Samuel de Champlain, have been part of the folklore of the Lake Champlain region. The lake borders New York and Vermont. Champlain and the Abenaki tribe were the first sightings of Champ in the historical record.

Champ remained elusive. The only notable visual evidence was a photo taken in 1977 by Sandra Mansi.

Until now.  For the first time in history, a video that allegedly captures the legendary lake monster on film is being hailed as the “most notable visual evidence” of Champ. Some compare it’s impact to the Patterson-Gimlin film impact on the Bigfoot cryptozoology community.

Independent filmmakers Kelly Tabor and Richard Rossi were shooting a fictional film ‘Lucy and the Lake Monster’ about a 9-year-old girl and her grandfather looking for Champ, a legendary lake monster rumored to live and lurk in the murky waters of Lake Champlain.  The film is based on their bestselling book of the same title.

As part of their shoot, their cameraman sent a drone above the lake in Bulwagga Bay, and what they saw in post-production stunned them.

They posted ten seconds of what is now known as the Tabor-Rossi footage on YouTube and 36,000 views later, it has provoked discussion and debate about what appears to some to be a plesiosaur swimming below the lake’s surface, behind a boat containing the two lead actors in their film, Emma Pearson and Richard Rossi.  The footage of the plesiosaur can be seen here: https://www.youtube.com/watch?v=Dkpzfqlt3PI.

(Plesiosaurs are a sea creature from the dinosaur-dominated Mesozoic era.)

Tabor and Rossi’s recent interview on the Cryptid Creature podcast was posted on Spotify. The duo submitted their footage and story for assessment by the two hosts, Todd Stevens and Brian Brock.  Stevens eloquently summed up his conclusion, affirming the veracity of the footage.

“The creature is bigger than the boat, fifty yards behind the boat, Stevens said.  “It has a plesiosaur body. It is not sturgeon, or multiple sturgeon. It is one large body moving.” The entire Cryptid Creatures interview with Tabor and Rossi can be heard here: https://play.cdnstream1.com/s/streamkastplus/cryptid-creatures/the-lake-champlain-monst-5a5bbe

Tabor first spotted the creature in the footage, editing on her large screen T.V.  “It’s poetic that Kelly saw it first,” Rossi said. “She has been looking for Champ for over fifty years.” Tabor grew up in a cabin on Lake Champlain in Crown Point, New York.

“We inadvertently caught this on camera,” Tabor said. “We weren’t trying to.”

If Kelly Tabor is the true believer of the screenwriting team, her writing partner Richard Rossi is the Doubting Thomas, insisting on the footage being evaluated by scientists with a doctorate in science and to prepare a report for peer review in 2025.

“I’m the more skeptical one compared to Kelly,” Rossi said.  “But there’s definitely something there.”

The filmmaking crew was so busy filming the movie, they didn’t catch the anomaly in the footage until later, in the post-production editing stage.

Multiple versions of their footage are now on Pinterest and YouTube as cryptozoologists use their tech savvy to zoom in on the Champ image, and use coloring to do morphological enhancements and evaluations.  

The Tabor-Rossi Champ footage is incorporated into their fictional film, ‘Lucy and the Lake Monster,’ at about the four-minute mark of the film. The movie has screened in theaters in New York, New Jersey, Vermont, Pennsylvania, California, and South Carolina.  This month, it won 12 awards in film festivals.  It will be released on DVD and streaming next year.

“As filmmakers, our primary focus is on the art form itself.  We don’t respond too much to the debate around the footage,” Rossi said. “We try to focus on doing the best job we can in our screenwriting, acting, cinematography, and music.  It’s nice that Champ has blessed us with the benefits of headlines that let people know about our book and the film, but at the end of the day, our focus is on showing the film and writing the next sequel. Champ has been a great publicist.”

“Champ is also one of the biggest stars in our new film,” Tabor added.

Media Contact:

Reporter Christy Collins

richardrossilive@gmail.com

https://www.lucyandthelakemonster.com/ 

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Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

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Press Release

This December, Meet Barracuda Coin The Next Big Crypto

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Since its inception in February 2023, Barracuda Coin has been preparing for a highly anticipated launch, positioning itself as a prominent player in both the cryptocurrency and sports sectors. Backed by significant sponsorship deals with numerous sports events, Barracuda Coin is poised to make an impactful entrance into the crypto space, aligning itself with the competitive energy of professional sports.

Ethereum-Based Token with a Strong Focus on Sports

Barracuda Coin is built on the robust Ethereum blockchain, ensuring security and reliability for all transactions. With a total supply of 75,000,000 tokens, Barracuda Coin is already gaining traction through its involvement in MMA and K1 sports sponsorships and has established itself as a key sponsor for numerous professional sports events.

In tandem with the coin’s launch, Barracuda Coin will release a unique NFT collection featuring high-performing athletes, giving fans and collectors a unique opportunity to own exclusive digital assets tied to their favorite sports icons.

Staking Program for Early Investors

To reward early supporters, Barracuda Coin is launching an attractive staking program with two levels of rewards:

  • Investors who join during the reservation phase will receive 75% monthly interest for 6 months.
  • Those participating in the presale will enjoy a 30% monthly interest over the same period.

Important Dates and Pricing

  • Reservation Phase: Beginning on November 4, 2024, and running through November 28, 2024, the price per Barracuda Coin (BARR) during this period will be $0.019.
  • Presale Phase: After the reservation period ends, the presale will begin at $0.05 per token, gradually increasing up to $0.15.
  • Official Launch: Scheduled for December 23, 2024, with the token price projected to reach $0.36.

Barracuda Coin and Pay-Per-View Entertainment

Designed with the entertainment and sports industry in mind, Barracuda Coin is set to seamlessly integrate with the pay-per-view model, making it the ideal token for fans. With fast, secure, and transparent transactions, Barracuda Coin will allow users to easily access premium sports content and live events, bypassing the challenges of traditional currency exchanges.

About Barracuda Coin

Barracuda Coin is more than a cryptocurrency; it’s a platform connecting the worlds of sports, crypto, and digital assets. Focused on creating a space for sports enthusiasts, collectors, and investors alike, Barracuda Coin offers a comprehensive platform that includes a strong staking program, an exclusive NFT collection, and seamless integration with pay-per-view sports. With these innovative offerings, Barracuda Coin is set to establish itself as a leader in both the cryptocurrency and entertainment sectors.

Register and Be Part of the Barracuda Coin Community

Investors are encouraged to participate in the reservation phase to secure tokens at the lowest price and maximize staking rewards. For more information, visit https://barracuda-coin.io/

Media Contact:

Barracuda Coin

support@barracuda-coin.io

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Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

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