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CMS (867/8A8): NDA of Innovative Drug Y-3 for Injection for Acute Ischemic Stroke Accepted in China

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SHENZHEN, CHINAChina Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that on 11 December 2025, the New Drug Application (NDA) of Class 1 Innovative Drug Y-3 for Injection (proposed English generic name: Loberamisal for Injection) (“Y-3 for Injection” or the “Product”) has been accepted by National Medical Products Administration of the People’s Republic of China (NMPA). The Product is a brain cytoprotectant indicated for the treatment of acute ischemic stroke.

 

With well-defined targets and clear mechanism of action, Y-3 for Injection is able to exert multiple therapeutic effects. As the world’s first brain cytoprotectant developed based on the important targets PSD95-nNOS and MPO, in the pathological processes of stroke, Y-3 for Injection acts on multiple key pathological processes of the ischemic cascade in ischemic stroke. Through multi-target, highly selective synergy, it is more conducive to exerting brain cytoprotective effects. The Product has an excellent therapeutic effect on ischemic stroke and the potential to prevent post-stroke depression and anxiety symptoms.

 

Y-3 for Injection demonstrates excellent clinical data with excellent efficacy and a favorable safety profile. The results of Phase II clinical trial of the Product in China indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (40mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group, with a rate difference of 16%. The Phase III clinical trial of the Product in China was conducted by Beijing Tiantan Hospital, Capital Medical University as the leading site. It has enrolled nearly 1,000 patients with acute ischemic stroke within 48 hours of onset across approximately 40 research centers nationwide, aiming to evaluate the efficacy and safety of Y-3 for Injection in treating patients with acute ischemic stroke within 48 hours of onset. The Phase III clinical study met the primary efficacy endpoint, with patients achieving significant clinical benefits and an overall favorable safety profile. The key study results are planned to be presented at international academic conferences, and the full study will be published in international academic journals.

 

The Central Nervous System (CNS) is one of the core advantageous fields of CMS, where a deeply integrated layout has been progressively established. The product portfolio has solidified the market foundation, including the marketed innovative drug VALTOCO (Diazepam Nasal Spray), the original brand drug Deanxit (Flupentixol and Melitracen Tablets), and the improved new drug ZUNVEYL (Benzgalantamine Gluconate Enteric-coated Tablets), which is currently under NDA review. The addition of Y-3 for Injection will further strengthen the product portfolio, generating highly efficient synergies in terms of expert networks and market resources. It is expected that if approved for marketing, Y-3 for Injection will bring a new generation of brain cytoprotectant with excellent efficacy and more comprehensive therapeutic effects to Chinese patients with ischemic stroke. Leveraging the successful commercialization experience and compliant and efficient operation system, the Group will accelerate the accessibility of innovative therapies to benefit more patients.

 

More Information about Y-3 for Injection

The pathological processes of acute ischemic stroke are highly complex and interconnected. There is an urgent clinical need for multi-target, multi-mechanism coordinated interventions to achieve more effective regulation of the complex ischemic cascade, thereby improving treatment outcomes and enhancing patients’ quality of life. Y-3 for Injection is able to uncouple PSD95-nNOS, inhibit MPO activity, and enhance the activity of α2-GABAA receptor (a subtype of GABAA receptor with antidepressant and anxiolytic effects). With this multi-target, highly selective synergistic mechanism, it is expected to achieve a technological breakthrough in the simultaneous intervention of “stroke treatment and prevention of post-stroke depression and anxiety”, making Y-3 for Injection a promising novel brain cytoprotectant with excellent efficacy and more comprehensive therapeutic effects.

 

The results of Phase II clinical trial of Y-3 for Injection for the treatment of acute ischemic stroke were presented as an oral poster at the 10th European Stroke Organisation Conference in 2024 (ESOC 2024). It indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (20mg, 40mg, 60mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group (20mg: 67.8% vs 60.7%, 40mg: 76.7% vs 60.7%, 60mg: 70.0% vs 60.7%). Moreover, the Product showed comparable safety to placebo in acute ischemic stroke patients, exhibiting good tolerability.

 

On 24 August 2023, the Group through its wholly-owned subsidiary entered into a Collaboration Agreement (the “Agreement”) with Neurodawn Pharmaceutical Co., Ltd. (“NeuroDawn”), a clinical needs-oriented pharmaceutical company driven by innovation and R&D. In accordance with the Agreement, the Group obtains an exclusive promotion right in mainland China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. The term of the Agreement is permanent.

 

About Stroke

According to the Guideline for Prevention and Treatment of Cerebrovascular Disease (2024 Edition) issued by the National Health Commission, approximately 3.94 million new stroke cases occur in China each year, accounting for one-third of the global new cases[1]. Among these, ischemic stroke accounts for about 72%, with over 2.8 million new cases annually; the number of existing stroke patients in China has exceeded 28 million[1]. Data from China’s cause-of-death monitoring in 2021 shows that stroke-related deaths accounted for 23% of the national total deaths[1]. Over the past three decades, the disease burden of stroke-related disabilities in China has continued to increase[1]. Coupled with factors such as the accelerating aging of the population, the pressure of stroke prevention and control will further intensify in the future, posing enormous challenges to patients’ families and society[1]. In addition, post-stroke depression and anxiety are common complications of stroke, with incidence rates of approximately 30% and 25% respectively[2]. They can hinder the recovery of patients’ neurological functions, even increase the risk of death, and severely affect patients’ prognosis. Y-3 for Injection holds significant potential value for the long-term neurological function improvement and overall prognosis of a vast number of stroke patients, indicating broad market prospects.

 

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 in its advantageous specialty fields, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.

 

Reference

  1. National Health Commission of the People’s Republic of China. Guideline for Prevention and Treatment of Cerebrovascular Disease (2024 Edition) [J]. Chinese Journal of Magnetic Resonance Imaging, 2025, 16(1): 1-8. DOI: 10.12015/issn.1674-8034.2025.01.001.
  2. Chen Xinyu, Lyu Xiaohan, Li Ruina, et al. Post-Stroke Anxiety [J]. International Journal of Cerebrovascular Disease, 2022, 30(2): 129-133. DOI: 10.3760/cma.j.issn.1673-4165.2022.02.010.

 

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/

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Press Release

Nicolas Marketplace Launches An Italian-Inspired Salami Collection

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Nicola’s Marketplace, an Italian specialty food retailer based in Kenilworth, New Jersey, announced the launch of an Italian-inspired salami and cured meat collection featuring sliceable Calabrian salami, spreadable ’nduja, duck prosciutto, and specialty coppa. The collection expands the company’s assortment of chef-curated products for charcuterie boards, antipasti platters, gifting, and at-home entertaining.

Kenilworth, New Jersey, United States, 20th Jun 2026 — Nicola’s Marketplace, an Italian specialty food retailer based in Kenilworth, New Jersey, has launched an Italian-inspired salami and cured meat collection designed to give customers more ways to explore traditional flavors, distinct textures, and regional food influences.

The collection brings together a selection of cured meats and spreadable salami products that can be served individually or combined as part of a charcuterie board, antipasti platter, specialty food gift, or Italian-inspired meal.

Among the featured products is Spotted Trotter Calabrian Salami, a sliceable cured meat with a savory flavor profile and noticeable spice. Calabrian-style salami is associated with the bold culinary traditions of Calabria, a region in southern Italy known for its use of chili peppers and robust seasonings.

The collection also includes two spreadable ’nduja options:

’Nduja Guys of Spilinga Spicy Spreadable Salami, 16 Ounces

’Nduja di Spilinga Spicy Spreadable Salami, 8 Ounces

Unlike firm salami that is sliced before serving, ’nduja has a softer consistency that makes it suitable for crostini, pizza, pasta sauces, roasted vegetables, sandwiches, and appetizers. Its texture and spicy flavor give customers another way to experience the culinary traditions associated with Calabria.

The assortment extends beyond salami to include additional specialty cured meats. Spotted Trotter Duck Prosciutto offers a distinct alternative to traditional pork-based prosciutto, while Spotted Trotter Coppa adds another sliceable cured meat option for customers preparing boards, appetizers, or Italian-inspired spreads.

“The goal of this collection is to help customers experience the variety that makes Italian specialty foods so enjoyable,” said Chef Nicola DiGiorgio, Founder of Nicola’s Marketplace. “Each product brings something different to the table. A sliceable Calabrian salami, a spreadable ’nduja, duck prosciutto, and coppa can all work together to create a board with a wider range of flavors and textures.”

The new collection is intended for both casual meals and special occasions. Customers can serve the cured meats with cheese, olives, crackers, taralli, honey, bread, roasted peppers, and other antipasti items. The products can also be incorporated into pasta dishes, sandwiches, and appetizer recipes.

Company representatives said the addition supports Nicola’s Marketplace’s broader focus on expanding access to specialty foods through its online store. Customers across the United States can explore chef-curated products that were previously more commonly found in specialty markets, regional food shops, or local Italian retailers.

The salami and cured meat collection joins the company’s existing assortment of handcrafted ravioli, artisan pasta, sauces, cheeses, olive oils, balsamic vinegars, baked goods, desserts, gift sets, and imported pantry items.

Products are available online according to current availability and published fulfillment schedules.

Shop now at nicolasmarketplace.com and explore Italian-inspired salami, cured meats, antipasti, and specialty foods.

About Nicola’s Marketplace

Founded by Chef Nicola DiGiorgio in 2022, Nicola’s Marketplace brings together authentic Italian flavors and farm-fresh ingredients to offer high-quality, handcrafted ravioli, sauces, cheeses, olive oils, desserts, specialty pantry items, and chef-curated gift selections. What began at local farmers’ markets has grown into a nationwide destination for artisan Italian food lovers.

Official website: https://nicolasmarketplace.com
Instagram: https://www.instagram.com/nicolasmarketplace
Facebook: https://www.facebook.com/nicolasmarketplace

Media Contact

Organization: Nicolas Marketplace

Contact Person: Chef Nicola

Website: https://nicolasmarketplace.com/

Email: Send Email

Address:735 Fairfield Ave, Kenilworth, NJ 07033

City: Kenilworth

State: New Jersey

Country:United States

Release id:46262

The post Nicolas Marketplace Launches An Italian-Inspired Salami Collection appeared first on King Newswire. This content is provided by a third-party source.. King Newswire makes no warranties or representations in connection with it. King Newswire is a press release distribution agency and does not endorse or verify the claims made in this release. If you have any complaints or copyright concerns related to this article, please contact the company listed in the ‘Media Contact’ section

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Bryan Tsikouris Says Claude AI’s Discovery of a Critical Zcash Vulnerability Signals a New Era for Cybersecurity

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San Francisco, CA, Jun 20, 2026, ZEX PR WIRE — The discovery of a critical vulnerability in the Zcash blockchain by a security researcher working with Anthropic’s Claude AI has sparked discussion in cybersecurity. The flaw, which reportedly existed for years, could have allowed the creation of counterfeit Zcash tokens. The discovery has highlighted a broader trend that technology and security expert Bryan Tsikouris believes will reshape the future of cyber defense.

According to reports, the vulnerability was identified during an AI-assisted security audit using Claude Opus 4.8. Researchers indicated that the flaw had remained undetected for nearly four years despite scrutiny from experienced developers and cryptographers. Following public disclosure of the issue, Zcash experienced a sharp market decline as investors reacted to concerns about the cryptocurrency’s integrity and security.

For Tsikouris, however, the most important aspect of the story is not the market reaction but what the discovery reveals about the evolving role of artificial intelligence in cybersecurity. “This is one of those moments that forces the technology industry to rethink what is possible,” said Tsikouris. “The fact that an advanced AI system helped uncover a vulnerability that had remained hidden for years demonstrates how quickly cybersecurity capabilities are changing. We are entering an era where AI is becoming an essential partner in identifying risks that human teams may overlook.”

Tsikouris has spent decades working in software and network security, helping organizations identify weaknesses before they become costly incidents. Throughout his career, he has witnessed multiple waves of technological transformation, from the emergence of personal computing to the rise of cloud infrastructure and blockchain systems. He believes AI-assisted security research may ultimately have an impact comparable to those earlier technological shifts. “For years, cybersecurity professionals have relied on manual code reviews, automated scanning tools, and penetration testing to find vulnerabilities,” Tsikouris explained. “Those methods remain extremely valuable, but AI introduces something new. It can analyze massive amounts of code, identify patterns, test assumptions, and evaluate potential attack paths at a scale that would be difficult for human teams to match.”

The Zcash incident is not an isolated example. Recent reports have shown that advanced AI models can identify hundreds of high-severity software vulnerabilities across open-source projects, often accelerating processes that traditionally required significant human effort. Researchers and developers are increasingly using AI systems to augment security testing, code auditing, and vulnerability analysis.

Tsikouris believes this trend will create a significant competitive advantage for organizations that embrace AI-powered security programs. “Cybersecurity has always been a race between defenders and attackers,” he said. “What AI changes is the speed of that race. Organizations that leverage AI to evaluate their systems continuously will be able to discover and remediate vulnerabilities faster than ever before. That capability could dramatically reduce the likelihood of costly breaches.”

At the same time, Tsikouris cautions that AI is not a substitute for experienced security professionals. Instead, he views it as a force multiplier that enables experts to focus on higher-level analysis and decision-making. “AI can identify potential vulnerabilities, but human expertise remains critical,” Tsikouris said. “Security professionals provide context, validate findings, assess business impact, and determine the best course of action. The strongest cybersecurity programs will combine AI-driven analysis with experienced human judgment.”

He also notes that the rise of AI-assisted vulnerability discovery presents new challenges. If defenders can use advanced AI to uncover hidden flaws, attackers may eventually use similar technologies to identify and exploit weaknesses more quickly. This dynamic makes proactive security investments increasingly important. “The organizations that wait to adapt will face growing risks,” Tsikouris said. “AI is raising the ceiling for both offensive and defensive cybersecurity capabilities. The key is ensuring that defenders stay ahead.”

Looking ahead, Tsikouris expects AI-assisted security audits to become a standard component of software development, blockchain security, and enterprise risk management. He believes businesses of all sizes should begin exploring how AI can strengthen their security posture today rather than treating the technology as a future consideration. “The Zcash discovery may be remembered as more than just a cryptocurrency security incident,” Tsikouris concluded. “It could become one of the clearest examples of how artificial intelligence is transforming cybersecurity. The organizations that learn to work alongside these systems will be better positioned to protect their assets, their customers, and their future.”

About Bryan Tsikouris

Bryan Tsikouris is a seasoned technology expert based in Illinois with decades of experience in software and network security. As an independent consultant, he helps organizations identify vulnerabilities, strengthen operational resilience, and integrate emerging technologies such as blockchain and artificial intelligence. Throughout his career, Bryan has helped businesses prevent costly disruptions and improve their long-term security posture.

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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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From a Calling to International Recognition: ENKU Brings Japanese Calligraphy to Global Audiences

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Japan, 19th Jun 2026 — Self-taught Japanese calligraphy artist ENKU is developing a contemporary body of work that combines traditional calligraphy, performance, installation art, and cultural storytelling.

Beginning his calligraphy journey in 2024 without formal training, ENKU draws inspiration from language, Japanese cultural traditions, history, and the relationship between written characters and human experience.

Through exhibitions, live performances, and collaborative projects, ENKU explores how calligraphy can be experienced not only as writing, but also as visual art, movement, sound, light, and reflection.

Latest Publicly Released Work

Picture 1

Exhibited in Shibuya, Tokyo, in November 2025, ENKU’s latest publicly presented work explores themes of meaning, purpose, reflection, focus, direction, and character through a composition inspired by traditional Japanese and Buddhist visual concepts. The work is structured around two symbolic worlds: one connected to spirit, wisdom, and clarity, and the other connected to life, light, and origin.

The composition brings together four interconnected concepts related to purpose, focus, direction, and character. Created using gold and silver foil, the appearance of the work changes depending on the viewer’s position and angle. ENKU created the piece with the intention of encouraging reflection, calm, and contemplation.

Koto and Calligraphy Collaboration Performance

Picture 2

In June 2025, ENKU presented a collaborative performance combining Japanese koto and live calligraphy. For the performance, he created a custom gold folding screen and incorporated two central themes: the miracle of life and the flow of time.

Using glow-in-the-dark materials, ENKU transformed the performance space into an immersive visual experience, expressing these ideas through lines and points of light emerging from darkness. The work invited audiences to experience changing perspectives through the folding screen structure, light, and movement.

The Story Behind the Artist

ENKU traces the beginning of his calligraphy journey to a deeply personal experience in late 2023, which inspired him to begin studying calligraphy independently in March 2024 despite having no formal training or prior experience beyond elementary school handwriting classes.

Originally drawn to language, Japanese culture, tradition, and history, ENKU’s work explores the origins and meanings of words, the beauty of written forms, and the cultural idea that words can carry influence beyond their literal definitions.

From First Exhibition Challenge to Ongoing Practice

Shortly after beginning calligraphy, ENKU decided to pursue international opportunities and applied for a New York exhibition after discovering an open call through social media. Once accepted, he faced the challenge of creating an exhibition-ready artwork despite never having made one before.

As the deadline approached, he struggled to create a work he felt satisfied with. A single phrase, translated as “Divine Wind,” came to mind, and the piece inspired by that phrase became his first exhibited work. ENKU describes this as his first major wall as an artist.

Why Calligraphy Matters in the Age of AI

ENKU believes contemporary calligraphy offers a physical, time-intensive, and human experience in an increasingly digital age. He sees the act of creating and encountering calligraphy as something that can refine people’s sensibilities and give viewers a direct experience of being alive.

At a time when AI is becoming increasingly present, ENKU’s work emphasizes hand-made expression, material presence, physical effort, and the emotional impact of written form.

Future Vision

Through calligraphy, ENKU aims to become an artist active not only in Japan but around the world. One of his long-term goals is to create a work valued at 100 million yen.

Japanese Taiko Drums, Koto, and Calligraphy Collaboration Performance

Picture 3

In November 2024, ENKU presented an early collaborative performance combining Japanese taiko drums, koto, and calligraphy. The performance explored the relationship between sound, language, meaning, and written expression through layered calligraphic forms.

This performance marked one of ENKU’s first attempts to expand calligraphy beyond the page and into a live, multi-sensory format.

About ENKU

ENKU is a self-taught Japanese calligraphy artist based in Tokyo. Beginning his calligraphy practice in 2024, he combines traditional Japanese calligraphy with contemporary performance, installation, light-based expression, and themes rooted in language, culture, history, and human experience.

Media Contact: 

ENKU | Contemporary Calligraphy Artist

Email: enku.u.sky@gmail.com

Phone: +81 80 4189 3903

Instagram: https://www.instagram.com/enku.u_do01 

LinkedIn: https://www.linkedin.com/in/enku11011  

Media Contact

Organization: Contemporary calligraphy artist ENKU

Contact Person: ENKU

Website: https://www.linkedin.com/in/enku11011

Email: Send Email

Country:Japan

Release id:46259

The post From a Calling to International Recognition: ENKU Brings Japanese Calligraphy to Global Audiences appeared first on King Newswire. This content is provided by a third-party source.. King Newswire makes no warranties or representations in connection with it. King Newswire is a press release distribution agency and does not endorse or verify the claims made in this release. If you have any complaints or copyright concerns related to this article, please contact the company listed in the ‘Media Contact’ section

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