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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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3 months ago

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SHENZHEN, CHINA – China 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

Sunshine Jewelries Emphasizes Thoughtful Design With Jewelry Made for Real Life, Real Wear, and Everyday Confidence

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7 hours ago

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March 2, 2026

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  • A continued focus on pieces designed for lasting comfort and meaningful personal use

California, USA, 2nd March 2026, ZEX PR WIRE — Sunshine Jewelries highlights its ongoing commitment to thoughtful design and jewelry created for real wear. The brand’s current direction centers on pieces that support daily life, personal milestones, and long-term use rather than short-lived trends or single-occasion styling.

“We focus on creating pieces people reach for instinctively, whether they are dressing for work, meeting friends, or marking a meaningful moment.”

The brand’s latest emphasis reflects a growing shift toward jewelry that feels natural in everyday settings. Rather than treating jewelry as something reserved for events alone, Sunshine Jewelries approaches design as part of a person’s routine. Necklaces, earrings, bracelets, and rings are developed with balance, proportion, and comfort in mind, allowing each piece to move easily from morning to evening without feeling overstated or impractical.

“Jewelry should feel dependable, not limit how often it gets worn,” said a representative from Sunshine Jewelries. “Our designs are meant to fit into real wardrobes and real lives, while still holding meaning and presence.”

Materials across current collections include sterling silver, 10K and 14K gold, and carefully selected stones set with secure construction. Each design prioritizes wearability, accurate sizing, and thoughtful finishes that hold up to repeated use. Attention to comfort plays a central role, from smooth edges to reliable closures that support confidence during daily wear.

Sunshine Jewelries also continues to place importance on emotional connection. Many pieces are created with gifting in mind, offering options suitable for birthdays, anniversaries, career milestones, and personal celebrations. Clean silhouettes and versatile designs allow jewelry to feel personal without being tied to a single moment or trend cycle.

Alongside design philosophy, Sunshine Jewelries maintains a customer-focused shopping experience through its online store. The brand offers secure checkout, clear product information, fast delivery, and real-time order tracking to support a smooth purchasing process. This operational consistency reflects the same care applied to product design.

By reinforcing its commitment to jewelry made for real life, Sunshine Jewelries continues to position itself as a brand grounded in intention, wearability, and emotional relevance. The focus remains on pieces that stay present in daily routines, becoming part of personal stories rather than background accessories.

Current collections are available through the Sunshine Jewelries online store.

About Sunshine Jewelries

Sunshine Jewelries is a handcrafted jewelry brand dedicated to creating meaningful pieces designed for everyday wear and life’s important moments. With a focus on quality materials, thoughtful design, and careful craftsmanship, the brand creates jewelry meant to be worn often, gifted with purpose, and remembered over time.

Contact Information

Email: sunshinejewelry25@gmail.com
Website: https://sunshinejewelleries.com

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Press Release

Sunshine Jewelries Launches a Line Featuring Everyday Staples for Work, Events, and Gifting

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7 hours ago

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March 2, 2026

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  • A new collection focused on refined essentials designed to move effortlessly from daily wear to meaningful occasions

California, USA, 2nd March 2026, ZEX PR WIRE — Sunshine Jewelries has announced the launch of a new jewelry line centered on everyday staples created for work settings, special events, and thoughtful gifting. The release reflects the brand’s continued focus on jewelry that feels composed, wearable, and intentional from the moment it is worn, while maintaining the craftsmanship and material standards the brand is known for.

“We think of jewelry as part of someone’s routine, not just an accessory for rare occasions. This collection was shaped around real life, where a bracelet might be worn to work, to dinner, and then gifted later as something remembered.”

The new line brings together earrings, necklaces, rings, and bracelets designed with proportion, comfort, and longevity in mind. Rather than focusing on statement-only pieces, the collection prioritizes refined designs that integrate easily into daily routines, professional wardrobes, and personal milestones. Each piece is crafted to feel balanced on the body, offering a sense of polish without excess.

This launch responds to a growing demand for jewelry that can transition smoothly across different moments of life. From meetings and formal events to celebrations and gifting, the collection is structured to support versatility while retaining visual presence. Materials include sterling silver, 10K and 14K gold, and carefully selected stones set with attention to detail and secure construction.

“Our goal with this line was to create pieces people could rely on, not just admire,” said a representative from Sunshine Jewelries. “These are designs meant to be worn repeatedly, paired easily, and trusted for both everyday settings and moments that matter.”

The collection also reflects Sunshine Jewelries’ emphasis on thoughtful gifting. Many pieces are positioned as meaningful options for birthdays, anniversaries, weddings, and professional milestones. With clean silhouettes, dependable closures, and accurate sizing, the jewelry is designed to feel personal while remaining universally wearable.

In keeping with the brand’s customer-first approach, Sunshine Jewelries continues to offer fast delivery, secure checkout, and real-time order tracking across its online store.

By focusing on everyday staples, Sunshine Jewelries reinforces its belief that jewelry should feel natural, expressive, and lasting. The new line stands as a continuation of the brand’s philosophy that each piece carries meaning, shaped not only by design but by how and when it is worn.

The collection is now available through the Sunshine Jewelries online store.

About Sunshine Jewelries

Sunshine Jewelries is a handcrafted jewelry brand dedicated to creating refined, meaningful pieces for everyday wear and special occasions. With a focus on quality materials, thoughtful design, and careful craftsmanship, the brand creates jewelry meant to be worn, gifted, and remembered.

Contact Information

Email: sunshinejewelry25@gmail.com
Website: https://sunshinejewelries.com

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Cloud PR Wire

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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

Context Releases 2025 Luxury Fashion Sustainability Benchmark on ESG Disclosures

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7 hours ago

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March 2, 2026

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London, United Kingdom, 2nd Mar 2026 — A new 2025 Luxury Fashion Sustainability Benchmark released by sustainability consultancy Context reveals a growing divide between the depth of environmental disclosures and social transparency. The benchmark analyses the public sustainability and ESG reporting of 10 of the world’s largest luxury fashion companies, including Burberry, Chanel, LVMH, and Kering.

Social Sustainability: Placing People at the Centre

The benchmark assesses how effectively luxury fashion companies identify, manage, and report on key sustainability issues across five categories. It evaluates reporting maturity and transparency, rather than actual sustainability performance. The findings highlight the growing importance of developing a more holistic sustainability strategy that places people at the centre. While companies are integrating actionable targets and goals related to their material issues, such as climate, transparency doesn’t yet extend far enough to the people behind the products.

“As regulatory scrutiny increases and expectations rise, credible leadership will depend on companies being as open about social impacts, risks and opportunities as they are about emissions and other environmental topics,” said Helen Fisher, Managing Director at Context.

Key findings from the 2025 Luxury Fashion Sustainability Benchmark include:

  • Communicating a strategy: All luxury fashion companies provided updates on their sustainability strategy, but the extent to which it covered the company’s most material environmental, social, and governance issues varied.
  • Double materiality: 40% had communicated their impacts on planet and society, and the financial implications of those impacts, by reporting the results of a double materiality assessment.
  • Governance: Sustainability governance is well-established at both the Board and executive levels, but detailed ESG risk management disclosures are sparse.
  • Climate metrics: Luxury fashion companies tend to report more extensive climate-related data, but transparent communication on setbacks or underperformance is limited.
  • Nature: Nature reporting is slowly rising, with half following science-backed guidance from the Science Based Targets Network (SBTN). Only one company has SBTN validated freshwater and land targets.
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  • Social impact: Reporting on social issues is weaker than on environmental and governance topics, indicating potential blind spots in supply chain risk.
  • Reporting frameworks: Most luxury fashion companies report against at least one sustainability reporting framework, such as the Global Reporting Initiative Standards, commonly used by companies to publicly report their impacts on the planet, economy, and society.

Download the full 2025 Luxury Fashion Sustainability Benchmark.

About Context

Context is a consultancy specialising in corporate sustainability strategy, reporting, and communications. For more than 25 years, it has helped over 250 clients across a wide range of sectors and markets to navigate the evolving sustainability landscape.

Media Contact

Organization: Context

Contact Person: Helen Fisher, Managing Director

Website: https://contextsustainability.com/

Email: Send Email

City: London

Country:United Kingdom

Release id:41950

The post Context Releases 2025 Luxury Fashion Sustainability Benchmark on ESG Disclosures 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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