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China Medical System（00867）Obtained Class 1 Innovative Drug Long-acting Anti-IL-4Rα Monoclonal Antibody MG-K10

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SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 24 January 2025, the Group through subsidiaries of the Company entered into a Collaboration Agreement with Hunan Mabgeek Biotechnology Co., Ltd. (“Mabgeek Biotechnology”) and its subsidiary for Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection MG-K10 (“MG-K10” or the “Product”). The Group has obtained the co-development right as specifically agreed upon in the Agreement and exclusive commercialization right to the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan Region and Singapore (the “Territory”); Mabgeek Biotechnology will support the commercialization activities and is responsible for the sale and supply of the Product. The collaboration term is perpetual.

 

IL-4Rα is considered a key target for the treatment of type 2 inflammatory diseases, such as atopic dermatitis (AD), asthma, prurigo nodularis, etc. Anti-IL-4Rα monoclonal antibodies are among the best-selling biologics in this field. MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that simultaneously blocks the signaling of key type 2 inflammatory cytokines IL-4 and IL-13. Following Fc mutation, MG-K10 allows long dosing interval owing to its prolonged half-life, and it is expected to be the first long-acting anti-IL-4Rα monoclonal antibody marketed in China. Currently marketed anti-IL-4Rα drugs require dosing every two weeks, whereas MG-K10 only requires dosing every four weeks, demonstrating good efficacy and safety. MG-K10 has the potential to be the Best-in-Class (BIC).

 

This collaboration marks another significant milestone for Dermavon (formerly known as CMS Skinhealth)’s layout in the dermatology field. MG-K10 will enrich the global differentiated innovative pipeline of Dermavon, and will strongly synergize with the existing product portfolio, such as marketed innovative drug ILUMETRI (tildrakizumab injection), marketed exclusive drug Hirudoid (mucopolysaccharide polysulfate cream) and dermatology-grade skincare products of Heling soothing product series (developed for AD patients), and innovative pipeline drugs ruxolitinib cream (for the topical treatment of mild to moderate AD and non–segmental vitiligo) and povorcitinib (for the treatment of non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis and chronic spontaneous urticaria), etc. Leveraging its proven clinical development and commercialization capabilities, the Group will fully cooperate with Mabgeek Biotechnology to promote the approval of MG-K10 in China, bringing a new treatment option with lower dosing frequency, good efficacy and safety to patients with type 2 inflammatory diseases in China.

 

More information about MG-K10

MG-K10 is a Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection that used for the treatment of type 2 inflammatory diseases, including AD, asthma, prurigo nodularis, allergic rhinitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, chronic obstructive pulmonary disease and so on. It holds substance patents in specific countries/regions within the Territory.

 

MG-K10 has entered Phase III clinical trials in China for AD, asthma, and prurigo nodularis. In the completed Phase II clinical trials for adult moderate-to-severe AD and moderate-to-severe asthma, MG-K10 has demonstrated good efficacy and safety[1-2]. Additionally, MG-K10 has obtained IND approval for eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis in China.

 

According to Frost & Sullivan, the global market for treatments targeting IL-4Rα is expected to reach US$28.7 billion by 2030, with a compound annual growth rate (CAGR) of 21.8% from 2020 to 2030. In China, the market is projected to reach US$4.08 billion by 2030, with a CAGR of 76.8% from 2020 to 2030.

 

About AD indication

MG-K10’s first indication, AD, is a chronic inflammatory skin condition characterized by severe itching. It is the most burdensome non-fatal skin disease globally, with at least 230 million people affected worldwide[3]. AD is also a prevalent and high-burden chronic disease in China, with the prevalence showing an upward trend[3]. According to the Global Burden of Disease Study 2019, the number of AD patients in China increased by 25.65% from 1990 to 2019[3]. It is estimated that there are approximately 36.09 million AD patients in China[3], with approximately 9.625 million suffering from moderate-to-severe AD[4].

 

Current treatment options for AD primarily include topical and systemic treatments. For moderate-to-severe AD, topical medications are often insufficient to achieve disease control, necessitating the initiation of systemic treatments. However, due to the limitations in efficacy and safety of traditional systemic therapies for AD, moderate-to-severe AD patients often experience delays in systemic treatment initiation, poor compliance, and suboptimal disease control, leaving a significant unmet need in clinical practice[3]. MG-K10, with its extended dosing interval of once every four weeks, is expected to improve patient adherence and provide a new, effective, and safe systemic treatment option for patients with moderate-to-severe AD.

 

About Mabgeek Biotechnology

Mabgeek Biotechnology was founded in 2016 and has always adhered to the research and development concept of “innovation, efficiency and safety”, focusing on the fields of allergic inflammatory diseases and autoimmune diseases. Mabgeek Biotechnology is equipped with a research and development team composed of top industry experts. With excellent research capabilities and deep industry experience, Mabgeek Biotechnology uses its unique TEADA high-throughput antibody screening platform to develop innovative antibody drugs with high biological activity, excellent druggability, and differentiation. Mabgeek Biotechnology is committed to providing safer, more effective and more convenient treatment solutions for patients worldwide. For more information about Mabgeek Biotechnology and its products, please visit: https://www.mabge.com/.

 

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 data of the product’s Phase II clinical trial for AD indication as disclosed by Mabgeek: https://www.mabge.com/en/index.php?c=show&id=23
  2. The interim data of the product’s Phase II clinical trial for asthma indication as disclosed by Mabgeek: https://www.mabge.com/index.php?c=show&id=18
  3. Chinese Society of Dermatology, China Dermatologist Association. Clinical pathway for the diagnosis and treatment of moderate to severe atopic dermatitis in China (2023): an expert consensus[J]. Chinese Journal of Dermatology, 2023, 56(11): 1000-1007. DOI: 10.35541/cjd.20230247.
  4. Mao, Dandan et al. Prevalence and risk factors of atopic dermatitis in Chinese adults: a nationwide population-based cross-sectional study. Chinese medical journal vol. 136,5 604-606. 5 Mar. 2023, DOI:10.1097/CM9.0000000000002560

 

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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Press Release

Imarafy’s 2025 Pro 16 and Ultra 25 Redefine Affordable Luxury, Selling Out 10,000 Units on Day One

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January 24, 2025

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Today, Imarafy, a Texas-based disruptor in the electronics market, announces a resounding success with the launch of its highly anticipated smartphones: the Imarafy Pro 16 and the Imarafy Ultra 25. Priced at just $199.85, these feature-packed devices delivered a performance rivaling premium flagship models priced at over $1,000—achieving a historic sell-out of 10,000 units within 24 hours.

The Pro 16 and Ultra 25: Where Innovation Meets Affordability

Blending elegance, innovation, and practicality, the Pro 16 and Ultra 25 boast:

  • 5G Connectivity:  Seamless speed for streaming, gaming, and productivity.
  • Massive Storage: Up to 1TB of memory to keep all your photos, apps, and videos in one place.
  • 16GB RAM:  Superior multitasking and smooth performance.
  • Sleek Aesthetic:  Six bold color options designed for every personality.

“Our phones are more than devices—they’re a statement. We’re bringing high-end technology to consumers at a price point that was previously unimaginable,” said Nelson Kamwaro, also known as Nelson Nyutu, founder and CEO of Imarafy.

Available exclusively on Imarafy.com, the Pro 16 and Ultra 25 come with free nationwide shipping.

Behind the Vision: Nelson Kamwaro’s Leadership

Imarafy’s instant success can be attributed to the innovative vision of Nelson Kamwaro. With extensive experience in exports, online business, and digital marketing, Kamwaro’s leadership has positioned Imarafy as a trailblazer in the tech industry.

“Nelson Nyutu is a tireless leader who’s redefining what’s possible in this space,” said a company spokesperson. “His deep understanding of online business and customer needs has set the stage for Imarafy’s rapid rise.”

A Phenomenal Day-One Success

Imarafy’s data-driven approach to digital marketing played a crucial role in the product’s success. Targeted campaigns on Meta platforms drove massive traffic to Imarafy.com, where eager customers seized the opportunity to own a luxury smartphone at a fraction of the price.

Feedback from early buyers highlights the phones’ premium design, unmatched value, and cutting-edge features.

Imarafy’s Roadmap for the Future

With this groundbreaking launch, Imarafy has its sights set on global markets. The company plans to expand into Europe, Africa, and Asia, introducing its affordable premium technology to a worldwide audience.

“Our mission is to democratize technology,” Kamwaro added. “With the Pro 16 and Ultra 25, we’ve proven that you don’t need to break the bank to own a premium smartphone.”

About Imarafy

Founded in Texas, Imarafy is a forward-thinking electronics brand dedicated to creating high-quality, affordable products. With a focus on innovation, affordability, and customer satisfaction, Imarafy is redefining the global tech landscape.

Media Contact:

1.  Company name: Imarafy

2.  Website link: Imarafy.com

3.  Contact email: support@imarafy.com 

4.  Country: usa

5.  City: Texas

6.  Contact person name: Nelson Nyutu

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IJEX Exchange: Your Reliable Partner in the Growing Crypto Market with MSB Certification

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January 24, 2025

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January 24, 2025 – The cryptocurrency market in 2025 is rapidly evolving, and investors are more eager than ever to participate in the thriving digital asset ecosystem. As Bitcoin and other cryptocurrencies surge in value, the demand for secure and trustworthy trading platforms has never been higher. At IJEX Exchange, we understand the importance of building trust and maintaining the highest security standards in an ever-changing market.

With geopolitical shifts, particularly the re-election of Donald Trump as the U.S. President, the global financial landscape is set to change. This shift will likely bring new regulatory measures that could either enhance or challenge the growth of cryptocurrencies. Against this backdrop, it is more critical than ever for investors to choose a platform that offers stability, transparency, and the necessary compliance to navigate this uncertain future.

IJEX Exchange stands out not only for its robust security but also for its commitment to regulatory excellence. In addition to holding the prestigious U.S. MSB certification, we are also certified by Canada’s FINTRAC and Singapore’s ACRA. These certifications reflect our adherence to the highest global standards in financial services, reinforcing our reputation as a reliable and trusted partner for both retail and institutional investors.

A Platform You Can Trust

At IJEX Exchange, we take compliance and security seriously. The MSB certification, alongside our FINTRAC and ACRA certifications, ensures that we operate with the utmost integrity, following strict anti-money laundering (AML) and Know-Your-Customer (KYC) procedures. This multi-jurisdictional certification strategy enhances the credibility of our platform, providing investors with the confidence they need to trade securely and reliably.

These certifications are a mark of excellence in the crypto industry, demonstrating our commitment to operating within the regulatory frameworks of the U.S., Canada, and Singapore. By aligning ourselves with these leading financial authorities, we offer a secure and compliant environment where investors can feel safe knowing that their transactions and assets are protected.

Why Choose IJEX Exchange?

  1. Global Certifications: IJEX Exchange holds certifications from the U.S. MSB, Canada’s FINTRAC, and Singapore’s ACRA, ensuring full compliance with international financial regulations.
  2. Advanced Security Protocols: We employ state-of-the-art security measures to safeguard user data and assets, providing a secure trading environment.
  3. User-Friendly Platform: Whether you’re a first-time investor or an experienced trader, IJEX Exchange offers a seamless and intuitive platform to meet your trading needs.
  4. Global Reach: Our platform offers access to a wide range of cryptocurrencies and trading pairs, serving investors worldwide.
  5. Dedicated Support: Our expert support team is available around the clock, ready to assist with any questions or concerns that arise.

A Bright Future in Crypto

With 2025 ushering in new opportunities for cryptocurrency and a more favorable regulatory environment for digital assets, now is the perfect time to be involved. IJEX Exchange’s robust security and compliance practices, coupled with our global certifications, position us as a reliable and trusted partner in this growing market.

As we move forward, IJEX Exchange remains committed to maintaining the highest standards in the industry, ensuring that our platform provides the security, transparency, and support that investors need to thrive in the ever-evolving crypto space.

Contact Information:

Company Name: IJEX Exchange LTD.

Contact person: Henry Sullivan

Email: support@ijex.com

Website: https://ijex.com/ 

FinCEN MSB Registration Number: 31000257059546

FINTRAC MSB Registration Number: M24884993

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Press Release

Bitcoin Surges to New Heights – TXEX Exchange Strengthens Security with MSB Certification

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5 hours ago

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January 24, 2025

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January 24, 2025 – The year 2025 promises to be a transformative period for the cryptocurrency market, as Bitcoin soars to new record highs, sparking renewed global interest and excitement. Amid this surge, TXEX Exchange continues to solidify its reputation as a trusted and reliable platform by enhancing its security protocols and ensuring compliance with the highest standards. Recently, TXEX Exchange earned the prestigious MSB (Money Services Business) certification from the U.S. Department of Treasury, further reinforcing its commitment to providing a safe and secure trading environment for its users.

With Bitcoin breaking past the $100,000 mark, the dynamics of the global financial markets are evolving. As the world witnesses significant political shifts, particularly with the re-election of Donald Trump as the U.S. president, the landscape for digital currencies is set to change dramatically. The new administration’s approach to fiscal policy and regulation could have far-reaching implications for the future of cryptocurrency, driving demand for exchanges that adhere to robust security and regulatory standards.

As cryptocurrencies gain momentum in 2025, TXEX Exchange stands at the forefront, offering a secure, compliant, and user-friendly platform for both individual investors and high-net-worth clients. With the MSB certification in hand, TXEX Exchange sets itself apart as a leader in the industry, ensuring that clients’ assets are safeguarded with the highest level of care.

Strengthening Trust with MSB Certification

The MSB certification is an essential credential for any exchange looking to operate with transparency and in full compliance with U.S. financial regulations. For TXEX Exchange, this certification signifies a robust commitment to anti-money laundering (AML) standards, customer verification (KYC), and overall operational integrity. Investors can feel confident knowing that TXEX Exchange adheres to strict regulatory requirements, providing an extra layer of trust in a volatile market.

Why TXEX Exchange?

  1. Compliance with U.S. Standards: With MSB certification, TXEX Exchange ensures full compliance with U.S. financial regulations, offering investors peace of mind.
  2. State-of-the-Art Security: TXEX Exchange employs top-tier security measures to protect user assets and personal information, making it a trusted platform for traders.
  3. Seamless Trading Experience: Our platform is designed to offer an efficient and secure trading environment, capable of handling large volumes of transactions with ease.
  4. Global Reach and Support: Serving investors around the world, TXEX Exchange offers a comprehensive suite of cryptocurrencies and trading pairs.
  5. Expert Assistance: Whether you’re just starting or are an experienced trader, our dedicated support team is always available to assist with your trading needs.

Conclusion: A Secure Future for Cryptocurrency Trading

With Bitcoin’s remarkable rise and the political landscape shifting under the influence of the newly re-elected U.S. president, the cryptocurrency market is more exciting and uncertain than ever before. Now, more than ever, it is essential to choose an exchange that is committed to maintaining the highest levels of security and regulatory compliance. TXEX Exchange’s MSB certification is a testament to our dedication to providing a trustworthy platform for our users.

As we look ahead to the opportunities and challenges of 2025, TXEX Exchange is committed to staying at the cutting edge of the industry, ensuring that our users have access to a secure and reliable trading environment that supports their investment goals.

Contact Information:

Company Name: TX Exchange

Contact person: Sophia Mitchell

Email: support@txex.com

Website: https://txex1.com/ 

MSB Registration Number: 31000269479677

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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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