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China Medical System: New Drug Application for Vitiligo Indication of Ruxolitinib Phosphate Cream Accepted in China

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SHENZHEN, CHINAChina Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on September 24, 2024, the New Drug Application (NDA) for vitiligo indication of ruxolitinib phosphate cream (the “ruxolitinib cream” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA). This is another substantial milestone for ruxolitinib cream in China, following the approval for Urgent Clinical Import by Hainan Medical Products Administration and approval for marketing in Macau for vitiligo, and it is also a key step in benefiting over ten million of patients with vitiligo in China.

 

Ruxolitinib cream achieved positive results in Chinese Real-World Study. The primary efficacy endpoint was the proportion of patients in the treatment group who achieved F-VASI 75 response at week 24, which was 49.5%, significantly higher than the target value of 14.1% (p<0.0001). The study met its primary endpoint, demonstrating that ruxolitinib cream is effective in treating patients with nonsegmental vitiligo, reducing the area of the lesions, and repigmenting the skin. All secondary efficacy endpoints showed a trend of benefit consistent with the primary efficacy endpoint, and the treatment effect for vitiligo continued to improve with longer treatment duration. Adverse events mostly had severity levels of grade 1 or 2. No adverse event (AE) leading to discontinuation or withdrawal, and no serious adverse event (SAE) related to the study drug occurred.

 

While advancing the process of NDA for the Product, the Group is conducting the transfer of ruxolitinib cream from overseas production to domestic production (localization technology transfer), which is being orderly promoted by the Contract Development Manufacturing Outsourcing Organization (CDMO), and the lab-scale and pilot trial studies have been completed and under scale-up production. The Group strives to complete the localization study as soon as possible, register in Mainland China and obtain marketing approval, so as to enable the Chinese patients with vitiligo to use the innovative product.

 

Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which results from the loss of pigment-producing cells known as melanocytes. It is estimated that there are approximately 14 million vitiligo patients in China[1]. Non-segmental vitiligo patients account for approximately 85% of them. Topical corticosteroids (TCS) and calcineurin inhibitors (CI) are used off-label for non-segmental vitiligo, however, these therapies have clinical deficiencies with long-term adverse reactions of long-term treatment or limited efficacy[23]. If the Product being successfully approved for marketing in China, it will be the first prescription drug approved for repigmentaton in vitiligo in Mainland China, bringing novel treatment hopes for Chinese vitiligo patients.

 

CMS has always adhered to its mission of providing competitive products and services to meet unmet medical needs. Guided by innovation strategy, the Group continuously strengthens its independent R&D as well as external collaboration, enriching its product pipelines. Looking ahead, CMS will continue to identify products with differentiated advantages globally and efficiently promote their clinical development and commercialization, bringing more novel and effective drugs to patients.

 

About ruxolitinib cream

Ruxolitinib cream, (Opzelura), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States[4]. Ruxolitinib cream (Opzelura) is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable[5]. In Europe, ruxolitinib cream (Opzelura) is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age[6].

 

The Product is not approved by the NMPA for any indication in Mainland China. However, on 12 August 2023, the Product was approved by Hainan Medical Products Administration for Urgent Clinical Import, and officially became available to applicable patients in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) on August 18, for the topical treatment of non-segmental vitiligo in adults and adolescents aged 12 and above with facial involvement. Benefiting from the Early and Pilot Implementation Policy granted by the state to Hainan Free Trade Port and the Pilot Zone, patients with vitiligo in China can apply for the Product in Boao Super Hospital first and receive treatment from the expert team. In addition, ruxolitinib cream was approved by the Pharmaceutical Administration Bureau (ISAF) of Macau on 11 April 2024 for the topical treatment of non-segmental vitiligo with facial involvement in adult and adolescents form 12 years of age.

 

On 2 December 2022, the Group through a subsidiary of the Company, a dermatology medical aesthetic company (“CMS Skinhealth”) entered into a Collaboration and License Agreement (the “License Agreement”) with Incyte for topical formulations of ruxolitinib for the treatment of autoimmune and inflammatory dermatology diseases. In accordance with the  License Agreement, the Group through CMS Skinhealth received an exclusive license to develop, register and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor-Leste and Brunei Darussalam) (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The License Agreement commenced on its effective date and has a royalty term of ten years from the date of the commercial sale of the Product in the Territory (the “Royalty Term”). Upon the expiration of the Royalty Term, the License Agreement may be renewed for a period of ten years thereafter (the “Initial Extended Royalty Term”) as per certain conditions defined in the License Agreement. Upon the expiration of the Initial Extended Royalty Term, the License Agreement may be extended for a period otherwise agreed by both sides as per certain conditions defined in the License Agreement.

 

Incyte has worldwide rights for the development and commercialization of the Product, marketed in the United States and Europe as Opzelura®. Opzelura and the Opzelura logo are registered trademarks of Incyte.

 

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. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7
  2. Consensus on the diagnosis and treatment of vitiligo (2021 version)
  3. Kubelis-López DE, Zapata-Salazar NA, Said-Fernández SL, Sánchez-Domínguez CN, Salinas-Santander MA, Martínez-Rodríguez HG, Vázquez-Martínez OT, Wollina U, Lotti T, Ocampo-Candiani J. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021 Aug;22(2):797. doi: 10.3892/etm.2021.10229. Epub 2021 May 25. PMID: 34093753; PMCID: PMC8170669.
  4. Drug approval information can be found on the FDA official website, as follows: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-t…
  5. Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-an…
  6. Drug approval information can be found on the EMA official website, as follows: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura

 

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

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

Source: China Medical System Holdings Ltd.

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Entrepreneur Joseph Majeesh Shares Insightful Blog on Achieving Work-Life Balance Without Sacrificing Success

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Calgary, Canada, 26th November 2024, ZEX PR WIRE, Entrepreneur and business leader Joseph Majeesh has been featured in an exclusive online blog discussing one of the most pressing challenges for today’s entrepreneurs: achieving work-life balance while maintaining productivity. In his thought-provoking article, Work-Life Balance for Entrepreneurs: How to Stay Productive Without Burning Out, Majeesh shares his personal experiences and strategies for navigating the demands of entrepreneurship without losing sight of personal well-being.

Majeesh, an experienced professional known for his success in franchise development and recruitment, delves into the importance of balance for sustainable growth. Drawing from years of building businesses across industries, including managing major projects in Canada and operating renowned franchises like Dairy Queen, he offers actionable advice tailored for entrepreneurs.

“Entrepreneurship is exciting but also demanding. Achieving a balance between work and life isn’t about reducing ambition—it’s about ensuring you have the energy, focus, and clarity to excel in both areas,” Majeesh explains in the blog.

Key Takeaways from the Blog

Majeesh highlights several strategies for avoiding burnout and achieving sustainable success:

  • Time Management: Entrepreneurs should prioritize tasks based on urgency and importance, allowing for a focus on high-impact work while delegating less critical responsibilities.

  • Setting Boundaries: Defining work hours and communicating them to clients and teams helps maintain separation between professional and personal life.

  • Self-Care: Incorporating exercise, healthy eating, and mindfulness into daily routines ensures physical and mental well-being.

  • Learning to Say No: By focusing on projects and opportunities that align with their goals, entrepreneurs can avoid unnecessary distractions.

  • Leveraging Technology: Tools for automation and scheduling can improve efficiency without overwhelming personal time.

Through these practical approaches, Majeesh emphasizes that achieving balance is not only possible but also vital for long-term success.

Majeesh’s Commitment to Entrepreneurial Growth

With a career spanning multiple industries, Joseph Majeesh’s journey is marked by resilience, innovation, and a commitment to creating opportunities. His ability to manage diverse ventures while fostering personal growth and community engagement has earned him respect in the business world.

This latest blog reflects his dedication to empowering fellow entrepreneurs with actionable insights and personal experiences. “Success isn’t just about building a thriving business; it’s about living a fulfilling life,” Majeesh says.

About Joseph Majeesh

Joseph Majeesh is a Calgary-based entrepreneur with expertise in recruitment, franchise development, and business management. From humble beginnings in Kerala, India, to leading successful ventures in Canada, Majeesh’s career is a testament to vision and hard work. He is known for his innovative approach to business and his passion for building opportunities that impact lives positively.

To read the full blog, click here.

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Miami Beach CPA Firm, LLC Expands Forensic Accounting Services to Combat Financial Fraud Across Key Industries

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Miami, FL, 26th November 2024, ZEX PR WIREMiami Beach CPA Firm, LLC, a leading provider of accounting, tax, and consulting services, has announced an expansion of its forensic accounting services to strengthen its fight against financial fraud across essential sectors, including real estate, healthcare, hospitality, and technology. With increased threats of fraud across industries, the firm’s enhanced forensic accounting services are designed to help businesses identify financial discrepancies, investigate fraudulent activity, and implement effective strategies to safeguard financial integrity.

According to the firm, the expansion comes in response to a growing demand for specialized accounting expertise to address complex financial fraud cases, especially in industries vulnerable to financial crimes. With a team of seasoned Certified Public Accountants (CPAs) skilled in forensic analysis, Miami Beach CPA Firm leverages advanced data analytics tools and a meticulous approach to uncovering financial irregularities and fraudulent patterns.

“At Miami Beach CPA Firm, we recognize that the stakes for businesses today are higher than ever when it comes to protecting financial assets from fraud,” says the company spokesperson. “Our forensic accounting services are built on precision, confidentiality, and the ability to adapt to each client’s unique industry challenges. This expansion underscores our commitment to offering specialized services that directly support our clients’ need to combat financial fraud effectively.”

The firm’s forensic accounting services cater to various scenarios, including embezzlement, insurance fraud, misappropriation of funds, and financial statement manipulation. Leveraging Miami Beach CPA Firm’s depth of experience, the forensic accounting team follows a multi-phase approach: gathering and analyzing financial data, identifying potential indicators of fraud, and presenting clear, defensible findings for legal proceedings when required. The firm’s services are especially beneficial in legal contexts, where expert testimony and detailed financial analysis are essential for successful outcomes.

Miami Beach CPA Firm has built a reputation for excellence in accounting and tax services, serving a diverse client base across Miami and beyond. Their services are customized to meet the demands of each client, with a focus on protecting their financial interests through advanced, client-centric solutions. By expanding its forensic accounting capabilities, Miami Beach CPA Firm, LLC aims to reinforce its leadership position in the accounting sector while making a positive impact on the financial security of businesses across multiple industries.

For more information on Miami Beach CPA Firm’s forensic accounting services and how they can support your business in the fight against financial fraud, please visit https://miamibeachcpafirm.com/.

About Miami Beach CPA Firm, LLC

Miami Beach CPA Firm, LLC is a full-service accounting firm based in Miami, Florida, specializing in accounting, tax, and consulting services for individuals and businesses across various sectors. With a commitment to personalized and expert service, the firm assists clients with tax planning, financial consulting, forensic accounting, and more.

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Ammar Jali Shares Experience in Kilifi, Kenya, Highlighting the Unique Charm of Coastal Living and Local Connections

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Michigan, US, 26th November 2024, ZEX PR WIRE, Seasoned traveler and entrepreneur Ammar Jali has added another unforgettable destination to his East African adventures: the coastal town of Kilifi, Kenya. Known for its warm Indian Ocean waters and vibrant local culture, Kilifi left a lasting impression on Jali, who immersed himself in the town’s relaxed lifestyle, enjoyed scuba diving in crystal-clear waters, and experienced an enchanting evening with new friends.

The Allure of Kilifi’s Coastal Waters
Located along Kenya’s northern coastline, Kilifi is celebrated for its serene beaches and inviting waters. Jali describes Kilifi’s coastline as nothing short of paradise, with turquoise waters that stretch for miles, making it a haven for ocean lovers and water sports enthusiasts alike. “The Indian Ocean along Kilifi’s coast is warm and welcoming,” he shares. “The gentle waves and clear waters make it ideal for activities like snorkeling and scuba diving, providing an intimate look at the vibrant marine life beneath the surface.”

Jali’s visit to Kilifi included a scuba diving excursion that took him into the heart of the ocean’s colorful coral reefs. “Diving in Kilifi was a surreal experience,” he recalls. “The clarity of the water allows you to see an incredible variety of marine life, from schools of tropical fish to intricate coral formations. It’s a reminder of the beauty that lies beneath the surface, often hidden from our daily view.” This underwater adventure gave Jali a newfound appreciation for Kilifi’s natural resources, which attract both locals and travelers seeking tranquil escapes.

Connecting with Locals and Making New Friends
While Kilifi’s coastline and ocean views were captivating, it was the people and culture that truly enriched Jali’s experience. During his stay, he had the opportunity to meet a local group of friends, Italian expatriates who had retired in Kilifi and made it their home. Their warmth and openness transformed a casual encounter into a genuine connection. “Meeting people who have chosen Kilifi as their place of retirement made me see the town in a new light,” says Jali. “Their stories of moving to Kilifi, drawn by its charm and relaxed pace of life, added a layer of depth to my visit.”

Invited to a dinner hosted by his new Italian friends, Jali had the chance to meet other locals, each with their own unique story and connection to Kilifi. Describing the evening as magical, he recalls how the gathering was filled with laughter, storytelling, and a shared appreciation for the coastal town that had brought them all together. “Sitting at a dinner table surrounded by people from different backgrounds, all united by their love for Kilifi, was an unforgettable experience,” he shares. “It reminded me that travel is not just about seeing new places, but about connecting with the people who call those places home.”
Kilifi’s Appeal to Retirees and Expatriates

Kilifi has become a popular destination not only for travelers but also for expatriates and retirees from around the world who seek a peaceful and fulfilling lifestyle. Its welcoming community, low cost of living, and picturesque surroundings have turned Kilifi into an appealing haven for those looking to settle down. Jali was intrigued by the lifestyle of his Italian friends, who had fully embraced Kilifi’s laid-back pace and found a sense of community among fellow residents. “It’s clear that Kilifi offers something special, a slower, more meaningful way of life where relationships and nature take center stage,” says Jali.

A Memorable Evening in Kilifi
Jali’s dinner with his Italian friends and other locals was filled with warmth and hospitality. Gathered around a table laden with freshly prepared dishes that highlighted the flavors of the coast, the evening offered a perfect blend of local culture and international camaraderie. “Sharing a meal in Kilifi with people from various backgrounds made me realize the town’s unique ability to bring people together,” reflects Jali. “There was something magical about the setting, the sound of the waves in the background, the laughter, and the genuine connection among everyone present.”

This evening in Kilifi provided Jali with a richer understanding of the town’s charm, beyond its natural beauty. For him, it represented the essence of travel: connecting with others, learning from their stories, and finding common ground. “Kilifi has a way of opening your heart and reminding you of the value of meaningful connections,” he says. “It’s these interactions that stay with you long after you’ve left the place.”

Embracing the Spirit of East African Travel
Reflecting on his experiences, Jali encourages travelers to explore Kilifi and the broader East African region with an open mind and a willingness to connect. “East Africa has so much to offer beyond its landscapes,” he emphasizes. “It’s the people, the unexpected friendships, and the shared experiences that make traveling here so transformative.” Jali’s time in Kilifi highlights his belief that the true beauty of travel lies in the stories we collect along the way and the connections we make with others.

For those considering a trip to Kilifi, Jali’s advice is to embrace both the adventure of the ocean and the warmth of its community. “Let Kilifi surprise you,” he suggests. “Spend time with the locals, share a meal, and take in the simple joys that make this place unforgettable. It’s a destination that will stay with you long after you’ve left its shores.”

To learn more visit: http://ammarjali-travel.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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