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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, CHINA – China 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[2、3]. 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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Richy Media Revolutionizes PR with Advanced Newswire Publishing and Customized Distribution Solutions

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October 18, 2024

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Richy Media is an award-winning press release distribution and newswire publishing company that is transforming the way businesses connect with their target audiences. With a commitment to innovation and customer satisfaction, Richy Media offers a comprehensive suite of services designed to amplify brand messaging and achieve exceptional news outlets placements.

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“In today’s dynamic media world, PR communication is paramount,” says Karlo Bilal, Founder & CEO @ Richy Media. “We are passionate about growing businesses with media technology and expertise they need to share their stories and achieve their PR objectives.”

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About Our Company

Richy Media is a press release distribution and newswire publishing company dedicated to helping businesses achieve their communication goals. With a focus on innovation, customer satisfaction, and a results-oriented strategy, we empower businesses to connect with their target audiences and amplify their brand message.

Contact information:

Karlo Bilal, Founder & CEO @ Richy Media

pr@richymedia.com

https://richymedia.com

Operations: Worldwide

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A Green Future Driven by Solar photovoltaic SPUSDT Solar PV Adoption

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October 18, 2024

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As the global climate crisis intensifies, more and more countries and regions recognize that promoting and adopting clean energy has become a key means of combating climate change. Among the various renewable energy technologies, solar photovoltaic (PV) stands out for its cost-effectiveness and environmental benefits, becoming a vital driver of the global energy transition. However, achieving global solar PV adoption requires not only technological advancements but also the establishment of industry standards, regulatory frameworks, and international cooperation. As a leading blockchain energy trading platform, SPUSDT is dedicated to promoting the global adoption of solar PV and providing innovative technical and regulatory solutions to ensure the sustainable development of the industry.

The Key to Global Adoption: Lowering Barriers and Enhancing Market Access

To achieve global solar PV adoption, the first challenge is to reduce market entry barriers. In traditional energy markets, the cost of participating in solar energy production and trading is often high, particularly for small and medium-sized enterprises (SMEs) and individual users. The complexity of installing solar systems and engaging in energy trading can be overwhelming. SPUSDT addresses these challenges through decentralized blockchain technology, significantly lowering these barriers. With SPUSDT, any individual or business can easily participate in solar energy trading, regardless of their generation capacity. They can directly connect with global consumers or investors through the platform, enabling swift and efficient energy transactions. This streamlined market entry mechanism not only reduces transaction costs but also improves energy efficiency, accelerating the widespread adoption of solar PV.

In addition, SPUSDT integrates with the USDT stablecoin to ensure price stability in energy transactions. This allows global users to avoid the volatility of the cryptocurrency market and secure more stable returns. This trading model attracts more investors into the solar PV market, further promoting the adoption and application of solar energy.

Establishing Industry Standards: Promoting Solar PV Standardization

In the global promotion of solar PV, establishing unified industry standards and norms is a crucial step. Solar system installation, operation, and maintenance must adhere to strict technical standards to ensure safe and efficient electricity generation. However, the global solar PV industry currently lacks consistent technical regulations, with different regions imposing varying installation standards and quality requirements. This inconsistency limits the widespread adoption of solar PV. SPUSDT actively promotes the establishment and dissemination of industry standards, aiming to create uniform regulations for the global solar PV market.

SPUSDT also plans to collaborate with international standardization organizations to drive the global unification of solar PV-related technical standards. For instance, the platform will work with bodies like the International Electrotechnical Commission (IEC) and the International Renewable Energy Agency (IRENA) to promote best practices in solar system installation, generation, transmission, and maintenance. This global standardization effort will help reduce market barriers and foster cross-border energy trading and cooperation.

International Regulation: Ensuring Compliance and Transparency in Solar PV Trading

As the solar PV market rapidly expands, international regulatory issues become increasingly important. The global adoption of solar PV requires more than technological breakthroughs; it also demands transparency and regulatory compliance in the market. To this end, SPUSDT implements multi-level international regulatory measures, ensuring that every transaction complies with relevant laws and regulations, thereby protecting market participants’ rights.

Firstly, SPUSDT collaborates closely with governments and regulatory bodies worldwide, ensuring its operations comply with local energy and financial regulatory frameworks. The platform has established a dedicated compliance team that monitors policy changes across different regions in real time. Based on the specific legal requirements of each country or region, the platform adjusts its operational processes accordingly. Whether in Europe, Asia, or North America, SPUSDT strictly adheres to local energy and financial regulations, ensuring that platform users can trade within a legal framework.

Moreover, the platform leverages the transparency and immutability of blockchain technology to create a robust audit and traceability system. Every transaction, every solar PV system’s generation data, and every energy delivery is meticulously recorded on the blockchain, ensuring that all transactions are open and transparent. This transparent record-keeping system not only helps users track the source of their energy but also provides regulators with powerful market oversight tools. Through these measures, SPUSDT ensures the compliance and transparency of global solar PV trading, fostering the healthy development of the market.

Promoting International Cooperation: Facilitating Global Solar Energy Connectivity

To further accelerate the global adoption of solar PV, SPUSDT actively promotes international cooperation and collaboration. The platform utilizes cross-chain technology to seamlessly connect with other blockchain networks, enabling users from different countries and regions to engage in cross-border energy trading freely. Cross-chain technology breaks down traditional geographic barriers in energy markets and fosters global energy market connectivity, providing the technical support necessary for the global expansion of solar PV.

Additionally, SPUSDT plans to collaborate with multiple international clean energy funds, green investment institutions, and multilateral development banks to advance project financing and development for solar PV. Through these partnerships, the platform will attract more international investors to participate in the construction of large-scale solar PV projects worldwide. This international cooperation will not only accelerate the adoption of solar PV but also contribute significantly to achieving global sustainable development goals.

The launch of the SPUSDT platform marks not only a significant innovation in solar energy trading but also a critical step toward global solar PV adoption. By lowering market entry barriers, establishing unified industry standards, enhancing international regulatory cooperation, and fostering global market connectivity, SPUSDT provides comprehensive technical and policy support for the future development of the global clean energy market. As solar PV continues to be widely adopted around the world, SPUSDT is poised to become a driving force in the global renewable energy market, contributing to the realization of a green future.

Contact name: Saif

Company name: HRG

Website https: https://hrginvestment.com/

Country: UAE

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ZainTECH and Urbi Forge Strategic Partnership to Drive Geospatial Innovation across the MENA Region

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October 18, 2024

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  • The agreement was signed at GITEX Global 2024, to integrate Urbi’s refined geospatial insights with ZainTECH’s digital expertise
  • Partnership will  see the companies drive substantial improvements across key sectors including environmental sustainability, transportation, real estate development, security, risk management, and healthcare.

Nahla Elbanhawy – MEA Business Development Manager, Urbi, Youssef Hindy – Account Manager, Urbi, Mohammed Al Beloushi – Deputy CEO, Urbi, Alexander Sysoev – Co-Founder, Urbi, Andrew Hanna – CEO, ZainTECH, Pavel Mochalkin – CEO, Urbi Maatje Rencken –  VP Digital Solutions, ZainTECH, Amr Elenein – CCO, Urbi

Dubai, United Arab Emirates, 18th October 2024, ZainTECH, the integrated digital solutions provider of Zain Group today announced signing a  memorandum of understanding (MoU) with Urbi,  the developer of a cutting-edge geo-platform that integrates all the necessary data, algorithms, and tools to address challenges in mapping, location data, navigation, and spatial analysis, aimed at merging Urbi’s refined geospatial insights with ZainTECH’s digital expertise. 

Signed at GITEX Global in Dubai, where ZainTECH is an exhibitor for the second year in-a-row, and has a stand located in Hall 21, Stand C10, the partnership will provide the region with innovative geospatial solutions as ZainTECH looks to leverage its innovative digital solutions with Urbi’s specialized geospatial capabilities. Urbi’s expertise in geospatial services, combined with ZainTECH’s robust digital solutions, will enhance ZainTECH’s ability to tackle complex regional issues by integrating sophisticated mapping and analytics with cutting-edge digital technology.

Andrew Hanna, CEO of ZainTECH commented, “Urbi has numerous compelling capabilities that could support the further upliftment of some of our solutions. The ability to have the highest quality geospatial information available in a secure, quick, and reliable manner is an extremely valuable proposition, and we look forward to integrating such resources across our portfolio of offerings.”

Pavel Mochalkin, CEO of Urbi said, “Partnering with ZainTECH marks a significant milestone for Urbi as we strive to redefine geospatial innovation in the MENA region. This collaboration will enhance our capacity to leverage geospatial technology, significantly expanding the opportunities for businesses and governments to experience the benefits of our services. Ultimately, it will help bring-to-life our vision of transforming everyday scenarios into a winning, transformative reality.” 

The collaboration is also set to leverage ZainTECH’s capabilities in emerging technologies such as AI, blockchain, and IoT, which are crucial for developing next-generation geospatial solutions. This aligns with Urbi’s focus on using innovative technologies to enhance spatial data utilization and smart city applications. Thus together, the companies are looking to drive substantial improvements across key sectors such as environmental sustainability, transportation, real estate development, security, risk management, and healthcare

With a joint commitment to environmental sustainability, ZainTECH’s involvement in smart building technologies and sustainability assessments, combined with Urbi’s focus on sustainable urban and environmental planning, will enhance their capacity to deliver eco-friendly and efficient solutions.

During GITEX Global, Jad Hammoud ZainTECH Vice-President – GTM, Alliances and Revenue Marketing and Patrik Eriksson, Director of Data Technology & Delivery, presented a compelling overview at Urbi’s stand, revealing the innovative digital strategies planned for the region. 

Both ZainTECH and Urbi look forward to implementing their joint strategies and witnessing the transformative impact of their solutions. 

About ZainTECH

ZainTECH is a regional integrated digital solutions provider, unifying Zain Group’s ICT assets to offer a unique value proposition of comprehensive digital solutions and services under one roof. The company is positioned to drive the transformation of enterprise and government customers in the MENA region by providing a center of excellence and managed solutions across the ICT stack, including cloud, cybersecurity, big data, IoT, AI, smart cities, drones and robotics, and emerging technologies.

ZainTECH leverages Zain’s global reach, unique regional footprint, and infrastructure across its operations in Kuwait, Saudi Arabia, Bahrain, Jordan, Iraq, and the United Arab Emirates, as well as in other key markets in the Middle East.

ZainTECH forms a key pillar in the evolution of Zain’s core telecom business to maximize value and build on the company’s many strengths to selectively create and invest in growth verticals beyond standard mobile services. This ultimately supports Zain’s vision of becoming a leading ICT and digital lifestyle provider.

For more information, please visit www.zaintech.com

About Urbi

Urbi is a global leader in geo-intelligence, providing cutting-edge solutions for smart cities, urban planning, and navigation. With a focus on data accuracy and innovation, Urbi empowers governments and organizations to make informed decisions and optimize urban infrastructure. To learn more, please visit www.urbi.ae

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