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CMS (867.HK/8A8.SG): Ruxolitinib Phosphate Cream Obtained China NDA Approval, Becoming The First and Only Targeted Drug for Vitiligo in China

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3 months ago

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SHENZHEN, CHINA – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that its subsidiary, Dermavon Holdings Limited (“Dermavon”, an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement published by the Group on 22 April 2025 for details) received approval from the National Medical Products Administration of China (NMPA) on 30 January 2026 for the New Drug Application (NDA) of ruxolitinib phosphate cream (the “Product”) for the treatment of non-segmental vitiligo with facial involvement in children aged 12 years and older and adult patients. It is the first and only targeted drug approved in China for vitiligo, addressing a significant unmet clinical need.

Ruxolitinib phosphate cream is the first and only drug approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for repigmentation in nonsegmental vitiligo[1,2]. Prior to receiving formal NDA approval, the Group benefited from the “Early and Pilot Implementation” policy granted to the Hainan Free Trade Port and Lecheng Pilot Zone (“Lecheng Pilot Zone”), the “Hong Kong and Macau Medicine and Equipment Connect” policy, and the clinically urgently needed imported drug policies of the Beijing and Tianjin Free Trade Zones, and had already initiated the pilot application of ruxolitinib phosphate cream. Currently, Boao Super Hospital has prescribed ruxolitinib phosphate cream to over 7,000 patients with non-segmental vitiligo, and more than twenty hospitals in Guangzhou, Shenzhen, Dongguan, Foshan, Zhongshan, Zhuhai, Jiangmen, Huizhou, Beijing and Tianjin have provided prescription services for the Product, demonstrating its clinical potential.

The product has shown positive results in both overseas clinical studies and the real-world study in China: in two identical Phase III double-blind, randomized, placebo-controlled studies (TRuE-V1 and TRuE-V2) conducted overseas, the proportion of patients achieving the primary efficacy endpoint of at least 75% improvement in the Facial Vitiligo Area Score Index (F-VASI 75) after 24 weeks of treatment with ruxolitinib phosphate cream was 29.9% in both studies, significantly higher than the 7.5% and 12.9% in the placebo groups, respectively. Continued use up to 52 weeks showed sustained repigmentation[3]. In accordance with the relevant regulations of the Lecheng Pilot Zone’s real-world data application pilot project, ruxolitinib phosphate cream underwent real-world study in China, demonstrating positive efficacy consistent with the results of overseas pivotal clinical studies. All secondary efficacy endpoints in both domestic and overseas clinical studies showed a benefit trend consistent with the primary efficacy endpoint, and the treatment effect for vitiligo continued to improve with prolonged treatment. Furthermore, according to safety monitoring data from the Lecheng Pilot Zone, no new safety event was identified, no adverse event (AE) leading to discontinuation or withdrawal of treatment occurred, and no study drug-related serious adverse event (SAE) occurred.

This approval in vitiligo brings new hope for treatment to over 10 million vitiligo patients in China, addressing urgent clinical needs. At the same time, it will add to Dermavon’s product portfolio in the field of skin treatment, potentially synergizing with Dermavon’s commercialized innovative drug ILUMETRI (tildrakizumab injection), commercialized exclusive drug Hirudoid (mucopolysaccharide polysulfate cream), and a series of innovative drugs under development and dermatological skin care products, in terms of expert network and market resources, thereby potentially enhancing Dermavon’s position in the field of skin health.

Furthermore, the Phase III clinical trial in China of ruxolitinib phosphate cream for the treatment of mild to moderate atopic dermatitis (AD) has achieved positive results. Currently, the Group is actively advancing the NDA for ruxolitinib phosphate cream for the treatment of AD in China, which, if approved, will provide a new treatment option for a broader patient population with AD in China.

About Vitiligo

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 10.3 million vitiligo patients in China and non-segmental vitiligo patients account for approximately 8.2 million[4]. Existing therapies, such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), have clinical limitations, with adverse reactions or limited efficacy with long-term use. The NDA approval of ruxolitinib phosphate cream successfully fills the gap in targeted drug treatment for vitiligo and is of great landmark significance. 

More About Ruxolitinib Phosphate Cream

Ruxolitinib phosphate cream (Opzelura®), a novel cream formulation of the selective JAK1/JAK2 inhibitor ruxolitinib developed by Incyte, is approved for the topical treatment of nonsegmental vitiligo in adult and patients aged 12 years and older, and for the short-term and non-continuous chronic treatment of mild to moderate AD in patients aged 2 years and older without immunodeficiency in the U.S. In Europe, ruxolitinib phosphate cream is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

The Group, through a subsidiary of Dermavon entered into a Collaboration and License Agreement with Incyte for ruxolitinib phosphate cream on 2 December 2022, obtaining 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 (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The subsidiary of Dermavon has sublicensed the relevant rights for the Product outside Mainland China to the Group (excluding Dermavon and its subsidiary).

Incyte has worldwide rights for the development and commercialization of ruxolitinib phosphate cream, 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 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. The U.S. FDA approval information can be found on the Incyte official website, as follows:

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream

  1. The EMA approval information can be found on the Incyte official website, as follows:

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar

  1. The clinical studies information can be found on the Opzelura® official website, as follows:

https://www.opzelura.com/opzelura-prescribing-information

  1. China Insights Consultancy’s industrial report

 

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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Valetax Enhances Leadership Team with Appointment of John Taylor as CCO

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7 hours ago

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May 6, 2026

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Singapore, 6th May 2026, ZEX PR WIRE — Valetax has appointed John Taylor as Chief Commercial Officer (CCO), a move aimed at reinforcing its global commercial framework and supporting the company’s next stage of expansion.

John brings over 25 years of experience in global financial markets, with a background spanning senior leadership roles across Tier 1 investment banks and leading CFD brokerages. He has held board level positions including CEO, COO, CIO, and CFO, providing him with a well-rounded perspective on both strategic direction and operational execution.

Over the course of his career, John has worked across more than 20 countries and has been involved in growth initiatives across regions including MENA, South Africa, Brazil, India, Europe, and Southeast Asia. His experience includes business expansion, cross-border integration, and the development of operations in high growth markets, as well as involvement in mergers and acquisitions and post-acquisition integration.

In his new role, John will be responsible for leading Valetax’s global commercial strategy, with a focus on strengthening market structure, developing partnership networks, and aligning commercial initiatives with product and client experience priorities.

Viktor, CEO of Valetax, commented:
 “Bringing John into the business reflects our continued focus on building a strong and disciplined commercial organisation. His experience across international markets and leadership roles will support our efforts to scale effectively while maintaining a clear strategic direction.”

John Taylor said:
 “Valetax has established a solid platform, with a clear focus on technology, product, and client experience. There is a strong opportunity to further develop its commercial structure and expand its reach across key markets. I look forward to working with the team as the company continues to grow.”

The appointment underscores Valetax’s commitment to strengthening its leadership team as it continues to expand globally and enhance its offering as a technology focused brokerage.

About Valetax

Valetax is a global multi asset brokerage delivering a technology driven trading experience. The company offers advanced infrastructure, competitive conditions, and scalable solutions for traders and partners, with a focus on transparency, performance, and innovation.

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Creeper Defeater Announces Skeeter Weeper 2.0, the Next Generation Smart Mosquito Fogging and Misting System

Published

7 hours ago

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May 6, 2026

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The new upgraded system delivers smarter app controls, expanded coverage, faster setup, and a more advanced plant powered formula designed to help families reclaim outdoor living.

United States, 6th May 2026 – CREEPER DEFEATER today announced the launch of Skeeter Weeper 2.0, the latest evolution of its smart mosquito fogging and misting system engineered to help homeowners defend outdoor spaces against mosquitoes and other pests without relying on harsh chemical pesticides. Building on the success of the original Skeeter Weeper system, the new 2.0 model introduces expanded smart functionality, enhanced treatment performance, improved convenience, and a refined natural formula designed for modern outdoor living. 

Skeeter Weeper 2.0 was developed to give homeowners greater control over pest management while prioritizing safety for families, pets, pollinators, and outdoor environments. The upgraded system combines app controlled precision fogging with a proprietary plant powered concentrate formulated to repel and eliminate mosquitoes, flies, gnats, fleas, ticks, no see ums, mites, aphids, and additional outdoor pests. 

“Outdoor spaces should feel relaxing and enjoyable, not overrun by mosquitoes and chemical heavy solutions,” said a spokesperson for CREEPER DEFEATER. “Skeeter Weeper 2.0 represents a major leap forward in smart outdoor pest defense. We focused on making the system more powerful, easier to use, and more compatible with the way families want to live outdoors today.”

Among the most significant upgrades in Skeeter Weeper 2.0 is its enhanced smart control platform. Homeowners can activate treatments directly from their smartphones and customize misting durations from as little as 10 seconds up to two minutes depending on weather conditions, infestation levels, and pest activity. The system allows users to control treatments remotely, helping create a more flexible and responsive pest management experience. 

The new generation system also expands scalable yard protection. Each additional unit is capable of adding approximately 1,000 square feet of treatment coverage, allowing users to customize protection for patios, pools, gardens, fences, entertainment areas, and larger outdoor properties. 

Designed with simplicity in mind, Skeeter Weeper 2.0 installs in under 10 minutes directly out of the box, eliminating the need for complicated professional installation often associated with traditional mosquito misting systems. 

At the core of Skeeter Weeper 2.0 is CREEPER DEFEATER’s upgraded proprietary eight ingredient formula featuring Lemon Balm, Frankincense Resin, Cedarwood Oil, Soy Oil, Thyme Oil, Geraniol, Mild Soap, and naturally occurring Vitamin E. The company states the new, optimized formula is four times more concentrated than leading competitors while excluding common ingredients considered problematic for pets or pollinators, including vinegar, alcohol, garlic, peppermint oil, and citronella oil. 

The formula was specifically developed to align with EPA FIFRA 25(b) minimum risk pesticide standards and avoid synthetic neurotoxins commonly associated with conventional mosquito control systems. According to CREEPER DEFEATER, the system is designed to be pet safe, child conscious, garden friendly, and pollinator conscious when used as directed. 

Skeeter Weeper 2.0 also introduces improved treatment flexibility. Users can target mosquito activity during key peak periods such as dawn and dusk or activate treatments immediately before outdoor gatherings. The ultra fine mist is designed to settle and blanket the treatment zone within approximately five minutes, helping the formula reach hard to access areas including nooks, crannies, moisture collection points, dense landscaping, and other environments where mosquitoes and pests commonly breed and hide.

Regular treatment cycles are designed to help interrupt mosquito breeding and reduce pest populations over time while maintaining short term protection for up to six hours depending on environmental conditions. 

As part of the launch, every Skeeter Weeper 2.0 system includes a complimentary on body bug spray and a free bottle of repellent concentrate with a refill plan purchase.

The launch comes amid growing consumer demand for alternatives to harsh chemical pesticides.

Skeeter Weeper 2.0 is proudly assembled in Dallas, Texas and is now available through CREEPER DEFEATER.

For more information visit CREEPER DEFEATER online or email Hello@CreeperDefeater.com.

ABOUT CREEPER DEFEATER

CREEPER DEFEATER develops premium natural pest control solutions designed to help homeowners protect indoor and outdoor spaces using plant powered ingredients and smart application systems. The company focuses on creating products that balance effectiveness, convenience, and safety for people, pets, and pollinators. 

Media Contact:

CREEPER DEFEATER
Media Relations Department
Dallas, Texas
Website: Visit CREEPER DEFEATER

Media Contact

Organization: Creeper Defeater

Contact Person: Support team

Website: https://creeperdefeater.com/

Email: Send Email

Country:United States

Release id:44764

The post Creeper Defeater Announces Skeeter Weeper 2.0, the Next Generation Smart Mosquito Fogging and Misting System 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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Press Release

Creeper Defeater Announces Critter Cannon 2.0, an Upgraded Liquid Repellant Dispenser for Targeted, Pet-friendly Pest Control

Published

8 hours ago

on

May 6, 2026

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The new handheld shooter features improved water-resistant formula performance, precision application, and a flexible refill program designed to help homeowners manage pests more effectively.

United States, 6th May 2026 – CREEPER DEFEATER today announced the launch of Critter Cannon 2.0, an updated liquid pest control dispenser engineered to give homeowners a more controlled and efficient way to manage unwanted pests without relying on harsh chemical pesticides. Building on the original Critter Cannon, the new 2.0 model introduces improved outdoor durability, enhanced application control, and an optimized plant-based formula designed for real-world conditions.

Critter Cannon 2.0 was developed to provide a more precise and responsive pest control experience while maintaining a strong focus on safety for pets, families, and the surrounding environment. The system combines a rechargeable electric handheld sprayer with an upgraded liquid repellant solution designed to deter a wide range of common pests in targeted areas such as gardens, patios, fence lines, and property perimeters.

“Pest control should be effective without being excessive or complicated,” said a spokesperson for CREEPER DEFEATER. “Critter Cannon 2.0 gives users a simple, controlled way to apply treatment exactly where it’s needed, with a formula designed to perform outdoors while remaining considerate of pets and the environment. It’s also a whole lot of fun to use!”

The Critter Cannon 2.0 features a dual-capacity system, including a high-capacity drum and a smaller magazine, allowing users to adapt to different treatment sizes and scenarios. The device delivers consistent bursts of liquid repellant at the push of a button, offering more control and accuracy compared to traditional spray methods.

At the core of the system is the upgraded Critter Cannon Ammo, an enhanced version of CREEPER DEFEATER’s plant-based pest control formula. The new formulation is designed to be more water-resistant, helping maintain effectiveness in outdoor conditions while reducing the need for frequent reapplication.

The formula avoids synthetic pesticides as well as commonly used natural irritants such as vinegar, alcohol, and peppermint. Instead, it uses a blend of plant-based ingredients including lemon balm, frankincense resin, cedarwood oil, soy oil, thyme oil, and geraniol, a compound naturally found in rose oil. A mild soap aids in even dispersion, while vitamin E serves as the preservative.

According to CREEPER DEFEATER, the upgraded solution is designed to deliver strong repellant performance while remaining safe for use around dogs and cats when used as directed, and considerate of pollinators and outdoor environments. The higher concentration of active ingredients is intended to provide improved performance compared to many conventional products that rely on harsher or more irritating components.

To support consistent use, CREEPER DEFEATER offers a subscription refill program for Critter Cannon Ammo. This program allows customers to receive refills on a regular schedule, helping maintain treatment consistency without the need for manual reordering.

The Critter Cannon system is assembled in the United States, reflecting the company’s focus on quality control and responsible manufacturing.

CREEPER DEFEATER also continues to support a broader mission beyond pest control. Ten percent of company profits are dedicated to initiatives focused on combating online predators and supporting safer communities through prevention, education, and resources for individuals and families.

Critter Cannon 2.0 is now available through CREEPER DEFEATER.

For more information visit CREEPER DEFEATER online or email Hello@CreeperDefeater.com.

ABOUT CREEPER DEFEATER
CREEPER DEFEATER develops premium natural pest control solutions designed to help homeowners protect indoor and outdoor spaces using plant-based ingredients and smart application systems. The company focuses on creating products that balance effectiveness, convenience, and safety for people, pets, and pollinators.

Media Contact:

CREEPER DEFEATER
Media Relations Department
Dallas, Texas
Website: Visit CREEPER DEFEATER

Media Contact

Organization: Creeper Defeater

Contact Person: Support team

Website: https://creeperdefeater.com/

Email: Send Email

Country:United States

Release id:44765

The post Creeper Defeater Announces Critter Cannon 2.0, an Upgraded Liquid Repellant Dispenser for Targeted, Pet-friendly Pest Control 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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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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