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  • Zhejiang Medical Technology Development Co., Ltd.

    2020 year
    04
    24 day
    WINHEALTH PHARMA AND CLINUVEL SIGNED COLLABORATION AGREEMENT TO INTRODUCE SCENESSE® TO CHINA

    喜讯丨维健医药与CLINUVEL 就SCENESSE(R)引入中国达成合作协议


    Hangzhou, China and Melbourne, Australia, 24 April 2020

     

    HK WinHealth Pharma Group (hereafter referred to as “WinHealth Pharma”) and CLINUVEL signed a cooperation agreement on SCENESSE®, a new drug for treating the erythropoietic protoporphyria (EPP), indicating the first cooperation in the rare disease field.


    Through WinHealth Pharm and its subsidiaries, the Australian-based company CLINUVEL will launch SCENESSE® (afamelanotide 16mg) in the People’s Republic of China for the treatment of the rare genetic metabolic disorder erythropoietic protoporphyria (EPP).1 

     

    It is estimated that 5,000 Chinese residents live with EPP, while no therapy has been approved prior to SCENESSE®.

     

    EPP is an inherited disorder which causes debilitating burns and internal tissue damage whenever patients expose themselves to visible light, particularly sunlight. Patients will suffer severe skin pain and lesions, and  are thus forced to live indoors, deprived from birth of social contacts and a normal life.

     

    The innovation SCENESSE® was approved by the European Medicines Agency (EMA) in October 2014 and by the US Food and Drug Administration (FDA) in October 2019. Before 2014, no systemic photoprotective drug has been approved around the globe.  Afamelanotide, a potent hormone and the active ingredient in SCENESSE®, acts on blood vessels (vaso-active) and reduces swelling (anti-phlogistic) protecting patients against any light source and ultraviolet (UV) radiation.

     

    WINHEALTH PHARMA AND CLINUVEL

    Under an exclusive Collaboration Agreement, Winhealth Pharma and CLINUVEL will cooperate to introduce SCENESSE® to China through WinHealth Pharma and its subsidiaries. CLINUVEL will remain responsible for the pharmacovigilance and safety monitoring of the product, benefiting Chinese EPP patients, guaranteeing their safety and protecting their rights in the same time. . The commercial terms of the collaboration have not been disclosed.

     

    COMMENTARY

    “It has taken some time in selecting a reputable Chinese partner with a firm standing locally, more so to find one who shows the same  vision as we do,” CLINUVEL’s Director of Global Operations, Mr Lachlan Hay said. “In Winhealth Pharma we believe we have identified a trustworthy counterpart who will work towards the same goals as CLINUVEL’s team. The long-term thinking of Winhealth’s management fits well within our horizon.”

     

    “CLINUVEL has gradually become known in our sector for blazing the trail on clinical, regulatory, and reimbursement matters. With the expansion of our R&D facilities in Singapore, we progressively became focussed on China as part of our long-term entry to Asia.”

     

    “EPP is a severe rare disorder in China representing an unmet medical need,” Winhealth’s founder, Chair and CEO, Mr Jack Wang said. “We are very excited about the partnership with CLINUVEL and looking forward to bringing the breakthrough therapeutic into China in the very near future.  As an organisation dedicated to the local development and commercialisation of branded therapeutics in the China region, Winhealth focuses on bringing external innovation from world-reputable firms into the hands of the Chinese patients. We will be working closely with our colleagues at CLINUVEL in order to accelerate the availability of SCENESSE® to the Chinese patients.”

     

    CLINUVEL is a specialty pharmaceutical company focussed on rare and critical diseases with expertise in finance, clinical and regulatory affairs.

     

    WinHealth Pharma is a leading and fast-growing local development and commercialization organization with vast experience in serving international life science firms and knowledge of product registration in the People’s Republic of China.

     

    – End –

     

    1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL’s website at www.clinuvel.com

     

    About CLINUVEL PHARMACEUTICALS LIMITED

    CLINUVEL PHARMACEUTICALS LTD is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 and the US Food and Drug Administration in 2019 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information please go to http://www.clinuvel.com.

     

    SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD.

     

    About WINHEALTH PHARMA GROUP

    WINHEALTH PHARMA GROUP is an innovative pharmaceutical company based in Hong Kong and mainland China focusing on bringing in and commercializing proprietary therapeutics that address areas of severe unmet or underserved medical need in the Greater China market, including rare disorders, respiratory and infectious disease, cardiovascular, hepatology, dermatology and urology.  By providing fully-integrated local development, regulatory and commercialization services to international branded therapeutics, Winhealth has grown to be one of the leading CDCO (Contract Development and Commercialization Organization) organization in China serving more than 10 international companies including Roche, Boehringer-Ingelheim, Pfizer, Kyowa Kirin, Shionogi and Cumberland Pharmaceuticals. Headquartered in Hong Kong, China, WINHEALTH has operation centres and offices in Hangzhou, Shanghai, Beijing, Guangzhou, Hainan, Tokyo and Munich. For more information please go to http://www.winhealth.hk

     

    Forward-Looking Statements

    This release contains forward-looking statements, which reflect the current beliefs and expectations of WinHealth Pharma’s management. Based on expectations and assumptions about the available information, the statements may involve several known and unknown risks that could cause our future results to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks and uncertainties relating to domestic and international macroeconomic conditions such as overall market conditions and changes in interest rates and currency exchange rates, which are particularly applicable to forward-looking statements relating to products. Product risks and uncertainties include, but are not limited to, the completion and termination of clinical trials; obtaining of regulatory approval; statements and concerns about product safety and effectiveness; technical progresses; adverse results of major litigations; medical reform and changes in domestic and foreign laws and regulations. In addition, there are manufacturing and marketing risks for existing products, including but not limited to capacity failure to meet demands, access to raw materials, market entry of competitive products and force majeure. The company undertakes no intention or obligation to update or modify any forward-looking statements, whether as a result of new information, future events or otherwise.


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