Neovii and Fosun Pharma Enter into an Exclusive Agreement for Development and Commercialization for Grafalon in China
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ST. GALLEN, Switzerland, Sept. 07, 2022 (GLOBE NEWSWIRE) — Neovii Pharmaceuticals AG (“Neovii”), a Swiss based global specialty-care biopharmaceutical company, and Shanghai Fosun Pharmaceutical Industry Development Co. Ltd (“Fosun Pharma Industry”), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”, Stock Code: 600196.SH, 02196.HK), a global pharmaceutical and healthcare industry group deep-rooted in China, have entered into an exclusive agreement (the “Agreement”), under which Neovii has granted Fosun Pharma Industry an exclusive license to develop and commercialize Neovii’s Grafalon® (rabbit anti-human T-lymphocyte globulin, ATLG) in Chinese Mainland, Hong Kong SAR, Macau SAR and Taiwan region.
Under the Agreement Neovii is entitled to receive upfront, regulatory and commercial sales milestones as well as proceeds from supplying Grafalon® to Fosun Pharma Industry.
The parties’ aim is to firstly strengthen Grafalon’s position in the field of transplantation medicine in China, in which it is already approved for marketing and included in China’s National Reimbursement Drug List. Further, the Agreement entails clinical development to expand Grafalon’s regulatory approval in China to the prevention of Graft versus Host Disease following allogenic stem cell transplantation (“SCT”), so as to align its approved usages in China with those in Europe and other countries worldwide. Additional objective is to evolve Grafalon’s usages from transplantation medicine to auto-immune and onco-hematology conditions, where Grafalon has the potential to positively-transform the lives of patients suffering from severe diseases with high unmet need. The Agreement also sets the foundation to expand the cooperation to additional products of Neovii, starting from NB-15, a novel, clinical-stage therapy that is under development for the treatment of Mitochondrial neurogastrointestinal encephalomyo-pathy (MNGIE), an ultra-rare, devastating and uniformly fatal disorder.
Wen Deyong, CEO of Fosun Pharma said: “Grafalon has an excellent effect in solid organ transplant recipients, especially those with a high risk of rejection. We are very pleased to be working with Neovii to bring this product into China. Going forward, we will leverage our advantages in nephrology and hematology and more areas to make the medicines accessible to patients and benefiting more Chinese patients.”
Dr. Christian Loss, CEO of Neovii said: “As a leading global pharmaceutical and healthcare industry group in China, Fosun Pharma is the ideal partner to develop and commercialize Grafalon in China. This collaboration positions Grafalon for sustained growth in China and advances the development in stem cell transplant and beyond as in devastating auto-immune and other diseases. We look forward to working with Fosun Pharma to bring Grafalon to more patients in-need in China.”
Neovii was supported by Marshal Ma of Link China Pharma Solutions (Cambridge, UK based), who gave valuable help in the negotiation process.
Grafalon® (Rabbit anti-human T-lymphocyte globulin, ATLG, formerly also known as “ATG-Fresenius S” and “ATG-F”) was developed by Neovii and is used to improve patients’ outcomes in transplantation medicine in more than 50 countries and, in selected countries, also to treat aplastic anemia. With more than 250,000 treated patients, 30 years of clinical experience and leadership position in many countries, Grafalon® has transformed the way transplant teams manage the care of their patients and is uniquely addressing significant unmet needs. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.
Neovii is a Swiss-based, global, fully integrated, rapidly-growing, commercial-stage, specialty-care biopharmaceutical company with sales in more than 50 countries. Neovii has a proven track-record of over more than three decades in pursuing its mission to bring novel life-transforming therapies to patients that suffer from devastating conditions with significant unmet medical needs. Neovii is a member of the Neopharm Group that, through its family of companies, is engaged in research, development and commercialization of a broad range of products and added-value services in three major segments: Pharmaceutical, Medical and Consumer Healthcare, with revenues exceeding $500 million and more than 1,000 employees worldwide.
Cautionary Note on Forward-Looking Statements
This press release, the statements herein or those of representatives and partners of Neovii related thereto contain, or may contain, among other things, certain “forward-looking statements”. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Neovii’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” or similar expressions. These statements are based upon the current beliefs and expectations of Neovii’s management and are subject to significant risks and uncertainties. Actual results (including, without limitation, those relating to the SCT approval in China) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Neovii’s control). Neovii undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, as well as central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, gene therapy, ADC and PROTAC, to enhance its innovation capabilities.
Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth”, with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.
For more information, please visit Fosun’s official website: www.fosunpharma.com.
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