News And Events
Neovii and Fosun Pharma Enter into an Exclusive Agreement for Development and Commercialization for Grafalon in China
(September 7, 2022, Rapperswil, Switzerland and Shanghai, China) 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.
About GrafalonGrafalon® (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 40 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. 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.
About NeoviiNeovii 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.
About Fosun PharmaFounded 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 ascentral 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.
Grafalon: 20 mg/ml concentrate for solution for infusion. Active substance: Anti-human T-lymphocyte immunoglobulin from rabbits. Other excipients: Sodium dihydrogen phosphate dihydrate, phosphoric acid (85%), water for injections. Indications: Grafalon is indicated in combination with other immunosuppressive medicinal products for the suppression of immune competent cells, which are the cause for acute rejection or graft-versus-host disease (GVHD). Grafalon is usually administered for the following indications:
• Prevention of acute transplant rejection in patients receiving allogeneic solid organ transplantation (SOT) in combination with other immunosuppressive medicinal products
• Therapy of acute corticosteroid-resistant rejection after allogeneic SOT if the therapeutic effect of methylprednisolone treatment has proven unsatisfactory
• Prevention of graft-versus-host disease (GVHD) in adults with haematological malignancies following stem cell transplantation (SCT) from matched unrelated donors in combination with standard Cyclosporin A/methotrexate prophylaxis. Contraindications:
• Hypersensitivity to the active substance or to any of the excipients
• Patients with bacterial, viral, parasitic or mycotic infections, which are not under adequate therapeutic control
• SOT patients with severe thrombocytopenia, i.e. less than 50,000 platelets/μl
• Patients with malignant tumours except in cases where SCT is performed as part of the treatment. Undesirable effects /
Adverse reactions: Very common: CMV infection, urinary tract infection, anemia, headache, tremor, flushing, dyspnea, vomiting, nausea, diarrhea, abdominal pain, pyrexia, chills. Common: Bacterial sepsis, pneumonia, pyelonephritis, herpes infection, influenza, oral candidiasis, bronchitis, rhinitis, sinusitis, nasopharyngitis, skin infection, lymphoproliferative disorder, pancytopenia, thrombocytopenia, leukopenia, anaphylactic shock, anaphylactic reaction, hypersensitivity, hyperlipidemia, paresthesia, photophobia, tachycardia, hypotension, venoocclusive disease, hypertension, cough, epistaxis, stomatitis, hyperbilirubinemia, erythema, pruritus, rash, myalgia, arthralgia, back pain, musculoskeletal stiffness, renal tubular necrosis, hematuria, asthenia, chest pain, hyperthermia, mucosal inflammation, peripheral edema, blood creatinine increased, Cytomegalovirus antigen positive, C-reactive protein increased.
Uncommon: Catheter site infection, Epstein-Barr virus infection, gastrointestinal infection, erysipelas, wound infection, polycythemia, fluid retention, hypercholesterolemia, shock, lymphocele, reflux esophagitis, dyspepsia, drug eruption, renal failure, renal necrosis, edema, hepatic enzymes increased. Of special interest: Cytokine release related symptoms are frequently observed. Hypersensitivity reactions and hematological changes (thrombocytopenia, leukopenia) are commonly observed. Anemia is very commonly observed. The occurrence of anaphylaxis/anaphylactic shock requires immediate termination of the infusion.
Patients treated with immunosuppressive regimens have an increased susceptibility to infections. In the first year after SOT, the majority of patients who received Grafalon developed infections of bacterial, viral or mycotic origin. The incidence of malignancy occurring after Grafalon treatment is generally low across studies and publications and is comparable with the incidence observed with other combinations of immunosuppressive medications. Rare cases of hemolysis were reported in connection with Grafalon administration and were fatal in isolated cases. Currently available data on the paediatric population are limited. Available information indicates that the safety profile of
Grafalon in paediatric patients is not fundamentally different to that seen in adults. Further information: Medicinal product subject to medical prescription. For more detailed information and information on posology and method of administration refer to full prescribing information. Warning: Keep out of the sight and reach of children.
Please refer to the nationally approved product information of your country. Marketing Authorisation Holder: Neovii Biotech GmbH, Am Haag 6+7, 82166 Gräfelfing, Germany. Revision Date: 24 June 2022. Source: DE_Grafalon_SPC 02/2022_EN. ID-Number: 1690/A/20220624/GRAF/1