Expand product pipeline, Baiji Shenzhou wins two more orphan drugs

January 13, 2020 / Meitong news agency / -- EUSA Pharma (hereinafter referred to as EUSA) and Baiji Shenzhou announced on January 13 that they had reached an exclusive development and commercialization agreement on the orphan biological preparation drugs sylvant ® (stauximab) and qarziba ® (dinutuximab beta) in Greater China According to the terms of the agreement, EUSA has authorized the right of Baiji Shenzhou to develop and commercialize sylvant ® in Greater China and qarziba ® in mainland China Under the terms of the agreement, Baiji Shenzhou will fund and take over the clinical development and Drug Administration declaration of the above drugs in these areas EUSA will receive an advance payment and will be eligible for payment up to a total of US $160 million when the drug administration and commercialization milestones are reached EUSA will also be eligible for tiered royalties for future product sales "Our team is looking forward to working with EUSA to develop sylvant and qarziba commercially," said Dr Wu Xiaobin, general manager and President of Baiji China In countries and regions outside China, patients with rare diseases have benefited from these two important biological agents This cooperation also further demonstrates our determination to bring high-quality drugs to patients in China and the world " Lee Morley, CEO of EUSA Pharma, commented: "today's exclusive cooperation agreement with Baiji Shenzhou is an important milestone in our commitment to bring new cancer and rare disease treatment to patients all over the world Baiji Shenzhou has unique development and commercialization capabilities in China, focusing on bringing innovative targeted tumor drugs to patients In the coming months, we look forward to working together to ensure that patients in China also benefit from these two important orphan drugs " Sylvant ® is currently approved in more than 40 countries around the world for the treatment of idiopathic multicentric Castleman disease (IMCD), a rare and life-threatening orphan indication of failing lymphoid hyperplasia Qarziba ® is the only targeted tumor immunotherapy approved by the European Drug Administration (EMA) for the treatment of high-risk neuroblastoma Neuroblastoma is a kind of invasive neoplasm, and it is the most common solid tumor originated outside the brain in children Both drugs have obtained the fast track approval qualification of China National Drug Administration (nmpa), and are in line with the review and approval procedures for overseas new drugs urgently needed in clinical practice Jefferies International LLC is the exclusive advisor to EUSA for this transaction About qarziba ® (dinutuximab beta) qarziba ® is a monoclonal antibody that binds to a specific target of gD2 overexpressed on neuroblastoma cells Dinutuximab beta was approved by the European Commission in 2017 for the treatment of high-risk neuroblastoma patients over one year old who had previously received induction chemotherapy and achieved partial remission, followed by myeloablative treatment and stem cell transplantation, or patients with recurrent or refractory neuroblastoma, regardless of residual lesions Before the treatment of recurrent neuroblastoma patients, appropriate measures should be taken to stabilize the progress of any disease Dinutuximab beta should be used in combination with interleukin-2 (IL-2) in relapsed / refractory patients and patients who have not achieved complete remission after first-line treatment About sylvant ® (stuximab) sylvant ® is a monoclonal antibody, which is used to block the activity of IL-6 in patients with IMCD Sylvant ® has been approved in many countries and regions for the treatment of multicentric Castleman disease (MCD) patients with negative human immunodeficiency virus (HIV) and negative human herpesvirus-8 (HHV-8) IMCD is a rare and life-threatening lymphoproliferative disease, which can produce abnormal proliferation of immune cells, and has many similarities with lymphoma in symptoms and histological characteristics About EUSA Pharma, founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focusing on cancer and rare diseases The company has large-scale commercial operations in the United States and Europe, as well as a certain scale in several other markets around the world EUSA Pharma's management team is experienced and has successfully established many pharmaceutical enterprises EW healthcare partners, the company's main investor, has provided strong capital For more information, please visit www.eusapharma.com About Baiji Shenzhou Baiji Shenzhou is a global, commercial stage, R & D-based biotechnology company, focusing on the research and development of molecular targeting and immunotumor therapy At present, Baiji Shenzhou has more than 3300 employees in mainland China, the United States, Australia and Europe, and its research product line includes new oral small molecule and monoclonal antibody anti-cancer drugs At present, Baiji Shenzhou is also building a drug combination program for anti-cancer treatment, aiming to bring lasting and far-reaching impact on the life of cancer patients Baichi sells its own Btk inhibitor brukinsa in the United States Gamma (zebudinib); in China, its anti-pd1 antibody drug baizean ® (tirelizumab) has been approved for marketing Under the authorization of Xinji Logistics Co., Ltd (which belongs to Bristol Myers Squibb), Baiji Shenzhou will sell Abraxane ® paclitaxel for injection (albumin binding type), refumex ® (lenalidomide) and vidasha ® (azacytidine for injection) in China; under the authorization of Amgen, Baiji Shenzhou plans to sell angavi ® (xgeva ®) desurmab injection in China [i] [I I] [i] Abraxane ® is a registered trademark of abraxis Co., Ltd (belonging to Bristol Myers Squibb Company); rife Myers ® and vidasha ® are registered trademarks of Xinji Pharmaceutical Co., Ltd (belonging to Bristol Myers Squibb Company) [II] xgeva ® is a registered trademark of Amgen 37