Cinda biology and Incyte will cooperate to promote multiple anti-cancer therapies

December 17, 2018 / Meitong news agency /-- Xinda biopharmaceutical (Hong Kong stock exchange code: 01801), a Chinese biopharmaceutical company dedicated to R & D, production and sales of innovative drugs for the treatment of major diseases such as tumors and autoimmune diseases; Incyte company (NASDAQ Stock Code: incy), a biopharmaceutical company focused on the discovery, development and sales of innovative drugs The two companies jointly announced today that they have reached a strategic cooperation and exclusive licensing agreement to promote the clinical development and commercialization of pemigatinib (FGFR1 / 2 / 3 inhibitor), itacitinib (Jak1 inhibitor) and parsaclisib (pi3kδ inhibitor) single drug or combination therapy in mainland China, Hong Kong, Macao and Taiwan According to the cooperation agreement, Incyte will receive a down payment of US $40 million from Cinda bio and a second cash payment of US $20 million expected after the first application of new drugs in China in 2019 HERV é hoppenot, President of Incyte, said: "Cinda biology is composed of senior managers with rich experience in global and local drug development With rich product chain and perfect drug development and commercialization platform, it is our ideal partner in China The cooperation with Cinda biology provides us with an important opportunity to further serve the global oncology community Cinda biology's perfect innovative drug clinical research operation platform will better promote the development of clinical trials of pemigatinib, itacitinib and parsaclisib We expect these products to provide more treatment options for Chinese patients " "Incyte is the only pharmaceutical company among the top ten most innovative enterprises in the world in 2018 Adhering to the consistent open and innovative attitude, we are happy to cooperate with such an innovative cancer treatment drug benchmark enterprise This is another major international cooperation of Cinda biology after the international cooperation of Lilly, adimab and Hanmi of South Korea Xinda biology has also expanded from the original field of macromolecular drug development to the field of small molecules, expanding the company's product pipeline and creating more opportunities for business cooperation " Dr Yu Dechao, founder, chairman and President of Cinda biopharmaceutical, said, "the clinical data of the three products we have cooperated with are encouraging We believe that the innovative small molecule drugs of Incyte, such as pemigatinib, itacitinib and parsaclisib, will hopefully change the treatment of cholangiocarcinoma, bladder cancer, non Hodgkin's lymphoma and other tumors in China In addition, we will explore the synergistic effect of these three products and other products of Cinda biology, so as to develop more joint therapies that benefit patients all over the world and maximize the product value " According to the provisions of the cooperation agreement, Cinda bio will pay the down payment of US $40 million to Incyte first, and it is expected that in 2019, after the first application of new drugs in China, Cinda bio will pay US $20 million as the second cash payment to Incyte In addition, Incyte will be eligible for potential development milestone payments of up to $129 million and potential commercial milestone payments of up to $202.5 million Further financial details of the cooperation were not disclosed About pemigatinib (incb54828, FGFR inhibitor), pemigatinib is an oral small molecule inhibitor for FGFR 1, 2 and 3, and its relevant preclinical data reflect the excellent efficacy and safety for tumors with FGFR gene mutation FGFR plays an important role in tumor cell growth, survival, metastasis and tumor angiogenesis The research shows that FGFR gene mutation, translocation, fusion, rearrangement and other abnormalities are closely related to the growth of a variety of tumors Pemigatinib has carried out a phase II clinical trial to verify the safety and efficacy of FGFR gene mutation driven cancer Among them, light (fiberblast growth factor receiver in oncology and geography Trials) series of clinical trials include: light-201 for patients with locally advanced non resectable or metastatic bladder cancer with positive FGFR3 mutation / fusion; light-202 for patients with locally advanced non resectable or metastatic intrahepatic cholangiocarcinoma with positive FGFR2 rearrangement and previous treatment failure; light-203 for patients with myeloid / lymphocytic hematoma with FGFR1 gene rearrangement; and light-302, i.e Clinical trials for FGFR2 gene rearrangement positive patients with intrahepatic cholangiocarcinoma will be carried out by the end of 2018 About itacitinib (incb39110, Janus kinase 1 inhibitor), itacitinib is a new, efficient and selective small molecule inhibitor of Jak1 signaling pathway Currently, it is being used in the clinical evaluation of patients with acute and chronic graft-versus-host diseases and patients with advanced non-small cell lung cancer (combined with EGFR inhibitor oxitinib) Gravitas-301 is a randomized, double-blind, controlled phase III clinical study to assess the efficacy of itacitinib or placebo in combination with corticosteroids in the treatment of acute graft-versus-host disease The corresponding data will be disclosed in 2019 Gravitas-309 is a randomized, double-blind, controlled phase III clinical study to evaluate the combination of itacitinb or placebo with corticosteroids as a first-line treatment for patients with chronic graft-versus-host disease Relevant data will be disclosed in early 2019 About parsaclisib (incb50465, pi3kδ inhibitor), parsaclisib is a new oral inhibitor for pi3kδ, which plays an important role in the growth and survival of B-cell lymphoma The highly selective and effective data of parsaclisib in preclinical studies have the potential to provide clinical benefits for patients with lymphoma and other malignant blood tumors At the same time, early data support that PI3K δ is also an important target in tumor microenvironment In the phase II clinical study of citadel series (clinical investigation of targeted PI3K delta infection in lymphamas), we explored the efficacy and safety of parsalisib for non-Hodgkin's lymphoma, including follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma In addition, the phase I and phase II clinical studies of parsalisib were carried out in myelofibrosis, locally advanced or metastatic solid tumors and diffuse large B-cell lymphoma About Incyte, a biopharmaceutical company headquartered in Wilmington, Delaware, USA, which focuses on the R & D, development and commercialization of innovative therapies For more information about Incyte, please visit our website at www.incyte.com With regard to Xinda biology, it is the ideal and goal of Xinda biology to develop high-quality biological medicine that people can afford Founded in 2011, Cinda biology is committed to the development, production and sale of new monoclonal antibody drugs for the treatment of major diseases such as cancer On October 31, 2018, Cinda bio pharmaceutical was listed on the main board of the Hong Kong stock exchange with the code of Hong Kong Stock Exchange: 01801 At present, the company has established a high-quality technology platform throughout the development cycle of biological innovative drugs, including R & D, pharmaceutical development and industrialization, clinical research and marketing platforms, and has established a product chain including 17 new monoclonal antibody varieties, covering four disease areas, including tumor, fundus oculi disease, autoimmune disease, metabolic disease, and four varieties enter clinical phase III In the study, two products (cindilimab injection and adalimumab injection biological similar drugs) were accepted by the State Food and drug administration, and cindilimab injection entered the priority review Xinda biology has set up a team of high-end biomedical development and industrialization talents with international advanced level, including many returned experts, and has reached strategic cooperation with Lilly Pharmaceutical Group, adimab, Incyte and other international pharmaceutical companies Xinda bio hopes to work with you to improve the development level of China's biopharmaceutical industry, so as to meet the people's drug access and the people's pursuit of life and health.