Authorization

China National Medical Products Administration Approves BeiGenea??s Tislelizumab for Patients with Classical Hodgkina??s Lymphoma Who Have Received at Least Two Prior Therapies

Second BeiGene-discovered drug to receive regulatory approval, first in China





Tislelizumab is an antia??PD-1 antibody specifically designed to minimize binding to FcI?R on macrophages

BEIJING, China and CAMBRIDGE, Mass., Dec. 27, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkina??s lymphoma (cHL) who have received at least two prior therapies. The new drug application (NDA) was previously granted priority review by the NMPA. Following the recent approval of BRUKINSAa?? (zanubrutinib) by the U.S. Food and Drug Administration (FDA), tislelizumab is BeiGenea??s first drug approved in China.Developed by BeiGene scientists, tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcI?R, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells.a??Wea??ve been working to develop improved therapies for cancer patients around the world. The discovery of immunotherapy revolutionized the cancer treatment paradigm and has since brought new treatment options and hope to people with cancer,a?? commented John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene. a??Tislelizumab is a differentiated anti-PD-1 antibody and has demonstrated encouraging clinical efficacy and safety in patients with relapsed/refractory cHL. We look forward to its further development in a broad array of solid tumors and hematological malignancies.a??Professor Jun Zhu, M.D., Ph.D., Director of the Lymphoma Department at Beijing Cancer Hospital commented, a??Anti-PD-1 antibodies are becoming a new treatment option for lymphoma patients. With a complete response rate of more than 60%, BeiGenea??s tislelizumab has demonstrated significant efficacy and a good safety profile as a monotherapy in patients with relapsed/refractory cHL. The approval of tislelizumab will bring a meaningful treatment option for those patients with cHL in China.a??a??Currently, BeiGene is conducting 15 registration-enabling clinical trials to evaluate tislelizumab in 23 countries and regions globally in prevalent cancer types such as lung, liver, esophageal and gastric cancers, with over 4,800 patients enrolled to date in its broad development program. We are grateful to the dedicated clinicians and particularly the patients who participated in these clinical studies,a?? said Wendy Yan, Senior Vice President and Global Head of Regulatory Affairs at BeiGene.
See also:
Leave a comment
News
  • Latest
  • Read
  • Commented
Calendar Content
«    Январь 2020    »
ПнВтСрЧтПтСбВс
 12345
6789101112
13141516171819
20212223242526
2728293031