Peking University People's Hospital

NANJING, China, Nov. 6, 2024 /PRNewswire/ -- On November 1, Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-034, a humanized bispecific T-cell engaging antibody targeting both GPRC5D and CD3 which is independently developed by Leads Biolabs with global intellectual property rights for treatment of multiple myeloma (MM), has been granted the Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA). LBL-034, a novel bispecific antibody designed using Leads Biolabs' proprietary T cell engager antibody technology platform "LeadsBodyTM", is the world's third GPRC5D-targeted CD3 T-cell engager to enter clinical stage, according to Frost & Sullivan. By simultaneously binding to CD3 on T cells and the tumor-associated antigen GPRC5D on cancer cells, LBL-034 brings T cells into close proximity with cancer cells, effectively activating the T cells to attack and kill the targeted cancer cells. LBL-034 has exhibited higher GPRC5D binding affinity and potency while being less prone to inducing T cell exhaustion and cell death. Extensive preclinical and early clinical research strongly indicates that LBL-034 has the potential to be best in class. We received IND approvals from the NMPA and FDA in July 2023 and commenced a phase I/II first in human, open-label, multi-center, dose escalation/expansion study of LBL-034 in patients with relapsed/refractory multiple myeloma (RRMM), in November 2023 in China. Sponsored by Leads Biolabs, led by Professor Lu Jin from Peking University People's Hospital with participation of multiple clinical trial centers, the preliminary data of this study demonstrated favorable safety profile and robust efficacy. The preliminary data will be presented at the 66th ASH Annual Meeting in San Diego, USA in December 9, 2024. This ODD approval is a recognition by the FDA regarding the significant potential of Leads Biolabs' LBL-034 in the treatment of MM. It will help accelerate the clinical development and marketing process of LBL-034 globally. According to the Orphan Drug Act of the United States, ODD is established by FDA to encourage the development of drugs for treating rare diseases. It provides a series of incentives for new drug development, including but not limited to: (1) tax credits for clinical trial expenses; (2) specific guidance from FDA on all stages of clinical research; (3) exemption of the application fee for new drug registration; and (4) 7 years of market exclusivity after listing. Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said " I am pleased to see the positive progress in our development of the new medications to benefit patients with rare diseases like MM. MM remains an incurable malignancy and with the increasing lines of treatment, the interval between the tumor relapses will become shorter and shorter, and eventually it will evolve into RRMM, which seriously threatens human life and health. It is urgent to develop new and more effective treatment options. LBL-034 adopts a unique molecular design, and the preliminary clinical results indicate its promising antitumor efficacy and safety. We will expedite the clinical development of LBL-034 and strive to bring safe and effective treatment options to MM patients around the world as early as possible. " Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said " LBL-034 is the first product from Lead Biolabs to receive Orphan Drug Designation from FDA, marking a successful step for us on this challenging but meaningful journey. Taking this opportunity, we will further optimize our pipeline layout, broaden our exploration boundaries in the biopharmaceutical field, and provide innovative solutions for more unmet medical needs." About multiple myeloma Multiple myeloma (MM) is a malignant neoplasm of plasma cells that is caused by abnormal proliferation of clonal plasma cells, accounting for 1% of neoplastic diseases and approximately 10% of hematological cancers globally. The latest data from the SEER registry database showed that, in 2021, there were approximately 179,000 MM patients in the US, meeting the FDA's criteria for defining a rare disease. In recent years, significantly advancement have been made in the treatment of MM through successful development of proteasome inhibitors, immunomodulatory drugs, selective nuclear export inhibitors, CD38-targeting antibodies, bispecific antibodies, and CAR-T cell therapies. However, despite these achievements, there remains an unmet clinical need for more effective treatment options. According to SEER data, in 2024, it is estimated that there will be around 35,780 newly diagnosed MM patients in the US, accounting for approximately 1.8% of all new cancer cases reported nationwide. Additionally, it is projected that about 12,540 deaths will occur due to MM-related complications during this period—equating to roughly 2.0% of all cancer deaths recorded nationally. Therefore, urgent attention needs to be given towards developing novel therapies to address this pressing medical challenge. About Leads Biolabs Nanjing Leads Biolabs Co., Ltd is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally. Backboned by our proprietary technology platforms and robust drug development capabilities, we have curated a rationally designed and differentiated pipeline of 12 innovative drug candidates, six of which have successfully progressed into the clinical stage. Leads Biolabs is committed to providing safe, effective, accessible and affordable new drugs to address the unmet needs of patients around the world. For more information, please visit SOURCE Leads Biolabs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI and HONG KONG, Nov. 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that it will present the latest data from two clinical studies of selinexor in two Posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024), taking place on December 7-10, 2024, in San Diego, CA, the United States. Details on the Posters: Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study Publication Number: 4748 Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Eastern time) 7:00 AM - 9:00 AM, December 10, 2024 (Beijing time) First Author: Dr. Jin Lu (Peking University People's Hospital) Corresponding Author: Dr. Jian Hou (Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine) Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch Publication Number: 4448 Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Eastern time) 7:00 AM - 9:00 AM, December 10, 2024 (Beijing time) First Author: Dr. Rong Tao (Fudan University Shanghai Cancer Center) Corresponding Author: Dr. Huiqiang Huang (Sun Yat-Sen University Cancer Center) About XPOVIO® (selinexor) XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]). About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

International Myeloma Foundation (IMF) to hold AMN Awards Ceremony at the 8th AMN Summit in Seoul, South Korea on Saturday, October 19SEOUL, South Korea, Oct. 17, 2024 (GLOBE NEWSWIRE) -- The International Myeloma Foundation (IMF) announced that it will be holding the Asian Myeloma Network (AMN) awards ceremony on Saturday, October 19, during the 8th Annual AMN Summit in Seoul, South Korea from October 17-20, 2024. This year’s 8th Annual AMN Summit will be Asia’s largest gathering ever of myeloma specialists, along with patients and caregivers. The Asian Myeloma Network Distinguished Service Award was conceived to recognize and honor the lifelong achievements of deserving AMN myeloma specialists, who have made a considerable impact in the field of myeloma research, clinical trials, and patient support. This year’s AMN Distinguished Service Awardee is Dr. Wenming Chen — chief physician, professor, and doctoral supervisor. Dr. Chen is the Director of the Department of Hematology in Beijing Chaoyang Hospital; the Department of Hematology in Capital Medical University; and the Multiple Myeloma Research Center of Beijing. He leads the Beijing branch of the National Clinic Research Center for Hematologic Diseases and heads the Myeloma Talent Team of Beijing Hospital Administration. Dr. Chen is the Chairman of the Hematology Committee, Hematology Youth Committee, and the Hematology Laboratory Diagnosis Committee of the Chinese Medical Association. Other positions that Dr. Chen currently holds are the following: Vice President, Beijing Association for the Promotion of Popular Health; Vice-Chairman of the Myeloma Committee, Chinese Society of Clinical Oncology; Deputy Leader of the Myeloma Committee, Hematology Committee of Chinese Medical Association, Chinese Medical Doctor Association, and the Chinese Auto-Stem Cell Transplantation. Dr. Chen is also an executive member of the Chinese Immunological Society, the Hematological Oncology Committee of China Anti-Cancer Center Association; a member of the International Myeloma Working Group (IMWG) and an executive member of the Asian Myeloma Network (AMN). He has received more than ten grants, including major national science and technology projects, the National Natural Science Foundation of China, and the Natural Science Foundation of Beijing. Dr. Chen has published over 300 academic papers and has written more than ten books related to multiple myeloma. He is also chief editor of six books, and co-editor of five textbooks. In 2007, Dr. Chen cooperated with the IMF and held the first academic forum on multiple myeloma in Beijing, China. In 2009, the IMF signed a comprehensive cooperation agreement with China in Beijing. “The IMF is thrilled to congratulate Dr. Chen on receiving the prestigious AMN Distinguished Service Award. Dr. Chen's exceptional contributions to the field of myeloma research, clinical trials, and patient support make him a truly deserving recipient,” said IMF President & CEO and 28-year myeloma patient Yelak Biru. “As a founding member of the AMN, Dr. Chen's tireless efforts to promote myeloma treatment throughout Asia and to train young Chinese hematologists have been invaluable. His expertise and dedication have significantly advanced the region's understanding and treatment of myeloma.” “We are honored to have Dr. Wenming Chen as part of the IMF community and look forward to celebrating his achievements at the 8th Annual AMN Summit in Seoul,” he further expressed. "As this year's AMN Distinguished Awardee and as one of the AMN's founding members, the IMF recognizes Dr. Wenming Chen's notable contributions to myeloma research, clinical trials, and treatments. We applaud his zealousness in educating and training aspiring hematologists in China. This prestigious recognition is truly well-deserved, and the global myeloma community collectively celebrates Dr. Chen's achievements and hard work in the field of myeloma," said IMF Chairperson of the Board Dr. S. Vincent Rajkumar, who will be presenting the prestigious award to Dr. Chen on the evening of the AMN awards ceremony. "A founding member of the AMN, Dr. Chen has worked tirelessly to promote myeloma treatment throughout Asia and to enhance the training of young Chinese hematologists. He richly deserves this international recognition,” said IMF Vice President Senior Vice President of Global Affairs Daniel Navid. According to IMF SVP Navid, “the Asian Myeloma Network's Executive Committee launched the AMN Distinguished Service Award in 2023 to recognize important contributions in scientific research and myeloma treatment in Asia.” "The AMN Distinguished Service Award is an important milestone in the continued development of this important regional initiative. The AMN’s body of work—including clinical trials, basic myeloma research, physician training, and patient support—is becoming increasingly recognized. The AMN Distinguished Service Award provides a spotlight to honor leading Asian myeloma specialists,” said Mr. Navid. The AMN Distinguished Service Awarding Ceremony will be held on Saturday, October 19, with IMF Chairperson of the Board Dr. S. Vincent Rajkumar presenting the award to Dr. Chen. Other speakers at the award ceremony include Prof. Jin Lu (Peking University People's Hospital — Beijing, China), and Dr. Wen Gao (Beijing Chaoyang Hospital — Beijing, China). To learn more about the Asian Myeloma Network and its annual summit and programs, visit myeloma.org. ABOUT MULTIPLE MYELOMA Multiple myeloma is a cancer of the bone marrow plasma cells — white blood cells that make antibodies. A cancerous or malignant plasma cell is called a myeloma cell. Myeloma is called “multiple” because there are frequently multiple patches or areas in bone where it grows. It often involves damage to bone and kidneys. Multiple myeloma is still incurable, but great progress has been made in terms of survival over the last two decades. The disease is twice as common and is diagnosed at a younger age in African Americans than white Americans. The most common presenting symptoms include fatigue and bone pain. ABOUT THE INTERNATIONAL MYELOMA FOUNDATION Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest global foundation focusing specifically on multiple myeloma. The Foundation's reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org. Follow the IMF on: X (Twitter): @IMFmyelomaInstagram: @imfmyelomaFacebook: @myelomaLinkedIn: International Myeloma Foundation Media Contacts: Peter AntonPanton@myeloma.org Jason LondonJlondon@myeloma.org