TiumBio and Hansoh Pharma Announce Clinical Trial Approval of 'HS-10518/TU2670' from NMPA in China
- Category: Small Molecules
- Published on Thursday, 06 July 2023 11:57
- Hits: 1928
- Hansoh plans to develop 'TU2670 (Hansoh's code: HS-10518)' as a best-in-class novel GnRH antagonist in China
- TiumBio will complete the last patient dosing in a Phase 2a clinical trial of TU2670 in endometriosis in Europe by the end of the year
BOSTON, MA, USA and SEONGNAM, South Korea I July 5, 2023 I TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focusing on discovering and development innovative therapeutics for patients with rare and incurable diseases, and Hansoh Pharmaceutical Group Co., Ltd. (SEHX: 3692), a leading biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) approved Hansoh's Investigational New Drug (IND) application for clinical study of HS-10518 (also known as TU2670), the management of moderate to severe pain associated with endometriosis .
TU2670 is an investigational orally active non-peptide gonadotropin-releasing hormone (GnRH) antagonist for the treatment of endometriosis and uterine fibroids, with improved dosing convenience and a superior safety profile compared to existing treatments. In August, 2022, TiumBio entered into a licensing agreement with Hansoh Pharma for TU2670 for up to $170M plus tiered royalties upon net sales. Under the terms of the agreement, Hansoh Pharma obtained exclusive rights to develop and commercialize TU2670 in Greater China.
"We are very excited to receive IND approval from the NMPA for HS-10518 (TU2670), a differentiated innovative drug. With Hansoh Pharma's extensive clinical development and commercialization experience in China, we look forward to developing TU2670 and hope that it will soon be available for patients in China," commented Ms. Sun Yuan, Executive Director of the Board of Hansoh Pharma.
"We are very pleased with the positive feedback from the NMPA. TiumBio is working closely with Hansoh Pharma to successfully develop TU2670 as a potentially best in class GnRH antagonist therapy for patients with endometriosis in China," said Hun-taek Kim, Ph.D., MBA, Founder and CEO, TiumBio. "We are proceeding with a Phase 2a clinical trial in Europe as scheduled, and the last patient dosing is expected to be completed within the second half of this year," he added.
Endometriosis is a disorder in which the endometrial tissue lining the inside of the uterus grows outside the uterus and is known to cause severe pelvic pain, menstrual pain, lower abdominal pain, and infertility which occurs in about 11% of women of childbearing age. It is estimated that there are about 18 million patients with endometriosis in Europe.
About TU2670 (HS-10518)
TU2670 is an orally active non-peptide GnRH antagonist currently undergoing a Phase 2a clinical study in the EU for the treatment of endometriosis. The first-in-human (FIH) study of TU2670 with healthy premenopausal female volunteers in South Korea was completed in 2016, demonstrating an excellent safety and tolerability profile for TU2670. The pharmacodynamic measurements from the FIH study indicated the superior suppressive effects of TU2670 on both gonadotropins and sexual hormones, consistent with previous results from the preclinical animal studies. A Phase 1b study with multiple ascending dose (MAD) was conducted in Germany, resulting in a favorable safety profile and significant suppression of E2 levels.
About TiumBio Co., Ltd.
TiumBio (KOSDAQ: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Our mission is to expand the hope and happiness of mankind through our science. TiumBio has three lead pipeline assets in either Phase 2 or Phase 1 clinical trials: TU2218, an oral immuno-oncology therapy targeting TGF-beta and VEGFR2; TU2670, an orally active non-peptide GnRH antagonist and TU7710, a bypass-factor treatment specifically designed for hemophilia patients who have developed neutralizing antibodies. With our expertise in drug development, we are dedicated to discovering and developing innovative treatments to ease the burden of debilitating diseases. Visit http://www.tiumbio.com/en/ for more information about TiumBio.
About Hansoh Pharmaceutical Group
Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 12,150 dedicated employees in China and the United States.
Founded in 1995, Hansoh pharma has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, Central Nervous System (CNS) disorders, infectious diseases, diabetes, and autoimmune diseases and other major therapeutic areas. With the support of over 1,650 highly skilled R&D professionals, Hansoh Pharma has successfully discovered and developed multiple drug candidates into NMPA-approved innovative medicines, including Aumolertinib (Ameile®, 阿美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations, Flumatinib (Xinfu®, 昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML), PEG-Loxenatide (Fulaimei®, 孚来美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes, Morinidazole (Mailingda®, 迈灵达®), a third-generation nitroimidazole antibiotic, tenofovir amibufenamide (恒沐®), the first second-generation oral anti-HBV drug developed in China and Saint Luolai, a long-acting peptide-based erythropoiesis-stimulating agents (ESA). Through collaboration and partnership, NMPA has granted approval to Inebilizumab (Xinyue®, 昕越®)，a humanized anti-CD19 monoclonal antibody, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD). For more information, visit www.hspharm.com.