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TiumBio and Hansoh Pharma Announce Clinical Trial Approval of HS-10518/TU2670’ from NMPA in China
· 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
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 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.
Contacts:
[TiumBio]
Junseok Jang, Sr. Manager, Corporate Communications
& Investor Relations
Suna Cho,
Manager, Corporate Communications & Investor Relations