TiumBio and Hansoh Pharma Announce Clinical Trial Approval of ‘HS-10518/TU2670’ from NMPA in China

TiumBio Co., Ltd. and Hansoh Pharmaceutical Group Co., Ltd. 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.