• Clinical Trial Approval of merigolix (TU2670, HS-10518) for the inhibition of premature LH (luteinizing hormone) surges in women undergoing COS (controlled ovarian stimulation) in China

 TiumBio (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable disease, announced today that its partner, Hansoh Pharma, has expanded the clinical indications of merigolix (Hansoh's code: HS-10518), an oral gonadotropin-releasing hormone receptor antagonist.

Hansoh Pharma recently received approval for an IND (Investigational New Drug) application targeting ART, expanding the development area of merigolix.

COS has been an integral part of ART treatment cycles. Availability of different gonadotropins for ovarian stimulation and gonadotropin releasing hormone (GnRH) analogues for prevention of premature rise of LH during follicular phase offer an opportunity for a successful outcome in women with different subsets of ovarian response. 

Orally administered merigolix may be important in the control of premature endogenous LH surge and in reducing the cycle cancellation rate, with an improvement of pregnancy rate per cycle. Currently, in COS regimens, gonadotropin-releasing hormone (GnRH) products are only available in injectable form, which caused the pain and relatively high cost.

"Hansoh Pharma's selection of ART as a new indication is significant," said Hun-Taek Kim, Ph.D., MBA, CEO of TiumBio. "Compared to other indications, ART requires a shorter treatment period, which will enable faster development," he added.

Meanwhile, merigolix is an oral GnRH receptor antagonist being developed for the treatment of endometriosis, uterine fibroids, and ART. TiumBio entered into a licensing agreement with Hansoh Pharma for merigolix 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 merigolix in Greater China.