시험관아기시술(IVF)등 보조생식술(ART) 활용때 

                메리골릭스는 황체형성호르몬의 조기 상승 억제

체내 다수의 난포가 성장하도록 도와 임신 성공률 증대

먹는 약으로 주사제형 보다 투약 편의성-치료비용 절감

 

희귀난치성질환 치료제 연구개발기업인 티움바이오(KOSDAQ: 321550)는 파트너사인 중국 한소제약(Hansoh Pharma)이 메리골릭스(Merigolix, HS-10518)의 임상 적응증을 추가했다.

21일 한소제약은 이번에 ART(Assisted reproductive technology)에 대한 임상시험계획서(IND) 승인을 받으며 메리골릭스 개발 적응증을 확장했다고 밝혔다. 

보조생식술(ART)는 시험관아기시술(IVF, In vitro fertilization), 난자/배아 냉동보존술(Egg and embryo cryopreservation) 등 인공적 생식과정 유도 시술을 의미하며 난임 및 불임 등 치료방법으로 쓰인다. 

메리골릭스 경구 복용 단계는 보조생식술 진행에 필수적인 부분으로, 난자 채취 전 단계에서 다수 난포의 성숙을 위해 LH(황체형성호르몬)의 조기 상승을 예방하고 배란을 억제하여 임신율을 향상시킬 수 있다. 

현재 성선자극호르몬(GnRH) 제품들은 주사제형으로만 제공되고 있어 투약에 따른 통증과 높은 치료비용이 한계점으로 작용하는데, 메리골릭스는 경구용 치료제로 이런 단점을 보완할 수 있다.

김훈택 티움바이오 대표는 “파트너사 한소제약이 메리골릭스의 신규 적응증으로 선택한 ART는 중요한 적응증이다. ART는 다른 적응증 대비 투약 기간이 짧아 빠른 기간안에 임상개발을 완료할 수 있어 중국내에 상업화를 앞당길 수 있다”고 말했다.

한편, 메리골릭스는 자궁내막증, 자궁근종, ART 등 적응증에서 개발 중인 티움바이오의 성선자극호르몬 억제제(GnRH antagonist) 치료제로, 지난 2022년 중국 한소제약과 티움바이오는 중국시장 내 개발 및 상업화 권리에 대하여 1억7000만 달러(약 2,400억 원) 규모의 기술이전 계약을 체결한 바 있다. 

[영문자료]

TiumBio’s Partner Hansoh Pharma Expands Indications for Merigolix (HS-10518) with Initiation of ART (Assisted Reproductive Technology) Development

Ÿ   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.

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. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development.

Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis, uterine fibroids, and assisted reproductive technology. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors.

With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at www.tiumbio.com/en and connect with us on LinkedIn.