merigolix (TU2670) / Tium Bio, Daewon Pharma, Jiangsu Hansoh Pharma - LARVOL DELTA

A Study of HS-10518 in Healthy Adult Premenopausal Females in China (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: West China Second University Hospital

New P1 trial • Infertility • Sexual Disorders

TiumBio's Partner Hansoh Pharma Expands Indications for Merigolix (HS-10518) with Initiation of ART (Assisted Reproductive Technology) Development (PRNewswire) - "TiumBio...announced today that its partner, Hansoh Pharma, has expanded the clinical indications of merigolix...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...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."

New trial • Women's Health

A Study Evaluating Food Effect on Pharmacokinetics of HS-10518 (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Endometriosis • Gynecology • Women's Health

TUC3PII-01_TU2670 Phase IIa Clinical Study (clinicaltrials.gov) - P2 | N=86 | Completed | Sponsor: TiumBio Co., Ltd. | Recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Sep 2023 ➔ Jan 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Pain • Women's Health

TiumBio reports positive results for endometriosis treatment (Pulse by Maeil Business News Korea) - P2 | N=83 | NCT05138562 | Sponsor: TiumBio Co., Ltd. | "TiumBio...announced on Tuesday that it confirmed the pain reduction efficacy of its endometriosis treatment, TU2670 (merigolix), in a phase 2a clinical trial in Europe....Among the four groups comprising 83 individuals, the Merigolix 120 mg group experienced an average pain reduction of 4.3 points from the baseline, the 240 mg group experienced a reduction of 5.4 points, and the 320 mg group experienced a reduction of 6.2 points. In contrast, the placebo group only experienced an average reduction of 2.7 points, and no serious adverse reactions to the medicine were reported."

P2a data • Endometriosis • Women's Health

TiumBio Secures KRW 38.5 Billion in Anticipation of Upcoming Clinical Data (PRNewswire) - "TiumBio Co., Ltd...today announced the completion of a stock financing of 2,320,185 shares of its convertible preferred shares at a price of KRW 8,620 per share in a private placement. TiumBio sold the stock to SK Chemicals Co., Ltd. securing 20 billion won to fund its development of lead pipeline assets...The funds will be primarily allocated to support its clinical programs that include a Phase 2 trial of merigolix, a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in endometriosis, and a Phase 1b trial of TU2218, a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF, in combination with pembrolizumab, and a Phase 1 trial of TU7710, a recombinant protein designed to treat people with hemophilia who have inhibitors...'we look forward to sharing results with all stakeholders from the ongoing Phase 2 trial in endometriosis....expected in the first half of 2024.'"

Financing • P2 data • Endometriosis • Hemophilia • Oncology • Solid Tumor • Women's Health

TiumBio’s endometriosis drug registered as ‘merigolix’ under WHO INN (Korea Biomedical Review) - "TiumBio...said on Tuesday its investigational treatment for endometriosis, TU2670, has been officially registered by the World Health Organization (WHO) under the International Nonproprietary Name (INN), 'merigolix'....The WHO assigns INNs to pharmaceutical substances to prevent prescription misuse and improve information communication and convenience; therefore, pharmaceutical products containing TU2670 should now be labeled as 'merigolix.'"

Commercial • Endometriosis • Uterine Leiomyoma • Women's Health

A Study of HS-10518 in Healthy Female Participants (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Endometriosis • Gynecology • Women's Health

TiumBio unveils key updates on endometriosis, immunotherapy, hemophilia pipelines (Korea Biomedical Review) - "TiumBio announced on Sunday the fourth-quarter global clinical trial updates for its lead pipelines, including its endometriosis drug candidate TU2670. TiumBio is currently conducting a phase 2a clinical trial of TU2670 in endometriosis patients in Europe, with plans to generate European top-line data in the first half of next year....Tiumbio aims to enhance its convenience and effectiveness by developing TU2670 as an oral formulation."

Clinical • P2a data • Endometriosis • Women's Health

"Announcement of the top line in the first half of next year"… Tium Bio, Endometriosis European Clinical Speed [Google translation] (Money Today Network (MTN)) - "...Tium Bio...announced that it had completed the recruitment of patients for phase 2 clinical trials in Europe for TU2670, which is currently being developed as a new drug for endometriosis. A total of 86 patients participated in the clinical trial. An official from Tium Bio said, 'Patient recruitment has been completed as originally planned,' and 'patient medication will be completed in the second half of this year.' Accordingly, it is said that the main results of the TU2670 European phase 2 will be confirmed in the first half of next year."

Enrollment closed • P2a data • Endometriosis • Women's Health

TiumBio and Hansoh Pharma Announce Clinical Trial Approval of ’HS-10518/TU2670’ from NMPA in China (PRNewswire) - "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....'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'..."

New trial • Trial status • Endometriosis • Immunology • Pain • Uterine Leiomyoma • Women's Health

Hansoh Pharmaceutical Group Company Limited Announces HS-10518 Capsules A Category 1 Innovative Drug, Has Been Granted A Clinical Trial Notice (Market Screener) - "The board of directors of Hansoh Pharmaceutical Group Company Limited announced that 'HS-10518 Capsules' (license-in as TU2670, the 'Product'), a Category 1 innovative drug, has been granted a clinical trial notice issued by the National Medical Products Administration of the People's Republic of China, and is intended to be used for the management of moderate to severe pain associated with endometriosis and management of heavy menstrual bleeding associated with uterine leiomyomas."

New trial • Endometriosis • Uterine Leiomyoma • Women's Health

Tium Bio acquires additional European patent for endometriosis treatment 'TU2670' [Google translation] (Health in News) - "Tium Bio announced on the 14th that it has additionally acquired a European patent for 'TU2670', which is being developed as a treatment for endometriosis.The additional patent acquired this time is for the salt and crystalline form of 'TU2670', an endometriosis treatment, and for the improvement of its pharmaceutical use. Improvement in physical properties, solubility and storage stability of the drug through the new salt and crystalline form It is an improved patent with a main content....As part of its Evergreening patent strategy, Tium Bio has extended the European patent expiration date for 'TU2670' to 2038 by acquiring additional crystalline patents this time."

Patent • Endometriosis • Women's Health

Tium Bio, endometriosis new drug candidate 'TU2670' selected as an innovative start-up package by the Ministry of SMEs and Startups [Google translation] (Yakup Shinmoon) - "Tium Bio...announced on the 15th that endometriosis candidate material 'TU2670' was selected as a support target for the follow-up support project for the innovative start-up package (nurturing new industry startups) hosted by the Ministry of SMEs and Startups. With the selection of this project, Tium Bio will receive support for part of the costs, such as the European clinical trial of TU2670, for one year....Meanwhile, the phase 2a clinical trial in Europe, which is being conducted by Tium Bio, is cruising with more than 90% of patients enrolled, and administration to all patients is expected to be completed within the year."

Enrollment status • Financing • CNS Disorders • Endometriosis • Women's Health

Tium Bio, endometriosis, anti-cancer, hemophilia treatment triangular formation is growing [Google translation] (Money Today) - "Endometriosis treatment 'TU2670' European clinical phase 2a data is expected to be confirmed early next year at the earliest. Tium Bio plans to complete TU2670 phase 2a patient administration by the end of the year. TU2670 is a pipeline that has already exported the rights to Korea (Daewon Pharmaceutical) and China (Hanso Pharmaceutical). We are currently discussing technology transfer to advanced markets such as the US and Europe. Depending on the results of phase 2a clinical trials in Europe, discussions on technology transfer following TU2670 are expected to begin in earnest."

Licensing / partnership • P2a data • Trial completion date • Endometriosis • Women's Health

’Development of new drugs and securing revenue sources’… Tium Bio catches two rabbits [Google translation] (Economic Review) - "According to the biopharmaceutical industry on the 23rd, Tium Bio is conducting a phase 1 clinical trial cohort 5 for single administration of the immuno-anticancer drug 'TU2218'. Tium Bio plans to end cohort 5 within this month, and the final stage, cohort 6, is expected to enter next month....Endometriosis treatment 'TU2670' has completed more than 80% of European clinical patient recruitment. It plans to complete patient administration within the year."

Trial status • Endometriosis • Oncology • Solid Tumor • Women's Health

Tium Bio “Completed CMC transfer to Hanso Pharmaceutical in China…Expected to receive 2 billion won“ [Google translation] (Hankyung) - "Tium Bioannounced on the 24th that cooperation on 'TU2670', a new drug candidate for endometriosis, with China's Hanso Pharmaceutical is accelerating. Tium Bio signed a technology export contract worth $170 million with Hanso Pharmaceutical in August. It is about the rights of TU2670 in China, and it received 4.5 million dollars (about 6.4 billion won) as a down payment in September of this year....The European phase 2a clinical trial of TU2670, which is underway by Tium Bio, is being conducted in five European countries. More than 60% of patients were said to have been recruited. Administration will be completed next year, and based on the results of phase 2a, a technology transfer contract is planned."

Commercial • Enrollment status • Licensing / partnership • Endometriosis • Women's Health

TiumBio gets $4.5 million upfront from China’s Hansoh Pharmaceutical (Korea Biomedical Review) - "TiumBio said...that it received a $4.5 million upfront payment from China’s Hansoh Pharmaceutical under the previous licensing agreement involving TU2670, a new endometriosis treatment....TiumBio and Hansoh signed a $170 million deal, including a $4.5 million upfront payment, for the exclusive license to develop and commercialize TU2670 within China."

Commercial • Licensing / partnership • Endometriosis • Women's Health

Tium Bio, which had no L/O performance, reduced its sales to less than 100 million won [Google translation] (thebell) - "Compared to 2020, sales decreased by about 1 billion won (about 95%) and operating loss increased by 19.4 billion won (about 146%). Net loss increased by 20 billion won to 32.4 billion won during the same period....The company announced that its operating loss increased last year due to clinical development costs for NBP604 (hemophilia treatment candidate) ; NCE403 (endometriosis treatment candidate)..."

Commercial • Endometriosis • Genetic Disorders • Hemophilia • Women's Health