Baituowei (goserelin acetate sustained-release microspheres for injection) / Luye Group, BeOne Medicines - LARVOL DELTA

Rapidly dissolving microneedle patch embedded with long-acting microspheres for sustained release of goserelin. (PubMed, J Control Release) - "The GSR-MN patch demonstrates excellent biocompatibility and biosafety, and is capable of sustaining goserelin release over a 28-day period. The therapeutic outcomes were comparable to those of conventional intramuscular goserelin microsphere administration, offering a promising strategy to improve patient adherence and reduce treatment-associated discomfort."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy of triplet therapy based on organoid drug sensitivity testing in lung metastatic hormone-sensitive prostate cancer. (ASCO 2025) - "The triple regimen of goserelin acetate extended-release microspheres in combination with rezvilutamide and docetaxel demonstrated encouraging outcomes in HSPC with lung metastasis. The construction of organoid and drug sensitivity assays holds great potential in facilitating more precise screening of suitable treatment regimens for individual patients."

Clinical • Metastases • Anemia • Constipation • Gastric Cancer • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Musculoskeletal Pain • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

The impact of different formulations of goserelin on testosterone suppression in patients with prostate cancer: A real world observational research. (ASCO 2025) - " This analysis was conducted in real-world clinics, focusing on patients diagnosed with prostate cancer who had initiated goserelin acetate extended-release microspheres for injection dosed every 4 weeks (dosing intervals of 28, 56, and 84 days) and goserelin acetate sustained-release depot dosed every 12 weeks (dosing intervals of 84, 168, and 252 days) to compare the efficacy of different dosage forms of goserelin and the effect of dosing delay on testosterone control. The present study examined the impact of delayed injection of goserelin on testosterone control. It is imperative to direct greater attention to the development of effective follow-up strategies and the enhancement of adherence to androgen deprivation therapy in prostate cancer patients, with a view to improving clinical outcomes."

Clinical • Real-world • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Goserelin Extended-Release Microspheres versus Sustained-Release Implant in Prostate Cancer: Real-World Evidence on Efficacy and Safety (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: Aerospace Center Hospital; Aerospace Center Hospital

HEOR • New P4 trial • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Observational Study on the Injection Experience and Quality of Life of Breast Cancer Patients After Switching from Goserelin Acetate Sustained-Release Implants to Injectable Goserelin Microspheres (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Dalian Medical University; No. 467, Zhongshan Road, Shahekou District, Dalian City, Liaoning Province

HEOR • New P4 trial • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER

Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex® for patients with premenopausal breast cancer (PubMed, Zhonghua Zhong Liu Za Zhi) - "All patients concomitantly received oral tamoxifen (TAM). Both treatments were well-tolerated. LY01005 is as effective as Zoladex® in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile."

Clinical • Journal • Breast Cancer • Oncology • Solid Tumor

Effectiveness, Safety, and Economic Evaluation of Goserelin Microspheres for Injection and Goserelin Sustained-Release Implants in Prostate Cancer Patients: A Real-World Study (clinicaltrials.gov) - P=N/A | N=400 | Active, not recruiting | Sponsor: Qianfoshan Hospital

HEOR • New trial • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Nano and liposome cancer chemotherapy: A review of advances in drug delivery with applications. (PubMed, Int J Clin Pharmacol Ther) - "Notably, nanomedicines, including goserelin sustained-release implants, doxorubicin liposomes, albumin-bound paclitaxel, and paclitaxel liposomes, have been effectively utilized in tumor treatment in China [1]. The development of efficient and safe co-delivery systems that facilitate the effective transport and precise release of drugs within the cancerous tissues while also elucidating the internalization of nanoparticles into tumor cells and their functional mechanisms represents critical areas for future research. Concurrently, advancements in nanocarriers and tumor treatment are anticipated to yield superior therapeutic outcomes and improved quality of life for cancer patients."

Journal • Oncology • Solid Tumor

Big news! Congratulations on the successful inclusion of goserelin microspheres in the 2025 latest version of the National Medical Insurance Catalogue for the new indication of breast cancer [Google translation] (163.com) - "On November 28, 2024, the National Healthcare Security Administration announced the results of the 2024 National Healthcare Security Catalog Adjustment, which will be officially implemented from January 1 of the following year. The adjustment to the healthcare security catalog includes goserelin microspheres (Baituowei) for the indication of premenopausal and perimenopausal breast cancer requiring hormone therapy."

Reimbursement • Breast Cancer • Oncology • Solid Tumor

To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Luye Pharma : The World’s Only Goserelin Microsphere Formulation (Baituowei) Approved in China for the New Indication of Breast Cancer (Market Screener) - "Luye Pharma Group...and BeiGene...announced that a new indication for Luye Pharma's innovative formulation, Goserelin Microspheres for Injection (Baituowei), has been approved by China's National Medical Products Administration (NMPA): to be used for treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones."

Non-US regulatory • Breast Cancer • Oncology • Solid Tumor

Luye Pharma Group Ltd. Announces National Medical Products Administration of People’s Republic of China Approves its Goserelin Microspheres for Injection for Treatment of Prostate Cancer for Patients Requiring Androgen Deprivation Therapy (Market Screener) - "The board of directors of Luye Pharma Group Ltd. announced that the Group's innovative formulation, Goserelin Microspheres for Injection (LY01005, or Baituowei), has been approved by the National Medical Products Administration (NMPA) of the People's Republic of China for the treatment of prostate cancer for patients requiring androgen deprivation therapy (ADT) on 30 June 2023....In the meanwhile, the Group and BeiGene Ltd. will also officially commenced their strategic partnership for the commercialization of this product....In addition to prostate cancer, Baituowei is also being reviewed for its New Drug Application (NDA) in China for the treatment of breast cancer."

Licensing / partnership • Non-US regulatory • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Pharmacokinetics, Pharmacodynamics and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX® (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Luye Pharma Group Ltd. | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX® (clinicaltrials.gov) - P3 | N=188 | Completed | Sponsor: Luye Pharma Group Ltd. | Recruiting ➔ Completed

Trial completion • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER

Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial. (PubMed, Chin Med J (Engl)) - P3 | "LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile."

Head-to-Head • Journal • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Pharmacological and toxicological studies of a novel goserelin acetate extended-release microspheres in rats. (PubMed, Front Pharmacol) - "The safety profile of LY01005 was largely the same with Zoladex. These results strongly support the planned LY01005 clinical trials."

Journal • Preclinical

Pharmacokinetics, Pharmacodynamics and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX® (clinicaltrials.gov) - P1; N=23; Active, not recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX® (clinicaltrials.gov) - P3; N=188; Recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P3 trial • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER

Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX® (clinicaltrials.gov) - P3; N=290; Completed; Sponsor: Luye Pharma Group Ltd.; Recruiting ➔ Completed; Trial completion date: May 2022 ➔ Mar 2021; Trial primary completion date: Nov 2021 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Goserelin Acetate Sustained Release Microspheres Injection（LY01005）for Prostate Cancer (clinicaltrials.gov) - P3; N=290; Recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor