A Randomized,Controlled Phase III Study on Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.

Start Date01 Aug 2026

Sponsor / Collaborator

Beijing Biostar Pharmaceuticals Co. Ltd.

ChiCTR2600124228

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Utidelone Combined with Anlotinib as Second-Line Therapy for Advanced Non-Specific Soft Tissue Sarcoma: A Multicenter, Single-Arm, Phase II Clinical Study

Start Date07 May 2026

Sponsor / Collaborator-

NCT07449481

/ WithdrawnPhase 2IIT

A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors

Brain metastasis represents one of the worst prognostic outcomes in advanced malignant tumors. Approximately 10% to 40% of patients with solid tumors develop brain metastases, a incidence rate significantly higher than that of primary malignant brain tumors. Over 80% of patients present with multiple brain metastases at diagnosis, often precluding surgical intervention.
Brain metastases typically occur in the late stages of cancer. Patients have often received multiple prior therapies and developed resistance to first- and second-line drugs, leaving limited pharmacological options. The rapid growth of intracranial tumors poses an immediate threat to life. Consequently, radiotherapy and surgery currently form the cornerstone of clinical management for these patients. Thus, developing effective systemic therapies is an urgent and unmet medical need .
Utidelone, a new-generation epothilone anticancer agent, has demonstrated good efficacy and safety. Previous studies indicate that utidelone achieves higher concentrations in most tissues, including the brain, compared to plasma, suggesting its ability to readily cross the blood-brain barrier . Furthermore, a Phase III clinical trial in metastatic breast cancer showed that utidelone in combination with capecitabine significantly improved the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to capecitabine alone in patients previously treated with anthracyclines and taxanes .
A separate Phase II study demonstrated that bevacizumab combined with carboplatin achieved a central nervous system objective response rate (CNS ORR) of 63%, with a median PFS of 5.62 months and a median OS of 14.1 months in breast cancer patients with brain metastases . Regarding safety, utidelone has a relatively low incidence of adverse reactions aside from peripheral neurotoxicity .
Based on this evidence, this proposed study aims to evaluate the efficacy and safety of utidelone and bevacizumab, combined with etoposide for breast cancer cohorts or without etoposide for lung cancer cohorts, in patients with malignant tumor brain metastases.

Start Date01 May 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

[+2]

100 Clinical Results associated with Utidelone

100 Translational Medicine associated with Utidelone

100 Patents (Medical) associated with Utidelone

223

Literatures (Medical) associated with Utidelone

01 May 2026·Translational Cancer Research

Utidelone exhibits favorable responses in refractory patients with advanced breast cancer

Article

Author: Lan, Xiaofeng ; Bai, Xue ; Song, Lin ; Liu, Meidi ; Huang, Jiayi ; Xie, Xiaofeng ; Lei, Rongmei ; Zhang, Qiuyi ; Chen, Liping ; Du, Caiwen ; Chen, Xuelian

Background:

Utidelone plus capecitabine has brought therapeutic and survival benefits in the second-line treatment of patients with advanced breast cancer (ABC). However, its efficacy in the subsequent treatment remains to be disclosed. Our study aimed to investigate the efficacy and safety of utidelone in the treatment of refractory ABC in real-world.

Methods:

In this single-center, retrospective cohort study, clinical data were retrospectively collected from patients who received utidelone at Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen after developing resistance to anthracyclines or taxanes. The median progression-free survival (PFS) was estimated using the Kaplan-Meier method, and statistical analysis was performed using SPSS 18.0 software (IBM SPSS, Armonk, NY, USA).

Results:

A total of 20 patients were included in the study, 95% of whom had previously received third-line therapy or more at the time of utidelone treatment. The overall objective response rate (ORR) and disease control rate (DCR) were 15% and 80%, respectively, with a median PFS of 4.7 months [95% confidence interval (CI): 2.98-6.42]. Patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR⁺/HER2^-) exhibited better efficacy, with an ORR of 30% and a DCR of 90%. Among the five patients who developed brain metastases (BMs) and received combined anti-angiogenic therapy, the intracranial ORR (iORR) and intracranial DCR (iDCR) were 20% and 100%, respectively. In general, utidelone was well tolerated, with neurotoxicity being the main adverse event.

Conclusions:

Utidelone demonstrates favorable efficacy and safety in patients with refractory ABC, particularly in HR⁺/HER2^- patients. The combination of utidelone with anti-angiogenic therapy shows promising intracranial anti-tumor activity and is expected to be a preferred option for ABC in subsequent lines of treatment.

01 Jan 2026·Frontiers in Oncology

Atrial fibrillation during palliative chemotherapy with utidelone: a case report.

Article

Author: Chen, Baoying ; Shen, Qihuan ; Shi, Huadi ; Xu, Zumin ; Huang, Yuhao ; Li, Haoran

This report describes a 57-year-old male patient with metastatic breast cancer who experienced atrial fibrillation during the infusion of utidelone as palliative chemotherapy. All cardiological examinations conducted before treatment were normal. There was no evidence of thyroid dysfunction, nor any objective data indicating acute or chronic cardiovascular disease. Other combination drugs have been used in clinical practice for decades and rarely have proarrhythmic activity. The innovative drug utidelone, independently developed in China, was approved by the National Medical Products Administration (NMPA) of China in 2021 for the treatment of patients with metastatic breast cancer. Cardiotoxicity has not been prominently reported in prior clinical trials of utidelone. Although a definite causal relationship cannot be confirmed, the close temporal association and clinical course suggest that utidelone may have contributed to the arrhythmias. This case highlights the need for careful cardiac monitoring during treatment.

01 Jan 2026·Advances in Protein Chemistry and Structural Biology

Pathological microtubule dynamics in Parkinson’s disease: Mechanisms and therapeutic implications

Review

Author: Prajapati, Vijay Kumar ; Baghel, Kirti ; Singh, Satyendra ; Dubey, Ateendra Kumar

Parkinson's disease (PD) is a progressive neurodegenerative disorder primarily marked by the degeneration of dopaminergic neurons in the substantia nigra and the pathological accumulation of misfolded α-synuclein in Lewy bodies. This chapter explores the underrecognized role of microtubule (MT) dysregulation in PD pathogenesis, linking disruptions in cytoskeletal integrity to impaired axonal transport and neuronal survival. The fundamental biology of MTs, their dynamics, and their regulation by motor proteins and associated proteins like MT-associated proteins (MAPs), tau, and gamma-tubulin complexes. Special attention is given to how mutations linked to PD, such as those in SNCA (α-synuclein), Parkin, PINK1 (PTEN-induced kinase 1), and LRRK2 (leucine-rich repeat kinase 2), lead to MT destabilization, impaired mitophagy, and disruptions in axonal transport. A self-perpetuating cycle of MT disruption and α-synuclein aggregation is proposed, resulting in synaptic failure and dopaminergic neuron loss. The chapter also evaluates emerging therapeutic strategies targeting MT stabilization, including LRRK2 inhibitors, MT-stabilizing agents like Epothilone D, and approaches to modulate α-synuclein aggregation. Challenges such as the blood-brain barrier, off-target effects of MT-targeting drugs, and patient-specific variability in drug response are critically discussed. The future directions include CRISPR-Cas9-based gene therapies and personalized medicine, emphasizing the need for a deeper understanding of PD-related molecular pathways. This comprehensive overview highlights MT dynamics not just as collateral damage but as a central element in PD pathology, offering novel insights into potential avenues for intervention.

News (Medical) associated with Utidelone

22 May 2026

·www.biospace.com

HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting

HONG KONG and FLORHAM PARK, N.J., May 22, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA. Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025. Additionally, further analyses of the fruquintinib’s FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead Author Presentation details SPONSORED STUDIES A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas Zhi Peng, Beijing, China 4011 Rapid Oral Abstract Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 1, 2026 1:15 PM CDT Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 Elena Elez, Barcelona, Spain 3555 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang, Beijing, China 4531 Poster Session: Genitourinary Cancer – Kidney and Bladder Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden Yuanyuan Qu, Shanghai, China 4533 Poster Session: Genitourinary Cancer – Kidney and Bladder Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 Xiaotian Han, Shanghai, China e17612 Publication Only: Gynecologic Cancer INVESTIGATOR-INITIATED STUDIES Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial Jianmin Xu, Shanghai, China LBA3563 Poster Session: Gastrointestinal Cancer – Colorectal and Anal CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Yue Liu, Hangzhou, China TPS3680 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial Joseph Tintelnot, Hamburg, Germany TPS3684 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety Chang Wang, Changchun, China 2631 Poster Session: Developmental Therapeutics – Immunotherapy Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study Yun Xu, Shanghai, China 3528 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) Wenhua Li, Shanghai, China 3534 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases Mengzhou Guo, Shanghai, China 3552 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study Xiaodong Zhu, Shanghai, China 4063 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) Hao Wen, Shanghai, China 5579 Poster Session: Gynecologic Cancer Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study Wangjun Liao, Guangzhou, China e15539 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study Yifu He/Jiayu Niu, Hefei, China e15560 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer Qian Li, Nanning, China e15571 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial Wei Li, Suzhou, China e15583 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States Vasu Bansal, Kansas City, US e15713 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) Beibei Chen, Zhengzhou, China e16033 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study Yanhong Gu, Nanjing, China e16070 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/Jingtao Zhong, Jinan, China 4136 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial Wenquan Wang, Shanghai, China 4198 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial Huijuan Yang, Shanghai, China 5586 Poster Session: Gynecologic Cancer Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study Bei Xu, Shanghai, China 8119 Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou, Wuhan, China e16172 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study Shasha Fan, Changsha, China e16222 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study Xiang Han, Qingdao, China e20079 Publication Only: Lung Cancer – Non-Small Cell Local-Regional/ Small Cell/Other Thoracic Cancers About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

Clinical ResultPhase 2ASCOPhase 1Immunotherapy

16 Dec 2025

·www.prnewswire.com

Breaking the "Untreatable": Biostar Pharma's UTD1 Achieves First Patient Dosing in U.S. for Pivotal Clinical Trial for Breast Cancer Brain Metastases

SAN FRANCISCO, Dec. 15, 2025 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code: 2563.HK), today announced that the first patient has been dosed for one of its key oversea clinical studies: the U.S. pivotal clinical study (NCT06764940) of Utidelone Injection(UTD1) combined with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM). The study adopts a two-stage design and plans to enroll approximately 120 subjects. The primary endpoint is the central nervous system objective response rate (CNS-ORR). Nearly 20 top tier clinical institutes across the United States are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte, Robert H. Lurie Comprehensive Cancer Center at Northwestern University, University of Colorado Hospital, Augusta University, and University of California Los Angeles. Utidelone's unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux enable it to cross the blood-brain barrier (BBB) and prevent or treat brain metastases of solid tumors, setting it apart from taxanes, which are also microtubule stabilizers. A Phase II clinical study of utidelone combined with bevacizumab and chemotherapy for HER2-negative BCBM, which enrolled 34 subjects, was presented orally at the 2025 ASCO Annual Meeting [1]. The results showed a CNS-ORR of 67.6%, a central nervous system clinical benefit rate (CNS-CBR) of 88.2%, and a median central nervous system progression-free survival (CNS-PFS) of 15 months. The results of another Phase II clinical study of utidelone combined with bevacizumab for HER2-negative BCBM were published in JAMA Oncology in 2025 [2]. 47 subjects were recruited in the study, with a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months. In both studies, most treatment-related adverse events (TRAEs) were Grade 1-2, controllable, and reversible. The U.S. FDA has also granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases. Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]. Due to the presence of the BBB, many breast cancer treatments were unable to achieve effective concentrations intracranially, leading to generally poor prognoses for BCBM patients, particularly those with HER2-negative BCBM, whose median progression-free survival is only 2-6 months. However, there is currently no clearly effective drug therapy for HER2-negative BCBM, and no drugs worldwide have been approved for this indication, highlighting a significant and urgent unmet medical need. Utidelone has the potential to change this landscape, offering a new treatment option and hope for survival to these patients. About Biostar Biostar is an integrated biopharma company focusing on the development of innovative anti-cancer drugs utilizing its synthetic biology R&D platform. The company is listed on the Hong Kong Stock Exchange (HK 2563) in 2024. We are actively selecting reliable global partners through out-licensing or co-development of Utidelone assets. We believe that our strong capabilities of R&D and manufacturing, coupled with our enriched commercial expertise, make us the preferred partner for global biopharmaceutical companies who share our goal of bringing innovative anti-cancer products to patients around the world. For additional information on partnering with Biostar, please contact our business development team at [email protected]. SOURCE Biostar Pharma, Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 2Orphan Drug

15 Sep 2025

·www.prnewswire.com

Biostar Pharma Successively Achieved First Patient Dosing for Two Phase II/III Multiregional Clinical Trials of Utidelone Capsule (UTD2)

SAN FRANCISCO, Sept. 15, 2025 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", Stock Code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patients have been dosed for two phase II/III multiregional clinical trials (MRCT) of "Utidelone Capsule (UTD2) first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma" (NCT06841679) and "UTD2 treatment for platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer" (NCT07044349) on September 11, 2025 and September 12, 2025, respectively. Utidelone has demonstrated excellent clinical data in gastric cancer: in a completed Phase II study of Utidelone Injection (UTD1) combined with PD-1 inhibitor and oxaliplatin for the first-line treatment of unresectable locally advanced or recurrent/metastatic HER2-negative gastric cancer, 23 patients had completed efficacy evaluation. Among them, 15 achieved partial response (PR) and 8 achieved stable disease (SD), resulting in a 65.2% objective response rate (ORR) and 100% clinical benefit rate (CBR). The median progression-free survival (mPFS) was 6.1 months. The combination regimen was generally well-tolerated. Most treatment-related adverse events (TRAEs) were Grade 1-2, reversible, and manageable. The longest treatment duration received by a patient was 22 cycles [1]. Consequently, Utidelone was granted an Orphan Drug Designation by the U.S. FDA for the treatment of advanced gastric cancer. Besides gastric cancer, Utidelone has also shown considerable potential for treating ovarian cancer in previous clinical studies. A US Phase I clinical study of UTD2 as a monotherapy for advanced solid tumors had 12 evaluable patients, including one ovarian cancer patient with a complete response (CR) and another with PR, who had previously undergone 7 and 9 lines of therapy, respectively [2]. A Phase II clinical study of UTD1 as monotherapy for the treatment of advanced solid tumors had 10 evaluable patients in advanced ovarian cancer cohort, among them there were 1 PR and 3 SD. Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability and lower risk of developing cross-resistance. By utilizing its technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China's studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, and more suitable for adjuvant or maintenance therapy. Beyond gastric and ovarian cancers, Biostar is actively planning and advancing multiple clinical studies to expand UTD2's indications, including breast cancer adjuvant intensification therapy, pancreatic cancer, esophageal cancer, colorectal cancer, and so on. About NCT06841679 Study This study is a multi-national, open-label, randomized phase II/III clinical study of UTD2 combined with standard of care to evaluate the efficacy and safety in first-line patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, untreated with systemic treatment in the advanced setting. For the Phase II part, 78 subjects are planned to be enrolled in China, US, Europe and Japan. Its primary objectives are to evaluate the safety, efficacy, and pharmacokinetic profile of UTD2 in combination therapy. The Phase III part plans to enroll 700 subjects across multiple countries/regions. The primary endpoint is overall survival (OS), with secondary endpoints including PFS, ORR, and safety. About NCT07044349 Study This study is a multi-national, open-label, randomized Phase II/III clinical trial of UTD2 for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Phase II part plans to enroll approximately 84 subjects. Its primary objective is to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of UTD2 under different dosing regimens in the target patient population and to recommend a dose for Phase III. The Phase III part plans to enroll 480 subjects and is planned to be conducted in multiple countries and regions worldwide. Its primary objective is to evaluate the efficacy and safety of UTD2 compared to the investigator's choice of standard treatment in the target patient population. The primary endpoint is PFS, with secondary endpoints including OS, ORR, and others. About Utidelone Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO annual meetings and published in prestigious journals [3-4]. About Biostar Biostar is an integrated biopharma company focusing on the development of innovative anti-cancer drugs utilizing its synthetic biology R&D platform. The company is listed on the Hong Kong Stock Exchange (HK 2563) in 2024. We are actively selecting reliable global partners through out-licensing or co-development of Utidelone assets. We believe that our strong capabilities of R&D and manufacturing, coupled with our enriched commercial expertise, make us the preferred partner for global biopharmaceutical companies who share our goal of bringing innovative anti-cancer products to patients around the world. For additional information on partnering with Biostar, please contact our business development team at [email protected]. Reference [1] 2025 ASCO Abstract #: 4040 [2] 2025 ASCO Abstract #: 3030 [3] B. Xu, T. Sun, Q. Zhang, et al. Annals of Oncology, 2021, 32(2): 218-228 [4] Pin Zhang, Tao Sun, Qingyuan Zhang, et al. Lancet Oncol 2017; 18: 371-83 SOURCE Biostar Pharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1Phase 2Phase 3Orphan Drug

100 Deals associated with Utidelone

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KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB01873

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast cancer recurrent	China	Chengdu Biostar Pharmaceuticals Ltd.	11 Mar 2021
Metastatic breast cancer	China	Chengdu Biostar Pharmaceuticals Ltd.	11 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	24 Jul 2026
Gastroesophageal junction adenocarcinoma	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	28 Aug 2025
Gastrooesophageal junction cancer	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	28 Aug 2025
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Beijing Biostar Pharmaceuticals Co. Ltd.	28 Aug 2025
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	28 Aug 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Chengdu Biostar Pharmaceuticals Ltd.	08 Dec 2022
metastatic non-small cell lung cancer	Phase 3	China	Chengdu Biostar Pharmaceuticals Ltd.	08 Dec 2022
HER2-negative breast cancer	Phase 3	China	Sun Yat-Sen University	01 Mar 2022
Locally advanced breast cancer	Phase 3	China	Chengdu Biostar Pharmaceuticals Ltd.	01 Mar 2022
Locally advanced breast cancer	Phase 3	China	Sun Yat-Sen University	01 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05700084 (ASCO2026)	Phase 2	Metastatic breast cancer HR+ \| HER2-	44	Utidelone capsule + Capecitabine	biqlkvjmky(fthvympxcy) = dethctqigf doffcogbwh (oiokamrpxp, 36.7 - 67.5) View more	Positive	29 May 2026
ChiCTR2200061635 (ASCO2026)	Phase 2	Metastatic castration-resistant prostate cancer	43	Utidelone	gbtsvyopry(jckmxnmefx) = ukwypudwpa eaqcxuntyd (goikmizlvd ) View more	Positive	29 May 2026
NCT06973421 (FRUTD, ASCO2026)	Phase 2	Recurrent Platinum-Resistant Ovarian Carcinoma	14	Utidelone plus Fruquintinib	znpopsvyui(lylucysjdh) = apdlouzxez noamgtwcgl (dxykmiiwxw, 38.8 - 83.7) View more	Positive	29 May 2026
ASCO2026	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line \| Second line HER2-positive	94	Inetetamab + Pyrotinib + Utidelone	tyyhgjnver(yuxrqyzeyi) = tnclzvhkfp djicugvxag (zekiyqabag, 72.6 - 89.8) View more	Positive	29 May 2026
NCT05357417 (U-BOMB-HER, SABCS2025)	Phase 2	HER2 Positive Breast Cancer HER2-positive	50	Utidelone plus bevacizumab	hjbjlqochl(kraawweaei) = emudwvzqsm lloezzfmxt (ghnsvppvwm, 39.3 - 68.2) View more	Positive	12 Dec 2025
ChiCTR2200062161 (UTISARC, ESMO2025)	Phase 2	Metastatic Soft Tissue Sarcoma	27	Utidelone 30 mg/m	qubdcitdyy(hilxkdeurn) = jhuubmoshy ivcuhvenlh (sxcnxszuuc ) View more	Positive	17 Oct 2025
NCT05795920 (PRNewswire) Manual	Phase 2	Pancreatic carcinoma non-resectable First line	20	Utidelone + Gemcitabine	yqagzlenxr(cfwljwgnwo) = wkqtfhzvxb nacyvqcvhn (ggzfveukok ) View more	Positive	25 Sep 2025
NCT05357417 (U-BOMB, Pubmed \| JAMA Oncol) Manual	Phase 2	Metastatic HER2-Negative Breast Carcinoma HER2/Neu Negative	47	Utidelone +Bevacizumab	iosaezstdk(nawepknfzp) = euxhwzsczb qqlcmntprg (msfiqoihvm, 28.3 - 57.8) View more	Positive	01 Aug 2025
NCT05700084 (Phase I/II study of utidelone capsule, ASCO2025)	Phase 1/2	Advanced Malignant Solid Neoplasm	31	Utidelone capsule (UTD2) 50 mg/m^2/d-5day	epollbxerj(reekfnlvdc) = the most common ≥ Grade 3 AE was diarrhea appeared at 75 mg/m^2/d-7day, but recovered within 24 hours after supportive treatment ljjonpzhmk (jnhsmlcmgj ) View more	Positive	30 May 2025
	Phase 1/2	Advanced Malignant Solid Neoplasm	31	Utidelone capsule (UTD2) 75 mg/m^2/d-5day		Positive	30 May 2025
NCT04911907 (ASCO2025)	Phase 2	Esophageal Carcinoma \| Stomach Cancer First line HER2 negative	47	Utidelone + Sintilimab + Oxaliplatin	huyrpiwmnw(tcqnufclgf) = dqhmajxiwv bsjzrnunxg (cseewylgpg ) View more	Positive	30 May 2025
NCT04911907 (ASCO2025)	Phase 2		47	Utidelone + Tislelizumab + Capecitabine	huyrpiwmnw(tcqnufclgf) = inymiryuir bsjzrnunxg (cseewylgpg ) View more	Positive	30 May 2025

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