This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.

Start Date01 Sep 2025

Sponsor / Collaborator

Beijing Biostar Pharmaceuticals Co. Ltd.

NCT06841679

/ RecruitingPhase 2/3

A Multi-national, Open-label, Randomized Phase II/III Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.

Start Date28 Aug 2025

Sponsor / Collaborator

Beijing Biostar Pharmaceuticals Co. Ltd.

NCT06764940

/ RecruitingPhase 2

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine.
The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.

Start Date14 Jul 2025

Sponsor / Collaborator

Shaanxi Aoxing Pharmaceutical Co., Ltd.

100 Clinical Results associated with Utidelone

100 Translational Medicine associated with Utidelone

100 Patents (Medical) associated with Utidelone

269

Literatures (Medical) associated with Utidelone

23 Aug 2025·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Utidelone induces apoptosis and autophagy in small cell lung cancer cells through the ROS/AMPK signaling pathway].

Article

Author: Mu, X Q ; Wu, H B ; Hu, X F ; Yu, C N ; Zhao, Y Q

Objective: To investigate the effects and underlying molecular mechanisms of Utidelone (UTD1) in small cell lung cancer (SCLC). Methods: The study utilized small cell lung cancer H446 and H1048 cell lines along with animal models. Cell proliferation, cell cycle progression, apoptosis, autophagy, and related activities following UTD1 treatment were assessed using Cell Counting Kit-8 (CCK-8), flow cytometry, immunofluorescence staining, reactive oxygen species (ROS) generation assay, and Western blot analysis. The involvement of the ROS/adenosine monophosphate-activated protein kinase (AMPK) signaling pathway was also examined. Data analysis was performed using GraphPad Prism version 8 software. Results: UTD1 inhibited the viability of H446 and H1048 cells in a dose- and time-dependent manner. The half inhibitory concentrations (IC₅₀) of UTD1 for H446 and H1048 cells were 0.675 and 0.439 μg/ml, respectively. The proportion of cells in the G₂/M phase for H446 and H1048 cells in the UTD1 group at 6 h, 12 h, and 24 h was [(53.86±4.54)%, (68.59±5.49)%, (60.89±3.26)%] and [(46.83±2.20)%, (60.67±3.44)%, (57.88±5.11)%], which were significantly higher than that in the control group, except for the proportion of H1048 cells at 6 h [(38.99±2.60)% vs. (40.73±2.50)%, P＜0.05]. The apoptosis rates were [(23.57±0.12)%, (35.79±1.59)%, and (46.15±4.57)%] for H446 cells and [(23.05±2.70)%, (37.73±2.97)%, and (43.39±3.31)% for H1048 cells], all of which were significantly higher than those in the control group [(6.44±0.96)%, (6.31±0.75)%, respectively; all P＜0.05]. The number of LC3 fluorescent spots was [(56±11), (69±8), and (66±8)] for H446 cells and [(39±7), (56±12), and (50±11)] for H1048 cells, both significantly higher than those in the control group [(13±6) and (12±5), respectively; both P＜0.05]. The relative fluorescence intensity of ROS was 2.54±0.48, 2.85±0.68, and 5.03±0.72 for H446 cells and 2.26±0.51, 4.17±0.35, and 4.66±0.51 for H1048 cells, which were also significantly higher than those in the control group (P＜0.05). The expression levels of cyclin B1, cyclin A2, and P21 of H446 cells in the three time points were [(0.63±0.07, 0.33±0.05, 0.23±0.04), (0.68±0.08, 0.46±0.03, 0.27±0.06), and (0.64±0.03, 0.32±0.05, 0.22±0.03), respectively], all significantly lower compared to the control group (P＜0.05). The apoptosis rates of H446 and H1048 cells in the UTD1+Z-VAD-FMK group were (19.97±3.19)% and (17.68±3.14)%, both lower than those in the UTD1 group [(40.73±3.35)% and (39.82±2.45)%, respectively; all P＜0.05]. The absorbance values of H446 and H1048 cells in the UTD1+3-MA group were significantly higher than those in the UTD1 group at 6h, 12h, and 24h (all P＜0.05). The levels of p-AMPKα/AMPKα, LC3-II expression, and the percentage of apoptotic cells in the H446 and H1048 cells of the UTD1+NAC group were [(1.33±0.09, 1.33±0.11), (1.49±0.16, 1.55±0.05), (17.24±2.15)%, and (19.40±4.28)%], all of which were lower than those observed in the UTD1 group [(1.98±0.17, 2.23±0.23), (2.81±0.19, 2.49±0.38), (38.07±3.53)%, and (41.20±1.87)%, all P＜0.05]. The number of LC3 fluorescence points and the percentage of apoptotic cells in the H446 and H1048 cells of the UTD1+si-AMPKα group [(24±5, 23±3), (18.35±1.15)%, and (19.15±3.46)%] were all lower than those in the UTD1+si-NC group [(46±6, 36±6), (39.34±1.77)%, and (39.50±2.15)%, all P＜0.05]. The tumor inhibition rates in small cell lung cancer tumor-bearing nude mice for the 2.5 mg/kg UTD1 group and the 5 mg/kg UTD1 group were 46.43% and 58.33%, respectively. Furthermore, the proportions of apoptosis-positive cells and p-AMPKα-positive cells in the UTD1 group were significantly higher compared to the control group, while the levels of Ki-67 positivity were significantly reduced. Conclusion: UTD1 inhibits SCLC cell proliferation, induces G₂/M phase arrest, and promotes cell apoptosis and autophagy through the activation of the ROS/AMPK signaling pathway.

01 Aug 2025·Therapeutic Advances in Medical Oncology

Efficacy and safety of utidelone in pretreated patients with metastatic breast cancer in China: a multicenter, real-world study

Article

Author: Ouyang, Quchang ; Zhao, Yannan ; Gong, Chengcheng ; Xu, Fei ; Xie, Ning ; Hu, Shihui ; Wang, Hong ; Wang, Biyun ; Chao, Tengfei

Background::

Utidelone (UTD1), a genetically engineered epothilone derivative, has been approved in China for use in combination with capecitabine in treating metastatic breast cancer (MBC) patients previously treated with anthracyclines or taxanes.

Objectives::

To evaluate the real-world efficacy and safety of UTD1 in Chinese patients with MBC and to explore potential predictors of therapeutic effectiveness.

Design::

A multicenter, retrospective, real-world study.

Methods::

MBC patients who received UTD1 between March 2021 and August 2023 were identified using an electronic database. Outcome variables included progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AEs).

Results::

A total of 270 MBC patients were included, with 81.1% presenting with visceral metastasis and 23.7% with brain metastasis. The median number of treatment lines for UTD1 was 3. UTD1 showed a median PFS of 3.97 months (95% confidence interval (CI) 3.33–4.61) and a median OS of 20.63 months (95% CI 16.72–24.54). Among the patients, 17.4% received UTD1 monotherapy, and 82.6% received UTD1-based combination therapy. The median TTF was 2.80 months (95% CI 2.31–3.29). The ORR was 8.4%, and the CBR was 33.5%. The most common AE was peripheral neuropathy (PN, 55.2%). Patients with unresolved PN from previous therapy or receiving UTD1 through intravenous infusion on days 1–5 were more likely to develop ⩾grade 3 PN.

Conclusion::

UTD1 is a new option for patients who have previously received taxanes and anthracyclines, with its clinical toxicity controllable.

01 Aug 2025·Molecular Pain

Utidelone induces mechanical and cold allodynia in mice via TRPA1 activation

Article

Author: Gao, Wenwen ; Zhang, Yusong ; Dai, Liya ; Tao, Jialong ; Su, Cunjin

Objective::

Utidelone (UTD1), a recently approved epothilones analog in China for metastatic breast cancer, is endorsed in combination with capecitabine for metastatic breast cancer patients who have encountered first-line therapy failures. Despite its clinically verified therapeutic efficacy, it is concurrently associated with peripheral neuropathic pain, particularly affecting extremities. However, the etiology of UTD1-induced peripheral neuropathic pain remains unclear.

Methods::

The present investigation built a mouse pain model induced by UTD1, resulting in marked mechanical and cold allodynia.

Results::

Examination of the dorsal root ganglia unveiled a notable upregulation of TRPA1, accompanied by noteworthy alterations in oxidative stress-related markers, including ATF4, SOD2, CAT, and Cyt-C. The TRPA1 antagonist HC-030031, resulted in the alleviation of mechanical and cold allodynia in the UTD1-induced pain model, as well as two antioxidants, including Mito-tempo and edaravone.

Interpretation::

The present study will provide new strategies for pain relieving induced by UTD1.

News (Medical) associated with Utidelone

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

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyPriority Review

03 Sep 2024

·www.prnewswire.com

Biostar Announces Completion of Patient Recruitment for US Phase 1 Clinical Study of Utidelone Capsule

SAN FRANCISCO, Sept. 3, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that subject recruitment of a US Phase 1 clinical study of Utidelone Capsule (UTD2), a company's key pipeline product, for advanced solid tumors (NCT05681000) has been completed. This study is an open-label, dose-escalation Phase 1 clinical study, and conducted in several institutions across the US including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, and the Washington University in St. Louis. The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT); the secondary objective is to evaluate the efficacy and pharmacokinetic profile of UTD2 monotherapy in patients with advanced solid tumors. Five dose cohorts were explored in this study. After confirming the DLT (diarrhea) in the highest dose cohort, 75mg/m2/day x 5 days was determined as MTD. A total of 18 patients with more than 10 different types of advanced solid tumors were enrolled. The median age was 63 years old, and 2/3 of the patients had received ≥ 3 lines of prior treatments. As of now, efficacy evaluations were completed in 12 patients, and 1 complete response (CR, ovarian cancer), 1 partial response (PR, ovarian cancer), and 8 stable disease (SD, prostate cancer, testicular cancer, non-small cell lung cancer, pancreatic cancer, appendix adenocarcinoma, soft tissue sarcoma, etc.) were obtained with a clinical benefit rate of 83%. The results further demonstrated the broad-spectrum anti-tumor property of Utidelone. As for treatment duration, more than half of these patients received ≥3 cycles of treatments, and the maximum duration of response reached 36 weeks. In terms of safety, most treatment-related adverse events (TRAEs) were grade 1-2, and the most frequently seen TRAEs (incidence ≥ 20%, including all grades) were diarrhea (55.6%), fatigue (33.3%), and neutropenia (22.2%), all of which were manageable. The preliminary results of this study were also presented at the 2024 ASCO meeting. Dr. Li Tang, Chairman of Biostar Pharma commented: "This is the first study of UTD2 that has completed enrollment globally. We successfully achieved the primary objectives and observed encouraging efficacy and safety profiles. We are very grateful for the joint engagement and dedication of our US clinical institutions and investigators. We are confident that this blockbuster product will substantially change the administration regimen of microtubule inhibitors. We will advance the following pipelines for UTD2 at full speed and hopefully bring it to the market to benefit global cancer patients as soon as possible". Biostar is actively carrying out clinical studies of UTD2 in China and abroad. A pivotal study in China for advanced breast cancer led by Professor Xu Binghe, Cancer Hospital of Chinese Academy of Medical Sciences, is in recruitment. The preliminary findings of this study were also presented at the ASCO meeting in 2024; the China Phase 2 study for advanced solid tumors including ovarian cancer and cholangiocarcinoma, etc. is in initiation. In addition, US FDA has granted an Orphan Drug Designation (ODD) to UTD2 for the treatment of advanced gastric cancer, and Biostar is preparing for IND filing of a Phase 2/3 multi-reginal clinical study (MRCT) led by Professor Ruihua Xu of Sun Yat-sen University Cancer Center in both China and US simultaneously. Utidelone is a new-generation genetically engineered microtubule inhibitor. Utidelone Injection (UTD1) has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC) progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase 3 study data showed that UTD1 is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients, and the results were twice orally presented at ASCO annual meetings. Utidelone 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 with less prone to develop drug resistance, capability of crossing the blood-brain barrier so as to prevent and treat brain tumor, and high oral bioavailability. Multiple indication expansion clinical studies for UTD1 are also in progress in China and US, including but not limited to MRCT Phase 3 study for non-small-cell lung cancer (NSCLC), Phase 2 pivotal study for breast cancer brain metastasis in US and NSCLC brain metastasis in China, and Phase 3 study for breast cancer neoadjuvant in China. 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. By utilizing its synthetic biology 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, meaning more suitable for adjuvant and maintenance therapy. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.

Phase 1Clinical ResultPhase 3Orphan DrugPhase 2

100 Deals associated with Utidelone

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-	-	L01	DB01873

R&D Status

Approved

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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
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
Gastroesophageal junction adenocarcinoma	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	16 Jul 2025
Gastrooesophageal junction cancer	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	16 Jul 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	12 May 2023
metastatic non-small cell lung cancer	Phase 3	China	Beijing Biostar Pharmaceuticals Co. Ltd.	12 May 2023
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
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 2	-	Beijing Biostar Pharmaceuticals Co. Ltd.	01 Sep 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2200062161 (UTISARC, ESMO2025)	Phase 2	Metastatic Soft Tissue Sarcoma	27	Utidelone 30 mg/m	rfnxlqzmwl(lddqejyhrk) = cvbkzotkjp ekbsxbjlng (popairdaxk ) View more	Positive	17 Oct 2025
NCT05795920 (PRNewswire) Manual	Phase 2	Pancreatic carcinoma non-resectable First line	20	Utidelone + Gemcitabine	jvsmuifkud(gcuzitryql) = ojqpeltscr bzspfxzmrv (rqruxjypgm ) 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	ijpqethxib(sffqnpescv) = lsfoqafizq lsskmravgw (vgvifcekru, 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	zzrjhinpqb(jhaobitjif) = the most common ≥ Grade 3 AE was diarrhea appeared at 75 mg/m^2/d-7day, but recovered within 24 hours after supportive treatment wzlsfarepv (vxmilaiynz ) 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	pxtvuyxpew(vccjnllwke) = oexdubeipb ixezlivsek (xyauoetkgr ) View more	Positive	30 May 2025
NCT04911907 (ASCO2025)	Phase 2		47	Utidelone + Tislelizumab + Capecitabine	pxtvuyxpew(vccjnllwke) = kfybsbppvw ixezlivsek (xyauoetkgr ) View more	Positive	30 May 2025
NCT06125080 (UTILIZABLE, ESMO_BC2025)	Phase 2	Advanced Triple-Negative Breast Carcinoma	25	Utidelone + Bevacizumab + Tislelizumab	nyaiyrxvgi(znpaefyvxt) = fodnzcwxek reouuuxtdy (pupbjxdiqe ) View more	Positive	14 May 2025
NCT05795920 (NEWS)	Phase 2	Metastatic Pancreatic Cancer First line	20	优替德隆+吉西他滨	pzezqhujfr(cllxcaopof) = usmffdnuri hbrehaiqxt (dqirzeqemc ) View more	Positive	30 Sep 2024
NCT04911907 (ASCO2024)	Phase 2	Advanced Malignant Solid Neoplasm \| Advanced gastric carcinoma First line HER2 negative	79	Utidelone plus sintilimab and oxaliplatin	mtuhtxxzjz(ljkqftznnq) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. ocfgenbqpv (lhtcpcrinl ) View more	Positive	24 May 2024
NCT05700084 (ASCO2024)	Phase 1	Advanced breast cancer	5	Utidelone Capsule 50 mg/m2/d-5day	owguveeaki(ahfjyvneya) = pfumhfeftt tkyscizgjl (zlqjyappde )	Positive	24 May 2024
NCT05700084 (ASCO2024)	Phase 1	Advanced breast cancer	5	Utidelone Capsule 75 mg/m2/d-5day	owguveeaki(ahfjyvneya) = dpuiawcepg tkyscizgjl (zlqjyappde ) View more	Positive	24 May 2024
NCT05357417 (U-BOMB, ASCO2024)	Phase 2	Brain metastases HER2-negative	46	Utidelone plus bevacizumab	uvcknakdzo(agppkminjq) = kejelrktls flbpqroisu (xypjqqleyz, 28.9% - 58.9) View more	Positive	24 May 2024

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