A Phase I, double-blind, placebo-controlled, randomised, crossover study to assess the anti-inflammatory effects of orally inhaled PB01 following an inhaled lipopolysaccharide (LPS) challenge in healthy male volunteers.

开始日期2016-05-05

申办/合作机构

Paranta Biosciences Ltd.

ACTRN12615000984594

/ Completed临床1期

Randomised, double-blind, placebo-controlled Phase I study to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of orally inhaled PB01 administered to healthy subjects.

开始日期2015-09-22

申办/合作机构

Paranta Biosciences Ltd.

100 项与 PB-01 相关的临床结果

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100 项与 PB-01 相关的转化医学

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100 项与 PB-01 相关的专利（医药）

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项与 PB-01 相关的文献（医药）

2025-12-01·CURRENT MICROBIOLOGY

Bioactive Pigment Production by Stenotrophomonas rhizophila PB01: Partial Characterization and its Biological Applications

作者: Murugasamy, Kanimozhi ; Kathirvel, Preethi ; Kandasamy, Gayathri Devi

The rising concerns over synthetic colorants have driven demand for natural alternatives, aligning with the global shift toward eco-friendly products. However, the limited availability of natural pigments has spurred research into sustainable sources, particularly microorganisms. Bacteria, in particular, offer great potential for producing bioactive pigments due to their short life cycles, environmental resilience, scalability, and diverse metabolite production. Exploring bacterial pigments presents substantial potential for various industrial applications. This research focuses on the production of bioactive pigments from bacteria isolated from rhizosphere soil, detailing a simplified extraction process and comprehensive characterization, toxicity analysis, and biological applications. Among the isolates, PB01 an orange pigment producer, emerged as the most promising due to its confirmed safety, showing non-pathogenic behavior, antibiotic sensitivity, weak biofilm formation, and no hemolytic activity. A taxonomic analysis based on phenotypic and genotypic investigations revealed the identity of isolate PB01 as Stenotrophomonas rhizophila, exhibiting intracellular pigment production with methanol being the most effective solvent for extraction. UV-Visible and FTIR spectral analysis indicated that the extracted pigment is likely a carotenoid derivative. The pigment demonstrated significant antioxidant, anti-inflammatory, and α-glucosidase inhibitory activities. In addition, the extracted crude pigment did not induce any blood lysis, as confirmed by the hemocompatibility assay, and therefore it was utilized as a coloring agent in agar jelly. The present finding implies that bioactives from S. rhizophila could be employed as natural pigments in the food and pharmaceutical sectors.

2025-02-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design and synthesis of novel 3,7-dihydro-1H-purine-2,6-diones as DPP-4 inhibitors: An in silico, in vitro and in vivo approach

Article

作者: Bisht, Priya ; Pal, Anubroto ; Bhattacharya, Arka ; Verma, Sant Kumar ; Singh, Rajveer

The inhibition of enzyme DPP-4 is pivotal for targeting type 2 diabetes mellitus (DM). The study introduces two series of novel 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-diones derivatives (PB01-PB10) and 3,7-dihydro-1H-purine-2,6-diones compounds (PB11-PB16) were developed using linagliptin scaffold. Sixteen derivatives were synthesized and screened in vitro against DPP-4, revealing IC₅₀ ranging from 15.66 ± 2.546 to 28.45 ± 4.441 nM. Compounds PB01 and PB11 demonstrated high potency comparable to reference standard linagliptin (IC₅₀ = 15.66 ± 2.546, 16.16 ± 1.214, 15.37 ± 2.481 nM, respectively). Further studies showed that the compound possesses negligible cytotoxicity up to 100 μM concentration. A high glucose-induced DPP-4 upregulation model was further utilized to assess the protective effect of PB01 and PB11, and their efficacy was compared with linagliptin. PB01 and PB11 showed comparable protective effects against high glucose-induced ROS generation and mitochondrial superoxide production, and the compounds also effectively reduced the DPP-4 cellular expression. The in vivo anti-diabetic efficacy, effect on change in body weight, and OGTT due to PB01 and PB11 treatments were evaluated using the STZ-Nicotinamide-induced experimental model of diabetes in mice. Post induction of diabetes, the periodic estimation of blood serum glucose levels reveals that treatment with PB01 and PB11 decreased the high blood serum glucose levels in both acute and chronic studies. The expressions of DPP-4 were observed by IHC, Flowcytometry, and RT-qPCR. The docked complexes of both compounds, along with the standard drug linagliptin, were subjected to molecular dynamics simulation for 140ns to evaluate the complexes' stability and binding affinity.

2023-08-01·Poultry science

Enzymatic hydrolysis of minced chicken carcasses for protein hydrolysate production

Article

作者: Xinzhi Li ; Xing Zhang ; Shao-Quan Liu

Animal and poultry processing generates significant volumes of by-products that can be further processed for other uses. In this study, we treated minced chicken carcasses with proteases to produce protein hydrolysates that can be used as nutritional and/or flavor-enhancing ingredients. Five different microbial proteases were investigated for their abilities to hydrolyse the minced chicken carcass: Flavourzyme, Protamex, PB01, PB02, and PB03, with PB02 demonstrating the highest degree of hydrolysis (DH) of the minced chicken carcass (43.95%) after 4 h of hydrolysis. The essential hydrolytic parameters were optimized using response surface methodology in conjunction with Box-Behnken design. The optimal conditions were found to be: enzyme/substrate ratio of 3:100 (w/w), temperature of 51.20°C, pH of 6.62 ± 0.05, and substrate/water ratio of 1:1 (w/v) for 4-h hydrolysis, which resulted in a maximum DH of 45.44%. The protein recovery was 50.45 ± 2.05%, and the protein hydrolysate was high in free amino acids (7,757.31 mg/100 mL), of which essential and taste-active amino acids accounted for 41.74% and 92.64%, respectively. The hydrolysate was comprised mainly of low molecular weight peptides (1-5 kDa, 0.5-1 kDa, and <0.5 kDa), which were potential taste substances and flavor precursors. The resulting hydrolysate might be employed as a nutritive product, an ingredient for flavoring generation or a component of fermentation media.

项与 PB-01 相关的新闻（医药）

2025-12-11

·QQ浏览器

普愈新生丨中国首个儿童及青少年B-ALL CAR-T普基奥仑赛全国首方患者完成回输！

2025年11月7日，中国原研1类新药CAR-T产品普基奥仑赛注射液（以下简称普基奥仑赛）正式获批，用于治疗3~21岁CD19阳性的难治或复发（首次缓解12个月后复发需经挽救化疗）的急性B淋巴细胞白血病患者。这是在中国首个获批上市治疗儿童及青少年B-ALL的CAR-T药物，标志着我国儿童及青少年白血病治疗迈入了CAR-T细胞免疫治疗的新时代！11月7日，西部战区总医院开出了普基奥仑赛的全国首个处方，意味着这款中国自主创新的CAR-T疗法正式进入临床应用。值得关注的是，首方患者已于11月11日完成单采，并于12月4日完成CAR-T细胞回输。基于此，本刊特邀西部战区总医院易海教授，对这一具有里程碑意义的事件进行深度报道。2025.11.07：处方2025.11.11：单采2025.12.04：回输01《肿瘤瞭望-血液时讯》：普基奥仑赛的获批标志着CAR-T在我国儿童及青少年B-ALL治疗领域实现了从“无”到“有”的重大突破。您如何评价这一创新疗法在解决未被满足临床需求方面的价值？易海教授：急性淋巴细胞白血病（ALL）是儿童最常见的恶性肿瘤，约占整体儿童白血病的75%，其中以B-ALL最为常见，占儿童ALL的80%以上[1]。半个多世纪以来，多药联合化疗的策略使儿童ALL的治疗取得了显著的进展，5年总生存（OS）率达到85%~90%以上，但仍有15%~20%的患儿进入难治或复发阶段[2]，针对此类患者，如加大传统治疗的强度往往不能进一步提高疗效，反而会增加药物毒性，导致难治或复发B-ALL患者预后不佳，长期生存率较低，临床迫切期待疗效更好、毒性更低的药物来改善这些患者的生存预后和生活质量。在此背景下，普基奥仑赛的获批具有里程碑意义。作为我国首个自主研发的针对儿童B-ALL的靶向CD19的CAR-T药物，普基奥仑赛在一项国内多中心I/II期研究中展现出优异的疗效与良好的安全性，为复发或难治B-ALL患儿带来了新的治愈希望。普基奥仑赛的获批上市标志着我国在儿童及青少年B-ALL CAR-T细胞免疫治疗领域实现重大突破，填补了长期存在的治疗空白。随着该疗法在临床的广泛应用，我们期待它为更多复发/难治患儿带来获益，并通过持续积累临床数据，进一步巩固CAR-T疗法在儿童及青少年白血病治疗中的重要地位。02《肿瘤瞭望-血液时讯》：结合相关研究数据，请您谈谈普基奥仑赛在疗效与安全性方面有哪些突出优势？目前国内外指南对CAR-T治疗儿童B-ALL有哪些具体推荐？易海教授：综合分析普基奥仑赛的PB01[3]和PB07[4]两项研究数据，对于传统治疗及贝林妥欧单抗治疗无反应或复发的儿童及年轻成人B-ALL患者，普基奥仑赛展现出显著疗效，最佳缓解率达97.62%，微小残留病（MRD）阴性率达98.78%。≥12岁、难治性、既往接受过干细胞移植、TP53突变、 Ph+/Ph-like等高危患者均可从该治疗方案中获益。同时，其安全性和耐受性良好，相关不良事件均可控。≥3级细胞因子释放综合征（CRS）、≥3级免疫效应细胞相关神经毒性综合征（ICANS）和≥3级感染发生率均较低、持续时间短，且未见严重低丙种球蛋白血症。目前，国内外指南均已将CAR-T作为儿童r/r B-ALL的重要治疗手段：《中国临床肿瘤学会儿童及青少年白血病诊疗指南（CSCO 2025 ）》[5]指出，儿童难治或复发B-ALL患者可参加正在进行的CAR-T临床试验并作为Ⅱ级推荐（因指南发布时国内尚未有针对该适应症的CAR-T产品获批）；《NCCN儿童急性淋巴细胞白血病（2025.V3）》[6]将CD19 CAR-T药物推荐作为复发或难治性儿童B-ALL患者的重要治疗选择。钱程教授：重庆精准生物技术有限公司自2016年成立以来，始终专注于基因与细胞治疗领域的创新研发。普基奥仑赛注射液是公司的首个获批产品，我们历经十年研发攻坚，成功从实验室走向临床，标志着公司在细胞免疫治疗领域的重要突破。普基奥仑赛是我国首个获批治疗儿童及青少年r/r B-ALL的CAR-T产品，它的获批上市也体现了以精准生物为代表的中国生物医药创新企业的强大实力。随着普基奥仑赛全国首方落地临床，并已顺利完成CAR-T细胞回输，我们期待能为更多中国儿童及青少年r/r B-ALL患者带来更显著的临床获益。秉承“科技服务健康，精准维护生命”的愿景使命，精准生物已在全球多个国家和地区进行了研发布局，并实施推进了在白血病、淋巴瘤、骨髓瘤、肾癌、结直肠癌、肺癌、乳腺癌等领域的十余条产品研发管线。目前，精准生物已获得四个CAR-T细胞I类生物新药许可及十项适应症的注册临床默示许可。未来，我们将继续加大研发投入，推动更多创新产品的落地，致力于为中国乃至全球患者提供更加有效的治疗方案，助力生物医药行业的持续创新与发展。专家简介易海教授西部战区总医院西部战区总医院血液科主任医学博士，副主任医师，研究生导师美国布莱根与妇女医院访问学者主要从事白血病、淋巴瘤的造血干细胞移植工作主持国家自然科学基金中国中西医结合学会血液专委会委员中国康复医学会血液康复专委会委员四川省医学会血液专委会副主任委员四川省医师协会血液医师分会副会长钱程教授重庆精准生物董事长兼首席科学家教授，博士生导师，先后任北京大学临床肿瘤医院、第三军医大学西南医院、重庆大学肿瘤医院教授国家科技部“国家精准医学生物治疗国际联合研究中心”主任、国家科技部重点研发计划首席科学家美国基因治疗协会、欧洲基因治疗协会等常委委员、中国医药质量管理协会精准生物治疗技术质量研究专委会主任委员，重庆抗癌协会生物治疗专业委员会主任委员重庆市 “百人计划”、首批“科技创新人才”、“首批百名领军人才”、“十大重庆科技创业创新年度人物”获得者参考文献：[1]竺晓凡.儿童急性B淋巴细胞白血病的优化治疗.中国当代儿科杂志, 2023, 25(4):344-349.[2]张瑞东，王天有.儿童急性淋巴细胞白血病的免疫治疗[J].中华儿科杂志,2023,61(10): 865-868.DOI:10.3760/cma.j.cn112140-20230813-00101.[3]Zhenya Hong, Zhi Yang, Xiaoxi Zhou, et al. The Safety and Efficacy of p CAR-19B, a Scfv Humanlized CD19-Directed CAR-T for Patients with Relapsed/Refactory (R/R) CD19+ B-ALL. Blood 2022; 140 (Supplement 1): 4625–4626. doi: https://doi.org/10.1182/blood-2022-162134[4]Ruidong Zhang, Yang Cao, Xiaofan Zhu,et al. A Phase 2 Clinical Trial of Anti-CD19 CAR-T (pCAR-19B) in Chinese Pediatric and Young Adult with Relapsed/Refractory (R/R) CD19+ B-ALL: The First Pivotal Study in an Asian Population. Blood 2024; 144 (Supplement 1): 4205. doi: https://doi.org/10.1182/blood-2024-206408.[5]中国临床肿瘤学会指南工作委员会组织编写.中国临床肿瘤学会(CSCO)儿童及青少年白血病诊疗指南(2025).北京：人民卫生出版社，2025.4.[6]Pediatric Acute Lymphoblastic Leukemia.NCCN Guidelines Version 3.2025.

免疫疗法细胞疗法上市批准ASH会议临床1期

2025-04-24

·PRNewswire

Primo's Taoyuan Facility Achieves PIC/S GMP Certification, Paving the Way for Global Expansion in Nuclear Medicine.

TAIPEI, April 24, 2025 /PRNewswire/ -- Primo Biotechnology Co., Ltd. ("Primo") proudly announces that its Taoyuan pharmaceutical facility has successfully passed inspection by Taiwan Food and Drug Administration (TFDA) and has been award dual certification for PIC/S GMP and GDP. This achievement demonstrates Primo's dedication to meeting international quality standards for nuclear medicine production and sets the stage for global market growth. Continue Reading Primo Partners with ABX to Bring PB01 Closer to Taiwan’s Prostate Cancer Market. Since initiating construction in 2023, Primo has focused on establishing a high-efficiency, internationally compliant facility. By integrating advanced and automated production system with over 30 years of the team's radiopharmaceutical manufacturing experience in medical centers, the company achieved certification in less than two years. This milestone not only strengthens domestic supply capabilities but also accelerates clinical trial progress for new drug candidates and builds international client confidence—paving the way for expanded partnerships in the global markets. Furthermore, Primo obtained TFDA market approval in April 2025 for Fluorodeoxyglucose F-18 (18F-FDG). This essential radiopharmaceutical for PET/CT imaging plays a key role in diagnosing cancers as well as neurological and cardiac conditions. The commercial launch of F-18 FDG is expected positively contribute to the company's operational performance. Beyond F-18 FDG, Primo is actively developing a broad portfolio of radio theranostics radiopharmaceuticals. Recognizing the high technical and regulatory barriers within this field, Primo is also expanding into CRO (Clinical Research Organization) and CDMO (Contract Development and Manufacturing Organization) services. By integrating drug development, pre-clinical trials and manufacturing into its radiopharmaceutical platform. Primo enables close collaboration with partners and supports the acceleration of new drug approvals. In addition to GMP and GDP certification, Primo is licensed by Taiwan's Atomic Energy Council for the safe transport of radioactive materials. By following GDP standards, Primo ensures secure and efficient delivery of radiopharmaceuticals. Its strategic location, just 30 minutes from Taoyuan International Airport, provides a logistical edge for global operations. Securing PIC/S GMP and GDP certifications is a significant milestone for Primo. The company will continue to strengthen its manufacturing and research capabilities, enhancing its competitiveness in the global nuclear medicine market. By partnering with leading medical institutions worldwide, Primo is committed to delivering high-quality diagnostic and therapeutic radiopharmaceuticals to patients worldwide. About Primo Biotechnology Co., Ltd. Primo is a leading biotech company specializing in the development and manufacturing of radiopharmaceuticals. With internationally certified facilities, Primo is committed to using precision molecular imaging technology to bring hope and a future to cancer patients. Headquartered in Taipei, the company collaborates with domestic and international partners to drive advancements in precision cancer care. For more information, visit and follow on Facebook and LinkedIn. SOURCE Primo Biotechnology Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-03-19

·PipelineReview

Primo Partners with ABX to Bring PB01 Closer to Taiwan’s Prostate Cancer Market

TAIPEI, Taiwan I March 19, 2025 I In response to the growing burden of prostate cancer in Taiwan, Primo Biotechnology Co., Ltd. (“Primo”) has formed a strategic partnership with Germany-based ABX advanced biochemical compounds GmbH (ABX) to lay the groundwork for introducing PB01 to the Taiwanese market. Data from Taiwan Cancer Registry indicate a steady increase in both, the incidence and mortality of prostate cancer, in recent years [1], underscoring the urgent demand for more accurate diagnostic tools. Radelumin, an innovative diagnostic radiotracer tailored specifically for prostate cancer patients, has already gained approval in France and multiple European countries [2]. Using advanced PET/CT imaging technology, Radelumin and its equivalent for the Taiwanese market, PB01, enable precise detection of Prostate Specific Membrane Antigen (PSMA) expression, helping physicians identify and monitor prostate cancer with exceptional accuracy. Since its European debut in 2021 [2], Radelumin has become a widely adopted tool for early detection, staging, and recurrence monitoring in high-risk prostate cancer cases. The partnership between ABX and Primo aims to bring this vital diagnostic tool to Taiwan, offering a new level of precision in cancer care. Primo CEO’s statement: “Precision treatment begins with precise diagnosis. The official introduction of PB01 in Taiwan is not only a beacon of hope for Taiwanese prostate cancer patients but also a groundbreaking milestone in ushering a new era of precision radiological diagnostics for cancer care in the region.” ABX CEO’s statement: “Primo is an excellent partner in Taiwan, known for its robust and compliant manufacturing capabilities. We are confident of PB01’s potential in the Taiwanese market and look forward to seeing this technology become a cornerstone of precision medicine for prostate cancer.” About ABX advanced biochemical compounds GmbH ABX is a worldwide leader in the production of starting materials for radiopharmaceuticals, headquartered in Germany. The company specializes in research, development and manufacture of precursors, reagent kits and cassettes used in radiochemical labeling reactions, providing high-quality products and services in multiple countries and regions. ABX is dedicated to innovation and quality, advancing the global nuclear medicine field. About Primo Biotechnology Co., Ltd. Primo is a leading biotech company specializing in the development and manufacturing of radiopharmaceuticals. With internationally certified facilities, Primo is committed to using precision molecular imaging technology to bring hope and a future to cancer patients. Headquartered in Taipei, the company collaborates with domestic and international partners to drive advancements in precision cancer care. For more information, visit https://primobt.com and follow on Facebook and LinkedIn. Source: [1] Taiwan ministry of health and welfare national health service, Taiwan cancer registry. [2] ABX’s press release in 2023. SOURCE: Primo Biotechnology

诊断试剂

100 项与 PB-01 相关的药物交易

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