Pilot Study to Gain First Indications for the Impact of a Three-month's Oral Intake of an Iron Supplement With High Bioavailability on the Hemoglobin Concentration in Iron Deficient Blood Donors

The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomal iron preparation in whole blood donors with iron deficiency for three months.

开始日期2019-11-13

申办/合作机构

Medizinische Universität Graz

[+2]

CTRI/2012/09/002951 / CompletedN/A

A multicentre, randomized,open label,two-period, two-treatment,two-way crossover, bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug TemodalÂ® (Temozolomide) Capsules 250 mg (Manufactured by: Orion Corporation, Orion Pharma Division, Turku, Finland, Distributed by Schering-Plough Products Pharmaceuticals Ltd.,Brazil) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting condition.

开始日期2012-12-17

申办/合作机构

Fresenius Kabi Oncology Ltd.

CTRI/2012/03/002499 / CompletedN/A

A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, single dose bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug TemodalÂ® (Temozolomide) Capsules 250 mg (Manufactured by : SP Europe) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting condition

开始日期2012-07-05

申办/合作机构

Fresenius Kabi Oncology Ltd.

100 项与 Fresenius Kabi Austria GmbH 相关的临床结果

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0 项与 Fresenius Kabi Austria GmbH 相关的专利（医药）

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项与 Fresenius Kabi Austria GmbH 相关的文献（医药）

2021-12-01·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2区 · 医学

Explicating the molecular level drug-polymer interactions at the interface of supersaturated solution of the model drug: Albendazole

2区 · 医学

Article

作者: Joshi, Prachi ; Sodhi, Ikjot ; Samal, Sanjaya K ; Sangamwar, Abhay T ; Singh, Ridhima ; Kaur, Harpreet ; Mallepogu, Prabhakar ; Jena, Kailash C

Supersaturation as a formulation principle relates to the aqueous solubility of poorly soluble drugs in solution . However, supersaturation state of drugs tends to crystallize because of its thermodynamic instability thereby compromising the solubility and biopharmaceutical performance of drugs. The present study aims to investigate the supersaturation potential of albendazole (ABZ) and its precipitation via nucleation and crystal growth. We hypothesized the use of polymers will avoid ABZ precipitation by interacting with drug molecules. The drug polymer interactions are characterized using conventional methods of Fourier transform infrared (FTIR), Nuclear magnetic resonance (NMR) and Polarized light microscopy (PLM). We have used a novel approach of sum frequency generation (SFG) vibrational spectroscopic in exploring the drug polymer interactions at air-water interface. Recently we have reported the SFG for e rifaximin-polymer interactions (Singh et al., 2021). The supersaturation assay, saturation solubility studies and nucleation induction time analysis revealed polyvinyl alcohol (PVA) and polyvinyl pyrrolidone (PVP K30) as effective precipitation inhibitors thereby enhancing the ABZ equilibrium solubility and in vitro supersaturation maintenance of ABZ. Further, modification in the solid state of ABZ has confirmed the influence of polymers on its precipitation behaviour. We conclude that PVA and PVP K30 act as nucleation and crystal growth inhibitor, respectively for the precipitation inhibition of ABZ.

2021-06-15·World journal of diabetes4区 · 医学

Blood glucose response after oral lactulose intake in type 2 diabetic individuals

4区 · 医学

Article

作者: Esterl, Tamara ; Pauly, Lioba ; Neumann, Annalena ; Faerber, Valentin ; Svehlikova, Eva ; Schwejda-Guettes, Susann ; Mursic, Ines ; Stover, John Friedrich ; Sartorius, Tina ; Wargenau, Manfred ; Kuchinka-Koch, Angelika ; Pieber, Thomas R ; Gaigg, Barbara

BACKGROUND:

Lactulose is approved for the symptomatic treatment of constipation, a gastrointestinal (GI) complication common in individuals with diabetes. Lactulose products contain carbohydrate impurities (e.g., lactose, fructose, galactose), which occur during the lactulose manufacturing process. These impurities may affect the blood glucose levels of individuals with type 2 diabetes mellitus (T2DM) using lactulose for the treatment of mild constipation. A previous study in healthy subjects revealed no increase in blood glucose levels after oral lactulose intake. However, it is still unclear whether the intake of lactulose increases blood glucose levels in individuals with diabetes.

AIM:

To evaluate the blood glucose profile after oral lactulose intake in mildly constipated, non-insulin-dependent subjects with T2DM in an outpatient setting.

METHODS:

This prospective, double-blind, randomized, controlled, single-center trial was conducted at the Clinical Research Center at the Medical University of Graz, Austria, in 24 adult Caucasian mildly constipated, non-insulin-dependent subjects with T2DM. Eligible subjects were randomized and assigned to one of six treatment sequences, each consisting of four treatments stratified by sex using an incomplete block design. Subjects received a single dose of 20 g or 30 g lactulose (crystal and liquid formulation), water as negative control or 30 g glucose as positive control. Capillary blood glucose concentrations were measured over a period of 180 min post dose. The primary endpoint was the baseline-corrected area under the curve of blood glucose concentrations over the complete assessment period [AUC_{baseline_c (0-180 min)}]. Quantitative comparisons were performed for both lactulose doses and formulations vs water for the equal lactulose dose vs glucose, as well as for liquid lactulose vs crystal lactulose. Safety parameters included GI tolerability, which was assessed at 180 min and 24 h post dose, and adverse events occurring up to 24 h post dose.

RESULTS:

In 24 randomized and analyzed subjects blood glucose concentration-time curves after intake of 20 g and 30 g lactulose were almost identical to those after water intake for both lactulose formulations despite the different amounts of carbohydrate impurities (≤ 3.0% for crystals and approx. 30% for liquid). The primary endpoint [AUC_{baseline_c (0-180 min)}] was not significantly different between lactulose and water regardless of lactulose dose and formulation. Also with regard to all secondary endpoints lactulose formulations showed comparable results to water with one exception concerning maximum glucose level. A minor increase in maximum blood glucose was observed after the 30 g dose, liquid lactulose, in comparison to water with a mean treatment difference of 0.63 mmol/L (95% confidence intervals: 0.19, 1.07). Intake of 30 g glucose significantly increased all blood glucose endpoints vs 30 g liquid and crystal lactulose, respectively (all P < 0.0001). No differences in blood glucose response were observed between the different lactulose formulations. As expected, lactulose increased the number of bowel movements and was generally well tolerated. Subjects experienced only mild to moderate GI symptoms due to the laxative action of lactulose.

CONCLUSION:

Blood glucose AUC_{baseline_c (0-180 min)} levels in mildly constipated, non-insulin dependent subjects with T2DM are not affected by the carbohydrate impurities contained in 20 g and 30 g crystal or liquid lactulose formulations.

2018-08-07·World journal of gastrointestinal pharmacology and therapeutics

Blood glucose response after oral intake of lactulose in healthy volunteers: A randomized, controlled, cross-over study

Article

作者: Stover, John F ; Wargenau, Manfred ; Schön, Christiane ; Schwejda-Güttes, Susann ; Gaigg, Barbara ; Pauly, Lioba ; Kuchinka-Koch, Angelika ; Steudle, Jasmin

AIM:

To investigate possible changes of blood glucose levels after oral intake of lactulose in healthy subjects.

METHODS:

The study was performed as prospective, randomized, two-part study with 4-way cross-over design with n = 12 in each study arm. Capillary blood glucose levels were determined over a time period of 180 min after intake of a single dose of 10 g or 20 g lactulose provided as crystal or liquid formulation. During the manufacturing process of lactulose, impurities with sugars (e.g., lactose, fructose, galactose) occur. Water and 20 g glucose were used as control and reference. Because lactulose is used as a functional food ingredient, it may also be consumed by people with impaired glucose tolerance, including diabetics. Therefore, it is of interest to determine whether the described carbohydrate impurities may increase blood glucose levels after ingestion.

RESULTS:

The blood glucose concentration-time curves after intake of 10 g lactulose, 20 g lactulose, and water were almost identical. None of the three applications showed any changes in blood glucose levels. After intake of 20 g glucose, blood glucose concentration increased by approximately 3 mmol/L (mean C_max = 8.3 mmol/L), reaching maximum levels after approximately 30 min and returning to baseline within approximately 90 min, which was significantly different to the corresponding 20 g lactulose formulations (P < 0.0001). Comparing the two lactulose formulations, crystals and liquid, in the dosage of 10 g and 20 g, there was no difference in the blood glucose profile and calculated pharmacokinetic parameters despite the different amounts of carbohydrate impurities (1.5% for crystals and 26.45% for liquid). Anyhow, the absolute amount of single sugars was low with 0.3 g in crystals and 5.29 g in liquid formulation in the 20 g dosages. Lactulose was well tolerated by most volunteers, and only some reported mild to moderate mainly gastrointestinal side effects.

CONCLUSION:

The unchanged blood glucose levels after lactulose intake in healthy subjects suggest its safe use in subjects with impaired glucose tolerance.

166

项与 Fresenius Kabi Austria GmbH 相关的新闻（医药）

2024-10-17

·EndPoints

Evonik winds down German site, lays off 260 workers; Chiesi’s €400M facility

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Evonik is discontinuing keto acid manufacturing at its site in Hanau, Germany, by the end of 2025 and will lay off around 260 workers. The company is also looking at divestment and partnership options for its keto and pharma amino acid facilities in France and China, according to an Oct. 11 release. Italian biopharma Chiesi is launching a new €400 million ($433 million) facility in Europe to make monoclonal antibodies, enzymes and other proteins, the company said Monday. The new site will employ 200 staffers by the end of 2025. Indiana-headquartered SpectronRx is expanding to Europe with the radiopharma CDMO earmarking $50 million to build a radiolabeling facility for actinium-225 assets, the company told Endpoints Thursday. Construction in Mol, Belgium, is anticipated to be completed next month, with the site to be operational by the first quarter of 2025. EuroAPI has appointed Olivier Falut as its new chief financial officer. He is replacing Evelyne Nguyen who will stay at the company until the end of October, according to a Wednesday release. The company is in its “year of transition” as it undergoes major restructuring. Texas-based CDMO Matica Biotechnology has signed a new contract with biotech Mongoose Bio, the companies announced Wednesday . Matica Bio will manufacture lentiviruses for Mongoose Bio’s T cell receptor-engineered T cell therapy for cancer. RadioPharma CDMO AtomVie has partnered with Radiopharm Ventures, the company said Tuesday. AtomVie will manufacture the clinical-stage 177 lutetium-conjugated B7-H3-targeting radio antibody, dubbed 177Lu-BetaBart. Perspective Therapeutics’ manufacturing facility in Somerset, NJ, is now operational and has sent its first shipment, the company said Wednesday. The facility manufactures lead-203 and lead-212-labeled radiopharmaceuticals. Cellular Origins and Fresenius Kabi have embarked on a new collaboration for cell therapy manufacturing, the companies announced Wednesday. Cellular Origins will integrate Fresenius Kabi’s cell therapy processing tech into its robotic manufacturing platform, with the aim to manufacture cell therapies on a larger scale. CDMO Cambrex’s storage subsidiary Q1 Scientific has opened a new facility in Durham, NC, to expand storage capacity for pharmaceutical, medical device and life science customers in North America, Cambrex said Wednesday.

细胞疗法高管变更

2024-10-17

·Pharmaceutical Technology

Fresenius Kabi and Cellular Origins agree CGT manufacture automation

The development agreement will see Fresenius Kabi’s cell therapy processing technologies integrated into Cellular Origins’ robotic platform. Credit: Kotin/Shutterstock. Fresenius Kabi and Cellular Origins have announced a partnership to advance the field of cell and gene therapy (CGT) by automating the manufacturing process. Fresenius Kabi’s cell therapy processing technologies will be integrated into Cellular Origins’ Constellation robotic platform. The partnership’s primary objective is to streamline the production of cell therapies at scale, maintaining the use of developers’ preferred tools for processing. This initiative automates the production of advanced therapies, aiming to enhance production efficiency and reduce the risk of human error-induced inconsistencies. The integration process will initially concentrate on Fresenius Kabi’s Cue cell processing system. This system is expected to be fully automated within Constellation, covering aspects from consumable transport to full process operation and data management. See Also: mRNA Covid-19 vaccines may boost cancer immunotherapy effectiveness UNICEF secures one million mpox vaccines for Africa Cellular Origins CEO Dr Edwin Stone stated: “Cellular Origins has developed Constellation to enable fully industrialised manufacture of cell and gene therapies. “Forming strong collaborations is essential to ensuring the industry can implement the transformative power of automation whilst using the tools that are best for the biology and, therefore, for patients. Fresenius Kabi is an industry-leading developer of automated technologies to support the production of cell therapies. “This is why we are excited to be working closely with their team to unlock the power of automation throughout the entire manufacturing process, with the goal of bringing life-saving therapies to patients, faster and more affordably.” The companies will begin their integration efforts with the Cue cell processing system, which is tailored for automated and precise small-volume cell processing. Following success with Cue, the partnership then plans to extend its focus to include Fresenius Kabi’s broader cell therapy technology portfolio, such as the Lovo cell processing system and other products currently under development. In October 2024, Fresenius Kabi won US Food and Drug Administration approval for Otulfi (ustekinumab-aauz), a Stelara biosimilar. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

疫苗免疫疗法基因疗法细胞疗法信使RNA

2024-10-16

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第39期/总第160期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）共有5个新药获批上市。其中，NDA批准2个，BLA批准1个，新组合疗法批准1个，新适应症批准1个。与上个统计周期相比，本次减少8个批准新药。 9月27日，GE HealthCare宣布FDA批准Flyrcado（Flurpiridaz F 18）注射液用于已知或疑似冠状动脉疾病（CAD）的成年患者在休息或应激（药物或运动）下的正电子发射断层扫描（PET）心肌灌注成像（MPI），以评估心肌缺血和梗死。Flyrcado具有更高的诊断效力，半衰期为109分钟，无需现场生产和发生器维护，并能够分销到广泛的医院和成像中心网络。 9月30日，Fresenius Kabi宣布，FDA已批准了引用Stelara®（Ustekinumab）的乌司奴单抗生物仿制药的Otulfi™（Ustekinumab-aauz），用于治疗克罗恩病、溃疡性结肠炎、中度至重度斑块状银屑病和活动性银屑病关节炎。Otulfi™在中度至重度寻常型银屑病（斑块状银屑病）患者中显示出与参比药物Stelara®相当的疗效、安全性、药代动力学和免疫原性。Otulfi™被批准用于皮下和静脉制剂。Otulfi™禁用于对Ustekinumab或任何赋形剂有显著超敏反应的患者。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）共有8个新药申报上市。其中，NDA申报4个，BLA申报4个。与上次统计周期相比，本次增加2个NDA/BLA申报。 10月3日，AstraZeneca针对Calquence（Acalabrutinib）的补充新药上市申请已在美国被接受并授予优先审评，用于治疗既往未经治疗的套细胞淋巴瘤成人患者。将Calquence联合疗法患者的中位无进展生存期增加了近1.5年，其中mPFS为66.4个月，而SoC组为49.6个月。 NDA/BLA申报（部分）根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）共有5个药物获监管机构特殊资格认定。其中，化学药4个，生物药1个。本次获监管机构特殊资格认定的药物数量与上次统计周期相同。 10月1日，Papillon Therapeutics宣布FDA已授予PPL-002孤儿药资格认定，这是一种实验性基因修饰的CD34+造血干细胞和祖细胞（HSPC）疗法，用于治疗Danon病。这种疗法旨在表达功能性Lamp-2蛋白，该蛋白在Danon病患者中严重缺乏。在临床前研究中，PPL-002已被证明可以改善受影响组织的疾病表型。PPL-002的治疗方法涉及同时靶向患者的多个器官系统，具有改变和逆转疾病进展的潜力。 10月2日，Volastra Therapeutics宣布FDA已授予KIF18A抑制剂VLS-1488快速通道资格，用于治疗铂类耐药高级别浆液性卵巢癌（HGSOC）。VLS-1488的I/II期试验正在评估晚期肿瘤（包括HGSOC）患者的安全性、耐受性和初步疗效。Volastra的两种KIF18A抑制剂VLS-1488和Sovilnesib中的每一种都具有独特的特征，并且都在招募患者进行早期研究。特殊资格认定情况（部分） 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）新药临床研发状态更新共计55条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及免疫系统疾病等共计14个领域。其中，肿瘤领域临床进展更新居各领域之首，为17条：涉及化学药7条，生物药10条。 9月27日，科伦博泰在2024年CSCO学术年会上发表了TROP2 ADC芦康沙妥珠单抗（sac-TMT)治疗转移性三阴性乳腺癌（TNBC）的多项临床研究成果及进展。结果显示，芦康沙妥珠单抗组中位PFS为6.7个月，疾病进展或死亡的风险降低68%；OS期中分析显示化疗组的中位OS为9.4个月；HR为0.53，sac-TMT相比化疗发生死亡的风险降低47%。 10月3日，映恩生物在Clinicaltrial.gov网站上注册了DB-2304的I期临床试验。DB-2304为一款BDCA2 ADC新药，采用激素类似物作为paylaod，DAR值为4。BDCA2主要在pDC上表达，DB-2304结合后内吞并释放激素类似物到细胞中，促进抑制促炎细胞因子分泌的糖皮质激素反应基因的转录，抗体的结合本身也会抑制pDC活化和干扰素的产生，两种机制发挥协同效应。临床前研究证明这种协同效应的存在，DB-2304相比于临床上的BDCA2抗体可以更好的抑制炎性细胞因子的释放。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.09.28-10.04）全球（含中国）医药交易时间共计30起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有3个新药获NMPA批准上市。其中，BLA批准2个，新适应症批准1个。本次NMPA批准新药数量与上个统计周期相同。 9月30日，NMPA官网显示，康方生物的PD-1/CTLA-4双特异性抗体开坦尼®（卡度尼利单抗注射液）新适应症上市申请的技术审评建议结论状态更新为：制证完毕-待发批件，该新适应症为：卡度尼利联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性胃或胃食管结合部（G/GEJ）腺癌患者的一线治疗。COMPASSION-15研究中，PD-L1 CPS＜5和PD-L1 CPS＜1人群占意向治疗人群的比例分别达49.8%和23%。 9月30日，NMPA宣布齐鲁制药1类新药艾帕洛利单抗托沃瑞利单抗注射液上市申请已获得批准，适应症为用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。II期临床研究结果显示，ORR为33.8%，达预设主要终点，DCR为64.9%，PFS达到5.4个月，70.3%受试者发生了治疗相关不良事件。试验数据表明艾帕洛利托沃瑞利单抗作为复发/转移宫颈癌的后线治疗有效且安全。国内新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有17个新药获临床默示许可，涉及20个受理号。其中，化学药6个，治疗用生物制品11个。与上次统计周期相比，本次减少32个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有7个新药申报上市，涉及8个受理号。其中，化药4个，治疗用生物制品1个，预防用生物制品2个。与上个统计周期相比，本次减少3个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有15个新药申报临床，涉及25个受理号。其中，化学药9个，治疗用生物制品5个，预防用生物制品1个。与上次统计周期相比，本次减少79个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有2个药物获NMPA特殊资格认定。其中，化学药2个。与上次统计周期相比，本次减少4个获监管机构特殊资格认定的药物。 10月2日，CDE官网公示，恒瑞医药2.2类改良型新药HR19042胶囊拟纳入突破性治疗品种，针对适应症为活动性自身免疫性肝炎。HR19042是一款口服胶囊剂，能增强内皮细胞、平滑肌细胞和溶酶体膜的稳定性，抑制免疫反应和降低抗体合成，从而使组胺等过敏活性介质的释放减少和活性降低。恒瑞医药正在针对HR19042胶囊开展两项临床研究，分别为一项治疗自身免疫性肝炎的有效性和安全性研究的II期临床研究，以及一项治疗原发性IgA肾病的II/III期临床研究。 10月3日，CDE官网公示，迪哲医药申报的DZD9008片拟纳入突破性治疗品种，针对适应症为未接受过系统性治疗、携带EGFR 20号外显子插入突变的局部进展或转移性非小细胞肺癌（NSCLC）。舒沃替尼单药一线治疗EGFR exon20ins突变型晚期NSCLC的经确认cORR达78.6%，RP2D 300mg组mPFS为12.4个月，再次展现“高效低毒”的治疗潜力。目前III期临床研究WU-KONG28已在中国、欧美等多个国家开展。国内监管机构特殊资格认定药物 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内新药临床研发状态更新共计5条，涉及免疫系统、血液和淋巴系统疾病和皮肤病共计3个领域。其中，化学药1条，生物药3条，细胞疗法1条。与上次统计周期相比，本次减少2条国内新药临床研发状态更新。 9月29日，驯鹿生物在2024 IMS年会上展示了其全人源靶向BCMA的CAR-T疗法——伊基奥仑赛注射液在治疗复发难治性多发性骨髓瘤（R/R MM)的FUMANBA-1研究中不同淋巴细胞清除方案下的比较研究。研究结果表明足量的淋巴细胞清除预处理能够显著提升患者的缓解深度，延长缓解时间和无进展生存期。标准剂量组的ORR和严格意义上的sCR分别为100%和82.8%，两组在CRS和ICANS的严重程度和发生率上没有显著差异。 10月2日，康方生物的靶向于IL-12/IL-23的全人源单克隆抗体依若奇治疗中、重度斑块型银屑病受试者长期安全性和有效性III期临床研究结果于近日在EADV congress 2024向全球学界领域专家展示。依若奇短长期疗效均优异、长期疗效稳定，在减少银屑病面积和严重程度方面表现出色。患者在AK101-302研究中接受了对照药16周治疗后，第16周切换到依若奇治疗，PASI75应答率在第32周提升至81.4%，sPGA0/1达成率提升至71.1%，并在第52周稳定维持。国内新药研发进展（部分） 05 国内新药研发领域政策法规动态关于公开征求《生物类似药说明书撰写技术指导原则（征求意见稿）》意见的通知自2015年发布《生物类似药研发与评价技术指导原则（试行）》以来，国内已有多家制药企业开展生物类似药研发，部分已获准上市。为规范生物类似药说明书科学撰写，药审中心在已有经验的基础上，结合该类药物的研发特点，组织起草了《生物类似药说明书撰写技术指导原则》，现形成征求意见稿。我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻今日！康方生物双喜临门，两款抗体药物获批 9月30日，从中国国家药监局（NMPA）及康方生物官网公示可知，康方生物PCSK9单抗伊努西单抗注射液（AK102）上市申请已正式获批；PD-1/CTLA-4双特异性抗体卡度尼利单抗注射液新适应症获批。伊努西单抗注射液伊努西单抗适应症为：在控制饮食的基础上，与他汀类药物、或者与他汀类药物及其他降脂疗法联合用药，用于在接受中等剂量或中等以上剂量他汀类药物治疗后，仍无法达到低密度脂蛋白胆固醇（LDL-C）目标的原发性高胆固醇血症（包括杂合子型家族性和非家族性高胆固醇血症）和混合型血脂异常的成人患者。更多资讯，请阅读原文齐鲁制药PD-1/CTLA-4双功能组合抗体获批上市 9月30日，从中国国家药品监督管理局（NMPA）官网公示，齐鲁制药申报的艾帕洛利托沃瑞利单抗注射液（商品名：齐倍安）获附条件批准上市，适应症为既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。艾帕洛利托沃瑞利单抗注射液（艾托组合抗体，研发代号QL1706）是全球首个获批上市的PD-1/CTLA-4双功能组合抗体，由IgG4型PD-1抗体和IgG1型CTLA-4抗体按照特定的比例组成。CTLA-4和PD-1通路均能负向调节T细胞免疫功能，艾托组合抗体能同时靶向和阻断这两条免疫检查点信号通路，激活抗肿瘤免疫反应。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“1016创新药周报”，即可下载。

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