Phase I/II study evaluating the safety, tolerability, and efficacy of sacituzumab govitecan administered on day 1 and day 8 in combination with pegfilgrastim on day 2 in patients with unresectable or recurrent HER2-negative breast cancer

开始日期2026-09-01

申办/合作机构-

NCT07021989

/ Recruiting临床2期IIT

Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium

This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with response-adapted consolidation. This study will investigate using circulating tumor DNA (ctDNA) at pre-determined time points using Foresight CLARITY LDT, an ultra-sensitive liquid biopsy platform that detects Minimal residual disease (MRD) in patients with B-cell lymphomas using the phased variant enrichment and sequencing technology (PhasEDq) to determine response to study interventions.

开始日期2026-08-18

申办/合作机构

The University of California, San Francisco

[+3]

ChiCTR2600131972

/ Recruiting临床1期IIT

A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers

开始日期2026-07-02

申办/合作机构-

100 项与培非格司亭（安进）相关的临床结果

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100 项与培非格司亭（安进）相关的转化医学

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100 项与培非格司亭（安进）相关的专利（医药）

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122

项与培非格司亭（安进）相关的文献（医药）

2026-08-25·ANALYTICAL CHEMISTRY

Spectroscopic Signature of Apoptosis Induced by Venetoclax in Philadelphia-Positive Acute Lymphoblastic Leukemia

Article

作者: Nowakowska, Anna M. ; Pastorczak, Agata ; Dawiec, Patrycja ; Ostrowska, Kinga ; Jakubowska, Justyna ; Barańska, Małgorzata ; Majzner, Katarzyna ; Młynarski, Wojciech ; Szewczyk, Marta

Abstract:

Understanding why some leukemia cells undergo apoptosis upon venetoclax (VEN) treatment while others remain refractory is essential for improving therapeutic outcomes. Here, we integrate Raman microscopy, FT-IR imaging, and chemometrics to explore treatment-associated spectroscopic patterns linked to differential VEN response in Philadelphia-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL). Using two BCR-ABL1-positive cell lines with intrinsic differences in VEN sensitivity (BV-173, sensitive; SD-1, resistant), we combined classical biological readouts of apoptosis with multimodal vibrational profiling to characterize global biochemical changes induced by VEN. Sensitive BV-173 cells displayed spectroscopic changes consistent with apoptotic progression, reflected in coordinated alterations in nucleic acids, proteins, and lipids. In contrast, resistant SD-1 cells exhibited a distinct treatment-associated biochemical response profile consistent with nonapoptotic adaptation. Spectroscopic fingerprints enabled differentiation between apoptotic and nonapoptotic response patterns in the cell-line models studied. Our findings demonstrate that vibrational spectroscopy, integrated with chemometrics, may provide a complementary analytical framework for exploratory characterization of treatment-associated biochemical phenotypes in leukemia.

2026-07-01·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Safety assessment of Neulasta® (pegfilgrastim) in patients with solid tumors: a real-world adverse event analysis from the FAERS database

Article

作者: Lin, Keyun ; Chen, Shuang ; Huang, Shiying ; Jiang, Mei

The study was based on the FDA Adverse Event Reporting System (FAERS) database, with the objective of analysing the actual safety of Neulasta® (pegfilgrastim) in patients with solid tumours. This study also sought to provide a reference for the use of clinical drugs. For patients with solid tumors, data on adverse events (AEs) related to Neulasta® (pegfilgrastim) applications between the first quarter of 2004 and the fourth quarter of 2024 were collected and standardized. Subsequently, an analysis of the signal quantization technique was conducted. The following methods are included: Reporting Odds Ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and Multi-Item Gamma Poisson Shrinker (MGPS) method. A total of 193,534 reports were retrieved, encompassing 6,380 Adverse Drug Event (ADE) reports in patients diagnosed with solid tumors, with Neulasta® (pegfilgrastim) identified as the primary suspected pharmaceutical agent. Following the incorporation of duplicate PRIMARYID, the study comprised a total of 2,428 patients. At the level of system organ classes (SOCs), four SOCs were positive in the four signal quantification techniques, including musculoskeletal and connective tissue disorders, general disorders and administration site conditions, blood and lymphatic system disorders, injury, poisoning, and procedural complications. At the preferred term (PTs) level, 251 PTs were found from 26 SOCs, including febrile neutropenia, leukocytosis, eye swelling, lip swelling, swollen tongue, influenza-like illness, application site hemorrhage, injection site pain, application site pain, swelling face, hypersensitivity, lower respiratory tract infection, wrong technique in product usage process, unintentional medical device removal, accidental exposure to product, device use error, drug dose omission by device, intercepted product preparation error, product preparation error, device placement issue, underdose, abnormal white blood cell count, abnormal neutrophil count, increased white blood cell count, bone pain, myalgia, decreased mobility, pelvic pain, urticaria, and hyperhidrosis. These findings, while hypothesis-generating, require validation through controlled epidemiological studies due to the inherent limitations of spontaneous reporting databases. Neulasta® (pegfilgrastim) is a promising treatment option for patients with solid tumors. This study focused on the population of solid tumors, providing more references and support for the FDA-approved labeling regarding the drug-related adverse reactions of Neulasta® (pegfilgrastim) in the population with solid tumors.

2026-05-01·ANNALS OF INTERNAL MEDICINE

Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain

Article

作者: Lin, Yingyi ; Huang, Na ; Cheng, Minyi ; Zhang, Xiaoqi ; Zheng, Junqiu ; Wang, Kun ; Yang, Ciqiu ; Gao, Hong-Fei ; Li, Peiyong ; Chen, Yitian ; Zhang, Yuanqi ; Zhang, Liulu ; Li, Jieqing ; Liang, Minting ; Zhu, Teng ; Wu, Cangui ; Huang, Shengchao ; Chen, Yilin

BACKGROUND:

Pegfilgrastim-induced bone pain (PIBP) is common and lacks effective treatment.

OBJECTIVE:

To determine whether there is an association between the timing of pegfilgrastim administration and PIBP.

DESIGN:

Three-arm randomized controlled trial. (ClinicalTrials.gov: NCT05841186).

SETTING:

A tertiary A-level hospital.

PATIENTS:

Patients with I to III stage breast cancer who were naive to chemotherapy.

INTERVENTION:

Patients were randomly allocated in a 1:1:1 ratio to the 24-hour, 48-hour, or 72-hour group based on the timing of pegfilgrastim administration postchemotherapy.

MEASUREMENTS:

The primary end point was the area under the curve (AUC) of the daily worst bone pain score (assessed using the "worst pain" question from the Brief Pain Inventory, a 0 to 10 numerical rating scale [NRS]) for 5 consecutive days in the first chemotherapy cycle. Secondary end points included the incidence of severe bone pain (>5 on the NRS), neutropenia, and febrile neutropenia (FN).

RESULTS:

The intention-to-treat analyses included 159 patients, with 53 in each group. For the first cycle, in the 72-hour group, the mean AUC exhibited a statistically significant reduction from 12.74 in the 24-hour group and 14.20 in the 48-hour group to 6.05 (all P < 0.001). Furthermore, the incidence of severe bone pain also declined significantly from 58.5% in the 24-hour group and 66.0% in the 48-hour group to 22.6% in the 72-hour group (all P < 0.001). There was no substantial difference in the incidence of neutropenia among groups, and no patients developed FN.

LIMITATION:

Open label, single center, and relatively small sample size.

CONCLUSION:

Administration of pegfilgrastim 72 hours postchemotherapy reduced PIBP compared with 24- and 48-hour administration and did not seem to be associated with higher rates of neutropenia or FN.

PRIMARY FUNDING SOURCE:

National Natural Science Foundation of China.

392

项与培非格司亭（安进）相关的新闻（医药）

2026-10-12

·动脉网

Accord BioPharma推出 FILKRI™（filgrastim-laha）；现同时提供长效和短效 G-CSF选择Accord BioPharma Launches FILKRI™ (filgrastim-laha); Now Offers Both Long- and Short-Acting G-CSF Options

FILKRIis available with a permanent Q-code, standardizing the billing and reimbursement process across all sites of care. FILKRI 配有永久性的 Q 代码，从而在所有医疗场所统一计费和报销流程。RALEIGH, N.C. 北卡罗来纳州罗利, ，Oct. 12, 2026 2026年10月12日/PRNewswire/ -- /美通社/ --Accord BioPharma Accord BioPharma, Inc., the specialty division of ，Inc.，旗下的专业部门Intas Pharmaceuticals, Ltd. 英塔斯制药有限公司, focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim). FDA-approved in January 2026, FILKRI represents Accord BioPharma's continued expansion into oncology supportive care and furthers the company's goal to bring 20 biosimilars to the U.S. ，专注于肿瘤学、免疫学和中枢神经系统（CNS）疗法开发的公司，今天宣布在美国商业推出FILKRI™（filgrastim-laha），这是Neupogen®（filgrastim）的生物类似药。FILKRI于2026年1月获得FDA批准，代表了Accord BioPharma在肿瘤支持治疗领域的持续扩展，并进一步推进了该公司将20种生物类似药引入美国市场的目标。market by 2030.. 到2030年的市场。1 1FILKRI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). FILKRI 适用于以下情况：降低接受与严重发热性中性粒细胞减少症显著发生率相关的骨髓抑制性抗癌药物的非髓系恶性肿瘤患者的感染发生率（表现为发热性中性粒细胞减少症）；缩短急性髓系白血病（AML）患者在诱导或巩固化疗后的中性粒细胞恢复时间及发热持续时间；缩短接受清髓性化疗随后进行骨髓移植的非髓系恶性肿瘤患者的中性粒细胞减少症持续时间及中性粒细胞减少症相关的临床后遗症（例如发热性中性粒细胞减少症）的持续时间；降低有症状的先天性中性粒细胞减少症、周期性中性粒细胞减少症或特发性中性粒细胞减少症患者的严重中性粒细胞减少症后遗症（例如发热、感染、口咽溃疡）的发生率和持续时间；以及提高急性暴露于骨髓抑制性辐射剂量（急性辐射综合征的造血综合征）患者的生存率。FILKRI is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringe presentations, with pack sizes of one or 10 prefilled syringes per carton.. FILKRI 有 300 mcg/0.5 mL 和 480 mcg/0.8 mL 两种预充式注射剂规格，每盒包装含 1 支或 10 支预充式注射器。1 1The addition of FILKRI expands Accord BioPharma's granulocyte colony-stimulating factor (G-CSF) portfolio, giving U.S. physicians access to both short- and long-acting treatment options through FILKRI and UDENYCA FILKRI 的加入扩大了 Accord BioPharma 的粒细胞集落刺激因子（G-CSF）产品组合，使美国医生能够通过 FILKRI 和 UDENYCA 获得短效和长效治疗选择。® ®(pegfilgrastim-cbqv). These options help meet the individual needs of patients undergoing chemotherapy and their healthcare providers. （培非格司亭-cbqv）。这些选项有助于满足接受化疗的患者及其医疗保健提供者的个体化需求。2 2FILKRI will be manufactured end to end by Accord BioPharma's parent entity, Intas, and has been assigned a permanent Q-code (Q5172) by the U.S. Centers for Medicare & Medicaid Services (CMS), effective October 1, which will standardize the billing and reimbursement process across all sites of care. FILKRI 将由 Accord BioPharma 的母公司 Intas 进行端到端生产，并已被美国医疗保险和医疗补助服务中心（CMS）分配了一个永久 Q 代码（Q5172），该代码自 10 月 1 日起生效，这将使所有护理场所的 billing 和报销流程标准化。'The commercial launch of FILKRI with a permanent Q-code from day one is a significant milestone for Accord BioPharma and for cancer patients across the United States,' said Chrys Kokino, President of Accord North America. 'Having a permanent Q-code will simplify billing and streamline reimbursement, making it more timely and reliable for physicians treating patients.'. “FILKRI 从上市首日起即拥有永久 Q 代码，这对 Accord BioPharma 以及全美癌症患者而言是一个重要的里程碑。”Accord 北美公司总裁 Chrys Kokino 表示，“拥有永久 Q 代码将简化计费流程并优化报销程序，使为接受治疗的患者提供服务的医师能够更及时、更可靠地完成报销。”Addressing Critical Patient Needs in NeutropeniaManagement 应对中性粒细胞减少症管理中的关键患者需求As a G-CSF, FILKRI is indicated for use across several clinical settings in which neutropenia or its complications may occur, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Neutropenia is a condition characterized by lower-than-normal levels of neutrophils, a type of white blood cell that helps the body fight infections. 作为粒细胞集落刺激因子（G-CSF），FILKRI 适用于多种可能出现中性粒细胞减少症或其并发症的临床场景，并用于提高急性暴露于骨髓抑制性辐射剂量患者的生存率。中性粒细胞减少症是一种以中性粒细胞水平低于正常值为特征的疾病，中性粒细胞是帮助机体抵抗感染的一类白细胞。Cancer treatments, including chemotherapy, can damage neutrophils or the bone marrow that produces them.. 包括化疗在内的癌症治疗可能会损伤中性粒细胞或产生这些细胞的中枢骨髓。3 3'With FILKRI, alongside our established UDENYCA pegfilgrastim franchise, Accord now offers physicians the choice between long-acting and short-acting biosimilar G-CSF treatments to suit their clinical needs and preferences,' Kokino added. 'This demonstrates our deep commitment to oncology supportive care and positions us as a comprehensive partner for the oncology community.'. “凭借 FILKRI，以及我们已建立的 UDENYCA 聚乙二醇化非格司亭产品系列，Accord 现在为医生提供了长效和短效生物类似物 G-CSF 治疗之间的选择，以满足他们的临床需求和偏好，”科基诺补充道。“这彰显了我们对肿瘤支持治疗的坚定承诺，并使我们成为肿瘤学界的全面合作伙伴。”Filgrastim biosimilars have become well established in the U.S. market, accounting for approximately 77% of filgrastim market share as of the fourth quarter of 2025. 非格司亭生物类似药在美国市场已稳固确立，截至2025年第四季度，约占非格司亭市场份额的77%。4 4Expanding Access Through Competitive Pricing and Patient Support 通过竞争性定价和患者支持扩大可及性Through AccordCares®, a dedicated patient support program, the company is launching FILKRI with comprehensive patient resources, including benefits investigation and co-pay assistance, designed to connect patients to the information and resources they need, building on the proven foundation established with UDENYCA.. 通过AccordCares®这一专用的患者支持项目，公司推出FILKRI并提供全面的患者资源，包括福利核查和共付额援助，旨在帮助患者获取所需的信息和资源，此举建立在UDENYCA已验证的坚实基础之上。'At Accord, we believe that cost shouldn't prevent patients from receiving the cancer care they need,' said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. 'With FILKRI, we're continuing to build on our track record of bringing high-quality biosimilars to market that provide physicians more choice and can make a real difference in patient care and patient affordability. Accord BioPharma 数字与营销战略及运营高级副总裁 Nuvan Dassanaike 表示：“在 Accord，我们坚信费用不应成为患者获得所需癌症治疗的障碍。通过 FILKRI，我们继续秉承将高质量生物类似药推向市场的优良传统，为医生提供更多选择，并切实改善患者护理和提升患者的用药可负担性。”The permanent Q-code further enhances our ability to expand patient access from launch.'. 永久性Q代码进一步增强了我们在产品上市之初扩大患者可及性的能力。Building on Proven Leadership in Oncology Supportive Care 依托在肿瘤支持治疗领域经证实的领导力'The launch of FILKRI in the United States demonstrates our unwavering commitment to building a comprehensive oncology supportive care portfolio that addresses urgent medical needs,' said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. 'With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape by introducing biosimilars to the U.S. “FILKRI在美国的上市，彰显了我们坚定不移地致力于构建全面的肿瘤支持治疗产品组合，以满足迫切的医疗需求。”Intas Pharmaceuticals董事长兼总经理Binish Chudgar表示。“在拥有近五十年经验的全球领先企业Intas的支持下，Accord BioPharma正通过向美国市场引入生物类似药，改变传统的治疗格局。market. As our presence in the biosimilar market continues to grow, so does our commitment to offering high-quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need.'. 市场。随着我们在生物类似药市场的存在感不断增强，我们致力于提供高质量、价格合理的原研药替代方案，从而使更多患者能够获得所需的治疗。FDA approval of FILKRI was based on data demonstrating that FILKRI is highly similar to Neupogen, with no clinically meaningful differences. FILKRI 获得美国食品药品监督管理局（FDA）批准是基于相关数据，这些数据表明 FILKRI 与 Neupogen 高度相似，且不存在具有临床意义的差异。1 1IMPORTANT SAFETY INFORMATION 重要安全信息FILKRIis contraindicated FILKRI 禁忌使用in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. 适用于有对人粒细胞集落刺激因子（G-CSFs，如非格司亭或聚乙二醇化非格司亭产品）严重过敏史的患者。SplenicRupture: 脾破裂：Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. 已有在使用非格司亭制剂后发生脾破裂（包括致死病例）的报告。对于主诉左上腹或肩部疼痛的患者，应评估是否存在脾肿大或脾破裂。Acute Respiratory Distress Syndrome (ARDS): 急性呼吸窘迫综合征（ARDS）：ARDS has been reported in patients receiving filgrastim products 已有报告称，接受非格司亭制剂治疗的患者出现急性呼吸窘迫综合征（ARDS）。. 。Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS 对出现发热、肺部浸润或呼吸窘迫的患者进行急性呼吸窘迫综合征（ARDS）评估. 。Discontinue FILKRI in patients with ARDS. 在患有急性呼吸窘迫综合征（ARDS）的患者中停用 FILKRI。Serious Allergic Reactions: 严重过敏反应：Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products 已有报告指出，接受非格司亭制剂治疗的患者发生严重过敏反应，包括过敏性休克。. 。The majority of reported events occurred upon initial exposure 大多数报告的事件发生在初次暴露时. 。Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment 对过敏反应进行对症治疗。在接受非格司亭类产品治疗的患者中，包括过敏性休克在内的过敏反应可能在初始抗过敏治疗停药后数天内复发。. 。Permanently discontinue FILKRI in patients with serious allergic reactions. 对于出现严重过敏反应的患者，应永久停用 FILKRI。Sickle Cell Disorders: 镰状细胞病：Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products 接受非格司亭产品的镰状细胞病患者可能发生严重且有时致命的镰状细胞危象. 。Discontinue FILKRI if sickle cell crisis occurs. 若发生镰状细胞危象，请停用 FILKRI。Glomerulonephritis: 肾小球肾炎：Has occurred in patients receiving filgrastim products 在接受非格司亭产品治疗的患者中已发生. 。Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy 诊断依据为氮质血症、血尿、蛋白尿及肾活检。. 。Generally, events resolved after dose reduction or discontinuation of filgrastim products 通常，在减少剂量或停用非格司亭类产品后，事件得以解决. 。If causality is likely, consider dose-reduction or interruption of FILKRI. 如果因果关系可能性较大，应考虑减少FILKRI剂量或中断给药。Alveolar Hemorrhage and Hemoptysis: 肺泡出血与咯血：Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization 在接受FILKRI治疗以动员外周血祖细胞（PBPC）采集的健康供者中，已有肺泡出血的报告，其表现为肺部浸润和需要住院治疗的咯血。. 。Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication. 停用非格司亭制剂后，咯血症状缓解。FILKRI用于健康供者外周血祖细胞动员的适应症尚未获批。Capillary Leak Syndrome (CLS): 毛细血管渗漏综合征（CLS）：CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed 已有报道指出，在使用粒细胞集落刺激因子（G-CSF），包括非格司亭制剂后，可能出现毛细血管渗漏综合征（CLS），其特征为低血压、低白蛋白血症、水肿和血液浓缩。发作频率和严重程度各异，若治疗延误，可能危及生命。. 。Patients with symptoms should be closely monitored and receive appropriate treatment. 有症状的患者应接受密切监测并给予适当治疗。MyelodysplasticSyndrome (MDS) and Acute MyeloidLeukemia (AML): 骨髓增生异常综合征（MDS）和急性髓系白血病（AML）：Patients with Severe Chronic Neutropenia(SCN 患有严重慢性中性粒细胞减少症（SCN）的患者): ):Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. 在开始 FILKRI 治疗之前，请确认严重慢性中性粒细胞减少症（SCN）的诊断。据报道，在未接受细胞因子治疗的先天性中性粒细胞减少症的自然病程中，可发生骨髓增生异常综合征（MDS）和急性髓系白血病（AML）。在接受非格司亭类产品治疗 SCN 的患者中，也观察到染色体核型异常、转化为 MDS 以及 AML。Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. 异常细胞遗传学和骨髓增生异常综合征（MDS）与最终发展为髓系白血病相关。非格司亭类产品对异常细胞遗传学发展的影响，以及在存在异常细胞遗传学或MDS的患者中持续使用非格司亭的影响尚不明确。在这些情况下，应监测患者是否出现MDS/急性髓系白血病（AML）的体征和症状。If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered.. 如果严重慢性中性粒细胞减少症（SCN）患者出现异常细胞遗传学或骨髓增生异常，应仔细权衡继续使用 FILKRI 的风险与获益。Patients with Breast and Lung Cancer 乳腺癌和肺癌患者: ：MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. 在乳腺癌和肺癌患者中，非格司亭制剂与化疗和/或放疗联合使用已与骨髓增生异常综合征（MDS）和急性髓系白血病（AML）的发生相关。在这些情况下，应监测患者是否出现 MDS/AML 的体征和症状。Thrombocytopenia: 血小板减少症：Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts. 已有报告指出，接受非格司亭制剂治疗的患者会出现血小板减少症。应监测血小板计数。Leukocytosis: 白细胞增多症：Patients with Cancer Receiving MyelosuppressiveChemotherapy 接受骨髓抑制性化疗的癌症患者: ：White blood cell counts ≥ 100,000/mm 白细胞计数 ≥ 100,000/mm³3 3were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm 在每日剂量超过 5 mcg/kg 接受非格司亭产品的患者中，约有 2% 观察到上述情况。如果绝对中性粒细胞计数（ANC）超过 10,000/mm³，请停用 FILKRI。3 3after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI. 在化疗引起的中性粒细胞绝对计数（ANC）最低点出现后。在使用 FILKRI 治疗期间，每周至少监测两次全血细胞计数（CBC）。Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days. 停用非格司亭治疗通常导致循环中性粒细胞在1至2天内减少50%，并在1至7天内恢复至治疗前水平。Cutaneous Vasculitis: 皮肤血管炎：Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products 在接受非格司亭产品治疗的患者中，已有中度或重度皮肤血管炎的报道。. 。Most reports involved patients with SCN receiving long-term filgrastim therapy 大多数报告涉及接受长期非格司亭治疗的严重慢性中性粒细胞减少症患者. 。Hold FILKRI therapy in patients with cutaneous vasculitis 在皮肤血管炎患者中暂停 FILKRI 治疗. 。FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased. 当症状消退且绝对中性粒细胞计数（ANC）下降时，可减少FILKRI的剂量。Potential Effect on Malignant Cells: 对恶性细胞的潜在影响：FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established.. FILKRI是一种主要刺激中性粒细胞的生长因子。FILKRI作用的粒细胞集落刺激因子（G-CSF）受体也在肿瘤细胞系中被发现。不能排除FILKRI作为任何类型肿瘤的生长因子的可能性。非格司亭产品在慢性髓性白血病（CML）和骨髓增生异常综合征中的安全性尚未确立。Simultaneous Use with Chemotherapy and Radiation Not Recommended: 不建议与化疗和放疗同时使用：The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established 尚未确定 FILKRI 与细胞毒性化疗和放射治疗同时给药的安全性和有效性. 。Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy 在给予细胞毒性化疗药物前后24小时内，不得使用FILKRI。. 。The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy 尚未在接受同步放射治疗的患者中评估 FILKRI 的安全性和有效性. 。Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy. 避免将 FILKRI 与化疗和放疗同时使用。Nuclear Imaging: 核医学成像：Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging. 骨髓造血活性增加与核医学成像中短暂的阳性骨显像改变相关。Aortitis: 主动脉炎：Aortitis has been reported in patients receiving filgrastim products 已有报告指出，接受非格司亭类产品治疗的患者出现了主动脉炎。. 。It may occur as early as the first week after start of therapy 可能在治疗开始后的第一周就出现. 。Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) 临床表现可能包括全身性体征和症状，如发热、腹痛、不适、背痛以及炎症标志物升高（例如C反应蛋白和白细胞计数）。. 。Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected. 对于出现这些体征和症状但病因不明的患者，应考虑主动脉炎的可能性。若怀疑主动脉炎，应停用 FILKRI。The most common adverse reactions in patients: 患者中最常见的不良反应：with nonmyeloidmalignancies receiving myelosuppressiveanti-cancer drugs 患有非髓系恶性肿瘤并接受骨髓抑制性抗癌药物治疗的患者(≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea （与安慰剂相比，发生率差异≥5%）包括发热、疼痛、皮疹、咳嗽和呼吸困难with AML 使用 AML(≥ 2% difference in incidence) are pain, epistaxis and rash （发生率差异≥2%）为疼痛、鼻出血和皮疹with nonmyeloidmalignancies undergoing myeloablativechemotherapy followed by BMT 患有非髓系恶性肿瘤并接受清髓性化疗随后进行骨髓移植的患者(≥ 5% difference in incidence) is rash （发生率差异 ≥ 5%）为皮疹with severe chronic neutropenia(SCN) 患有严重慢性中性粒细胞减少症（SCN）(≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia （发生率差异≥5%）包括疼痛、贫血、鼻出血、腹泻、感觉减退和脱发INDICATIONS 适应症FILKRI is a leukocyte growth factor indicated to: FILKRI 是一种白细胞生长因子，适用于：Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever 降低接受骨髓抑制性抗癌药的非髓系恶性肿瘤患者中发热性中性粒细胞减少所表现的感染发生率，这些药物与显著的重度发热性中性粒细胞减少发生率相关Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) 缩短急性髓系白血病（AML）患者在诱导或巩固化疗后中性粒细胞恢复的时间及发热持续时间Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) 缩短接受清髓性化疗随后进行骨髓移植（BMT）的非髓系恶性肿瘤患者的中性粒细胞减少症持续时间及其中性粒细胞减少相关的临床后遗症（例如，发热性中性粒细胞减少症）Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia 降低先天性中性粒细胞减少症、周期性中性粒细胞减少症或特发性中性粒细胞减少症的症状性患者中，严重中性粒细胞减少症后遗症（如发热、感染、口咽溃疡）的发生率和持续时间Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) 提高急性暴露于骨髓抑制剂量辐射（急性放射综合征的造血综合征）患者的生存率http://www.fda.gov/medwatch http://www.fda.gov/medwatchFor more information, please see the 更多信息，请参见full Prescribing Information 完整处方信息. 。About Accord BioPharma 关于 Accord BioPharmaAccord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies. Accord BioPharma, Inc. 是 Intas Pharmaceuticals, Ltd. 的美国专业部门，而 Intas 是全球经验最丰富的生物类似药开发商之一。Accord BioPharma 专注于肿瘤学、免疫学和中枢神经系统（CNS）治疗领域，致力于扩大患者对高质量、可负担的生物制剂疗法的获取。The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab); JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab); ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA® (pegfilgrastim); and CAMCEVI® (leuprolide mesylate) injectable emulsion. 该公司获美国食品药品监督管理局（FDA）批准的商业产品组合包括：UDENYCA®（pegfilgrastim-cbqv），一种NEULASTA®（聚乙二醇化非格司亭）的生物类似药；FILKRI™（filgrastim-laha），一种NEUPOGEN®（非格司亭）的生物类似药；IMULDOSA®（ustekinumab-srlf），一种STELARA®（乌司奴单抗）的生物类似药；HERCESSI™（trastuzumab-strf），一种HERCEPTIN®（曲妥珠单抗）的生物类似药；OSVYRTI®（denosumab-desu），一种Prolia®（地舒单抗）的生物类似药；JUBEREQ®（denosumab-desu），一种Xgeva®（地舒单抗）的生物类似药；ENNUMO™（pegfilgrastim-pccg），一种NEULASTA®（聚乙二醇化非格司亭）的生物类似药；以及CAMCEVI®（亮丙瑞林甲磺酸盐）可注射乳剂。Accord BioPharma has received FDA approval on additional products including IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S. Accord BioPharma 已获得美国食品药品监督管理局（FDA）对更多产品的批准，其中包括 IMMGOLIS™（golimumab-sldi）——Simponi®（戈利木单抗）的生物类似药，以及 IMMGOLIS INTRI™（golimumab-sldi）——Simponi Aria®（戈利木单抗）的生物类似药。该公司的战略目标是在美国推出20种生物类似药产品。by 2030. For more information, visit . 到2030年。欲了解更多信息，请访问。www.accordbiopharma.com www.accordbiopharma.com. 。References: 参考文献：FILKRI (filgrastim-laha) injection. Prescribing Information. Accord BioPharma. FILKRI（非格司亭-laha）注射液。处方信息。Accord BioPharma。UDENYCA Prescribing Information. Coherus BioSciences. UDENYCA 处方信息。Coherus BioSciences 公司。Cleveland Clinic. Neutropenia. Updated June 9, 2022. Accessed October 2, 2026. 克利夫兰诊所。中性粒细胞减少症。更新于2022年6月9日。访问于2026年10月2日。https://my.clevelandclinic.org/health/diseases/21058-neutropenia https://my.clevelandclinic.org/health/diseases/21058-neutropenia. 。Samsung Bioepis. 三星生物制剂Biosimilar Market Report 生物类似药市场报告. 13th ed., Q2 2026. 第13版，2026年第二季度。All trademarks, logos and brand names are the property of their respective owners. 所有商标、徽标和品牌名称均归其各自所有者所有。Contact: 联系方式：[emailprotected] [email protected]SOURCE Accord BioPharma 来源：Accord BioPharma21 二十一% 百分比more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

生物类似药临床研究

2026-10-12

·BioSpace

Accord BioPharma Launches FILKRI™ (filgrastim-laha); Now Offers Both Long- and Short-Acting G-CSF Options

FILKRI is available with a permanent Q-code, standardizing the billing and reimbursement process across all sites of care. RALEIGH, N.C. , Oct. 12, 2026 /PRNewswire/ -- Accord BioPharma , Inc., the specialty division of Intas Pharmaceuticals, Ltd. , focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim). FDA-approved in January 2026, FILKRI represents Accord BioPharma's continued expansion into oncology supportive care and furthers the company's goal to bring 20 biosimilars to the U.S. market by 2030. 1 FILKRI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). FILKRI is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringe presentations, with pack sizes of one or 10 prefilled syringes per carton. 1 The addition of FILKRI expands Accord BioPharma's granulocyte colony-stimulating factor (G-CSF) portfolio, giving U.S. physicians access to both short- and long-acting treatment options through FILKRI and UDENYCA ® (pegfilgrastim-cbqv). These options help meet the individual needs of patients undergoing chemotherapy and their healthcare providers. 2 FILKRI will be manufactured end to end by Accord BioPharma's parent entity, Intas, and has been assigned a permanent Q-code (Q5172) by the U.S. Centers for Medicare & Medicaid Services (CMS), effective October 1, which will standardize the billing and reimbursement process across all sites of care. "The commercial launch of FILKRI with a permanent Q-code from day one is a significant milestone for Accord BioPharma and for cancer patients across the United States," said Chrys Kokino, President of Accord North America. "Having a permanent Q-code will simplify billing and streamline reimbursement, making it more timely and reliable for physicians treating patients." Addressing Critical Patient Needs in Neutropenia Management As a G-CSF, FILKRI is indicated for use across several clinical settings in which neutropenia or its complications may occur, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Neutropenia is a condition characterized by lower-than-normal levels of neutrophils, a type of white blood cell that helps the body fight infections. Cancer treatments, including chemotherapy, can damage neutrophils or the bone marrow that produces them. 3 "With FILKRI, alongside our established UDENYCA pegfilgrastim franchise, Accord now offers physicians the choice between long-acting and short-acting biosimilar G-CSF treatments to suit their clinical needs and preferences," Kokino added. "This demonstrates our deep commitment to oncology supportive care and positions us as a comprehensive partner for the oncology community." Filgrastim biosimilars have become well established in the U.S. market, accounting for approximately 77% of filgrastim market share as of the fourth quarter of 2025. 4 Expanding Access Through Competitive Pricing and Patient Support Through AccordCares®, a dedicated patient support program, the company is launching FILKRI with comprehensive patient resources, including benefits investigation and co-pay assistance, designed to connect patients to the information and resources they need, building on the proven foundation established with UDENYCA. "At Accord, we believe that cost shouldn't prevent patients from receiving the cancer care they need," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. "With FILKRI, we're continuing to build on our track record of bringing high-quality biosimilars to market that provide physicians more choice and can make a real difference in patient care and patient affordability. The permanent Q-code further enhances our ability to expand patient access from launch." Building on Proven Leadership in Oncology Supportive Care "The launch of FILKRI in the United States demonstrates our unwavering commitment to building a comprehensive oncology supportive care portfolio that addresses urgent medical needs," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape by introducing biosimilars to the U.S. market. As our presence in the biosimilar market continues to grow, so does our commitment to offering high-quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need." FDA approval of FILKRI was based on data demonstrating that FILKRI is highly similar to Neupogen, with no clinically meaningful differences. 1 IMPORTANT SAFETY INFORMATION FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. Splenic Rupture: Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome (ARDS): ARDS has been reported in patients receiving filgrastim products . Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS . Discontinue FILKRI in patients with ARDS. Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products . The majority of reported events occurred upon initial exposure . Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment . Permanently discontinue FILKRI in patients with serious allergic reactions. Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products . Discontinue FILKRI if sickle cell crisis occurs. Glomerulonephritis: Has occurred in patients receiving filgrastim products . Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy . Generally, events resolved after dose reduction or discontinuation of filgrastim products . If causality is likely, consider dose-reduction or interruption of FILKRI. Alveolar Hemorrhage and Hemoptysis: Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization . Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication. Capillary Leak Syndrome (CLS): CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed . Patients with symptoms should be closely monitored and receive appropriate treatment. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Patients with Severe Chronic Neutropenia (SCN ): Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered. Patients with Breast and Lung Cancer : MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. Thrombocytopenia: Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts. Leukocytosis: Patients with Cancer Receiving Myelosuppressive Chemotherapy : White blood cell counts ≥ 100,000/mm 3 were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm 3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI. Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days. Cutaneous Vasculitis: Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products . Most reports involved patients with SCN receiving long-term filgrastim therapy . Hold FILKRI therapy in patients with cutaneous vasculitis . FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased. Potential Effect on Malignant Cells: FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Simultaneous Use with Chemotherapy and Radiation Not Recommended: The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established . Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy . The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy . Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy. Nuclear Imaging: Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging. Aortitis: Aortitis has been reported in patients receiving filgrastim products . It may occur as early as the first week after start of therapy . Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) . Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected. The most common adverse reactions in patients: with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea with AML (≥ 2% difference in incidence) are pain, epistaxis and rash with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash with severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia INDICATIONS FILKRI is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) For more information, please see the full Prescribing Information . About Accord BioPharma Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies. The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab); JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab); ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA® (pegfilgrastim); and CAMCEVI® (leuprolide mesylate) injectable emulsion. Accord BioPharma has received FDA approval on additional products including IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S. by 2030. For more information, visit . References: FILKRI (filgrastim-laha) injection. Prescribing Information. Accord BioPharma. UDENYCA Prescribing Information. Coherus BioSciences. Cleveland Clinic. Neutropenia. Updated June 9, 2022. Accessed October 2, 2026. . Samsung Bioepis. Biosimilar Market Report . 13th ed., Q2 2026. All trademarks, logos and brand names are the property of their respective owners. Contact: abipr@accordhealthcare.com View original content to download multimedia: SOURCE Accord BioPharma

上市批准放射疗法

2026-10-11

·Pharma漫笔

医药行业新闻日报

Pharma漫笔日报头条要闻重点动态更多动态2026年10月11日 · 星期日 · 2026-10-11 每日简报Pharma Daily BriefingPharma漫笔日报医药行业新闻日报 · 2026年10月11日（周日）｜本期收录 18 条，按重要度评级10·11OCT · SUN更新于 10:05每日速览收录周期：10月10日（周六）全天 · 全球 MNC / Biotech / CXO / 监管动态24h内更新：17 条近期关键会议：AAO 2026 眼科年会（10/9—10/12 · 美国新奥尔良）· ESMO 2026 欧洲肿瘤内科学会年会（10/23—10/27 · 西班牙马德里）编者按：昨日全球医药的主轴，是美国 FDA 同日落下三项首创性决定，把"治疗前移"与"给药方式变革"两条线索同时推到台前。10 月 9 日，FDA 批准罗氏阿替利珠单抗联合氟尿嘧啶与奥沙利铂用于 III 期错配修复缺陷（dMMR）结肠癌术后辅助治疗，这是该药在美国的第 12 个适应症，也是免疫治疗首次进入这一人群——III 期 ATOMIC 研究纳入 712 例，联合治疗使复发或死亡风险降低约 50%，36 个月无病生存率 86% 对 76%。同日，梯瓦与 Medincell 合作的 WELTRUZA（奥氮平缓释注射混悬液）获批，成为全球首个每月一次皮下注射的长效奥氮平制剂，III 期 SOLARIS（675 例）三个剂量组 PANSS 改善均优于安慰剂（P<0.0001）；旭化成 pritelivir（HOVILPRI）获批用于免疫低下成人耐药性单纯疱疹皮损，III 期 PRIOH-1 显示 28 天完全愈合率 62.7% 对 34%（p=0.0047），为近 30 年该领域首个新机制口服药。国内方面，第二批全国中药饮片联盟集采中选结果由多省发文落地，10 月 15 日起执行。反向看，昨日最值得警惕的不是数据而是规则：圣诺生物公告其子公司与实控人因第七批国家集采醋酸奥曲肽注射液围标、涉嫌串通投标罪被提起公诉，涉案违法所得 1097.96 万元；盟科药业 ADC 项目及平台授权瑞士 ClearideBio 的议案以 6 票同意、1 票弃权通过，弃权董事直指对手方尽调不足与项目早期不确定性。后续跟踪三个锚点：10 月 23—27 日马德里 ESMO 2026 主席专场中国来源研究的数据成色、10 月 26 日 FDA 对 GSK 贝普若韦生的审评决定，以及 11 月将发布的 2026 年版国家医保药品目录与商保创新药目录。 —— 出品：Pharma漫笔日报共收录 18 条动态★★★★★ 3 条★★★★ 5 条★★★ 10 条24h内更新：17 条周末更新：18 条头条要闻Top Stories★★★★★ × 301★★★★★临床FDA审批MNC周末更新● 24h内更新10-09 FDA批准 · 罗氏宣布罗氏阿替利珠单抗获FDA批准III期dMMR结肠癌术后辅助治疗：免疫治疗首次进入该人群，复发或死亡风险降约50% 10 月 9 日，罗氏宣布 FDA 已批准阿替利珠单抗（Tecentriq）联合氟尿嘧啶与奥沙利铂化疗，用于 III 期错配修复缺陷（dMMR）结肠癌患者术后的辅助治疗，皮下剂型 Tecentriq Hybreza 同步获批，为该药在美国的第 12 个适应症，也是该人群首个获批的辅助免疫治疗方案。关键 III 期 ATOMIC 研究（n=712）显示，在改良 FOLFOX6 化疗基础上加用阿替利珠单抗，可使复发或死亡风险降低约 50%；36 个月无病生存率为 86% 对 76%（化疗单药）。约 25% 的结肠癌初诊即为 III 期，其中近三分之一患者 5 年内复发；约 15% 结肠癌携带 dMMR 或 MSI-H 特征，对免疫治疗更敏感。罗氏首席医学官 Levi Garraway 称该组合有潜力成为新标准治疗。推送原因免疫治疗首次敲开早期结肠癌辅助治疗大门，且以"生物标志物分层（dMMR/MSI-H）"作为用药前提，意味着结直肠癌围手术期路径与伴随诊断逻辑将同步重写，对国内同类 PD-(L)1 辅助适应症设计有直接对标意义。评级原因注册级 III 期随机对照证据+首个适应症级空白填补+覆盖人群大（约每四例结肠癌有一例 III 期），评5星。罗氏公告 · Pharmaceutical Executive · India Pharma OutlookIndia Pharma Outlook（ATOMIC 数据与获批解读，EN）PDUFA Tape（肿瘤审评日历，EN）02★★★★★临床FDA审批MNC周末更新● 24h内更新10-09 FDA批准 · 梯瓦/Medincell梯瓦WELTRUZA获FDA批准：全球首个每月一次皮下注射长效奥氮平制剂，III期SOLARIS三剂量组均达主要终点 10 月 9 日，梯瓦制药宣布 FDA 已批准 WELTRUZA（奥氮平缓释注射混悬液，研发代号 TEV-'749）上市，用于成人精神分裂症治疗，为全球首个且目前唯一获批的每月一次皮下注射长效奥氮平制剂，由梯瓦与 Medincell 合作开发，采用共聚物（SteadyTeq）原位储库缓释技术。关键 III 期 SOLARIS 研究（n=675）评估 318/425/531 mg 每月一次皮下给药：三个剂量组均达主要终点，PANSS 总分自基线至第 8 周较安慰剂平均差分别为 −9.71、−11.25、−9.69 分（均 P<0.0001）；CGI-S 评分改善 −0.47/−0.61/−0.53 分，PSP 评分升高 4.93/3.15/4.63 分（均 P<0.02）。全身安全性与已上市口服奥氮平制剂一致，未见新安全性信号。无需负荷剂量、无需口服补充、无需注射后留观。美国估计约 210 万人被诊断为精神分裂症。该药为梯瓦 Medincell 合作在美国获批的第二个产品（前一个为 2023 年获批的 Uzedy）。推送原因从"每日口服"到"每月一针"的给药范式切换，直接针对精神分裂症最核心的依从性难题；"无需负荷剂量+无需留观"把长效针剂的使用门槛降到接近普通门诊注射，对国内长效抗精神病药与微球/原位凝胶平台是清晰的对标方向。评级原因全球首个该剂型+III 期三个剂量组均达主要终点+覆盖患者基数大且为长期用药人群，评5星。梯瓦公告 · 医药魔方 · Reuters医药魔方（SOLARIS 数据与剂型细节）Reuters（Weltruza 获批，EN）药品价格315网（获批与依从性要点）03★★★★★临床FDA审批Biotech周末更新● 24h内更新10-09 FDA批准 · 旭化成旭化成pritelivir获FDA批准：近30年首个针对耐药性单纯疱疹新机制口服药，28天完全愈合率62.7%对34% 10 月 9 日，FDA 批准旭化成（Asahi Kasei，2026 年 4 月收购原研方德国 Aicuris）的 pritelivir（商品名 HOVILPRI）100 mg 片剂，用于免疫功能低下成人中对标准抗病毒治疗（阿昔洛韦、伐昔洛韦、泛昔洛韦等）应答不佳的黏膜皮肤单纯疱疹（HSV）皮损，为该领域近 30 年来首个新作用机制口服药——pritelivir 不经病毒胸苷激酶激活，而是直接阻断病毒复制所需的解旋酶-引物酶，因此对耐药株依然有效。关键研究 PRIOH-1 研究 C 部分（n=101）显示：截至第 28 天，pritelivir 组 63% 患者所有病灶完全愈合，对照组为 34%，调整后治疗差异 28.4 个百分点（95% CI 9.6—47.3；p=0.0047）；随访延长至最多 42 天时，完全愈合率分别为 82% 与 42%。药物不良反应发生率 22% 对 54%，因不良反应终止治疗 2% 对 20%，最常见为头痛（6%）。公司称美国约 1.5 万名患者适用，预计 2026 年底前在美国上市。推送原因耐药性单纯疱疹长期缺乏有效方案，新机制绕开了既有的胸苷激酶依赖路径，为免疫抑制人群（移植、肿瘤治疗、HIV）提供了"标准治疗失败后"的明确出路，也为抗病毒领域"新靶点补空白"提供了注册范式样本。评级原因近 30 年首个新机制+随机对照研究达统计学显著+适应症无替代方案，评5星。Asahi Kasei 公告 · Reuters · 药明康德腾讯新闻（PRIOH-1 数据全文摘录）India Pharma Outlook（获批与机制解读，EN）Reuters（FDA 批准摘要，EN）重点动态Focus★★★★ × 504★★★★政策监管集采周末更新● 24h内更新10-09 晚公告 · 10-10 发酵圣诺生物子公司及实控人因第七批国家集采围标被以串通投标罪提起公诉，涉案违法所得1097.96万元 10 月 9 日晚，圣诺生物（688117.SH）公告，公司全资子公司成都圣诺生物制药有限公司及实际控制人、董事长兼法定代表人文永均近日收到江苏省南京市雨花台区人民检察院《起诉书》，因涉嫌串通投标罪被提起公诉。据公安机关《起诉意见书》，圣诺制药涉嫌参与国家第七批集采药品醋酸奥曲肽注射液围标，相关人员承诺且公司实际以第五顺位中标；检察院查明圣诺制药销售该品种共 751.07 万支、销售金额约 1.17 亿元，认定违法所得约 1097.96 万元。公诉意见指出文永均系单位犯罪中直接负责的主管人员、共同犯罪中主犯，具有自首情节；圣诺制药系坦白，依法可从轻处罚。公司已于 2025 年度财务报表中就违法所得计提预计负债，最终罚金待法院审理确定，预计影响本年度或以后年度归母净利润；文永均在取保候审阶段仍正常履职，公司生产经营正常。推送原因这是集采围标从"价格与招采信用惩戒"上升到"刑事追责"并直接指向上市公司实控人的标志性案件，意味着集采合规风险不再只是"取消中选资格"，而是可能触及刑责与投标资格限制，对所有依赖集采品种销售的国内药企都是硬约束信号。评级原因制度级执法先例+涉及上市公司核心子公司与实控人+可能限制后续集采投标资格，评4星。公司公告 · 经济参考报 · 中国基金报经济参考报（起诉书要点与时间线）极目新闻（刑责与业务影响分析）05★★★★临床监管MNC周末更新● 24h内更新10-10 罗氏公告 · AAO 2026罗氏vamikibart两项III期一年数据亮相AAO 2026：UME视觉与黄斑厚度改善维持至52周，FDA已受理BLA 10 月 10 日，罗氏公布抗 IL-6 单抗 vamikibart 治疗葡萄膜炎性黄斑水肿（UME）的两项 III 期研究 MEERKAT 与 SANDCAT 的一年（52 周）数据，于美国眼科学会 AAO 2026 年会（10 月 9—12 日 · 新奥尔良）发布：52 周时，0.25 mg 与 1 mg 玻璃体腔注射组在视力获益与黄斑厚度（CST）降低上持续优于假注射对照，主要终点上取得视力提升的患者比例数值上高于对照组，关键次要终点获益同样维持。给药负担较低：约三分之二的合格患者在 16 周后无需再次注射，需要再治疗者多数仅补 1 针。治疗相关眼部不良事件与眼内炎症发生率低。FDA 已受理其 BLA，目标决定日为 2027 年 7 月；欧盟、中国和日本的注册申请也已提交并获受理。若获批，vamikibart 将成为 UME 首个非类固醇靶向治疗。UME 是葡萄膜炎患者中重度视力损害的首因，约 20% 患者确诊三年内进展为持续失明。推送原因眼科是继肿瘤之后最密集的数据读出领域，本次一年数据把"疗效能否维持"这一 III 期最关键的问题回答清楚；同时"16 周后约三分之二患者免于再注射"直接指向当前抗 VEGF 高频注射的现实痛点，对中国在研眼科长效/靶向抗炎管线有明确参照价值。评级原因随机对照 III 期一年随访数据+首个非类固醇靶向方案定位+BLA 已获受理，评4星。罗氏/Genentech 公告 · AAO 2026罗氏官方发布稿（MEERKAT/SANDCAT 一年数据，PDF·EN）AJMC（AAO 2026 议程与看点）06★★★★政策医保集采周末更新● 24h内更新10-10 多省医保局发文第二批全国中药饮片联盟集采中选结果多省落地：10月15日起执行，采购周期原则上1年 10 月 10 日，多个省级医保局集中发文落地第二批全国中药饮片采购联盟集采中选结果。海南省医保局发布《关于做好第二批全国中药饮片采购联盟集中采购中选结果的通知》，明确中选药品医保支付标准按中选价格确定，非中选药品延续原政策；山西省医保局通知自 10 月 15 日起正式执行中选结果，采购周期为 2026 年 10 月 15 日至 2027 年 10 月 14 日（视情况可延长 1 年），采购主体覆盖全省参与联采的公立医疗机构（含军队医疗机构）与医保定点社会办医疗机构，实际采购量在当年约定采购量 2 倍以内须按中选价保障供应。同日，四川省医保局发布省际联盟输尿管支架类、高频电刀、中性电极类、冠脉介入球囊类四类耗材中选结果落地通知，统一执行时间分别为 10 月 15 日、10 月 22 日、10 月 29 日。推送原因中药饮片集采是"集采从化药、生物药向中药与耗材延伸"的关键一环，省级执行文件密集落地意味着中选结果正式进入医院采购与医保支付环节，直接改变中药饮片企业的渠道结构与回款节奏，也影响下游中药制剂的成本曲线。评级原因国家级联采结果进入实质执行期+多品类同步落地+影响面覆盖中药与高值耗材两条线，评4星。国家联采办 · 各省医保局海南省医保局（中选结果落地通知）山西省人民政府（10月15日起执行）四川省医保局（四类耗材执行时间）07★★★★BD出海Biotech周末更新● 24h内更新10-09 晚公告 · 10-10 披露盟科药业MRX-23及STOPIN ADC平台授权瑞士ClearideBio：首付款100万美元，里程碑名义上限合计最高7.5亿美元 10 月 9 日晚，盟科药业（688373.SH）公告，公司拟与瑞士 ClearideBio Therapeutics AG 签订两项协议：一是 MRX-23（临床前 ADC）项目的全球独占许可，首付款 100 万美元（生效后按约定支付、不可退还），近期开发里程碑以许可产品首次获得临床试验申请批准为触发条件，研发、注册及销售里程碑付款名义上限合计 2.23 亿美元（含近期里程碑、不含首付款）；二是基于公司自研喜树碱载荷"STOPIN"ADC 平台的多项目选择权合作，ClearideBio 可就最多 6 个靶点或靶点组合项目行使选择权，每个已行权项目里程碑名义上限 1.25 亿美元，全部行权且各项目里程碑全部达成时合计上限 7.5 亿美元；若对方再许可，公司可获再许可收入分成，若自行商业化则可获销售提成。该议案在第二届董事会第三十次会议上以 6 票同意、0 票反对、1 票弃权通过，弃权董事提出交易对手经营与商务信息掌握不充分、项目处于早期阶段、建议完善条款等理由。推送原因本次为"单一项目全球独占许可+平台多项目选择权"的组合授权结构，反映国内小市值 Biotech 正把 BD 标的从已上市品种前移到临床前资产与技术平台；但首付款仅百万美元级、对手方成立于 2025 年 12 月，交易的落地确定性与治理透明度同样值得持续跟踪。评级原因平台级授权结构+里程碑名义上限规模可观，但首付款小、标处临床前、董事会存分歧，评4星。公司公告 · 中国证券报 · 巨潮资讯东方财富（许可协议公告全文）巨潮资讯（公告 PDF）财经网健康（交易要点）08★★★★CXO产能订单周末更新● 24h内更新10-10 经济参考报CXO产能与订单同步走高：药明康德在手订单664.3亿元、凯莱英16.73亿美元，多肽与高活产能加速扩建 10 月 10 日，经济参考报就医药生物企业扩产情况作出梳理：药明康德 2026 年半年度报告显示，截至 2026 年 6 月末，公司持续经营业务在手订单人民币 664.3 亿元，同比增长 25.2%，为满足客户需求进一步加速全球产能布局，提前启动常州新基地建设，预计全年资本开支由 65—75 亿元上调至 75—85 亿元，报告期末在建工程 82.47 亿元、较上年末增长 40.35%，主要来自美国特拉华州生产基地与新加坡研发及生产基地建设。凯莱英截至半年报披露日在手订单总额 16.73 亿美元、同比增长 53.77%，2026 年初至报告披露日新签订单同比增长 54.59%，化学大分子与生物大分子业务订单增长较快；公司新增 5 条高活产线已投产，预计 2026 年底多肽固相反应合成总产能将增至 69000 L。业内判断，本轮扩产由真实订单与商业化需求驱动，资源正从通用产能转向高壁垒、强需求赛道。推送原因在手订单与新签订单同时提速，叠加多肽、高活等新分子产能集中投放，说明 CXO 的景气回升已经体现在产能与资本开支决策上，而非仅停留在订单口径；这也是后续观察三季报与行业景气能否延续的先行参照。评级原因龙头订单与资本开支双向上修+扩产方向集中在多肽/高活等壁垒赛道，评4星。经济参考报 · 药明康德半年报 · 凯莱英半年报经济参考报（扩产有进有退）新浪财经（凯莱英订单结构解读）更多动态More★★★ × 1009★★★监管仿制药周末更新● 24h内更新10-10 公司公告上海医药氯维地平乳状注射液获批准生产：化学药品3类视同通过一致性评价 10 月 10 日，上海医药公告，下属上海上药第一生化药业有限公司收到国家药监局颁发的氯维地平乳状注射液《药品注册证书》（证书编号 2026S03524、2026S03525；国药准字 H20266064、H20266065），规格 50ml:25mg 与 100ml:50mg，注册分类为化学药品 3 类，获批生产。该药品主要用于治疗不适宜口服或预期口服药物治疗效果不佳的高血压，原研由阿斯利康开发、2008 年 8 月在美国获批。上药第一生化 2024 年 7 月提出注册上市申请并获受理，截至公告日已投入研发费用约人民币 5220 万元。IQVIA 数据显示，2025 年度中国大陆医院采购与氯维地平同机制的钙通道阻滞剂注射剂金额约人民币 9.11 亿元。推送原因围术期与重症高血压的注射剂型再添国产参与者，该场景竞争将进一步加剧；同时 3 类仿制药获批意味着在医保支付与医疗机构采购环节获得更大支持力度。评级原因获批生产但标的为成熟仿制品种、单品种市场体量有限，评3星。上海医药公告 · 巨潮资讯巨潮资讯（获批生产公告 PDF）10★★★监管生物药周末更新● 24h内更新10-10 公司公告科兴制药聚乙二醇化人粒细胞刺激因子注射液（GB-K02）上市许可申请获受理 10 月 10 日，科兴制药公告，公司收到国家药监局核准签发的关于在研药品聚乙二醇化人粒细胞刺激因子注射液（GB-K02）药品上市许可申请的《受理通知书》，受理号 CXSS2600161，剂型为注射剂，规格 6mg/0.6ml/支，申请事项为境内生产药品注册上市许可。GB-K02 适用于非髓性恶性肿瘤患者在接受易引起临床显著发热性中性粒细胞减少的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症（FN）为表现的感染发生率。该产品为长效人粒细胞刺激因子，通过聚乙二醇与基因重组技术制备的 G-CSF 偶联修饰，为原研 Neulasta 的生物类似药，分子结构、制剂处方、规格与适应症均与原研一致；相比普通 G-CSF 注射液可延长半衰期、减少给药次数，并缩减 3 度与 4 度粒细胞减少的持续时间。据国家癌症中心数据，2024 年我国恶性肿瘤新发病例估计 515.06 万例。推送原因长效 G-CSF 是肿瘤支持治疗中放量确定性较强的品种，国产上市申请获受理意味着该细分市场的供应结构可能再度调整。评级原因受理阶段、尚未获批，且属生物类似药，评3星。科兴制药公告 · 新浪财经新浪财经（上市许可申请获受理公告）11★★★监管疫苗周末更新● 24h内更新10-10 公司公告金迪克三价流感病毒裂解疫苗获批，本流感季四价疫苗停售 10 月 10 日，金迪克（688670.SH）公告，公司近日收到国家药监局批准颁发的流感病毒裂解疫苗《药品注册证书》。受世界卫生组织调整 2026—2027 北半球流感疫苗推荐组分、剔除 B/Yamagata 系病毒影响，公司本流感季不再销售四价流感疫苗，仅销售三价流感疫苗。公司同时提示，因产品刚获批、暂无可供销售产品，错过规模化销售时间窗口，经初步测算预计全年营收可能低于 1 亿元且不能实现扭亏，若触及财务类退市风险警示情形，上交所将对公司股票实施"退市风险警示"。同日科创板公告另显示，赛诺医疗冠脉球囊扩张导管获哥伦比亚 INVIMA 注册证。推送原因流感疫苗"三价回归"是 WHO 组分调整带来的行业结构性切换，四价产线的转换成本与排产能力将同时考验各家疫苗企业，是国内疫苗板块短期经营节奏的重要变量。评级原因获批本身为常规品种，但组分切换叠加公司自身财务风险提示，评3星。公司公告 · 巨潮资讯 · 腾讯新闻腾讯新闻（科创板晚报·金迪克公告要点）12★★★融资疫苗Biotech周末更新● 24h内更新10-09 完成交割Vaxcyte完成约11.5亿美元股票与可转债公开融资，用于31价肺炎疫苗III期与产能扩建 10 月 9 日，Vaxcyte（Nasdaq: PCVX）宣布完成此前公布的同步公开增发：以每股 64.00 美元发行 8,584,375 股普通股、以每份 63.999 美元发行 40 万份预融资权证，并发行本金总额 5.75 亿美元、票面利率 1.50%、2032 年到期的可转换优先票据，含承销商超额配售权全额行使，合计募资总额约 11.5 亿美元。募集资金将用于 VAX-31 成人与儿童项目临床开发（包括已入组的成人 III 期 OPUS-2、OPUS-3 研究、计划中的工艺一致性研究，以及婴儿 II 期剂量探索研究）、产能扩建与供应链建设、美国成人市场上市前的医学事务与商业化准备，以及早期管线研发。此前 VAX-31 关键 III 期 OPUS-1 研究已达成全部预设主要免疫原性与安全性终点。推送原因单笔融资回到十亿美元级，且资金明确指向 III 期与商业化产能同步推进，说明疫苗大品种的研发与产能投入强度正在回升，31 价覆盖若最终落地将直接改变成人肺炎球菌疫苗的竞争格局。评级原因融资规模可观但属已完成事项，产品尚处 III 期、BLA 计划 2028 年上半年递交，评3星。Vaxcyte 公告 · GlobeNewswireVaxcyte 投资者关系（交割公告，EN）BiopharmaWatch（融资结构摘要，EN）13★★★临床基因治疗Biotech周末更新10-08 发布 · AAO 2026Life Biosciences公布全球首个细胞重编程疗法ER-100一期阶段性数据：3例青光眼患者中2例视野改善 Life Biosciences 宣布其表观遗传重编程疗法 ER-100 一期临床试验的阶段性数据（AAO 2026 年会期间披露）：3 名开角型青光眼受试者接受单次玻璃体腔注射，并每日口服多西环素 8 周以诱导 OSK（OCT4、SOX2、KLF4）三因子表达。初始剂量 2×10¹¹ 载体基因组下，至第 56 天未报告剂量限制性毒性、特别关注不良事件或严重不良事件，已报告事件归因于注射操作、激素治疗或既存疾病；独立数据安全监查委员会已建议将剂量提升 3 倍至 6×10¹¹ 载体基因组。功能性观察方面，3 名受试者中 2 名在 Humphrey 视野检查中改善，至少 28% 的受检点在 56 天时提高超过 4 分贝。研究为开放标签、无对照设计，计划入组 18 人（12 例开角型青光眼、6 例 NAION），随访至 5 年，尚不足以证明疗效或确认细胞"年轻化"。推送原因细胞重编程首次从动物模型进入人体并给出可解读的安全性与早期功能性信号，为"部分重编程"这一前沿方向提供了临床起点；但开放标签、无对照、仅 3 例，任何疗效表述都应保持克制。评级原因技术方向标志性但样本极小、尚处安全性验证阶段，评3星。Life Biosciences 公告 · AAO 2026 · ClinicalTrials.govLongevity.Technology（一期数据解读，EN）凤凰网（中文报道与疗法机制）14★★★融资AI制药Biotech周末更新● 24h内更新10-10 公司披露利太智药完成近5000万元种子轮融资：AI原生多肽药物设计，讯飞创投等联合投资 10 月 10 日，利太智药（北京）科技有限公司宣布完成近 5000 万元种子轮融资，由讯飞创投、L2F 光源创业者基金及知名产业方联合投资，本轮资金将主要用于算力租用、核心管线研发、专利申报、人才招募及日常运营。公司成立于 2026 年 7 月，总部位于北京海淀，专注以生成式 AI 开展多肽新药设计；创始人贾寅君博士曾任清华大学智能产业研究院博士后，为 2026 年 1 月发表于《Science》的 DrugCLIP 研究共同第一作者。技术路径上，公司搭建"数据—模型—分子"三层体系，自建大规模闭源多肽合成数据集、遵循 Scaling Law 的多肽生成大模型，以及镜像多肽生成元件，并搭建 72 小时多肽"生成—合成"闭环平台；多条自研管线处于 HIT-to-lead 阶段，预计 2027 年初产出候选化合物。政策层面，工业和信息化部等十部门印发的《医药工业发展"十五五"规划》提出加快人工智能等新技术赋能药物研发。推送原因AI 制药的资金与团队正从"平台服务"叙事转向"AI 原生制药"，并落在多肽/环肽这一介于小分子与抗体之间的可编程模态上，是观察该赛道能否形成真实管线的重要早期样本。评级原因种子轮阶段、金额有限、尚无临床数据，评3星。投资界 · 科创板日报 · 医药魔方投资界（融资与技术路径）科创板日报（融资与行业数据）15★★★业绩中药周末更新● 24h内更新10-09 晚披露 · 10-10 报道沃华医药披露A股首份药企三季报：营收5.89亿元同比降5.73%，归母净利9265.45万元同比增44.78% 10 月 9 日晚，沃华医药（002107.SZ）披露 2026 年三季报，成为 A 股首家披露三季报的公司。前三季度公司实现营业收入 5.89 亿元，同比减少 5.73%；归属于上市公司股东的净利润 9265.45 万元，同比增长 44.78%；扣非净利润 9064.59 万元，同比增长 47.94%；基本每股收益 0.16 元。其中第三季度归母净利润 2508.82 万元，同比增长 29.87%。利润增长主要得益于营业成本与销售费用减少。产品端，核心产品心可舒片继续入选《国家基本药物目录（2026 年版）》，子公司江西沃华济顺医药的荷丹胶囊、荷丹片首次纳入该目录；公司持有 161 个药品批准文号（含 15 个独家产品），54 款产品入选 2026 版国家基药目录。新版基药目录评审首次将真实市场销量与循证医学证据作为前置准入门槛。推送原因A 股药企三季报由此启幕，"增利不增收"的费用驱动型增长与基药目录准入红利同时出现，为后续药企三季报的业绩成色定下需要仔细拆分的观察基调。评级原因单家公司业绩、体量有限，但具备三季报窗口的指示意义，评3星。证券时报 · 上海证券报 · 公司公告证券时报（三季报数据与基药目录）上海证券报（产品线与股东变化）16★★★融资AI制药Biotech周末更新● 24h内更新10-10 报道 · 定档 10-15Iambic Therapeutics定档10月15日纳斯达克上市：发行937.5万股、价格区间15—17美元，最高募资约1.59亿美元 10 月 10 日，临床阶段生命科学与技术公司 Iambic Therapeutics（代码 IAM）的上市安排被报道：公司计划于 2026 年 10 月 15 日在纳斯达克上市，发行 9,375,000 股，发行价区间 15—17 美元，最高募资约 1.594 亿美元；承销商为摩根大通、杰富瑞、美银证券与花旗集团。公司成立于 2019 年（原名 Entos），总部位于圣地亚哥，将自研 AI 模型与自动化高通量化学、生物学结合形成"模型提出分子—机器人实验室合成测试—数据回流再训练"的闭环平台。领衔管线 IAM1363 为选择性、可穿透血脑屏障的 HER2 抑制剂，正在 HER2 异常实体瘤中开展 1/1b 期试验，注册性研究最早可能于 2027 年启动；另有靶向 KIF18A 与 CDK2/4 的两个临床前项目计划于第四季度递交 IND。公司与 AbbVie、Takeda、Bayer 等有合作收入。推送原因在 IPO 市场整体审慎的背景下，AI 制药公司仍能推进纳斯达克上市，说明资本市场对该赛道的定价依据正在从"AI 概念"转向"临床阶段管线+平台可验证性"。评级原因发行安排属常规融资事件、尚未定价，评3星。Renaissance Capital · Reuters · 雷递网Renaissance Capital（发行条款与管线，EN）Reuters（AI 制药 IPO 与市场环境，EN）17★★★监管抗感染周末更新● 24h内更新10-10 公司公告众生药业子公司头孢克肟颗粒获《药品注册证书》：化学药品3类视同通过一致性评价 10 月 10 日，众生药业公告，全资子公司广东华南药业集团有限公司近日收到国家药监局核准签发的头孢克肟颗粒《药品注册证书》（证书编号 2026S03609；国药准字 H20266121），规格 50mg，申请事项为药品注册（境内生产），注册分类为化学药品 3 类，上市许可持有人为广东华南药业集团，生产企业为金鸿药业股份有限公司。头孢克肟颗粒适用于对头孢克肟敏感的链球菌属（肠球菌除外）、肺炎球菌、淋球菌、大肠埃希菌、克雷伯杆菌属等引起的急性支气管炎、肺炎、慢性呼吸系统感染继发感染、膀胱炎、肾盂肾炎等细菌感染性疾病，属《国家基本医疗保险、生育保险和工伤保险药品目录》乙类药品并纳入《国家基本药物目录》。米内网数据显示，头孢克肟颗粒 2023—2025 年在中国公立医院及城市实体药店销售总额分别为 5.54 亿元、5.15 亿元、4.29 亿元。本次获批标志着该产品视同通过化学仿制药一致性评价。推送原因口服头孢类抗感染品种的一致性评价继续推进，存量市场虽在下行，但基药与医保乙类身份仍是基层渠道的稳定放量基础。评级原因常规仿制药获批、品种销售额呈下降趋势，评3星。众生药业公告 · 新浪财经新浪财经（头孢克肟颗粒注册证书公告）18★★★临床肿瘤周末更新● 24h内更新10-10 中华网财经肺癌创新药格局重排：依沃西单抗美国审评目标日11月14日，EGFR×HER3双抗ADC等国内管线推进 10 月 10 日，中华网财经就国产肺癌创新药竞争格局作出梳理：全球首创 PD-1/VEGF 双抗依沃西单抗已在国内累计形成三项肺癌适应症（2024 年 5 月首次获批，2025 年获 PD-L1 阳性非小细胞肺癌一线单药，2026 年 8 月获联合化疗一线治疗晚期肺鳞癌）；III 期 HARMONi-6 研究显示，依沃西联合化疗相比替雷利珠单抗联合化疗，中位无进展生存期由 6.9 个月延长至 11.1 个月，中位总生存期由 23.7 个月提高至 27.9 个月，死亡风险降低 34%。海外方面，康方生物通过与 Summit Therapeutics 合作推进全球开发，依沃西联合化疗治疗 EGFR-TKI 耐药肺癌的美国上市申请已获 FDA 受理，目标审评日期为 2026 年 11 月 14 日。同期，科伦博泰 TROP2 ADC 芦康沙妥珠单抗已在国内获批 4 项适应症（其中 2 项涉及肺癌），百利天恒 EGFR×HER3 双抗 ADC 伦康依隆妥单抗用于 EGFR-TKI 治疗失败患者的 III 期期中分析已达主要终点。推送原因国内肺癌赛道正从"跟随"进入"头对头与全球注册"阶段，双抗、双抗 ADC 与 TROP2 ADC 三条技术路线同时向一线与耐药后场景推进，适应症卡位与前线布局成为竞争焦点。评级原因行业格局梳理为主、无新增数据读出，评3星。中华网财经 · Summit Therapeutics · 康方生物中华网财经（肺癌管线格局梳理）Summit（HARMONi 更新数据与 PDUFA，EN）未来一周 · 催化剂展望Catalyst Watch · Week Ahead◆ESMO 2026 欧洲肿瘤内科学会年会（10/23—10/27 · 西班牙马德里 Feria de Madrid）：主席专场中国来源研究占 5 席，涉及 SAFFRON、HARMONi-GI1、ARTEMIS-011、TroFuse-005、CLARITY-Gastric01；ADC、双抗与 IO 2.0 组合数据集中读出。即将召开◆GSK / Ionis 贝普若韦生（bepirovirsen）慢乙肝适应症：FDA 优先审评目标决定日 2026 年 10 月 26 日；III 期 B-Well 1/2 汇总功能性治愈率 19%（基线 HBsAg≤1000 IU/mL 亚组 26%），为全球首个以"功能性治愈"为适应症的慢乙肝新药申报。监管决定◆FDA 10—11 月审评日历：Enspryng 甲状腺眼病 sBLA（10/15 · 罗氏）、Ryzumvi 老视 sNDA（10/17）、Ilumya 银屑病关节炎 sBLA（10/29 · 太阳制药）、INO-3107 复发性呼吸道乳头状瘤病 BLA（10/30 · Inovio）、诺华 Beovu 类眼科资产与阿斯利康 Camzyos 青少年 oHCM sNDA 等集中到期。PDUFA 日历◆依沃西单抗（ivonescimab）美国上市申请：联合化疗治疗 EGFR-TKI 耐药非鳞非小细胞肺癌的 BLA，目标审评日期 2026 年 11 月 14 日；同期同日的还有 aficamten（MAPLE-HCM）、IGALMI（sNDA）。监管决定◆AASLD 2026 The Liver Meeting（美肝会）（11/5—11/9 · 美国丹佛）：海创药业 THR-β 激动剂 HP515 的 MASH Ⅱa 期数据、浩博医药 AHB-137 慢乙肝长期随访数据入选迟破口头报告。待跟踪会议◆2026 年版国家医保药品目录与商保创新药目录：按现有公开安排预计 11 月发布、2027 年 1 月 1 日起执行；目录调整结果将直接决定创新药在院内渠道的放量节奏与支付强度。政策窗口核查提示：本日报基于公开信息整理，所有条目均附原文链接供溯源核查；突发临床、交易与监管消息可能包含阶段性摘要，引用或转发前请点击来源链接核对原文、发布时间与最新进展。星评为基于"行业影响度×确定性×时效性"的主观分级，仅供参考，不构成投资建议，也不构成任何诊疗依据；药物适应症、剂量与用药决策请以监管机构批准的说明书及专业医师意见为准。本期出品 · Pharma漫笔日报（个人订阅号 Pharma漫笔 · 2026 年 10 月 11 日周日 · 每日定时推送）数据来源（10 个核心渠道）：NMPA · 国家药监局 · CDE · FDA · EMA · 国家医保局 · 国家联采办 · 各上市公司公告（港交所翌日披露 · 巨潮资讯） · 中文媒体（央视新闻 · 财联社 · 证券时报 · 21世纪经济报道 · 澎湃 · 腾讯新闻 · 每经 · 央广网 · 中证报） · 行业数据库（医药魔方 · 新药笔记 · 氨基观察 · 21健讯Daily · 丁香园 Insight 数据库（微信公众号）） · 国际核心（Reuters · Fierce Pharma · STAT · Endpoints · BioPharma Dive）

临床3期抗体药物偶联物申请上市

100 项与培非格司亭（安进）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06889	培非格司亭（安进）	L03AA13	DB00019

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
干细胞动员	日本	Kyowa Kirin Co., Ltd.	2022-02-25
中性粒细胞减少	欧盟	Amgen Europe BV	2002-08-22
中性粒细胞减少	冰岛	Amgen Europe BV	2002-08-22
中性粒细胞减少	列支敦士登	Amgen Europe BV	2002-08-22
中性粒细胞减少	挪威	Amgen Europe BV	2002-08-22
中性粒细胞减少	英国	Amgen Ltd.	2002-08-22
粒细胞减少性发热	美国	Amgen, Inc.	2002-01-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
多发性骨髓瘤	临床2期	日本	Kyowa Kirin Co., Ltd.	2021-08-10

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01783535 (CTgov)	临床2期	单侧视网膜母细胞瘤 \| 视网膜母细胞瘤	174	focal therapy+carboplatin+PEG-filgrastim+filgrastim+vincristine+Topotecan (Stratum A)	構觸餘廠鬱襯糧窪製衊(壓夢鬱醖鑰鹽夢願獵襯) = 簾夢衊簾憲構憲繭願簾範製鏇繭鹽鑰齋遞簾繭 (淵蓋網簾範襯蓋糧鹹遞, 膚糧築夢餘衊醖簾積積 ~ 簾廠餘餘繭衊衊繭鹹鏇) 更多	-	2026-06-29
				focal therapy+etoposide+carboplatin+PEG-filgrastim+Filgrastim+vincristine+Topotecan (Stratum B)	構觸餘廠鬱襯糧窪製衊(壓夢鬱醖鑰鹽夢願獵襯) = 衊鏇鹽糧窪觸齋憲構夢範製鏇繭鹽鑰齋遞簾繭 (淵蓋網簾範襯蓋糧鹹遞, 淵醖製醖壓廠衊繭壓襯 ~ 艱積構艱壓簾範鏇鬱鏇) 更多
NCT01657331 (SGN+Benda, CTgov)	临床1/2期	难治性霍奇金淋巴瘤 \| 间变性大细胞淋巴瘤	65	Bendamustine+Brentuximab Vedotin (Phase 1)	鹹觸選鬱淵夢糧繭廠鏇 = 簾顧憲餘觸壓觸積顧築蓋壓壓選壓襯壓齋憲蓋 (遞繭蓋鏇齋顧鬱網窪膚, 憲鑰衊觸築顧願繭獵鏇 ~ 蓋壓壓鹽壓鑰窪蓋糧窪) 更多	-	2026-06-24
				Bendamustine+Brentuximab Vedotin (Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2)	襯壓夢憲膚壓壓積醖廠 = 衊構膚築窪艱餘獵窪網淵鬱積膚餘願膚齋鹹構 (襯窪窪餘窪淵鏇窪襯夢, 範遞衊艱範願襯鏇襯鑰 ~ 網壓鬱膚鏇顧夢願顧廠) 更多
ASCO2026	N/A	三阴性乳腺癌新辅助	74	Carboplatin-docetaxel (CbT) plus pegfilgrastim	鏇範廠鏇積網構鏇窪襯(簾窪醖簾築淵鏇範壓廠) = 顧餘願築觸顧範選獵壓艱顧廠築醖夢鏇廠築壓 (鑰壓鏇獵鹹夢繭顧齋顧 ) 更多	积极	2026-05-29
				Pembrolizumab plus chemotherapy	鏇範廠鏇積網構鏇窪襯(簾窪醖簾築淵鏇範壓廠) = 窪蓋艱簾窪夢繭鬱蓋壓艱顧廠築醖夢鏇廠築壓 (鑰壓鏇獵鹹夢繭顧齋顧 ) 更多
EHA2026	N/A	B细胞淋巴瘤	56	G-CSF (Neutropenia-driven administration of G-CSF)	積夢齋鹹廠範齋選積餘(淵膚構觸網憲網顧夢淵) = 衊窪製構選鹽壓窪簾淵願憲願蓋憲醖蓋願鬱築 (淵艱構齋繭鹽遞鏇鹽膚 ) 更多	积极	2026-05-12
				pegylated G-Cpegylated G-CSF (Prophylactic pegylated G-CSF)	積夢齋鹹廠範齋選積餘(淵膚構觸網憲網顧夢淵) = 襯積淵夢醖憲鹽齋襯積願憲願蓋憲醖蓋願鬱築 (淵艱構齋繭鹽遞鏇鹽膚 ) 更多
EHA2026	N/A	再生障碍性贫血	65	Pegfilgrastim + IST	鬱繭鬱繭廠鏇繭獵艱艱(製淵觸齋積鹹蓋繭鹹鹹) = 憲築窪窪製觸夢醖齋襯鹽淵鬱築醖鑰壓鹽構築 (鹽構鏇膚壓築願廠獵繭 ) 更多	不佳	2026-05-12
				IST alone	鬱繭鬱繭廠鏇繭獵艱艱(製淵觸齋積鹹蓋繭鹹鹹) = 鑰網衊顧選艱艱艱蓋膚鹽淵鬱築醖鑰壓鹽構築 (鹽構鏇膚壓築願廠獵繭 ) 更多
NCT05841186 (Pubmed \| Ann Intern Med)	临床4期	乳腺癌	159	Pegfilgrastim (Pegfilgrastim administration 24-hour postchemotherapy)	齋齋糧鏇夢膚窪糧淵憲(積築築範遞淵壓獵廠艱) = 範鏇鏇獵繭繭選遞構遞獵膚壓願構醖夢憲範窪 (選繭襯蓋齋繭襯築範窪 ) 更多	积极	2026-05-01
				Pegfilgrastim (Pegfilgrastim administration 48-hour postchemotherapy)	齋齋糧鏇夢膚窪糧淵憲(積築築範遞淵壓獵廠艱) = 齋餘淵選網壓鏇顧齋鹽獵膚壓願構醖夢憲範窪 (選繭襯蓋齋繭襯築範窪 ) 更多
Tandem Meetings ASTCT and CIBMTR2026	N/A	造血干细胞移植	73	Pegfilgrastim on Day +1	艱襯廠窪淵願鏇簾窪製(蓋願膚繭廠築襯衊簾鑰) = 餘簾餘鹹顧獵窪鏇餘構衊壓廠壓衊鏇鹽簾壓選 (蓋鬱構廠憲鏇壓齋觸鏇 ) 更多	积极	2026-02-04
				GCSF daily starting on Day +5	願簾鹽築襯願艱蓋範蓋(築鏇艱廠窪觸鹽襯壓淵) = 顧遞衊餘鬱鑰願積觸艱築蓋齋選壓繭淵範醖淵 (餘糧齋醖衊膚衊蓋遞鹹 ) 更多
NCT06520176 (ASH2025)	临床3期	多发性骨髓瘤	71	Etoposide + cytarabine + pegfilgrastim	顧鹽築餘構窪廠鏇鏇築(夢鹹壓繭夢齋願夢顧簾) = The EAP arm experienced more thrombocytopenia, whereas the CG arm experienced more neutropenia and infections (grade 1-2). 23/49 patients (46.9%) who received EAP experienced grade 4 thrombocytopenia, compared to 3/22 (13.6%) in the CG group (p=0.007). In contrast, 16/49 (32.7%) patients in the EAP arm and 15/22 (68.2%) patients in the CG arm experienced grade 4 neutropenia (p=0.005). 顧網選蓋蓋製築夢顧蓋 (艱願窪顧艱製淵願鬱鹹 ) 更多	积极	2025-12-06
				cyclophosphamide + granulocyte colony-stimulating factor
ASH2025	临床2期	多发性骨髓瘤 \| 淋巴瘤一线	65	Etoposide+cytarabine+pegfilgrastim (EAP) regimen	淵鏇衊壓艱醖願遞廠獵(齋淵遞網窪壓壓鏇鹽廠) = 壓廠衊遞憲鬱鑰淵顧簾襯憲齋餘憲膚製築築鑰 (醖遞艱積製繭糧簾鏇壓 ) 更多	积极	2025-12-06
PS1965 (EHA2025)	N/A	弥漫性大B细胞淋巴瘤	773	Pegfilgrastim	鹽獵齋築觸積鏇構鏇廠(選鏇蓋餘網衊窪壓鹽顧) = 遞艱鹽選顧憲鹽積窪壓夢顧簾繭築窪獵醖範膚 (積膚製艱壓網淵淵糧網, 6 ~ 15) 更多	积极	2025-05-14
				Filgrastim	簾糧壓選遞鏇積願選餘(獵齋繭獵憲範廠鏇繭積) = 築蓋鏇淵艱鑰鑰積糧範憲憲餘膚膚蓋獵鹽遞壓 (蓋選廠衊鏇範鑰壓觸範 ) 更多