NANT 2021-02: A Randomized Phase 2 Study of 131I-MIBG With Vorinostat VS. 131I-MIBG With Dinutuximab vs. 131I-MIBG With Dinutuximab and Vorinostat for Relapsed or Refractory Neuroblastoma

Patients will then be randomized at study entry to one of three treatment arms. Patients on Arm A will receive a single treatment course with 131I-MIBG with vorinostat. Patients on Arm B will receive a single treatment course with 131I-MIBG and dinutuximab. Patients on Arm C will receive a single treatment course with 131I-MIBG with dinutuximab + vorinostat. After this course of treatment, we will check to see your response and then check to see how you are doing over time. All patients may choose to proceed to a second course of the same treatment if they and their physician feel healthy enough to do so. Approximately 118 patients will be receiving therapy on this trial.

开始日期2026-07-31

申办/合作机构

New Approaches to Neuroblastoma Therapy

[+2]

NCT06995872

/ Recruiting临床1期IIT

Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma

Background:
Neuroblastoma is a type of cancer that causes tumors in nerves. It affects mainly infants and toddlers, and it causes about 15 percent of cancer-related deaths in children.
Objective:
To test a new drug (rhIL-15), combined with 3 standard cancer drugs, in people with neuroblastoma.
Eligibility:
People aged 3 to 35 years with neuroblastoma that did not respond or returned after standard treatment.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of their heart and lungs. They will have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle.
Participants will be treated in 21-day cycles. They may have up to 4 treatment cycles.
rhIL-15 is given through a needle into a vein over 5 to 7 days during the first week of each cycle. Participants will stay in the hospital while they are receiving the rhIL-15.
Starting in the second week of the second cycle, participants will receive other drugs for treating cancer. They will have no study treatments during the third week of each cycle.
Participants will visit the clinic at least 2 times a week throughout all 4 treatment cycles. They will have a physical exam and blood tests during these visits. Imaging scans, bone marrow biopsy, and other tests will be repeated at the end of cycles 2 and 4.
Participants will have a follow-up visit 6 months after treatment ends. This visit will include a physical exam with blood and urine tests.

开始日期2025-10-21

申办/合作机构

National Cancer Institute

NCT06450041

/ Recruiting临床2期IIT

Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.

开始日期2024-12-16

申办/合作机构

United Therapeutics Corp.

[+1]

100 项与 Dinutuximab 相关的临床结果

登录后查看更多信息

100 项与 Dinutuximab 相关的转化医学

登录后查看更多信息

100 项与 Dinutuximab 相关的专利（医药）

登录后查看更多信息

168

项与 Dinutuximab 相关的文献（医药）

2026-01-15·CANCER

A pilot study of chemoimmunotherapy in the postconsolidation setting for high‐risk neuroblastoma (ANBL19P1): A report from the Children’s Oncology Group

Article

作者: Mariel Trunzo DNP ; Brian LaBarre MS ; Lisa States MD ; Rochelle Bagatell MD ; Kelly C. Goldsmith MD ; Sean G. Green PharmD ; Julie R. Park MD ; Lulu Chen MS ; Steven G. DuBois MD ; Ami V. Desai MD, MSCE ; Meaghan P. Granger MD ; Wendy Fitzgerald CRNP ; Araz Marachelian MD, MS ; Arlene Naranjo PhD

Abstract:

Background:

Survival for patients with high‐risk neuroblastoma remains poor despite current‐era multimodality treatment that includes postconsolidation GD2‐directed immunotherapy. Given the promising responses in patients who receive dinutuximab‐based chemoimmunotherapy in the relapsed setting, the Children’s Oncology Group ANBL19P1 study evaluated the feasibility of administering irinotecan, temozolomide, dinutuximab, and sargramostim after frontline consolidation with tandem autologous stem cell transplantation (ASCT).

Methods:

Patients with high‐risk neuroblastoma who received induction therapy followed by tandem ASCT and had no evidence of progressive disease (PD) were eligible. Treatment included five 28‐day cycles of temozolomide and irinotecan (days 1–5), dinutuximab (days 2–5), and sargramostim (days 6–12). Isotretinoin (days 8–21) was given during cycles 1–6. Therapy was deemed feasible if the 95% confidence interval placed on the percentage of patients that completed five cycles of chemoimmunotherapy without PD within 30 weeks contained 75% in the absence of excessive toxicity. Event‐free survival and overall survival were determined from the time of enrollment.

Results:

Forty eligible patients enrolled, and 35 (87.5%; 95% confidence interval, 73.9%–94.5%) completed five cycles without PD within 30 weeks, meeting the feasibility threshold. No unacceptable toxicities occurred on protocol therapy, including no toxic deaths. Five patients discontinued therapy early because of physician determination ( n = 2), patient/parent refusal of further therapy ( n = 2), and PD ( n = 1). The 2‐year event‐free and overall survival rates were 82.5% ± 6.1% and 92.5% ± 4.2%, respectively.

Conclusions:

The administration of chemoimmunotherapy in the postconsolidation setting after tandem ASCT is feasible and tolerable. Future studies will be needed to define the population most likely to benefit from this augmented postconsolidation therapy.

2025-11-01·APPLIED RADIATION AND ISOTOPES

Automated zirconium-89 and lutetium-177 antibody labeling and formulation using a Trasis MiniAIO module

Article

作者: van der Wildt, Berend ; Vlaswinkel, Carlijn A ; Koorn, Nathalie J ; Poot, Alex J ; Spoormans, Stijn A

INTRODUCTION:

Radiolabeled antibodies are used to select the right treatment for the right patient by determining antigen expression levels in vivo. In addition, antibodies labeled with therapeutic nuclides can be used for cancer treatment. To efficiently produce these labeled antibodies in constant high quality, automated procedures are desired. This research describes the labeling and formulation of zirconium-89 and lutetium-177 labeled Dinutuximab on the Trasis MiniAIO module, as proof-of-principle antibody to be used for GD2 imaging and therapy in neuroblastoma patients.

METHODS:

Dinutuximab was modified for labeling with a DFO- or DOTA-chelator using isothiocyanate chemistry. Radiolabeling with zirconium-89 and lutetium-177 and subsequent purification and formulation were performed using the Trasis MiniAIO and compared to manual synthesis procedures. Radiochemical purity was assessed by iTLC and HPLC. Immunoreactivity was evaluated using a radioligand binding assay on antigen coated wells.

RESULTS:

Radiolabeled products were obtained with good radiochemical yield of 76 ± 8 % for [⁸⁹Zr]Dinutuximab 70 ± 8 % for [¹⁷⁷Lu]Dinutuximab. Immunoreactivity was >50 % for zirconium-89 and lutetium-177 labeled constructs, which was similar to immunoreactivity of products obtained by manual synthesis. Manually obtained radiochemical yields were somewhat higher as a result of residual radioactivity in valves and tubings in automated synthesis runs, however losses were minimized through incorporation of several washing steps. Generally, yields were comparable with previously reported automation procedures and importantly, satisfactory for human application.

CONCLUSION:

We have developed a reproducible and high-yielding automated method for the synthesis and formulation of radiolabeled diagnostic and therapeutic antibodies on a Trasis MiniAIO module. This method should assist in obtaining labeled products with consistent quality while simultaneously reducing the workers radiation dose.

2025-08-01·JOURNAL OF CLINICAL ONCOLOGY

Phase I Study of ¹³¹ I-Metaiodobenzylguanidine With Dinutuximab ± Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A New Approaches to Neuroblastoma Therapy Trial

Article

作者: Cash, Thomas ; Vo, Kieuhoa T. ; Weiss, Brian D. ; Shahi, Ankita ; Mosse, Yael P. ; DuBois, Steven G. ; Villablanca, Judith G. ; Baregamyan, Anahit ; Zaborek, Jen ; Kennedy, Eleanor ; Goodarzian, Fariba ; Erbe, Amy K. ; Marachelian, Araz ; Groshen, Susan G. ; Granger, Meaghan ; Asgharzadeh, Shahab ; Sondel, Paul M. ; Park, Julie R. ; Jonus, Hunter C. ; Pawel, Bruce ; Shamirian, Anasheh ; Macy, Margaret E. ; Pinto, Navin ; Desai, Ami V. ; Matthay, Katherine K. ; Goldsmith, Kelly C. ; Crowley, Mary ; Chi, Yueh-Yun ; Acharya, Patricia T.

PURPOSE:

We conducted a phase I trial to determine the safety, tolerability, and preliminary antitumor activity of 131 I-metaiodobenzylguanidine (MIBG) combined with the anti-GD2 antibody dinutuximab with or without the histone deacetylase inhibitor vorinostat in patients with relapsed/refractory neuroblastoma (rNBL).

METHODS:

In part A, patients with MIBG-avid rNBL received MIBG intravenously (IV) on day 1 at 12, 15, or 18 mCi/kg per the rolling six design and dinutuximab (17.5 mg/m 2 once daily) IV on days 8-11 and 29-32 and granulocyte-macrophage colony-stimulating factor (250 mcg/m 2 once daily) subcutaneously on days 8-17 and 29-38. Autologous stem cells were infused on day 15. In part B, vorinostat at 180 mg/m 2 once daily was given orally on days 0-13 in combination with the part A recommended phase II dose (RP2D). Patients could receive two courses.

RESULTS:

Forty-five eligible patients enrolled, of whom 31 were evaluable. The median age was 7.5 (range, 2.9-24.1) years. For part A (n = 19), no dose-limiting toxicities (DLTs) occurred across all dose levels and courses, establishing the RP2D of MIBG to be 18 mCi/kg. In part B (n = 12), 1 DLT (grade 3 hypokalemia) occurred during course 1, and 3 of 11 patients who received a second course experienced DLT: grade 3 ALT increase, grade 4 hypoxia and grade 5 pneumonitis, and grade 3 fatigue. The best overall response rate (BORR; complete response [CR] + partial response [PR]) on part A was 42% with a CR/PR/minor response (MR) rate of 46%, and 19% progressive disease (PD) rate. For part B, the BORR was 42% with a CR/PR/MR rate of 75% and 0% PD rate.

CONCLUSION:

MIBG combined with dinutuximab was well tolerated with encouraging antitumor activity. Vorinostat added to this combination may augment responses in this heavily pretreated patient population.

项与 Dinutuximab 相关的新闻（医药）

2025-10-29

·Business Wire

United Therapeutics Corporation Reports Record Third Quarter 2025 Financial Results

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced record financial results for the quarter ended September 30, 2025, driven by continued year-over-year revenue growth in key products such as Tyvaso® and Orenitram®. Total revenues in the third quarter of 2025 grew seven percent year-over-year to $799.5 million, compared to $748.9 million in the third quarter of 2024. "Our commercial and clinical teams continue to deliver record results, validating our strategic objectives," said Martine Rothblatt, Chairperson and Chief Executive Officer of United Therapeutics. "The breakthrough results from our TETON-2 study in idiopathic pulmonary fibrosis could significantly broaden our therapeutic reach and accelerate our growth." Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, "This quarter we again achieved record total revenue and continued our double-digit growth for Tyvaso, reflecting a clear indication of the growing demand for our products. With laser focus and fierce determination, we are confident in our ability to sustain our growth trajectory." Third Quarter 2025 Financial Results Key financial highlights include (dollars in millions, except per share data): Three Months Ended September 30, Dollar Percentage 2025 2024 Change Change Total revenues $ 799.5 $ 748.9 $ 50.6 7 % Net income $ 338.7 $ 309.1 $ 29.6 10 % Net income, per basic share $ 7.73 $ 6.93 $ 0.80 12 % Net income, per diluted share $ 7.16 $ 6.39 $ 0.77 12 % Revenues The table below presents the components of total revenues (dollars in millions): Three Months Ended September 30, Dollar Percentage 2025 2024 Change Change Net product sales: Tyvaso DPI®(1) $ 336.2 $ 274.6 $ 61.6 22 % Nebulized Tyvaso®(1) 141.8 159.2 (17.4 ) (11 )% Total Tyvaso 478.0 433.8 44.2 10 % Remodulin®(2) 125.9 128.3 (2.4 ) (2 )% Orenitram® 131.1 113.2 17.9 16 % Unituxin® 47.9 61.1 (13.2 ) (22 )% Adcirca® 9.7 7.0 2.7 39 % Other 6.9 5.5 1.4 25 % Total revenues $ 799.5 $ 748.9 $ 50.6 7 % (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity® Pump and the RemunityPRO™ Pump. Total Tyvaso revenues grew by 10 percent to $478.0 million in the third quarter of 2025, compared to $433.8 million in the third quarter of 2024. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $58.1 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net revenue deductions. The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product’s launch and, to a lesser extent, increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act (IRA). The decrease in Nebulized Tyvaso revenues resulted primarily from higher gross-to-net revenue deductions and a decrease in quantities sold. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $11.7 million and, to a lesser extent, a price increase. The increase in quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. The decrease in Unituxin revenues resulted primarily from a decrease in quantities sold, partially offset by a price increase. The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions): Three Months Ended September 30, 2025 2024 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI(1) $ 336.2 $ — $ 336.2 $ 274.6 $ — $ 274.6 Nebulized Tyvaso(1) 133.9 7.9 141.8 145.2 14.0 159.2 Total Tyvaso 470.1 7.9 478.0 419.8 14.0 433.8 Remodulin(2) 110.7 15.2 125.9 115.4 12.9 128.3 Orenitram 131.1 — 131.1 113.2 — 113.2 Unituxin 46.5 1.4 47.9 57.6 3.5 61.1 Adcirca 9.7 — 9.7 7.0 — 7.0 Other 6.7 0.2 6.9 4.3 1.2 5.5 Total revenues $ 774.8 $ 24.7 $ 799.5 $ 717.3 $ 31.6 $ 748.9 (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity Pump and the RemunityPRO Pump. Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions): Three Months Ended September 30, Dollar Percentage 2025 2024 Change Change Category: Cost of sales $ 100.0 $ 81.8 $ 18.2 22 % Share-based compensation expense(1) 0.9 1.3 (0.4 ) (31 )% Total cost of sales $ 100.9 $ 83.1 $ 17.8 21 % (1) See Share-based compensation below. Cost of sales, excluding share-based compensation. Cost of sales for the three months ended September 30, 2025 increased as compared to the same period in 2024, primarily due to increases in: (1) royalty expense resulting from a growth in revenues; and (2) inventory reserve expense. Research and development. The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Three Months Ended September 30, Dollar Percentage 2025 2024 Change Change Category: External research and development(1) $ 63.5 $ 51.7 $ 11.8 23 % Internal research and development(2) 50.8 43.9 6.9 16 % Share-based compensation expense(3) 8.4 7.4 1.0 14 % Other(4) 4.8 0.5 4.3 860 % Total research and development expense $ 127.5 $ 103.5 $ 24.0 23 % (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before regulatory approval of the relevant product. (2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before regulatory approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-based compensation below. (4) Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations. Research and development, excluding share-based compensation. Research and development expense for the three months ended September 30, 2025 increased as compared to the same period in 2024, primarily due to: (1) increased expenditures related to manufactured organ and organ alternative projects; and (2) a $5.0 million milestone payment for drug delivery technologies. Selling, general, and administrative. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Three Months Ended September 30, Dollar Percentage 2025 2024 Change Change Category: General and administrative(1) $ 123.7 $ 100.4 $ 23.3 23 % Litigation accrual 0.8 65.1 (64.3 ) (99 )% Sales and marketing 28.3 20.7 7.6 37 % Share-based compensation expense(2) 29.8 33.0 (3.2 ) (10 )% Total selling, general, and administrative expense $ 182.6 $ 219.2 $ (36.6 ) (17 )% (1) Excluding litigation accrual. See Litigation accrual section below. (2) See Share-based compensation below. General and administrative, excluding litigation accrual and share-based compensation. General and administrative expense for the three months ended September 30, 2025 increased as compared to the same period in 2024, primarily due to increases in: (1) personnel expense due to growth in headcount; (2) legal expenses related to litigation matters; and (3) branded prescription drug fee expense associated with sales of Tyvaso DPI. Litigation accrual. In the third quarter of 2024, we accrued a liability of $65.1 million related to ongoing litigation with Sandoz Inc. This liability was $73.3 million as of September 30, 2025. We currently do not expect that the amount of any loss in excess of this accrual would be material to our financial results; however, the amount ultimately payable, if any, could be higher or lower than this amount depending on the amount of post judgment interest and the outcome of appeals. The litigation accrual is included within selling, general, and administrative in our consolidated statements of operations. Sales and marketing, excluding share-based compensation. Sales and marketing expense for the three months ended September 30, 2025 increased as compared to the same period in 2024, primarily due to increases in: (1) marketing expense; (2) personnel expense due to growth in headcount; and (3) sales commissions. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): Three Months Ended September 30, Dollar Percentage 2025 2024 Change Change Category: Stock options $ 11.3 $ 8.0 $ 3.3 41 % Restricted stock units 27.1 27.2 (0.1 ) — % Share tracking awards plan — 5.9 (5.9 ) (100 )% Employee stock purchase plan 0.7 0.6 0.1 17 % Total share-based compensation expense $ 39.1 $ 41.7 $ (2.6 ) (6 )% Income tax expense. Income tax expense for the three months ended September 30, 2025 and 2024 was $99.3 million and $79.5 million, respectively. Our effective income tax rate (ETR) for the three months ended September 30, 2025 and 2024 was 23 percent and 20 percent, respectively. Our ETR for the three months ended September 30, 2025 increased compared to our ETR for the three months ended September 30, 2024, primarily due to year-over-year changes in actual and forecasted annual pre-tax earnings. Share Repurchase. We entered into accelerated share repurchase agreements (ASR agreements) with Citibank, N.A. to repurchase approximately $1.0 billion of our common stock in each of August 2025 and March 2024 ($2.0 billion in the aggregate). During the three months ended September 30, 2025 and September 30, 2024, we received deliveries of 2,638,616 shares and 90,403 shares, respectively, under these ASR agreements. Webcast We will host a webcast to discuss our third quarter 2025 financial results on Wednesday, October 29, 2025, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. An investor presentation is available now, and after the webcast a replay of the webcast will also be available, at the same location on our website. United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun; we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. You can learn more about what it means to be a PBC here: unither.com/pbc. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to the TETON 2 study in idiopathic pulmonary fibrosis, including the opportunity to significantly broaden our therapeutic reach and accelerate our growth; our confidence in our ability to sustain our revenue growth trajectory; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of October 29, 2025, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation. REMUNITYPRO is a trademark of United Therapeutics Corporation. ADCIRCA is a registered trademark of Eli Lilly and Company. UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) Three Months Ended September 30, 2025 2024 (Unaudited) Total revenues $ 799.5 $ 748.9 Operating expenses: Cost of sales 100.9 83.1 Research and development 127.5 103.5 Selling, general, and administrative 182.6 219.2 Total operating expenses 411.0 405.8 Operating income 388.5 343.1 Interest income 46.4 49.8 Interest expense (3.0 ) (10.1 ) Other income, net 6.1 5.8 Total other income, net 49.5 45.5 Income before income taxes 438.0 388.6 Income tax expense (99.3 ) (79.5 ) Net income $ 338.7 $ 309.1 Net income per common share: Basic $ 7.73 $ 6.93 Diluted $ 7.16 $ 6.39 Weighted average number of common shares outstanding: Basic 43.8 44.6 Diluted 47.3 48.4 SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited, in millions) September 30, 2025 Cash, cash equivalents, and marketable investments $ 4,334.9 Total assets 7,351.1 Total liabilities 760.9 Total stockholders’ equity 6,590.2 Category: Earnings

财报

2025-08-09

·生物制药进展杂评

核药小公司Y-mAbs，4亿美元卖身，技术平台的花样~

近日，全球特种制药公司SERB Pharmaceuticals宣布完成对抗癌药企Y-mAbs Therapeutics的全面收购，交易总价值达4.12亿美元。此次收购以全现金形式进行。 Y-mAbs 看名字就是跟抗体相关，主要做核药~目前有一个上市产品—— DANYELZA® （那昔妥单抗，naxitamab）是一款单抗产品，靶点为GD2，用于治疗神经母细胞瘤。 GD2靶点上市产品： GD2（二唾液酸神经节苷脂）是神经外胚层起源的肿瘤细胞表达的一种表面抗原，在多种癌症实体的细胞表面过表达，是癌症免疫治疗的合理靶点，达妥西单抗（dinutuximab）和那昔妥单抗（naxitamab）已获FDA批准用于治疗高危NB的维持治疗。达妥西单抗因表达系统不同又有两个产品Dinutuximab beta（CHO细胞表达）和Naxitamab（hu3F8）。 naxitamab和Dinutuximab beta在国内已经上市，没有看到全球销售数据，在国内2022和2021年上市，到2024年国内销售分别在1.4和 2.6以人民币左右， Naxitamab2024年全球销量大约在2.4亿美元。其他在研产品如下：进度最快还是GD2靶点的核药Radiopharmaceuticals Pipeline 主要技术平台——SADA PRIT Technology Platform，(SADA，Self-Assembly DisAssembly； PRIT ，Pre-Targeted Radioimmunotherapy) 分子结构是个四具体，如下：每个单体（~70kDa）各部分功能如下：进入体内发挥作用，有两步：第一步结合到肿瘤上，看示意图至少会有两个结合位点结合上去，这样就增加了靶向性，减少器官脱靶~ 没结合上的四聚体药物粉丝会分离成单体，然后代谢~ 第二步：就是核素分子发挥作用了~ 没有看到太具体的技术细节~ 但是理解下来，通过四聚体或者叫做四抗，提高结合能力，避免脱靶，这是主要的核心点。这点和双抗ADC有异曲同工之处~ 最后一下问题：GD2的在研产品中CART产品比较多大概有26个进入临床研究的产品，抗体药物只有8个。

并购抗体药物偶联物免疫疗法上市批准引进/卖出

2025-07-30

·Business Wire

United Therapeutics Corporation Reports Record Second Quarter 2025 Financial Results

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced record financial results for the quarter ended June 30, 2025, driven by continued double-digit year-over-year revenue growth in key products such as Tyvaso DPI, Nebulized Tyvaso, Orenitram, and Unituxin. Total revenues in the second quarter of 2025 grew 12 percent year-over-year to a record $798.6 million, compared to $714.9 million in the second quarter of 2024. “Our second quarter yet again produced record-setting results driven by the strength of our foundational commercial business,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “We continue to believe there is no other biotech company like ours that provides this combination of sales growth and operating cash flow with near- to medium-term catalysts positioned for sustained long-term growth, starting with data from the TETON 2 study of nebulized treprostinil in idiopathic pulmonary fibrosis expected in September that could fundamentally improve options for patients with this progressive, deadly disease with few treatments available. “Equally, our strong financial position, confidence in these upcoming catalysts, and belief in our share price potential has led our Board of Directors to authorize up to $1 billion in share repurchases, affirming our commitment to a robust and balanced capital allocation philosophy.” Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, “We’re proud of the continued record performance for Tyvaso DPI, a best-in-class treprostinil dry powder inhaler that allows the flexibility of one breath per cartridge, four times a day, with low inspiratory effort. Further, no other commercially available treprostinil dry powder inhaler has been clinically studied with published data at higher doses1,2 or prescribed by more physicians to more patients than Tyvaso DPI. “We expect continued double digit revenue growth for Tyvaso and total revenues well into the future through strong commercial execution of our existing product portfolio coupled with the potential for our late-stage pipeline in pulmonary fibrosis and pulmonary hypertension.” ________________________________ 1 Spikes, L. A., et al. (2024, October). Long-term outcomes and dosing in the BREEZE study optional extension phase. CHEST, 166(4, Suppl), A6061–A6063. https://doi.org/10.1016/j.chest.2024.06.3583 2 Burger, C.D., et al. Exploratory Efficacy Analysis of INSPIRE Open-Label Extension Study With Inhaled Treprostinil (YUTREPIA™). American Thoracic Society International Conference 2023. https://liquidia.com/static-files/d5275811-d1af-4ac5-80d4-9bb4b7262d74 Second Quarter 2025 Financial Results Key financial highlights include (dollars in millions, except per share data): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Total revenues $ 798.6 $ 714.9 $ 83.7 12 % Net income $ 309.5 $ 278.1 $ 31.4 11 % Net income, per basic share $ 6.86 $ 6.26 $ 0.60 10 % Net income, per diluted share $ 6.41 $ 5.85 $ 0.56 10 % Revenues The table below presents the components of total revenues (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Net product sales: Tyvaso DPI®(1) $ 315.2 $ 258.3 $ 56.9 22 % Nebulized Tyvaso®(1) 154.4 139.9 14.5 10 % Total Tyvaso 469.6 398.2 71.4 18 % Remodulin®(2) 134.7 147.3 (12.6 ) (9 )% Orenitram® 123.9 107.1 16.8 16 % Unituxin® 58.4 51.7 6.7 13 % Adcirca® 6.5 5.7 0.8 14 % Other 5.5 4.9 0.6 12 % Total revenues $ 798.6 $ 714.9 $ 83.7 12 % (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity® Pump. Total Tyvaso revenues grew by 18 percent to $469.6 million in the second quarter of 2025, compared to $398.2 million in the second quarter of 2024. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $54.6 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net revenue deductions. The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product’s launch, including growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act (IRA). The growth in Nebulized Tyvaso revenues resulted primarily from an increase in quantities sold and, to a lesser extent, a price increase. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $10.6 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net revenue deductions. The increase in quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions): Three Months Ended June 30, 2025 2024 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI(1) $ 314.8 $ 0.4 $ 315.2 $ 258.3 $ — $ 258.3 Nebulized Tyvaso(1) 140.5 13.9 154.4 130.2 9.7 139.9 Total Tyvaso 455.3 14.3 469.6 388.5 9.7 398.2 Remodulin(2) 113.7 21.0 134.7 122.5 24.8 147.3 Orenitram 123.9 — 123.9 107.1 — 107.1 Unituxin 55.4 3.0 58.4 46.8 4.9 51.7 Adcirca 6.5 — 6.5 5.7 — 5.7 Other 5.0 0.5 5.5 4.6 0.3 4.9 Total revenues $ 759.8 $ 38.8 $ 798.6 $ 675.2 $ 39.7 $ 714.9 (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity Pump. Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: Cost of sales $ 86.6 $ 75.9 $ 10.7 14 % Share-based compensation expense(1) 1.0 1.9 (0.9 ) (47 )% Total cost of sales $ 87.6 $ 77.8 $ 9.8 13 % (1) See Share-based compensation below. Cost of sales, excluding share-based compensation. Cost of sales for the three months ended June 30, 2025 increased as compared to the same period in 2024, primarily due to an increase in: (1) royalty expense resulting from a growth in revenues; and (2) reserve expense resulting from increased production. Research and development. The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: External research and development(1) $ 62.4 $ 49.4 $ 13.0 26 % Internal research and development(2) 55.9 44.5 11.4 26 % Share-based compensation expense(3) 8.1 8.6 (0.5 ) (6 )% Other(4) 7.6 37.1 (29.5 ) (80 )% Total research and development expense $ 134.0 $ 139.6 $ (5.6 ) (4 )% (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product. (2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-based compensation below. (4) Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations. Research and development, excluding share-based compensation. Research and development expense for the three months ended June 30, 2025 decreased as compared to the same period in 2024, primarily due to $36.0 million in upfront non-refundable license payments for drug delivery device technologies in 2024, partially offset by: (1) increased expenditures in 2025 related to manufactured organ and organ alternative projects; and (2) a $5.0 million milestone payment made in 2025 for drug delivery device technologies. Selling, general, and administrative. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: General and administrative(1) $ 131.1 $ 113.0 $ 18.1 16 % Impairment of property, plant, and equipment (PP&E) 21.7 — 21.7 NM(2) Sales and marketing 31.0 25.4 5.6 22 % Share-based compensation expense(3) 28.7 39.2 (10.5 ) (27 )% Total selling, general, and administrative expense $ 212.5 $ 177.6 $ 34.9 20 % (1) Excluding impairment of PP&E. See Impairment of PP&E section below. (2) Calculation is not meaningful. (3) See Share-based compensation below. General and administrative, excluding impairment of PP&E and share-based compensation. General and administrative expense for the three months ended June 30, 2025 increased as compared to the same period in 2024, primarily due to: (1) personnel expense due to growth in headcount; and (2) legal expenses related to litigation matters. Impairment of PP&E. During the three months ended June 30, 2025, we recorded a $21.7 million impairment charge to write down the carrying value of certain PP&E. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: Stock options $ 11.1 $ 8.1 $ 3.0 37 % Restricted stock units 26.0 19.2 6.8 35 % Share tracking awards plan (STAP) — 21.9 (21.9 ) (100 )% Employee stock purchase plan 0.7 0.5 0.2 40 % Total share-based compensation expense $ 37.8 $ 49.7 $ (11.9 ) (24 )% The decrease in share-based compensation expense for the three months ended June 30, 2025, as compared to the same period in 2024, was primarily due to a decrease in STAP expense, as all remaining STAP awards were exercised during the first quarter of 2025. Income tax expense. Income tax expense for the three months ended June 30, 2025 and 2024 was $98.9 million and $77.2 million, respectively. Our effective income tax rate (ETR) for the three months ended June 30, 2025 and 2024 was 24 percent and 22 percent, respectively. Our ETR for the three months ended June 30, 2025 increased compared to our ETR for the three months ended June 30, 2024, primarily due to a decrease in excess tax benefits from share-based compensation. Webcast We will host a webcast to discuss our second quarter 2025 financial results on Wednesday, July 30, 2025, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. An investor presentation is available now, and after the webcast a replay of the webcast will also be available, at the same location on our website. United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun; we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. You can learn more about what it means to be a PBC here: unither.com/pbc. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our share repurchase program, the anticipated timing and outcome of the TETON 2 and TETON 1 clinical trials of Nebulized Tyvaso in idiopathic pulmonary fibrosis, including potential for these studies to improve options for patients with this disease; the anticipated readout of the ADVANCE OUTCOMES clinical trial of ralinepag; our near- to medium-term catalysts positioned for sustained long-term growth; our expectation of continued double digit revenue growth for Tyvaso and total revenues well into the future through strong commercial execution of our existing product portfolio coupled with the potential for our late-stage pipeline in pulmonary fibrosis and pulmonary hypertension; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of July 30, 2025, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries. ADCIRCA is a registered trademark of Eli Lilly and Company. UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) Three Months Ended June 30, 2025 2024 (Unaudited) Total revenues $ 798.6 $ 714.9 Operating expenses: Cost of sales 87.6 77.8 Research and development 134.0 139.6 Selling, general, and administrative 212.5 177.6 Total operating expenses 434.1 395.0 Operating income 364.5 319.9 Interest income 51.3 46.2 Interest expense (7.3 ) (11.6 ) Other (expense) income, net (0.1 ) 0.8 Total other income, net 43.9 35.4 Income before income taxes 408.4 355.3 Income tax expense (98.9 ) (77.2 ) Net income $ 309.5 $ 278.1 Net income per common share: Basic $ 6.86 $ 6.26 Diluted $ 6.41 $ 5.85 Weighted average number of common shares outstanding: Basic 45.1 44.4 Diluted 48.3 47.5 SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited, in millions) June 30, 2025 Cash, cash equivalents, and marketable investments $ 4,966.4 Total assets 7,908.0 Total liabilities 734.4 Total stockholders’ equity 7,173.6 Category: Earnings

财报

100 项与 Dinutuximab 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10559	Dinutuximab	L01XC	DB09077

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
神经母细胞瘤	美国	United Therapeutics Corp.	2015-03-10

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
神经节成神经细胞瘤	临床3期	美国	National Cancer Institute	2024-04-19
神经节成神经细胞瘤	临床3期	澳大利亚	National Cancer Institute	2024-04-19
神经节成神经细胞瘤	临床3期	加拿大	National Cancer Institute	2024-04-19
神经节成神经细胞瘤	临床3期	新西兰	National Cancer Institute	2024-04-19
难治性小细胞肺癌	临床3期	美国	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	澳大利亚	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	保加利亚	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	加拿大	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	法国	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	中国香港	United Therapeutics Corp.	2017-06-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04751383 (CTgov)	临床1期	复发性骨肉瘤 \| 复发性神经母细胞瘤 \| 难治性神经母细胞瘤 ... 更多	12	Magrolimab (Arm A: Magrolimab 30 mg/kg)	願醖願夢襯廠夢鑰鏇醖 = 顧壓鏇壓遞鏇蓋繭鹽艱積範壓淵鬱憲網繭餘網 (構構簾膚遞遞鏇顧顧齋, 廠鑰壓選構網夢壓醖衊 ~ 顧願壓鏇選淵築醖餘蓋) 更多	-	2026-01-21
NCT04751383 (CTgov)	临床1期	复发性骨肉瘤 \| 复发性神经母细胞瘤 \| 难治性神经母细胞瘤 ... 更多	12	Magrolimab (Arm A: Magrolimab 20 mg/kg)	願醖願夢襯廠夢鑰鏇醖 = 構觸獵願顧憲繭憲選築積範壓淵鬱憲網繭餘網 (構構簾膚遞遞鏇顧顧齋, 艱網壓艱構積夢鑰窪齋 ~ 鹽觸齋齋選鹽齋繭鹽遞) 更多	-	2026-01-21
NCT03794349 (Phase 1 study \| ANBL1821, CTgov)	临床2期	复发性神经母细胞瘤 \| 难治性神经母细胞瘤 \| 高风险神经母细胞瘤	94	Dinutuximab+Temozolomide+Sargramostim+Irinotecan Hydrochloride (Regimen A (Chemotherapy, Dinutuximab, Sargramostim))	積艱壓鏇淵衊顧糧齋選 = 願簾願壓蓋艱淵襯醖鹽齋製淵製顧構廠網壓積 (鹹鏇範廠襯築壓鏇憲憲, 遞製淵範鏇積積築廠鏇 ~ 觸選壓構窪淵觸鏇製襯) 更多	-	2026-01-21
NCT03794349 (Phase 1 study \| ANBL1821, CTgov)	临床2期	复发性神经母细胞瘤 \| 难治性神经母细胞瘤 \| 高风险神经母细胞瘤	94	Dinutuximab+Temozolomide+Sargramostim+Irinotecan Hydrochloride+Eflornithine Hydrochloride (Regimen B (Eflornithine, Chemotherapy, Dinutuximab))	積艱壓鏇淵衊顧糧齋選 = 簾餘淵製築範夢構積鹹齋製淵製顧構廠網壓積 (鹹鏇範廠襯築壓鏇憲憲, 廠獵顧築顧鏇遞遞構築 ~ 願淵顧鬱糧淵蓋鑰範廠) 更多	-	2026-01-21
NCT03332667 (CTgov)	临床1期	难治性神经母细胞瘤	45	131I-MIBG+potassium iodide+Dinutuximab+Sargramostim (Cohort A DL1)	艱獵範醖願鏇齋構網遞 = 鹽築衊選簾糧齋構構顧醖鬱鬱艱廠願淵夢獵築 (簾鑰繭鹹觸壓衊糧觸鬱, 構願憲簾選顧鏇衊積繭 ~ 積夢壓齋蓋選窪網膚糧) 更多	-	2025-04-16
NCT03332667 (CTgov)	临床1期	难治性神经母细胞瘤	45	131I-MIBG+potassium iodide+Dinutuximab+Sargramostim (Cohort A DL2)	艱獵範醖願鏇齋構網遞 = 鹹鏇齋鬱淵醖選鏇顧憲醖鬱鬱艱廠願淵夢獵築 (簾鑰繭鹹觸壓衊糧觸鬱, 鬱窪築壓糧願廠衊網齋 ~ 餘餘獵鑰鹹鑰構範鹽築) 更多	-	2025-04-16
NCT04385277 (ANBL19P1, CTgov)	临床2期	神经节成神经细胞瘤	41	FDG-Positron Emission Tomography+Iobenguane I-123+Dinutuximab+Temozolomide+Isotretinoin+Sargramostim+Irinotecan	糧構齋醖壓觸襯顧鬱選 = 壓膚淵鬱糧壓壓鹽壓夢糧範願憲淵構鹹醖鬱鹹 (獵襯範構齋製衊製獵鹹, 選鹽淵淵構醖艱鏇餘積 ~ 壓壓築艱製襯獵艱製積) 更多	-	2024-08-14
ASCO2024 人工标引	N/A	高风险神经母细胞瘤	1,393	Dinutuximab	築襯鬱壓餘鹹窪襯壓艱(憲醖簾窪築獵淵鬱餘淵): RR = 0.41 (95% CI, 0.22 ~ 0.75), P-Value = 0.004 更多	积极	2024-05-24
ASCO2024 人工标引	N/A	高风险神经母细胞瘤	1,393	Other therapies		积极	2024-05-24
NCT04385277 (ANBL19P1, ASCO2024)	临床2期	高风险神经母细胞瘤巩固 GD2 antibody	40	Temozolomide and irinotecan	選膚窪糧鏇鹽鹹蓋構選(觸淵夢繭遞糧齋襯蓋簾) = 願蓋構築餘襯衊範願顧蓋糧壓範艱鏇夢蓋積遞 (艱鬱憲鏇願顧鬱構願衊, 5.0) 更多	积极	2024-05-24
ASCO2024	N/A	高风险神经母细胞瘤 anti-disialoganglioside (GD2)	2,214	Dinutuximab	獵簾醖築鑰積艱鹹繭積(糧憲糧積鏇齋鏇憲餘鑰) = 蓋網廠鬱衊選網製鬱醖壓齋餘簾遞膚憲憲鬱壓 (鬱獵餘鹽觸鹹壓鑰網蓋, 0.52 ~ 0.69) 更多	积极	2024-05-24
NCT03786783 (ANBL17P1, CTgov)	临床2期	高风险神经母细胞瘤 \| 神经节成神经细胞瘤	42	External Beam Radiation Therapy+Etoposide+Carboplatin+Doxorubicin+Isotretinoin+Sargramostim+Topotecan+Dexrazoxane+Dinutuximab+Cyclophosphamide+Melphalan+cisplatin+Vincristine+Thiotepa	壓壓獵餘廠襯構醖鏇醖 = 構築蓋齋繭鏇鹽廠鹽窪膚遞簾餘膚繭顧鬱鑰餘 (膚遞鏇壓積顧淵淵蓋鏇, 壓糧範壓膚壓觸糧構遞 ~ 積積衊遞遞鹽網糧夢顧) 更多	-	2023-03-14
NCT01767194 (ANBL1221, Pubmed)	临床2期	难治性神经母细胞瘤 KIR/KIR-ligand genotypes \| Fc gamma receptors \| NCR3 ... 更多	-	Irinotecan and temozolomide (I/T) + anti-GD2 antibody dinutuximab (DIN) and granulocyte macrophage colony stimulating factory (GM-CSF)	淵餘壓鏇遞憲製選齋鬱(窪獵顧繭鬱膚窪鏇顧獵) = 鹽繭觸簾簾膚製鹹鹽淵繭蓋鏇構選獵膚鹽廠選 (醖蓋網網構齋願簾壓繭 )	-	2023-02-01
NCT00026312 (ANBL0032, Pubmed \| J Clin Oncol)	临床3期	神经母细胞瘤巩固	-	Postconsolidation immunotherapy including dinutuximab, granulocyte-macrophage colony-stimulating factor, and interleukin-2	餘淵窪窪夢蓋齋膚淵網(願鬱餘遞鹽蓋積夢夢鏇) = 壓繭醖構憲鹽積鹽製鑰窪膚構獵願憲築窪觸網 (膚範願淵顧餘膚餘夢艱 ) 更多	-	2022-12-10