This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.

开始日期2025-04-28

申办/合作机构

National Cancer Institute

NCT06022939 / Recruiting临床3期IIT

A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloidosis

This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis.

开始日期2024-07-01

申办/合作机构

National Cancer Institute

NCT05995626 / Recruiting早期临床1期IIT

Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia

Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previously reported for the treatment of scleroderma-induced microstomia. By using this laser technique, the investigator can reduce the pain of typical hyaluronidase injections and reap the therapeutic benefit of the laser treatment itself. The investigator's goal is to create greater mouth mobility for chewing and speaking as well as improved oral hygiene, self-esteem, and overall quality of life. Each participant will undergo three separate laser sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three months after the last laser session to evaluate the response.

开始日期2024-03-01

申办/合作机构

University of Nebraska

100 项与透明质酸酶（绵羊）相关的临床结果

登录后查看更多信息

100 项与透明质酸酶（绵羊）相关的转化医学

登录后查看更多信息

100 项与透明质酸酶（绵羊）相关的专利（医药）

登录后查看更多信息

4,370

项与透明质酸酶（绵羊）相关的文献（医药）

2024-02-01·International journal of biological macromolecules

Engineering biomimetic scaffolds by combining silk protein nanofibrils and hyaluronic acid

Article

作者: Zhang, Qiang ; Zhu, Lin ; Gao, Zixin ; Li, Xiufang ; Zhou, Shunshun ; Wang, Si ; You, Renchuan

Nanofibrous scaffolds mimicking important features of the native extracellular matrix (ECM) provide a promising strategy for tissue regeneration. However, 3D scaffolds mimicking natural protein nanofibers and bioactive glycosaminoglycans remain poorly developed. In this study, a biomimetic nanofibrous scaffold composed of natural silk protein nanofibers and glycosaminoglycan hyaluronic acid (HA) was developed. HA functionalization significantly improved the hydrophilicity and bioactivity of silk nanofibers (SNFs). SNFs can be assembled into nanofibrous aerogel scaffolds with low density and desirable shapes on a large scale. More importantly, with the assistance of HA, the silk nanofibrous aerogel scaffolds with ultra-high porosity, natural bioactivity, and structural stability in aqueous environment can be fabricated. In the protease/hyaluronidase solution, the SNF scaffolds with 10.0 % HA can maintain their monolithic shape for >3 weeks. The silk nanofibrous scaffolds not only imitate the composition of ECM but also mimic the hierarchical structure of ECM, providing a favorable microenvironment for cell adhesion and proliferation. These results indicate that this structurally and functionally biomimetic system is a promising tissue engineering scaffold.

2024-02-01·Theriogenology

The strong anti-hyaluronidase effect of ellagic acid markedly decreases polyspermy during in vitro fertilization, resulting in sustainment of the developmental potency in porcine oocytes

Review

作者: Yamanaka, Kenichi ; Hirai, Moe ; Tatemoto, Hideki ; Nagahama, Ayari ; Kawasaki, Kokoro ; Ishiki, Yuki ; Konno, Toshihiro

The present study investigated the effects of ellagic acid, a type of polyphenol that does not have a glycan and is composed of four hydroxyl groups and two lactone functional groups, on porcine in vitro fertilization (IVF) by focusing on its anti-hyaluronidase activity. A comparative analysis of ellagic acid and apigenin, which is commonly used as a hyaluronidase inhibitor, was performed. It compared the effects of ellagic acid and apigenin on hyaluronidase activity at different concentrations. The results showed that 10, 20, and 40 μM ellagic acid strongly reduced hyaluronidase activity (P < 0.05). The addition of 20 μM ellagic acid, but not apigenin, to porcine IVF medium effectively reduced polyspermy without decreasing sperm penetration or the formation rates of male pronuclei in cumulus-free oocytes. However, neither ellagic acid nor apigenin affected the number of sperm that bound to zona pellucida (ZP) or the induction of zona hardening and protease resistance. The percentage of acrosome-reacting sperm that bound to the ZP was markedly lower in the presence of 20 μM ellagic acid than in the untreated and apigenin-treated groups, even though the antioxidant capacity of ellagic acid was weaker than that of apigenin. Furthermore, a markedly higher percentage of embryos developed to the blastocyst stage in the ellagic acid-treated group, and the apoptotic indexes of expanded blastocysts produced by the ellagic acid treatment during IVF were significantly low. Therefore, the anti-hyaluronidase effect of ellagic acid markedly suppressed the induction of the acrosome reaction in sperm that bound to the ZP, resulting in a marked decrease in polyspermy under conditions that maintained high sperm penetrability during IVF and sustainment of the developmental potency in porcine oocytes.

2024-02-01·Journal of cosmetic dermatology

Nonsurgical rhinoplasty using the hyaluronic acid filler VYC‐25L: Safety and patient satisfaction in a retrospective analysis of 492 patients

Article

作者: Jalali, Arash

Abstract:

Background:

Aesthetic treatment of the nose with hyaluronic acid (HA) fillers is increasingly popular but carries a small risk of major complications. Large patient cohorts are required to better understand this risk.

Aims:

To evaluate safety and patient satisfaction in a large series of nonsurgical rhinoplasty treatments with the HA filler, VYC‐25L, in “real world” clinical practice.

Methods:

This was a retrospective analysis of consecutive adult patients undergoing nonsurgical rhinoplasty with VYC‐25L by a single injector between January 2020 and July 2022. All patients received initial treatment (typically ~0.3–0.5 mL of filler) and touch‐up at 4–6 weeks (~0.1–0.3 mL). Safety data were collected throughout a mean follow‐up of 11.1 months. Patient satisfaction was assessed using the FACE‐Q Satisfaction with Nose and Satisfaction with Outcome questionnaires.

Results:

A total of 492 patients were included (984 treatment sessions including touch‐ups). Of these, 467 (94.9%) were female and the mean age was 30.0 years. All treatments were associated with early transient edema; other adverse events included bruising (n = 123; 25%), residual asymmetry (n = 18; 3.7%), and suspected localized vascular occlusion (n = 3; 0.6%). The latter cases were easily resolved with hyaluronidase injection plus oral steroid and aspirin. No patients experienced infection, necrosis, blindness, lumps, granuloma, or delayed‐onset nodules. Mean Rasch‐transformed FACE‐Q scores were 90.2% for Satisfaction with Nose and 99.2% for Satisfaction with Outcome.

Conclusions:

In a large cohort of patients treated in routine practice based on a systematic approach, nonsurgical rhinoplasty with VYC‐25L was safe and effective.

项与透明质酸酶（绵羊）相关的新闻（医药）

2024-09-19

·GlobeNewswire-Health Care

argenx Announces Publication in The Lancet Neurology of Pivotal ADHERE Study Data in Chronic Inflammatory Demyelinating Polyneuropathy

ADHERE was largest and most innovative clinical trial of CIDP patients to date VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrated reduction in disease progression, reduced risk of relapse and rapid onset of action VYVGART Hytrulo is first and only neonatal Fc receptor (FcRn) blocker FDA-approved to treat CIDP September 19, 2024 – 7:00 am CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced publication in The Lancet Neurology of the pivotal ADHERE Study, the largest clinical trial to date in chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. This is the first time the ADHERE Study has been published in a peer-reviewed medical journal. A link to the full manuscript can be found here. “Since its approval in June, VYVGART Hytrulo is already transforming the lives of patients with CIDP,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “With today’s publication in The Lancet Neurology, we are also advancing scientific knowledge of the disease biology underlying CIDP and thereby helping to progress further innovation with the potential, like VYVGART Hytrulo, to significantly improve function for patients while easing the burdens associated with prior treatments.” Highlights from the ADHERE study: ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo69% (221/322) of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength99% of trial participants elected to participate in the ADHERE open-label extensionVYVGART Hytrulo was well-tolerated and safety results were consistent with the known safety profile of VYVGART in previous clinical studies and real-world use The ADHERE data demonstrate that VYVGART Hytrulo has a rapid onset of action, and can reduce CIDP disease progression and risk of relapse: Reduced risk of relapse: VYVGART Hytrulo reduced the risk of relapse by 61% as assessed by aINCAT deterioration (Stage B primary endpoint) versus placebo (HR 0.394 [95% CI 0.253–0.614]; p<0.0001).Reduced disease progression: VYVGART Hytrulo reduced the risk of CIDP disease progression based on time-to-first ≥4-point decrease in I-RODS score compared with Stage B baseline (HR 0.537 [95% CI 0.354–0.814]; nominal p=0.0034).Rapid onset of action: In Stage A, time to first improvement on aINCAT, I-RODS, or grip strength scores among the 25th percentile of patients was 9.0 days (95% CI 8.0-9.0) after the first dose of VYVGART Hytrulo; the median estimate was 22.0 days (15.0-23.0). In June 2024, the U.S. Food and Drug Administration approved VYVGART Hytrulo for the treatment of adult patients with CIDP. VYVGART Hytrulo is also approved for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. See FDA-approved Important Safety Information below and full Prescribing Information for VYVGART Hytrulo for additional information. What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). IMPORTANT SAFETY INFORMATIONDo not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART HYTRULO may cause serious side effects, including:Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab. Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART HYTRULO, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.What are the common side effects of VYVGART HYTRULO? The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About ADHERE Trial Design The ADHERE trial was a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled 322 adult patients with CIDP who were treatment naïve (not on active treatment within the past six months or newly diagnosed) or being treated with immunoglobulin therapy or corticosteroids. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and in order to be eligible for Stage A had to demonstrate active disease, with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment naïve patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) with VYVGART Hytrulo. ECI was achieved through improvement of the INCAT score, or improvement on I-RODS or mean grip strength if those scales had demonstrated worsening during the run-in period. In Stage B, patients were randomized to either VYVGART Hytrulo or placebo for up to 48 weeks. The primary endpoint was measured once 88 total relapses or events were achieved in Stage B and was based on the hazard ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an open-label extension study to receive VYVGART Hytrulo. About VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection. About Chronic Inflammatory Demyelinating Polyneuropathy Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person’s ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. There are approximately 24,000 patients in the U.S. currently receiving treatment for CIDP. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. Contacts Media: Ben Petokbpetok@argenx.com Investors: Alexandra Roy (US)aroy@argenx.com Lynn Elton (EU)lelton@argenx.com

上市批准临床结果临床研究免疫疗法

2024-09-15

·CPHI制药在线

首款国产IL-4Rα单抗获批上市；大冢制药第三代Bcr-Abl抑制剂泊那替尼获批上市 | 制药在线一周药闻复盘

点击蓝字关注我们本周，主要有两个大热点，一个就是两个创新药获批上市，另一个就是2024年欧洲肿瘤内科学会（ESMO）年会召开，不少重磅药公布了最新进展。下面我们来详细看一下：先看审评审批方面，大冢制药第三代Bcr-Abl抑制剂泊那替尼获批上市以及首款国产IL-4Rα单抗获批上市；再来看研发方面，多个重磅药公布了最新研究进展，康方生物/正大天晴一线治疗肝癌数据积极以及度普利尤单抗两项Ⅲ期研究成功；最后看交易及投融资方面，宝济药业就一款融合蛋白新药与欧加隆达成合作，首付款1200万美元。本周盘点包括审评审批、研发、交易及投融资三大板块，统计时间为9.9-9.14，包含34条信息。审评审批 NMPA 上市批准 1、9月9日，NMPA官网显示，大冢制药的泊那替尼片（ponatinib）获批上市，用于：1）既往用药耐药或不耐受的慢性髓性白血病（CML）；2）复发或难治性费城染色体阳性（Ph+）急性淋巴细胞白血病（ALL）；3）T315I阳性慢性髓性白血病（CML）或T315I阳性费城染色体阳性（Ph+）急性淋巴细胞白血病（ALL）。该药是一款克服T315I突变的第三代Bcr-Abl抑制剂。 2、9月9日，NMPA官网显示，Revance Therapeutics和复星医药联合申报的注射用A型肉毒毒素获批上市，用于暂时性改善成人因皱眉肌/或降眉间肌活动引起的中度至重度皱眉纹。这是复星医药超8000万美元引进的一款新一代A型肉毒素产品（代号为RT002），美国FDA已批准其用于治疗成人的中度至重度眉间纹，这款疗法有望只需每年注射两次就可以维持常年除皱。 3、9月9日，NMPA官网显示，圣和药业1类新药甲磺酸瑞厄替尼片（商品名：圣瑞沙）第二项适应症获批，用于表皮生长因子受体（EGFR）敏感突变的局部晚期或转移性非小细胞肺癌（NSCLC）患者的一线治疗。瑞厄替尼是圣和药业自主研发的第三代EGFR-TKI，此前该产品已于2024年6月获批。 4、9月12日，NMPA官网显示，康诺亚的司普奇拜单抗（商品名：康悦达）获批上市，用于治疗成人中重度特应性皮炎。司普奇拜单抗成为首款获批上市的国产IL-4Rα单抗。目前，国内除了司普奇拜单抗，还有度普利尤单抗（赛诺菲/再生元）和司普奇拜单抗两款IL-4Rα单抗获批上市。此外，还有8款IL-4Rα单抗处于Ⅲ期阶段，来自恒瑞医药、正大天晴、康方生物等药企。申请 5、9月12日，CDE官网显示，罗氏（Roche）的利司扑兰片（risdiplam）申报上市。利司扑兰是罗氏的一款神经罕见病创新药物，用于治疗脊髓性肌萎缩症（SMA），该药物的口服溶液剂型已在中国获批上市，此次上市申请的剂型为片剂。 6、9月13日，CDE官网显示，恒瑞医药1类新药注射用瑞康曲妥珠单抗（研发代号：SHR-A1811）申报上市，用于既往接受过至少一种系统治疗的局部晚期或转移性HER2突变成人非小细胞肺癌患者的治疗。该产品是恒瑞医药自主研发的、以HER2为靶点的抗体药物偶联物（ADC），拟用于HER2表达或突变的晚期实体瘤的治疗。临床批准 7、9月9日，CDE官网显示，阿斯利康1类新药AZD0780薄膜衣片获批临床，拟用于在标准治疗基础上低密度脂蛋白胆固醇（LDL-C）未达标的患者中进行血脂异常的治疗。AZD0780是一种口服PCSK9小分子抑制剂。 8、9月9日，CDE官网显示，正大天晴1类新药TQC3721吸入粉雾剂获批临床，拟开发用于慢性阻塞性肺病（COPD）患者的维持治疗。TQC3721是一款PDE3/4双重抑制剂。此前正大天晴开发了吸入用TQC3721混悬液剂型，目前正在中国开展治疗中重度COPD的Ⅱ期临床研究。 9、9月9日，CDE官网显示，融捷康1类新药RJK-RT2831注射液获批临床，拟开发治疗恶性血液肿瘤。RJK-RT2831注射液为靶向恶性血液肿瘤细胞表面特异性抗原的双特异性纳米抗体药物，在非临床研究中显示出了优秀的安全性和药效。该产品此前已经在美国获批临床。 10、9月10日，CDE官网显示，神州细胞1类新药SCTB35注射液获批临床，适应症为B细胞介导的自身免疫性疾病。SCTB35是神州细胞自主研发的一款CD20xCD3双特异性抗体。此前，该产品已经获批一项临床，用于治疗复发/难治性CD20阳性B细胞非霍奇金淋巴瘤。 11、9月10日，CDE官网显示，海擘生物1类新药注射用NC527-X获批临床，拟作为荧光造影剂用于实体瘤术中辅助识别恶性病变。这是其开发的近红外荧光肿瘤精准成像药物，它被设计为靶向低氧通路，有望成为全瘤种术中成像产品。 12、9月10日，CDE官网显示，君实生物抗PD-1单抗特瑞普利单抗注射液获批临床，拟联合西妥昔单抗用于复发或转移性头颈部鳞状细胞癌的一线治疗。截至目前，特瑞普利单抗已在中国内地获批10项适应症，涵盖黑色素瘤、鼻咽癌、尿路上皮癌、食管鳞癌、非小细胞肺癌、肾细胞癌、小细胞肺癌、三阴性乳腺癌。 13、9月11日，CDE官网显示，轶诺药业1类新药ENC0653软膏获批多项临床，针对适应症包括特应性皮炎和银屑病。ENC0653软膏是一款小分子化药。轶诺药业聚焦免疫及代谢并发症，正在针对免疫调节中的关键节点研发新型的抑制剂，用于自身免疫及慢性炎症性疾病的治疗。 14、9月12日，CDE官网显示，晶锐医药1类新药JRD-018片获批临床，拟开发治疗晚期恶性肿瘤。JRD-018是一款可入脑的BET抑制剂，能有效抑制c-Myc基因表达，达到抑制肿瘤生长疗效。该产品此前已经获美国FDA批准开展Ⅰ期临床研究。 15、9月13日，CDE官网显示，康诺亚生物1类新药CM380获批临床，拟开发治疗复发或难治性多发性骨髓瘤。CM380是一种GPRC5DxCD3双特异性抗体，可同时靶向识别并特异性结合多发性骨髓瘤细胞表面的GPRC5D，以及T细胞表面CD3受体，将免疫T细胞招募至靶细胞周围，诱导T细胞介导的肿瘤细胞杀伤（TDCC）作用杀伤骨髓瘤细胞。 16、9月13日，CDE官网显示，诺诚健华1类新药ICP-248片获批两项临床试验，拟联合阿扎胞苷治疗急性髓系白血病。ICP-248是诺诚健华在研的一款新型口服高选择性BCL2抑制剂。ICP-248可激活内源性线粒体凋亡通路，从而导致癌细胞迅速凋亡，发挥抗肿瘤作用。 17、9月13日，CDE官网显示，辉瑞（Pfizer）1类新药PF-06821497片获批两项临床试验，适应症为：拟联合恩扎卢胺用于未使用过针对转移性前列腺癌的新型内分泌治疗或化疗的转移性去势抵抗性前列腺癌男性患者的治疗。PF-06821497是一款在研的EZH2抑制剂。 18、9月14日，CDE官网显示，时迈药业1类新药注射用CMDE005获批临床，拟开发治疗EGFR阳性晚期实体瘤。这是该公司研发的重组人源抗EGFR-CD3酶控双特异性抗体，采用“遮蔽肽”封闭CD3结合活性。申请 19、9月10日，CDE官网显示，百济神州1类新药BGB-58067片申报临床，预测用于治疗实体瘤。BGB-58067是一款PRMT5抑制剂，为百济神州实体瘤在研产品，预计于2024年进入临床研究阶段，这是该产品首次在中国申报临床。突破性疗法 20、9月9日，CDE官网显示，海思科1类新药HSK31858片拟纳入突破性疗法，适应症为非囊性纤维化支气管扩张。HSK31858属于一种口服、强效和高选择性的二肽基肽酶1（DipeptidylPeptidase1,DPP1）小分子抑制剂，正处于Ⅱ临床研究阶段。 21、9月11日，CDE官网显示，天境生物1类新药普那利单抗注射液拟纳入突破性疗法，适应症为复发难治性风湿性疾病相关噬血细胞性淋巴组织细胞增多症（R/R MAS）。普那利单抗注射液（plonmarlimab，又称TJM2）是一款抗人粒细胞巨噬细胞集落刺激因子（GM-CSF）的中和抗体。 FDA 上市批准 22、9月11日，FDA官网显示，强生的古塞奇尤单抗（商品名：Tremfya）补充生物制品许可申请（sBLA）获批，用于治疗中重度活动性溃疡性结肠炎（UC）成人患者。古塞奇尤单抗是一款白介素-23（IL-23）抑制剂，2017年7月，古塞奇尤单抗率先在美国获批上市，用于治疗中重度斑块状银屑病。2019年，古塞奇尤单抗进入中国市场。 23、9月13日，FDA官网显示，罗氏旗下基因泰克的阿替利珠单抗皮下制剂获批上市，适用于阿替利珠单抗在美国获准用于成人的所有静脉注射适应症，包括某些类型的肺癌、肝癌、皮肤癌和软组织癌。这是美国地区首个也是唯一一个用于皮下注射的PD-(L)1抑制剂。 24、9月14日，FDA官网显示，罗氏的ocrelizumab&hyaluronidase（商品名：OcrevusZunovo）皮下制剂获批上市，用于治疗复发性多发性硬化（RMS）和原发性进展型多发性硬化（PPMS）。OcrevusZunovo是首个获批用于治疗RMS和PPMS的皮下制剂，该药物每年仅需注射两次，每次注射时间仅需10分钟。Ocrevus是一种人源化单克隆抗体，旨在靶向CD20阳性B细胞，2023年7月在国内申报上市。研发临床状态 25、9月11日，药物临床试验登记与信息公示平台显示，康方生物启动了AK112（依沃西单抗）联合AK117（莱法利单抗）对比帕博利珠单抗（K药）治疗头颈部鳞状细胞癌的头对头Ⅲ期研究。这是首个在实体瘤中探索CD47药物疗效的Ⅲ期研究。AK112是一款同时靶向PD-1和VEGF-A的IgG1亚型人源化双抗，AK117是新一代抗CD47的人源化IgG4亚型单抗。 26、9月13日，药物临床试验登记与信息公示平台显示，恒瑞子公司山东盛迪医药启动了一项在二甲双胍治疗后血糖控制不佳的成人2型糖尿病受试者中评价HRS-7535与达格列净相比的有效性和安全性的随机、双盲、Ⅲ期研究。这是首个进入Ⅲ期临床的国产小分子GLP-1R激动剂，进度仅次于礼来的小分子GLP-1R激动剂orforglipron。临床数据 27、9月10日，普米斯生物公布了双特异性抗体PM8002/BNT327联合化疗治疗EGFR突变非小细胞肺癌（NSCLC）的Ⅱ临床结果，结果显示，截至2024年4月12日，64例患者接受了PD-L1 TPS检测，所有患者均可进行安全性和有效性评估。总体ORR为54.7%，DCR为95.3%。在PD-L1 TPS<1%组，ORR为35.7%，DCR为92.9%；在TPS 1%~49%组，ORR为56.5%，DCR为100%；在TPS≥50%组，ORR为92.3%，DCR为92.3%。 28、9月10日，优卡迪生物（Unicar-Therapy）公布了ssCART-19治疗难治/复发急性淋巴细胞白血病（包括中枢神经系统白血病）的最新临床结果。疗效数据显示，在可评估疗效的患者(n=16)中，3个月内的ORR达到87.5%，完全缓解（CR）率为62.5%，完全缓解伴血液学不完全恢复（CRi）率为25.0%。DL1、DL2和DL3的6个月中位缓解持续时间（DOR）比例分别为100.0%、80.0%和0.0%。其中7例患者持续缓解6个月以上。此外，在ssCART-19输注前发生2级中枢神经系统浸润的患者没有发生ICANS，并且在ssCART-19治疗后持续缓解。 29、9月11日，赛诺菲宣布，度普利尤单抗（Dupilumab、商品名：Dupixent）治疗大疱性类天疱疮（BP）的Ⅱ/Ⅲ期ADEPT研究和治疗慢性自发性荨麻疹（CSU）的Ⅲ期LIBERTY-CUPID研究C部分均取得了积极结果。这也是BP领域第一款在后期研究中取得积极进展的生物制剂。度普利尤单抗是一种全人源IL-4Rα单克隆抗体。 30、9月13日，华东医药与誉颜制药合作的注射用重组A型肉毒毒素YY001治疗中、重度眉间纹适应症的Ⅲ期临床研究（代号YY001-001）完成，数据显示，YY001在大规模人群的Ⅲ期临床试验中表现出与已完成的Ⅰ/Ⅱ期临床结果的高度一致性；其有效性、安全性和免疫原性都达到了既定的临床试验终点，与对照药相比表现优异。YY001是由誉颜制药自主研发的注射用重组A型肉毒毒素，华东医药拥有YY001在中国大陆、香港、澳门医美适应症领域的独家商业化权益。 31、9月13日，康方生物和正大天晴公布了抗PD-1抗体派安普利单抗联合安罗替尼一线治疗晚期肝细胞癌的Ⅲ期研究结果，数据显示，在对PFS进行最终分析时（数据截至2023年6月5日），相比于索拉非尼组，安罗替尼+派安普利单抗的中位PFS显著改善（6.9个月vs2.8个月）；在对OS的中期分析中(数据截止日期:2024年1月29日)，相比于索拉非尼组，安罗替尼+派安普利单抗的中位OS显著延长（16.5个月vs13.2个月）。 32、9月13日，齐鲁制药公布了PD-1/CTLA-4双抗QL1706（艾帕洛利单抗/托沃瑞利单抗）一线治疗晚期肝细胞癌的Ⅱ/Ⅲ研究结果，数据显示，截至数据截止(2024年7月12日)，中位随访时间为6.7个月。ORR和DCR见上表。此时无进展生存期（PFS）尚不成熟。上述4组患者6个月PFS分别为78.5%、64.3%、53.8%和50.3%。4组患者中≥3级治疗相关不良事件发生率分别为46.7%、50.0%、46.7%和37.9%。。交易及投融资 33、9月12日，赛诺菲宣布，与RadioMedix和OranoGroup子公司OranoMed就开发AlphaMedix达成许可协议。AlphaMedix是一种靶向生长激素抑制素受体（SSTR）的α粒子激发的多肽偶联核素药物。根据协议，赛诺菲将负责AlphaMedix的全球商业化，而OranoMed将负责AlphaMedix的生产。RadioMedix和OranoMed将获得1亿欧元（约1.09亿美元）的预付款和高达2.2亿欧元（约2.39亿美元）的销售里程碑付款，并有资格获得分层特许权使用费。 34、9月12日，宝济药业及其全资子公司晟济药业宣布，与欧加隆就SJ02达成供应和转让协议，欧加隆中国将获得SJ02在中国大陆的独家商业化权益。根据协议，宝济药业及其全资子公司晟济药业将获1200万美元的首付款，并将根据商业化进程等获得额外款项。SJ02是由宝济药业全资子公司晟济药业自主研发的一款长效重组人促卵泡激素-CTP融合蛋白注射液（FSH-CTP），正处于中国上市申请阶段。 END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

上市批准临床3期优先审批

2024-09-14

·GlobeNewswire-Health Care

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous(IV) Tecentriq1,2 New subcutaneous (SC) option reduces treatment time to approximately seven minutes, compared with 30-60 minutes for IV infusion2 13 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).2 It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer. “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients faster and in more accessible settings.” “This approval represents a significant option to improve the patient experience,” said Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation. “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option." The FDA approval is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.1,2 The Phase II IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab, and the most common reasons were less time in the clinic, increased comfort during treatment and reduced emotional distress.4 4 out of 5 patients (79%) chose Tecentriq Hybreza to continue their treatment, after experiencing both formulations.4 Developing new formulations of our medicines is part of our commitment to improve the patient experience and support people living with different illnesses at every step of their treatment journey. With Tecentriq Hybreza and Roche’s 13 other subcutaneous therapies – available across various diseases – we offer additional administration options to meet the diverse preferences of patients. The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (outside the U.S. marketed as Tecentriq SC).5 Regulatory reviews in other countries and regions are ongoing. IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of Tecentriq Hybreza, compared with Tecentriq IV, in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The study enrolled 371 patients. The study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve. Efficacy, as measured by the objective response rate, progression-free survival, overall survival and duration of response, was similar between the SC and IV treatment arms and consistent with the known profile of Tecentriq IV. The safety profile of Tecentriq Hybreza was also consistent with that of Tecentriq IV.1,2 IMscin002 is a Phase II, global crossover study evaluating patient preference between the SC and IV formulations of Tecentriq. The study enrolled 179 patients, including people with PD-L1- positive resected Stage II-IIIB NSCLC who have completed adjuvant platinum-based chemo- therapy without evidence of disease recurrence, and untreated patients with PD-L1-high Stage IV NSCLC. The study met its primary endpoint, showing that 71% of participants preferred the SC formulation (21% preferred IV and 8% stated no preference); 79% opted for Tecentriq Hybreza to complete their treatment, after experiencing both formulations of Tecentriq. The study confirmed that switching between Tecentriq Hybreza and Tecentriq IV was well tolerated, with no new safety signals.4 Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream. Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS). In addition to intravenous infusion, Tecentriq has been approved as a subcutaneous formulation in 50 countries (outside the U.S. marketed as Tecentriq SC). The approved indications for Tecentriq Hybreza and Tecentriq SC mirror those of Tecentriq IV. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link. Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34(8):693-702. [2] Burotto M, et al. IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity and patient-reported outcomes (PROs) from the randomised Phase III study comparing atezolizumab (atezo) subcutaneous (SC) vs intravenous (IV) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at ESMO 2023 Congress. Poster #1447P, on display 23 October 2023. [3] FDA - U.S. Food and Drug Administration. Tecentriq: highlights of prescribing information. Last updated April 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf. Accessed July 2024. [4] Cappuzzo F, et al. Primary results from IMscin002: A study to evaluate patient- and healthcare professional reported preferences for atezolizumab subcutaneous vs intravenous for the treatment of NSCLC. Presented at ELCC on 21 March 2024. Abstract 244MO. [5] Roche. Roche’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes. Last updated 29 August 2024. https://www.roche.com/media/releases/med-cor-2023-08-29b. Accessed July 2024. The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法上市批准

100 项与透明质酸酶（绵羊）相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D04455	-	-	DB00070

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
尿道疾病	美国	Bausch & Lomb, Inc.	2004-05-05

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
疼痛	临床3期	美国	Bausch & Lomb, Inc.	2004-10-01
糖尿病性视网膜病变	临床3期	美国	Bausch & Lomb, Inc.	1998-11-01
糖尿病性视网膜病变	临床3期	加拿大	Bausch & Lomb, Inc.	1998-11-01
糖尿病性视网膜病变	临床3期	墨西哥	Bausch & Lomb, Inc.	1998-11-01
玻璃体积血	临床3期	美国	Bausch & Lomb, Inc.	1998-11-01
玻璃体积血	临床3期	加拿大	Bausch & Lomb, Inc.	1998-11-01
玻璃体积血	临床3期	墨西哥	Bausch & Lomb, Inc.	1998-11-01
非增殖性糖尿病视网膜病变	临床2期	美国	Bausch & Lomb, Inc.	2005-07-01
玻璃体脱离	临床2期	美国	Bausch & Lomb, Inc.	2005-07-01
药物过敏反应	临床1期	美国	Bausch & Lomb, Inc.	2004-03-01

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


WCD2023	N/A	瘢痕疙瘩	100	Triamcinolone acetonide + 5-fluorouracil	壓糧窪顧繭衊衊鏇繭鏇(窪鹽艱顧鑰顧範艱鹹觸) = 憲獵餘蓋壓淵醖顧觸鹹鑰艱範艱衊築範簾遞鹽 (壓壓廠構襯築鏇蓋鬱夢 ) 更多	-	2023-07-04
				Triamcinolone acetonide + 5-fluorouracil + Hyaluronidase	壓糧窪顧繭衊衊鏇繭鏇(窪鹽艱顧鑰顧範艱鹹觸) = 選鏇遞鹹鹽醖鬱鬱憲遞鑰艱範艱衊築範簾遞鹽 (壓壓廠構襯築鏇蓋鬱夢 )
WCD2023	N/A	瘢痕疙瘩	16	Intralesional injections of 5-FU, betamethasone, hyaluronidase	膚醖網淵憲簾鬱繭觸壓(鏇蓋遞願網顧襯積築壓) = 廠鏇鹽襯繭製鑰餘網艱憲艱齋膚膚願鑰蓋網夢 (廠壓憲餘窪積範壓襯艱 )	积极	2023-07-03
ARVO2018	N/A	-	12	Hyaluronidase (HYAL) 1000U/eye	鏇繭鑰簾觸齋憲壓獵簾(鬱鑰獵壓鹽窪鏇窪鹹醖) = 壓鹽鹽膚餘觸鹹網觸憲衊鹹築鬱鬱獵構製壓窪 (襯鑰餘壓觸觸繭壓衊夢 ) 更多	-	2018-07-01
				BSS (vehicle)	鏇繭鑰簾觸齋憲壓獵簾(鬱鑰獵壓鹽窪鏇窪鹹醖) = 顧築範獵鑰築鏇積糧鹽衊鹹築鬱鬱獵構製壓窪 (襯鑰餘壓觸觸繭壓衊夢 ) 更多
EULAR2010	N/A	关节积水	-	Hyaluronidase	鏇顧繭製鏇積壓鬱繭鏇(壓艱憲鹽選觸夢窪廠鑰) = 鏇夢餘鏇齋衊衊觸鹹構壓觸觸襯願鏇廠廠獵積 (襯廠觸積築鏇夢齋製蓋 )	-	2010-06-16
ARVO2009	N/A	-	-	Vitrase	顧夢鬱膚壓膚構鬱選醖(淵蓋積艱醖膚鹽膚築顧) = 積衊壓製糧獵繭遞窪艱鏇壓憲鬱淵醖獵醖憲艱 (築鬱網築網艱簾遞鹹觸 )	积极	2009-04-01
				Vitrase-lidocaine	顧夢鬱膚壓膚構鬱選醖(淵蓋積艱醖膚鹽膚築顧) = 繭選鹹蓋顧糧繭顧獵膚鏇壓憲鬱淵醖獵醖憲艱 (築鬱網築網艱簾遞鹹觸 )
ARVO2007	N/A	-	-	Plasmin + Hyaluronidase	壓鬱艱顧艱壓網築淵顧(遞獵齋餘製鑰鹹構鑰憲) = 鏇醖夢鹹鹽選壓願襯壓願簾衊艱淵獵衊餘廠鏇 (構淵築繭網糧遞顧網願 ) 更多	-	2007-05-01
				Plasmin	壓鬱艱顧艱壓網築淵顧(遞獵齋餘製鑰鹹構鑰憲) = 網鬱積鏇醖製顧願襯鬱願簾衊艱淵獵衊餘廠鏇 (構淵築繭網糧遞顧網願 ) 更多
ARVO2007	N/A	-	-	Vitrase (hyaluronidase injection) Ovine 200 USP units/mL	網糧網齋觸鏇繭鑰鹽窪(淵齋蓋構顧網網蓋範艱) = 鬱憲廠遞壓憲築範窪餘鏇獵簾範衊願鏇遞築鏇 (觸糧鑰醖廠壓觸壓築憲 )	-	2007-05-01
				Amphadase (hyaluronidase injection) Bovine 150 USP units/mL	網糧網齋觸鏇繭鑰鹽窪(淵齋蓋構顧網網蓋範艱) = 壓鑰遞襯築醖鏇夢築憲鏇獵簾範衊願鏇遞築鏇 (觸糧鑰醖廠壓觸壓築憲 )
ARVO2006	N/A	-	-	Vitrase	繭夢窪糧膚構繭製廠壓(鏇願獵憲鏇鬱餘鹽製艱) = 廠願構壓網選齋簾積鑰餘製網鑰製淵蓋衊蓋鹹 (築鹽膚艱窪選壓鏇艱廠 )	-	2006-05-01
ARVO2004	临床3期	玻璃体积血	742	Vitrase 7.5 IU	淵顧範壓鑰醖襯衊蓋艱(遞壓繭淵糧壓鏇鹹淵鑰) = 艱淵鏇簾餘遞範憲淵獵蓋鹽衊製積顧衊鏇廠遞 (蓋艱鹽衊餘網範顧築獵 )	-	2004-05-01
				Vitrase 55 IU	膚簾觸齋餘壓壓醖齋夢(膚齋觸鏇顧築襯壓製艱) = 觸鹹夢繭選壓簾積簾艱蓋壓鏇鏇願遞鹹襯夢鹹 (網鹹鹽鏇衊選壓獵窪獵 ) 更多
ARVO2003	临床3期	玻璃体积血	-	Vitrase 7.5 IU	遞憲製觸範餘製襯鬱鬱(遞顧簾範顧選鑰鑰鹹遞) = Most resolved by month 1 製鬱製觸鏇廠鬱構淵鬱 (齋製築淵糧齋襯繭鏇選 ) 更多	积极	2003-05-01
				Vitrase 55 IU