Evaluating the Tolerance, Compliance and Acceptability of a Nutritionally Complete Amino Acid-based Nutritional Supplement for the Dietary Management of Conditions With a Severe Impairment of the Gastrointestinal Tract in Children and Adults: a Case Study Series

Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content micronutrient profile has been developed to better meet the nutritional requirements of patients.
This series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.

开始日期2025-04-01

申办/合作机构

Nutricia UK Ltd

NCT06904872

/ Not yet recruiting临床2期

A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study of 2 Doses of Crofelemer for the Treatment of Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS).
Blinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution.
Patients will be randomized in a 1:1:1 ratio to crofelemer 3 mg/kg/dose TID, crofelemer 10 mg/kg/dose TID or placebo and randomization will be stratified by baseline PS volume (≤4 or >4 L/week).

开始日期2025-04-01

申办/合作机构

Napo Therapeutics SpA

NCT06326645

/ Recruiting早期临床1期IIT

Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome

The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. .

开始日期2025-03-03

申办/合作机构

The Cleveland Clinic Foundation

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100 项与短肠综合征相关的临床结果

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100 项与短肠综合征相关的转化医学

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0 项与短肠综合征相关的专利（医药）

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5,072

项与短肠综合征相关的文献（医药）

2025-06-01·Clinical Nutrition ESPEN

Transferability of metabolic balance studies in short bowel syndrome

Article

作者: De Meyere, Lise ; Tóth, Joran ; Verbeke, Kristin ; Jeppesen, Palle Bekker ; Vanuytsel, Tim ; Vandermeulen, Greet ; Verbiest, Astrid ; Andersen, Julie Hvid Møller ; Hvistendahl, Mark Krogh ; Joly, Francisca

BACKGROUNDMetabolic balance studies (MBS) are the gold standard method to assess the intestinal absorptive function in patients with short bowel syndrome (SBS). During a full MBS, patients are admitted to the hospital to collect duplicates of all ingested foods and drinks, as well as their fecal and urinary output, typically over a 72-h period. These collections are further processed to assess absorption of energy, macronutrients (nitrogen, fat and carbohydrate) and electrolytes (sodium, potassium, calcium and magnesium). Full MBS require dedicated laboratory personnel, equipment, knowledge and experience, which explains why they are currently only performed in one center.AIMWe aimed to explore the transferability of full MBS in patients with SBS from the reference center to a clinical center that was new to and unexperienced in MBS.METHODSA collaboration between the centers was initiated to transfer knowledge on how to perform MBS collections, how to process and how to analyze energy, macronutrient and electrolyte content in the collected samples. At practical level, transferability included successful MBS collecting and processing. At analytical level, transferability included the lyophilization of homogenized samples at both centers. The powder that was created at the reference center was measured at both centers to assess the transferability of the analytical methods; while the site-specific powder was measured at the corresponding center to determine full process transferability. The intraclass correlation coefficient (ICC) was calculated to define the absolute agreement between both centers.RESULTSA total of 21 MBS were performed in 7 patients with SBS at the new center. A total of 189 samples were collected, equally distributed among combined meals and drinks (n = 63), fecal output (n = 63) and urinary output (n = 63). Meals and drinks samples and fecal output samples were processed in the new center and lyophilized at both centers, with a perfect reliability for dry matter between the centers (ICC = 1). At the level of method transferability, there was an excellent absolute agreement between centers for energy and nitrogen analyses (ICC>0.9). For fat, the mean coefficients of variation (cv) between centers for fecal output (6.3 %) and meals and drinks (12.0 %) were higher, but ICC showed excellent (0.957) to good (0.787) agreement, respectively. Carbohydrate results differed more between the centers (mean cv of 17.5 % for fecal output and 16.4 % for meals and drinks), translating into a moderate (meals and drinks, ICC = 0.654) to good (fecal output, ICC = 0.812) reliability. Similar results and degrees of agreement as obtained for the method transferability were observed with the site-specific powder.CONCLUSIONOur study showed the feasibility of a full MBS transferability to a new unexperienced center with promising agreement of the results obtained between both centers. Our findings aim to inspire other specialized intestinal failure centers to adopt the full MBS methodology for both clinical practice and research purposes.

2025-05-01·Clinical Nutrition

Corrigendum to “Real-world experience of Teduglutide use in adults with short bowel syndrome: A seven-year international multicenter survey” Clin Nutr 2025 Feb 17:47:54–67

作者: Taus, Marina ; Aimasso, Umberto ; Schneider, Stéphane M ; Crivelli, Adriana ; Thibault, Ronan ; Martinuzzi, Andrés L N ; Livovsky, Dan M ; Gallitelli, Livia ; Rasmussen, Henrik H ; Kozjek, Nada Rotovnik ; Itzhaki, Moran Hellerman ; Pape, Ulrich-Frank ; Boluda, Esther Ramos ; Orlandoni, Paolo ; Gandullia, Paolo ; Krznaric, Zeljko ; Layec, Sabrina ; Santarpia, Lidia ; Sasdelli, Anna S ; Hütterer, Elisabeth ; Bergoin, Charlotte ; Poullenot, Florian ; Lamprecht, Georg ; Aguayo, Pilar Serrano ; Pironi, Loris ; Lal, Simon ; Regano, Nunzia ; Bueno, Marta ; Fehr, Rebecca ; Maíz-Jiménez, María ; Pelaez, Rosa Burgos ; Lezo, Antonella ; Vanuytsel, Tim ; Lopez-Urdiales, Rafael ; Chapman, Brooke ; Osland, Emma ; Zarpellon, Martina ; Carey, Sharon ; Martín, Cristina Campos ; Blüthner, Elizabeth ; Sobocki, Jacek ; Francini-Pesenti, Francesco ; Cuerda, Cristina ; Joly, Francisca ; Chen, Mona ; Bezmarević, Mihailo ; Ellegard, Lars ; Seguy, David ; Jezerski, Denise ; Martins da Rocha, Mariana Hollanda

2025-05-01·Pediatric Infectious Disease Journal

Bacillus clausii Bacteremia After Probiotic Usage in a Preterm Neonate With Short Bowel Syndrome

Article

作者: Shurab, Nada ; Sharma, Anju ; Mohamed, Ruwa ; Pérez-López, Andrés ; Al Maslamani, Eman ; Suleiman, Mohammed

453

项与短肠综合征相关的新闻（医药）

2025-04-29

·PRNewswire

Alcresta Therapeutics Announces Enrollment of First Patient in Clinical Trial Evaluating Use of RELiZORB in Pancreatitis Patients at Massachusetts General Hospital

WALTHAM, Mass., April 29, 2025 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that Massachusetts General Hospital (MGH) has enrolled the first patient in an investigator-initiated trial evaluating the efficacy of RELiZORB in managing exocrine pancreatic insufficiency (EPI) in tube-fed pancreatitis patients. "We are excited about the enrollment of the first patient in this study to evaluate the potential benefits of RELiZORB use in tube-fed pancreatitis patients. Acute pancreatitis is one of the leading gastrointestinal causes of hospital admissions, and there is a growing focus on managing long-term complications of pancreatitis, which includes EPI," said Casey Luckhurst, MD, Pancreatic and General Surgeon and Inpatient Director of Massachusetts General Hospital's Pancreatitis Treatment Center. Fat malabsorption is often associated with EPI conditions including pancreatitis, cystic fibrosis, and gastrointestinal cancers and can result in weight loss and serious gastrointestinal symptoms. For patients with fat malabsorption who require tube feeding, RELiZORB is the only FDA-cleared enzyme device designed to mimic the function of pancreatic lipase to improve absorption of fats for tube-fed patients. Studies have demonstrated that RELiZORB is safe, well-tolerated, and effective in improving fat absorption for patients with cystic fibrosis. "The initiation of study recruitment marks an important step toward expanding the body of clinical evidence that supports RELiZORB use in Alcresta's target therapeutic areas," said Michael Yeh, MD, Senior Vice President of Medical Affairs at Alcresta Therapeutics. "This is one of four clinical trials evaluating the safety and efficacy of RELiZORB in malabsorptive conditions supporting our mission to improve nutritional care and outcomes for tube-fed patients living with rare diseases." For more information about RELiZORB clinical trials, visit ClinicalTrials.gov: Pancreatitis: NCT06691893 Short Bowel Syndrome: NCT03530852 and NCT05635747 Critical Care: NCT05710315 About RELiZORB®  (iMMOBILIZED LIPASE) CARTRIDGE RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase and is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB was developed using Alcresta's proprietary enzyme immobilization technology, iLipase®, which is the digestive enzyme lipase bound to small polymeric bead carriers. RELiZORB connects in-line to enteral feeding systems. As enteral formula passes through RELiZORB, the bound lipase breaks down formula fats into an absorbable form prior to ingestion. RELiZORB was FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. Use was expanded to pediatric patients as young as two years old in August 2023 and expanded again for patients as young as one year old in January 2025. The next-generation RELiZORB device was introduced to market in May 2024 with broader formula compatibility, an increase in the number of devices used per day and use in both continuous and bolus-feeding set ups. About Alcresta  Therapeutics, Inc. Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally-fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and short bowel syndrome, which is marked by significant malabsorption due to limited absorptive area as a result of resection. Alcresta is currently developing a platform application for prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by Linden Capital Partners and HealthQuest Capital. More information can be found at . Internal Media Contact: Natalie Bronfin Alcresta Therapeutics, Inc. [email protected] 617-431-3600 SOURCE Alcresta Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床研究

2025-04-23

·BioPharmaDive

Roche looks to a Flagship startup in search of new immune drugs

Repertoire Immune Medicines has formed its second pharmaceutical partnership since changing course a few years ago, announcing Wednesday a new deal with Roches Genentech division to develop treatments for an unspecified autoimmune disease.Genentech will pay Repertorie, a startup launched by biotechnology company creator Flagship Pioneering, $35 million upfront to start the collaboration. Repertoire will then lead early discovery work, with Genentech handling development and eventually commercialization. The startup could receive up to $730 million in future payouts, as well as sales royalties, if the alliance yields any marketed medicines.Repertoire is built around a technology dubbed Decode thats designed to identify the components of the immune synapse, a type of junction between white blood cells that plays a key role in immune responses. Repertoire uses that information to uncover drugs for cancer and autoimmune conditions and, so far, has publicly disclosed nine bispecific antibodies or vaccines in its pipeline. All are in preclinical testing.Repertoire made much of that progress after a strategic reset, however. The company originally launched with a plan to make personalized cell therapies, but pivoted, laid off staff and switched its leadership after early study data disappointed.That directional change yielded a partnership last year with Bristol Myers Squibb to make tolerizing vaccines for autoimmune disorders. And around that time, Repertoire and Roche began engaging in deal talks too, according to CEO Torben Straight Nissen.The two collaborations have helped Repertoire navigate a tumultuous funding climate for drug startups. The company made partnerships a core piece of its strategy, in part because alliances could create a path forward that was independent of, and less reliant on, raising capital through equity.It harkens back to how biotech used to be in the old days, he said, when startups could use pharma deals to move up the value chain.Repertoire will help Roche develop therapies that treat an immune condition by targeting T cells. The companies arent divulging more specifics, including the disease at the center of the deal. However, Roche has been particularly active in immunology in recent years, cutting deals to acquire gut disease drug developer Telavantas well as autoimmune and cancer cell therapy maker Poseida Therapeutics.Roche has also been studying multiplebispecific T cell engagers, among them its lymphoma drug Lunsumio, in lupus.We look forward to translating the new discoveries Decode and the team at Repertoire will reveal to develop novel medicines for patients suffering from autoimmune diseases, Boris Zatra, Roches head of corporate business development, said in a statement. '

疫苗免疫疗法细胞疗法

2025-04-18

·药时空

2025年有望首次获批的6款创新多肽药物

自1922年胰岛素用于治疗糖尿病，肽类药物正式登上医学舞台。发展至今，全球已有近100种肽类药物获批。据弗若斯特沙利文数据预测，到2030年，全球多肽药物市场规模将达到2108亿美元，其中中国市场规模占全球比重维持在15%左右。多肽药物市场中，糖尿病、肿瘤和罕见病是拉动多肽药物市场扩容的“三驾马车”。2025年，以下6款创新多肽药物有望首次获批。1、ElamipretideElamipretide（依拉米肽）是一种肽化合物，可轻易穿透细胞膜，靶向线粒体内膜，并可逆性地与心磷脂（cardiolipin）结合。在临床前或临床研究中观察到该疗法可增加线粒体呼吸作用、改善电子递送链功能和ATP生成，并减少致病性活性氧（ROS）的形成。这种elamipretide-心磷脂结合已被证明可以使线粒体内膜结构正常化，从而改善线粒体功能。Elamipretide已获得美国FDA授予孤儿药资格、快速通道资格和罕见儿科疾病认定，以及欧洲药品管理局（EMA）的孤儿药资格，用于治疗巴思综合征——一种由tafazzin基因突变引起的疾病，该突变导致心磷脂水平降低，心磷脂是一种在线粒体功能中起主要作用的磷脂。这种疾病的特征是心脏异常、肌肉无力、反复感染和生长迟缓。1月23日，Stealth BioTherapeutics宣布，美国食品药品监督管理局（FDA）延长了用于治疗巴思综合征的Elamipretide新药申请（NDA）的审查期。NDA提交的包括来自2/3期TAZPOWER研究和3期SPIBA-001自然史对照研究的数据。FDA需要更多时间审查补充信息，其认为这一信息是对申请的重大修改。目前，新的处方药使用者费用法案的目标日期（PDUFA日期）是2025年4月29日。据悉，若是该药成功获批上市，将成为首个FDA批准的巴思综合征治疗药物。2、IcosemaIcoSema是诺和诺德研发的复方制品，由每周一次依柯胰岛素和每周一次司美格鲁肽（semaglutide）的固定比例组合。其中，依柯胰岛素是人胰岛素类似物，其氨基酸结构有三处进行了替换，并附加了C20二十烷脂肪二酸链，使该分子能够可逆地与白蛋白结合，从而将半衰期延长至196小时（约7天），并在经过3-4次每周一次注射后达到稳定状态。该疗法被设计为一周一次皮下注射使用。依柯胰岛素已在欧盟、加拿大、澳大利亚和日本以Awiqli为商品名获得批准。司美格鲁肽则是一种胰高糖素样肽-1（GLP-1）类似物，它通过突破性的肽链结构优化，使得分子半衰期延长至7天，实现了一周一次给药且血药浓度非常平稳。目前，诺和诺德已基于IcoSema针对2型糖尿病的COMBINE系列III期研究在欧盟提交其上市申请。其中COMBINE 1研究和COMBINE 3研究的结果已公开。随后，该药又于2024年12月在华申报上市并获受理。据悉，在COMBINE 3研究中，IcoSema取得了非劣效于甘精胰岛素U100和门冬胰岛素的结果。在总体基线HbA1c为8.30%的情况下，IcoSema组HbA1c降幅为-1.47%，而甘精胰岛素U100和门冬胰岛素组HbA1c降幅为-1.40（估计治疗差异：-0.06%）。此外，在基线体重为85.8kg的基础上，接受IcoSema治疗的患者体重显著减轻，IcoSema组体重减轻了3.6kg，而甘精胰岛素U100和门冬胰岛素组体重增加了3.2kg（估计治疗差异：-6.7kg）。3、NavepegritideNavepegritide（TransCon CNP，那韦培肽）属于一款长效的C 型利钠肽前药，被用于软骨发育不全的治疗。软骨发育不全属于人类最为常见的矮小症，是由编码成纤维细胞生长因子受体3(FGFR3)基因当中的一种常见致病突变所引发，这种突变会给骨骼生长的软骨内骨化过程带来影响。针对软骨发育不全发病机制的治疗手段始终是一项重大却尚未被满足的需求。据Ascendis Pharma在JPM 2025大会上透露，Navepegritide用于治疗软骨发育不全的疗法，计划在2025年第一季度向FDA提交新药申请（NDA），并在2025年第三季度向欧洲药品管理局（EMA）提交市场授权申请。在关键的ApproaCH试验中，Navepegritide显著改善了腿部弯曲，这是一种常见的并发症，而安慰剂组则观察到恶化。计划在2025年第四季度提交治疗低磷酸酯酶血症的临床试验申请（IND）。目前，此药已同时被FDA和EMA认定为孤儿药。4、ApraglutideApraglutide（阿帕拉格鲁肽）是Ironwood Pharmaceuticals公司通过收购VectivBio公司获得的一种新一代、人工合成的长效GLP-2类似物，拟开发用于一系列GLP-2在疾病病理生理学中可以发挥中心作用的罕见胃肠疾病。目前，该药治疗短肠综合征（SBS）的临床试验也已进入3期阶段；治疗胃肠道急性移植物抗宿主病的临床试验已进入2期阶段。Ironwood正在III 期STARS试验中测试Apraglutide，该试验于2024年2月显示，SBS患者对肠外支持的需求减少了25%，而安慰剂患者则减少了12%。Apraglutide也达到了其次要终点，包括能够至少停止肠外支持一天的患者比例增加。2025年1月，Ironwood宣布了一项大幅裁员计划，以投入更多资源推动其先导分子Apraglutide通过III期试验和滚动NDA提交。Ironwood还展示了来自STARS开放标签扩展研究的额外数据，显示更多患者因长期暴露Apraglutide而退出肠外支持。据悉，Ironwood已启动Apraglutide的滚动NDA提交，预计将在今年第三季度完成申报。5、Galinpepimut-SGalinpepimut-S（GPS）是一种多肽候选药物，已被改良以增强针对WT1蛋白的免疫反应的程度和持续时间。WT1蛋白是在多种癌症类型中过度表达的蛋白。在构成GPS的多肽混合物中，四种多肽中的两种多肽在单个氨基酸残基上经过刻意突变。这些突变肽被免疫系统识别为非自身产物，因此不易引发免疫耐受。这些突变肽通过人工智能（AI）设计，用于诱导针对癌细胞中突变肽和自然存在肽的强力T细胞反应，达到杀伤过度表达WT1蛋白的肿瘤细胞的效果。2025年1月，SELLAS Life Sciences Group（SELLAS）公司宣布，独立数据监测委员会（IDMC）已完成关键性3期临床试验REGAL的预定中期分析。该试验评估了在研多肽免疫疗法Galinpepimut-S（GPS）治疗急性髓系白血病（AML）的疗效和安全性。分析结果显示，试验参与者的中位总生存期超过12个月，而类似患者群体的预期生存期约为6个月。IDMC对中期数据的审查支持试验按照原始方案继续进行。REGAL是一项开放标签注册性3期临床试验，招募通过二线挽救治疗达到完全缓解（CR2）的AML患者。该试验的主要终点为总生存期。目前试验尚未揭盲，然而部分盲态数据已显示，在入组完成约10个月后，确认死亡的患者少于一半，且中位随访时间约为13.5个月（范围为1个月至超过3年）。这一结果表明中位生存期超过12个月，而类似患者群体的预期生存期约为6个月。此外，对接受GPS治疗的随机选取患者样本的早期免疫反应进行的盲态分析显示，80%的患者产生了特异性免疫反应。这些数据与GPS先前的试验结果一致。在2期临床试验中，接受GPS治疗的患者的中位总生存期为21个月，而接受标准治疗的患者仅为5.4个月，GPS组患者的特异性免疫反应率为64%。6、GlepaglutideGlepaglutide为一款潜在治疗SBS的长效GLP-2类似物液体制剂，并将配备可皮下注射的自动给药装置，旨在降低或消除SBS患者的肠外营养支持，FDA曾授予孤儿药资格。2024年12月，Zealand Pharma A/S宣布收到了FDA对Glepaglutide治疗SBS的新药上市申请（NDA）发出完整回复函（CRL），FDA的CRL中要求增加临床试验以提供Glepaglutide的拟上市剂量规格更多的有效性和安全性证据。Zealand Pharma A/S在表达失望之余，同时表示将与FDA进一步沟通，并在2025年启动一项III期临床研究以支持美国和欧盟的上市需要。根据Zealand Pharma的说法，向FDA提交申请是基于一项名为EASE-1（NCT03690206）的安慰剂对照的3期注册试验结果。该试验确实达到了其主要终点，即在24周时，与基线相比，每周两次的格列帕肽剂量使每周肠外支持量在统计学上显著减少了5.13升。然而，每周一次的glepaglutide却并没有达到统计学意义上的显著差异。（安慰剂2.85L vs 每周一次3.13L ）另外一个问题则出在第二个主要终点——临床响应率上，在Glepaglutide组中，有66%的患者出现具有临床意义的改善，对照组的临床响应率是38.9%。参考资料：[1] 2024年多肽药物行业进展. 知识药点. 2025-02-05.[2] 肽类药物：现状、进展与未来展望. 生物制品圈. 2025-03-07.[3] 多肽专栏 | 多肽药物研发和市场格局分析与展望. 中生药协. 2025-03-13.[4] 2025年4月，3款罕见病药有望在美国获批. 罕见病信息网. 2025-04-03.[5] FDA延长对Elamipretide治疗Barth综合征的审查. 香港济民药业. 2025-01-24.[6] 1月3款创新药有望获FDA批准. 药明康德. 2025-01-02.[7] Tides 速递 | 诺和诺德「依柯胰岛素司美格鲁肽复方」在华申报上市. 多肽圈. 2024-12-09.[8] 罕见病ACH“救命药”关键实验达主要终点，每年长高6厘米！. CPHI制药在线. 2024-10-24.[9] JPM 2025 Ascendis. 药政时势. 2025-01-15.[10] 同源不同命！作为GLP-1的“姐妹”，它却被开发治疗这些疾病. 医药观澜. 2024-07-05.[11] Ironwood裁员50%. 药物探索. 2025年01月31日.[12] 癌症患者总生存期延长一倍！多肽免疫疗法关键性3期临床试验中期结果积极. 药明康德. 2025年01月24日.[13] 临床证据不足！短肠综合征长效GLP-2类似物上市被拒. 药讯随说. 2024年12月20日.[14] FDA拒批长效GLP-2. 佰傲谷BioValley. 2024年12月20日.识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

孤儿药上市批准快速通道生物类似药