COACH: A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children with Achondroplasia - ASND0042

开始日期2024-07-26

申办/合作机构

Ascendis Pharma Growth Disorders A/S

NCT06433557 / Recruiting临床2期

A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia

This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.

开始日期2024-07-26

申办/合作机构

Ascendis Pharma Growth Disorders A/S

NCT05775523 / RecruitingN/A

A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

开始日期2023-03-20

申办/合作机构

Ascendis Pharma Endocrinology Division A/S

100 项与隆培促生长素相关的临床结果

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100 项与隆培促生长素相关的转化医学

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100 项与隆培促生长素相关的专利（医药）

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项与隆培促生长素相关的文献（医药）

2024-11-01·Advances in Therapy

Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis

Review

作者: de Fries Jensen, Lasse ; Højby, Michael ; Rossi, Annachiara ; Pietropoli, Alberto ; Antavalis, Vasileios ; Odgaard-Jensen, Jan

INTRODUCTIONSince direct comparisons of long-acting growth hormones (LAGHs) are lacking, analyses were performed to indirectly compare the efficacy and safety of somapacitan versus somatrogon and lonapegsomatropin in children with growth hormone deficiency (GHD).METHODSA systematic literature review (SLR) identified studies of once-weekly LAGHs for the treatment of pediatric GHD. Indirect comparisons (ICs) using a Bayesian hierarchical network meta-analysis and a random effects model were performed using daily growth hormone (GH) 0.034 mg/kg/day (base case) or 0.024-0.034 mg/kg/day (alternative analyses) as the common comparator to compare height outcomes to 52 weeks [annualized height velocity, height velocity standard deviation score (SDS), and height SDS]. Identified evidence did not allow IC of safety or longer-term efficacy outcomes so these were qualitatively described.RESULTSThe SLR identified two somapacitan trials, three somatrogon trials (one included in alternative analyses only), and one lonapegsomatropin trial comparing the LAGH with daily GH in treatment-naïve pre-pubertal children for IC. ICs revealed no differences at 52 weeks between somapacitan versus somatrogon and lonapegsomatropin, as well as daily GH, with respect to all growth outcomes considered in children with GHD. All three LAGHs had sustained efficacy and were generally well tolerated, with comparable efficacy and safety to daily GH, with the exception of observed injection site pain for somatrogon.CONCLUSIONNo efficacy and safety differences were identified in comparisons of once weekly somapacitan versus somatrogon and lonapegsomatropin, as well as daily GH. All treatments were generally well tolerated, with the exception of observed injection site pain for somatrogon.

2023-01-01·Hormone Research in Paediatrics

Weekly Growth Hormone (Lonapegsomatropin) Causes Severe Transient Hyperglycemia in a Child with Obesity

作者: Majidi, Shideh ; Dauber, Andrew ; Alkhatib, Einas H ; Estrada, Doris Elizabeth

Introduction: A 12-year-and-9-month-old non-Hispanic black male with a history of growth hormone deficiency, pituitary hypoplasia, prediabetes, obesity, hypertension, and hyperlipidemia was initiated on weekly growth hormone (lonapegsomatropin-tcgd) and then transiently developed symptomatic hyperglycemia to 500 mg/dL. We aimed to describe this medication’s effect. Case Presentation: He was born full term and appropriate for gestational age. He was referred to endocrinology at 3.5 years of age for short stature with a height SDS of −2.48. IGF-1 51.1 ng/mL and IGFBP-3 1.2 ng/mL were low. GH stimulation test noted baseline and peak GH of 0.1 ng/mL. MRI brain showed hypoplastic adenohypophysis, aplastic pituitary stalk, and ectopic neurohypophysis. There had been difficulty with adherence to daily GH over the following 9 years. BMI trajectory rose above 180% of the 95th percentile. By age 12, A1c was 6.6%. Metformin was started and increased to 1,000 mg twice daily. Subsequent A1c was 6.0%. Due to poor compliance with daily GH, at 12 years and 9 months, he was initiated on 22 mg (0.25 mg/kg/week) of weekly lonapegsomatropin-tcgd to improve compliance. The day after his first injection, he developed non-bloody, non-bilious emesis. He denied headaches and endorsed polyuria. Due to concern for increased intracranial pressure, he was sent to the emergency department; however, ophthalmologic exam was negative. Initial serum glucose was 500 mg/dL, then 336 mg/dL after 1-L normal saline. Hemoglobin A1c was 5.7%, urine glucose 3+ mg/dL, and urine ketones 2+ mg/dL. Venous pH of 7.379 and bicarbonate of 20.6 mmol/L ruled out diabetic ketoacidosis. Metformin was held during the hospitalization. Hyperglycemia rapidly improved with transient insulin administration. He received one dose of glargine 20 units. He was initiated on lispro carb ratio of 1:8 and correction factor 1:15 for target glucose 150 mg/dL. By day four, glucoses were below 100 mg/dL; lispro was discontinued, and he was discharged home. Weekly GH was discontinued with plans to resume daily GH therapy in several months. Conclusion: Lonapegsomatropin-tcgd offers the convenience of weekly rather than daily GH treatment; however, this patient developed a rapid increase in insulin resistance and hyperglycemia requiring insulin. The discrepancy between the glucose of 500 mg/dL and A1c of 5.7%, along with the rapid resolution of hyperglycemia, is further consistent with a medication side effect. Close glucose monitoring of patients initiated on weekly growth hormone is crucial, particularly in those with a history of prediabetes.

2022-06-16·The Journal of Clinical Endocrinology & Metabolism2区 · 医学

Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results

2区 · 医学

Article

作者: Chessler, Steven D ; Hofman, Paul L ; Casella, Samuel J ; Korpal-Szczyrska, Maria ; Maniatis, Aristides K ; Mygind, Per Holse ; Song, Wenjie ; Mao, Meng ; Chaychenko, Tetyana ; Komirenko, Allison S ; Chertock, Elena D ; Nadgir, Ulhas M ; Malievskiy, Oleg ; Thornton, Paul S ; Cappa, Marco ; Shu, Aimee D ; Vlachopapadopoulou, Elpis ; Beckert, Michael ; Aghajanova, Elena M ; Saenger, Paul ; Smith, Alden R

AbstractPurposeThe objectives of the ongoing, Phase 3, open-label extension trial enliGHten are to assess the long-term safety and efficacy of weekly administered long-acting growth hormone lonapegsomatropin in children with growth hormone deficiency.MethodsEligible subjects completing a prior Phase 3 lonapegsomatropin parent trial (heiGHt or fliGHt) were invited to participate. All subjects were treated with lonapegsomatropin. Subjects in the United States switched to the TransCon hGH Auto-Injector when available. Endpoints were long-term safety, annualized height velocity, pharmacodynamics [insulin-like growth factor-1 SD score (SDS) values], and patient- and caregiver-reported assessments of convenience and tolerability.ResultsLonapegsomatropin treatment during enliGHten was associated with continued improvements in height SDS through week 104 in treatment-naïve subjects from the heiGHt trial (−2.89 to −1.37 for the lonapegsomatropin group; −3.0 to −1.52 for the daily somatropin group). Height SDS also continued to improve among switch subjects from the fliGHt trial (−1.42 at fliGHt baseline to −0.69 at week 78). After 104 weeks, the average bone age/chronological age ratio for each treatment group was 0.8 (0.1), showing only minimal advancement of bone age relative to chronological age with continued lonapegsomatropin treatment among heiGHt subjects. Fewer local tolerability reactions were reported with the TransCon hGH Auto-Injector compared with syringe/needle.ConclusionsTreatment with lonapegsomatropin continued to be safe and well-tolerated, with no new safety signals identified. Children treated with once-weekly lonapegsomatropin showed continued improvement of height SDS through the second year of therapy without excess advancement of bone age.

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项与隆培促生长素相关的新闻（医药）

2024-11-11

·BFC医疗投资资讯

Capital market and BD weekly update from BFC Group

BFC Capital Market Update (November 2 - November 8) Market Overview Global Markets and Healthcare Sectors Post Strong Gains Amid Mixed Performance Last week, U.S. markets saw notable gains, with the Dow Jones Industrial Average up 4.6%, the S&P 500 rising 4.7%, and the Nasdaq Composite gaining 5.7%. In China, the Shanghai Composite Index and CSI 300 Index advanced by 5.5%, while the Hang Seng Index increased by 1.1%. In the healthcare sector, the U.S. Nasdaq Biotechnology Index rose 4.1%. Chinese healthcare indices also posted gains, with the SSE Health Care Index up 4.9%, the CSI Healthcare Index rising 6.4%, and the Hang Seng Healthcare Index recording a weekly increase of 2.9%. Major Biopharma Updates CARsgen Therapeutics Stock Rises 57.8% as Promising Preliminary Data for Off-the-Shelf CAR-T Therapy CT0590 Unveiled at 66th ASH Annual Meeting CARsgen Therapeutics（02171.HK, 科济药业） saw a cumulative increase of 57.8% last week. On November 6, the company announced that data for Zevor-cel (Zevorcabtagene autoleucel), CT071, and CT0590 would be presented in poster format at the 66th ASH Annual Meeting, with abstracts now available on the ASH website. Notably, this is the first human Phase I trial data for CT0590, an off-the-shelf CAR-T therapy targeting BCMA and NKG2A. Among the five enrolled participants, with a median follow-up of 16.6 months (ranging from 5.1 to 24.2 months), three patients achieved remission, including two with stringent complete response (sCR) and one with partial response (PR). Of the two patients with sCR, one with relapsed/refractory multiple myeloma (RRMM) has maintained remission for 23 months (sCR ongoing), while another with primary plasma cell leukemia (pPCL) has a duration of response (DOR) of 20 months. These preliminary results suggest that the CT0590 off-the-shelf CAR-T cell therapy is safe and capable of achieving deep and durable clinical remission. Hengrui Pharmaceuticals' Irinotecan Liposome Combination Therapy Shows 37% Reduction in Mortality Risk for Advanced Pancreatic Cancer in Phase III Trial On November 6, Hengrui Pharmaceuticals（600276.SH,恒瑞医药） announced results from a randomized, double-blind, parallel-controlled, multicenter Phase III clinical trial of Irinotecan Liposome (II) combined with 5-FU/LV as a second-line treatment for locally advanced or metastatic pancreatic cancer in patients who had previously failed gemcitabine treatment. The results indicated that the Irinotecan Liposome (II) combination therapy reduced the risk of death by 37% compared to the control group in pancreatic cancer patients. Business Development Updates In the past week, PharmaEngine secured Taiwan distribution rights for LIPORAXEL from Shanghai RMX Biopharma. Novo Nordisk partnered with Ascendis Pharma to use TransCon technology for semaglutide and other therapies. Royalty Pharma acquired U.S. royalty rights for Syndax's Niktimvo against GVHD. Nobelpharma licensed Y-mAbs' Danyelza for neuroblastoma in Japan. DRI Healthcare acquired global royalty rights for KalVista's sebetralstat for HAE. Nxera and Antiverse are collaborating on AI-based GPCR antibodies. Aditum Bio and Leads Biolabs formed Oblenio Bio for a tri-specific T-cell engager. Santen gained rights to Arctic Vision’s ARVN-001 for eye conditions in China. Zhida Pharma secured an option for Vivesto’s Apealea in Greater China. PharmaEngine to distribute Shanghai RMX Biopharma’s LIPORAXEL in China Nov 4, 2024 – PharmaEngine and Shanghai RMX Biopharma (a subsidiary of Haihe Biopharma) entered into an exclusive distribution agreement for LIPORAXEL (paclitaxel oral solution) in the Taiwan market. Novo Nordisk to use Ascendis Pharma' TransCon Technology to develop, manufacture and commercialize therapeutics including Semaglutide for metabolic diseases and cardiovascular diseases worldwide Nov 4, 2024 – Novo Nordisk entered into an exclusive worldwide research and development collaboration and license agreement with Ascendis Pharma for TransCon technology to develop, manufacture and commercialize therapeutics including semaglutide , by reducing their dosing frequency for the treatment of metabolic diseases and a product-by-product exclusive license in cardiovascular diseases. Royalty Pharma to acquire royalty rights of Syndax's Niktimvo against GVHD in the US Nov 4, 2024 –Royalty Pharma entered into a synthetic royalty funding agreement for Syndax Pharmaceuticals ' Niktimvo (axatilimab) against chronic graft-versus-host disease (GVHD) in the United States. Nobelpharma to commercialize Y mAbs Therapeutics' Danyelza for relapsed/refractory high risk neuroblastoma in Japan Nov 4, 2024 –Nobelpharma entered into an exclusive license and distribution agreement with Y-mAbs Therapeutics to commercialize Danyelza for the treatment of relapsed/refractory high risk neuroblastoma in Japan. DRI Healthcare to acquire royalty rights of KalVista's sebetralstat against HAE worldwide Nov 4, 2024 – DRI Healthcare signed a synthetic royalty financing agreement to acquire rights of KalVista Pharmaceuticals ' sebetralstat against hereditary angioedema (HAE) worldwide. Nxera and Antiverse to design and globally commercialize AI based antibodies for GPCRs Nov 5, 2024 – Nxera agreed with Antiverse to design and globally commercialize AI based antibodies for G-protein coupled receptors (GPCRs). Aditum Bio and Leads Biolabs Announce the Formation of Oblenio Bio to Develop a Tri-Specific T-Cell Engager for Autoimmune Disorders Nov 7, 2024 – Aditum Bio and Leads Biolabs today announced the formation of Oblenio Bio, which is being formed in conjunction with an exclusive option and license agreement to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody for autoimmune diseases. Aditum Bio will fund Oblenio Bio and the parties will collaborate to rapidly bring LBL-051 into clinical studies. Santen to commercialize Arctic Vision' ARVN-001 for UME and other ophthalmic indications in China excluding Taiwan, Hong Kong and Macau Nov 7, 2024 – Santen signed an agreement with Arctic Vision to commercialize ARVN-001 for uveitic macular edema (UME) and certain other ophthalmic indications in China excluding Taiwan, Hong Kong and Macau. Zhida Pharma to sign an option to develop and commercialize Vivesto’s Apealea for ovarian cancer in China, Hong Kong, Macau and Taiwan Nov 7, 2024 –Zhejiang Zhida Pharmaceutical signed an exclusive license option agreement with Vivesto to develop and commercialize anticancer product Apealea (paclitaxel micellar) for ovarian cancer in China, Hong Kong, Macau and Taiwan. References： 1.https://www.carsgen.com/en/news/carsgen-to-present-zevor-cel-ct071-and-ct0590-at-ash-2024-annual-congress/ 2.https://www.hengrui.com/media/detail-665.html

细胞疗法临床2期免疫疗法引进/卖出

2024-11-09

·Insight数据库

辉瑞 Ignite 计划与本土 Biotech 达成首次合作；东北制药、康缘药业买公司，扩管线......

Insight 数据库「医药交易」模块显示，本周全球范围内共发生 21 项医药交易（截至 11 月 8 日），涉及诺和诺德、辉瑞、极目生物、维立志博、沙砾生物、天泽云泰等公司。其中：约一半数量的医药交易与中国生物医药公司有关，既有产品授权，如智擎生技、智达药业分别就紫杉醇产品达成合作，也有公司收购，如华润博雅、康缘药业、东北制药等宣布或完成公司收购； NewCo 和 T 细胞衔接器（TCE）持续火热，维立志博与生物技术风险投资公司 Aditum Bio 就前者 CD19/BCMA/CD3 三特异性 TCE 成立新公司，合作涉及金额超 6 亿美元；另外还有其他公司达成新合作，如诺和诺德超 2.8 亿美元合作开发长效 GLP-1 激动剂，极目生物以 8500 万美元将其眼科新药在中国大陆的独家商业化权利授予 Santen 等。下面，Insight 数据库将节选部分备受关注的交易案例做介绍，仅供读者参阅。多家中国公司达成新合作天广实、康源博创与辉瑞达成合作天广实和康源博创联合宣布与辉瑞签署合作备忘录，各方将共同致力于多发性骨髓瘤患者的创新治疗方案的临床开发。新闻稿表示，这是辉瑞 Ignite 计划在中国落地以来，与中国大陆本土生物科技公司的首次合作。辉瑞 Ignite 计划涵盖了从临床前到临床、商业供应、生产等合作领域，目的是助力国内生物医药公司加速创新。天广实专注于自身免疫疾病及肿瘤领域创新型抗体靶向药物研发及产业化，康源博创则专注于双抗/多特异性抗体研发。复宏汉霖与 SVAX 公司达成战略合作复宏汉霖与 SVAX 公司达成战略合作，双方将于沙特阿拉伯设立合资公司，并整合前者的生物药研发及生产能力与后者的本地注册、市场准入和商业化优势资源，推动复宏汉霖多款产品的全球注册与商业化。根据协议，双方将在合作地区就复宏汉霖的一系列产品进行合作开发、本地注册、生产及商业化，包括阿达木单抗 HLX03、贝伐珠单抗 HLX04。另外，此次合作框架中的首批项目还包括共同投资开发帕博利珠单抗生物类似药 HLX17，并推动其全球注册上市。维立志博携手 Aditum 成立 NewCo 维立志博和生物技术风险投资公司 Aditum Bio 宣布，基于前者 CD19/BCMA/CD3 三特异性 T 细胞衔接器（TCE）LBL-051 成立一家名为 Oblenio Bio 的新公司，并达成独家选择权及许可协议。前者将授予新公司在全球范围内开发、生产和商业化 LBL-051 的独家选择权和许可，后者将为新公司提供资金，双方将合作推进 LBL-051 进入临床研究。 LBL-051 通过同时靶向 CD19 和 BCMA，有望在多种抗体介导的自身免疫性疾病中清除更广泛的病理性 B 细胞，从而激发更强效且持久的疗效。根据协议，维立志博将有权获得 3500 万美元的首付款和近期付款，在达成开发、监管注册、销售里程碑后，还将有权获得最高达 5.79 亿美元的后续款项。极目生物 8500 万美元售出 ARVN001 部分权利 Santen 和极目生物（Arctic Vision）就后者眼科新药 ARVN001 签署商业合作协议。根据协议，Santen 获得 ARVN001 在中国大陆（不包括中国台湾、香港和澳门地区）的独家商业化权利，后者将获得高达 8500 万美元的预付里程碑付款。 ARVN001 是一款专为脉络膜上腔注射给药的糖皮质激素曲安奈德脉络膜上腔注射混悬液，已在美国获批用于治疗葡萄膜炎性黄斑水肿（UME），并正被开发用于糖尿病黄斑水肿（DME）等其他眼底疾病。此前，极目生物获得了 ARVN001 在大中华区、韩国、东盟十国、印度等地的开发和商业化独家权益。沙砾生物与天泽云泰达成合作沙砾生物与天泽云泰就后者 CRISPR-AaCas12bMAX 基因编辑工具及相关基因编辑技术达成合作，用于前者开发、制造及商业化其特定细胞治疗产品。沙砾生物成立于 2019 年，是一家专注于 TIL 等肿瘤免疫细胞治疗的创新型医药公司。新闻稿表示，这也是天泽云泰的 ViCas®CRISPR 编辑技术平台达成的首次对外合作。该平台包括识别多种 PAM 序列的高效编辑器，独有的 gRNA 骨架和稳定化定点修饰策略、高活性编辑器重组蛋白、以及 mRNA-LNP 编辑系统等。智擎生技与海和药物就紫杉醇口服溶液签署协议智擎生技宣布与海和药物控股子公司诺迈西完成签署 Liporaxel（紫杉醇口服溶液）的经销合约。智擎公司成为 Liporaxel 在中国台湾的独家经销商，负责申请新药查验登记（NDA）及后续市场推广、销售等业务。 Liporaxel 由韩国 Daehwa Pharmaceutical 研发和制造，诺迈西于 2017 年 9 月独家取得它在中国大陆、台湾、香港地区及泰国等地的研发、生产及销售权益。该产品采用创新的脂质乳化药物运输技术（DH-LASED Platform）开发，已在中国获批用于晚期胃癌患者的治疗。智达药业获得紫杉醇胶束独家中国权益智达药业宣布与瑞典研发公司 Vivesto 签订合作协议，将独家获得欧洲批准上市「紫衫醇胶束」Apealea 在中国的全部权益。未来该公司还将负责生产该产品，供应全球市场。 Apealea 是一种水溶性、静脉注射的新型紫杉醇制剂，通过采用 Vivesto 公司专有的赋形剂 XR17，形成 20-60 纳米大小的胶束提高了紫杉醇的溶解度，从而改善药物输送和降低毒性。该药已获得欧盟委员会的上市授权，可联合卡铂用于治疗首次复发的铂敏感性上皮性卵巢癌、原发性腹膜癌和输卵管癌的成年患者。东北制药、康缘药业等买公司，扩管线东北制药拟 1.87 亿元收购鼎成肽源 70% 股权东北制药召开第九届董事会第三十三次会议，以同意 11 票、反对 0 票、弃权 0 票，审议通过了《关于签署的议案》，拟收购鼎成肽源 70% 的股权。本次股权收购价款大约为 1.87 亿元。鼎成肽源成立于 2014 年，专注于实体肿瘤细胞治疗产品的开发及转化。该公司已开发了 TCR-T、TCR 蛋白药和创新型 CAR-T 等 10 余款细胞治疗产品，靶点涉及 KRAS 突变、 EGFRvIII、AFP 和 Claudin18.2 等。其中，靶向 KRAS G12D 的 TCR-T 细胞药物已进入 1 期临床。康缘药业 2.7 亿元收购中新医药康缘药业发布公告称，拟以自有资金 2.7 亿元收购中新医药 100% 股权。康缘药业控股股东康缘集团持有中新医药 70% 股权，对应转让价款 1.89 亿元。南京康竹持有中新医药 30% 股权，对应转让价款 0.81 亿元。中新医药聚焦代谢性疾病及神经系统疾病领域，目前在研管线已有 4 个创新药进入临床阶段，分别是：1）重组人神经生长因子注射液（rhNGF），拟用于视神经损伤的治疗；2）重组人神经生长因子滴眼液（rhNGF），拟用于神经营养性角膜炎的治疗；3）三靶点长效减重（降糖）融合蛋白（GGGF1），拟用于 2 型糖尿病、超重或肥胖治疗；4）双靶点长效降糖（减重）融合蛋白（GGF7），拟用于 2 型糖尿病、超重或肥胖治疗。华润博雅 18.2 亿元收购绿十字华润医药董事会宣布，关于其附属子公司华润博雅生物建议收购 Green Cross HK（绿十字香港）100% 股权已根据购股协议的条款及条件完成，Green Cross HK 成为华润博雅生物的全资附属公司并作为华润医药的非全资附属公司入账。根据华润医药此前公告，这项收购花费了华润博雅生物自有资金 18.2 亿元。通过此次收购，华润博雅生物将全资控股一家血液制品生产企业，新增一张生产牌照、 4 个在营单采血浆站，并新增 2 个省份区域的浆站布局，从而为该公司整合行业资源、拓展新浆站开辟新路径。其它授权合作诺和诺德与 Ascendis 达超 2.8 亿美元合作 Ascendis Pharma 宣布，已向诺和诺德授予其 TransCon 技术平台的全球独家许可，以开发、生产和商业化诺和诺德在代谢性疾病（包括肥胖和 2 型糖尿病）方面的专有产品，以及心血管疾病产品的独家许可。该合作的主要项目是每月一次的 GLP-1 受体激动剂候选产品，最初将针对肥胖和 2 型糖尿病。根据协议，Ascendis 公司将有资格基于主要项目获得总计 2.85 亿美元的预付款、开发和监管里程碑付款，还将有资格获得基于销售的里程碑付款等款项。对于每种额外的代谢或心血管疾病产品候选药物，Ascendis 公司将有资格获得高达 7750 万美元的开发和监管等里程碑款项。 Y-mAbs 和 Nobelpharma 就抗肿瘤新药达成合作 Y-mAbs Therapeutics 与 Nobelpharma 宣布，双方已签订一项独家许可和分销协议，前者授予后者在日本开发和商业化 Danyelza（naxitamab gqgk），用于治疗复发/难治性高风险神经母细胞瘤患者，并可能用于复发性骨肉瘤。根据协议，Y-mAbs 将获得与签订该协议有关的 200 万美元预付款，并有权获得该产品获批后商业销售的利润分享，以及高达 3100 万美元的产品和商业里程碑付款。Danyelza 是一种靶向神经节苷脂（GD2）的人源化单克隆抗体，可用于与粒细胞-巨噬细胞集落刺激因子（GM-CSF）联合治疗神经母细胞瘤患者。 Synaffix 与 BigHat 合作开发下一代 ADC Synaffix 公司宣布，已将其 ADC 技术授权给 BigHat Biosciences，后者将结合前者的技术及抗体设计平台开发新的 ADC 管线项目。这项合作有助于推进 BigHat 公司的下一代 ADC 计划，该计划处于 IND-enabling 阶段。Synaffix 公司技术的结合旨在进一步提高 BigHat 公司下一代 ADC 的安全性和有效性。 Synaffix 公司专注于将其临床阶段平台技术商业化，以开发具有最佳治疗指数的 ADC。其专有 ADC 技术平台旨在通过显著增强疗效和耐受性，使任何抗体成为「best-in-class」的 ADC。Lonza 公司已于 2023 年 6 月宣布收购 Synaffix 公司，涉及 1 亿欧元现金及高达 6000 万欧元的额外对价。除了上述案例，本周还有一些其它公司也达成了不同类型的合作，限于篇幅，此处不再一一介绍。欲了解本周更多授权合作信息，可点击阅读原文前往 Insight 数据库「医药交易」模块查看。封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

并购生物类似药

2024-11-08

·GBIHealth

进博会2024：上药控股与赛诺菲、辉瑞等公司达成一系列合作

2024年11月6日，上药控股宣布在第七届中国国际进口博览会（CIIE）上达成一系列合作。具体如下：与赛诺菲签署深化战略合作协议双方此前曾于2023年底达成创新战略合作，本次深化合作旨在探索医药商业创新深度融合的广阔合作前景，让医药创新成果更快更好惠及国内百姓。与辉瑞中国达成战略合作双方将进一步深化在疫苗领域的合作，包括产品推广、创新产品引入以及政策研究等多个方面。与吉利德科学就HIV长效治疗领域产品达成战略合作双方将充分发挥各自在HIV治疗领域的业务专长，即吉利德科学在研发生产方面的优势与上药控股在进口分销方面的专长，就HIV产品进行深度合作。双方将在全国多地共同推进HIV产品的区域覆盖。与拜耳健康消费品开启新品战略合作双方于2016年首次携手，共同开展拜耳旗下五个品牌药在中国市场的商业运作，探索跨国药企在中国合约销售（CSO）的可行模式。其后，双方还于2020年CIIE达成合作签约。本次再度合作旨在发挥各自平台优势，共同推动新品在全渠道的高质量发展。与赛生药业达成战略合作凭借赛生药业在创新药领域的产品开发和商业化优势，结合上药控股在临床试验、进口分销、零售覆盖以及创新增值服务方面的优势，双方将围绕赛生药业引进的创新药产品在中国境内的商业化展开深入合作。上药控股将为赛生药业创新药提供全生命周期服务。与维昇药业合作升级维昇药业将上药控股旗下创新药全生命周期服务平台上药国际供应链有限公司确认为进口隆培促生长素注射液及其配套专用自动注射器在中国大陆的进口总经销商。隆培促生长素是截至目前为止唯一优效于生长激素日制剂的长效生长激素，其在国内的上市申请已获国家药监局受理。与海和药物达成战略合作双方将聚焦肿瘤领域开展长期合作，依托各自优势，深化务实合作，互惠共赢发展，加速新产品的商业化进程，助力医药创新的成果更快地惠及广大患者。此外，上药控股还在CIIE上与卫材、诺华、百济神州、曙方医药等药企达成了合作。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

疫苗

100 项与隆培促生长素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	隆培促生长素	-	DB16220

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
生长激素缺乏症	美国	Ascendis Pharma Endocrinology Division A/S	2021-08-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
生长激素缺乏症	申请上市	中国	维昇药业（上海）有限公司	2024-03-08
生长激素缺乏症	申请上市	中国	Vetter Pharma-Fertigung GmbH & Co. KG	2024-03-08
生长激素缺乏症	申请上市	中国	Ascendis Pharma Endocrinology Division A/S	2024-03-08
软骨发育不全	临床2期	英国	Ascendis Pharma Growth Disorders A/S	2024-07-26
软骨发育不全	临床2期	丹麦	Ascendis Pharma Growth Disorders A/S	2024-07-26
特纳综合症	临床2期	美国	Ascendis Pharma A/S	-
内分泌系统疾病	临床前	中国	Ascendis Pharma A/S	2019-12-30
内分泌系统疾病	临床前	中国	维昇药业（上海）有限公司	2019-12-30
垂体疾病	临床前	中国	Ascendis Pharma A/S	2019-12-30
垂体疾病	临床前	中国	维昇药业（上海）有限公司	2019-12-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03344458 (enliGHten, CTgov)	临床3期	生长激素缺乏症	298	Lonapegsomatropin	糧鏇憲積築窪齋築鑰憲(鹹製醖憲構顧壓築築觸) = 網範顧艱選構齋壓蓋鹽簾繭齋蓋憲鬱衊窪鹽獵 (衊選築繭餘蓋餘遞襯築, 鹹糧鹹糧壓餘膚鏇壓衊 ~ 觸範鏇窪遞壓積觸憲網) 更多	-	2024-05-08
foresiGHt (Biospace) 人工标引	临床3期	生长激素缺乏症	259	TransCon hGH	觸範鹹鹽醖製襯餘膚範(積鬱衊鏇製醖築積鹹鹹) = 製觸蓋鏇膚壓繭壓艱糧襯窪壓艱網鏇構鑰觸構 (壓鏇簾願獵夢壓遞觸憲 ) 更多	积极	2023-12-19
				Placebo	觸範鹹鹽醖製襯餘膚範(積鬱衊鏇製醖築積鹹鹹) = 顧鹽鑰觸窪觸壓獵選淵襯窪壓艱網鏇構鑰觸構 (壓鏇簾願獵夢壓遞觸憲 ) 更多
enliGHten (GlobeNewswire) 人工标引	N/A	生长激素缺乏症	81	TransCon hGH	(衊憲壓窪顧鹹廠鹽鏇醖) = The most commonly reported adverse events over the course of the trial were categorized as infections, injury, and respiratory/thoracic/medical disorders. The majority of adverse events were mild in severity and unrelated to treatment. No adverse events led to discontinuation of the study treatment. 鹹範積壓窪鏇網製積繭 (顧選獵鬱鑰廠壓夢網鏇 )	积极	2023-09-23
				TransCon hGH (at the beginning of the open-label extension trial)
ESPE2023	临床3期	生长激素缺乏症	298	Lonapegsomatropin	(繭蓋鑰願廠鬱夢廠衊願) = 鹹獵醖築襯繭糧膚齋壓衊構糧窪積淵鹽鑰糧積 (選蓋鑰觸齋醖夢蓋觸鑰, 6)	-	2023-09-21
NCT04326374 (PRNewswire) 人工标引	临床3期	生长激素缺乏症	150	human growth hormone (Longpei growth promoting hormone group)	(遞膚糧蓋鹽蓋膚選壓網) = 廠廠憲構淵壓廠簾鹹壓獵觸觸築選簾選糧鹹製 (憲襯蓋觸構簾觸願餘糧 )	积极	2022-11-17
				human growth hormone (growth hormone daily preparation group)	(遞膚糧蓋鹽蓋膚選壓網) = 遞襯艱鬱艱網餘糧獵齋獵觸觸築選簾選糧鹹製 (憲襯蓋觸構簾觸願餘糧 )
NCT04326374 (PRNewswire) 人工标引	临床3期	生长激素缺乏症	150	lonapegsomatropin	(衊觸淵鬱壓壓艱蓋餘齋): P-Value = 0.0010	优效	2022-05-23
				daily growth hormone
NCT03305016 (CTgov)	临床3期	生长激素缺乏症	146	Lonapegsomatropin	積觸網觸壓觸餘窪蓋廠(鑰願願蓋願襯壓網膚鏇) = 獵製顧鹹鹹鹽膚衊襯觸鹽獵醖鏇鑰憲淵鏇築構 (夢衊壓衊遞憲醖齋膚鹽, 鏇憲鏇鑰網糧淵憲鏇窪 ~ 顧範獵淵窪繭製鏇獵鏇) 更多	-	2022-01-04
NCT01947907 (Pubmed \| J Clin Endocrinol Metab) 人工标引	临床2期	生长激素缺乏症	53	TransCon GH	(蓋鬱蓋衊鹽鹹製遞顧糧) = 繭網獵鹹壓壓鏇襯製鹹窪蓋積繭鬱選餘觸餘鹽 (積遞網觸鹽窪範遞願襯 )	积极	2017-05-01
				Genotropin	(蓋鬱蓋衊鹽鹹製遞顧糧) = 鹹鹽願憲觸襯範範鏇艱窪蓋積繭鬱選餘觸餘鹽 (積遞網觸鹽窪範遞願襯 )
NCT01247675 (CTgov)	临床2期	生长激素缺乏症	37	ACP-001 (TransCon hGH) (ACP-001, 0.02 mg hGH/kg/wk)	廠壓醖獵簾鑰鹽糧簾獵(獵衊鑰餘衊遞醖鑰膚衊) = 繭願鏇襯鹹醖齋鏇獵廠鹽醖壓鏇廠構製壓衊襯 (齋淵鬱構顧廠襯膚壓選, 壓衊鹹壓廠選醖範壓構 ~ 醖餘製繭積築憲鬱遞選) 更多	-	2017-03-09
				ACP-001 (TransCon hGH) (ACP-001, 0.04 mg hGH/kg/wk)	廠壓醖獵簾鑰鹽糧簾獵(獵衊鑰餘衊遞醖鑰膚衊) = 簾壓願鑰醖積構夢築鹹鹽醖壓鏇廠構製壓衊襯 (齋淵鬱構顧廠襯膚壓選, 廠艱繭壓鹽繭構築鬱鏇 ~ 衊膚繭蓋膚簾淵顧夢觸) 更多
NCT01947907 (CTgov)	临床2期	生长激素缺乏症	53	ACP-001 (ACP-001, Dose-level 1)	簾蓋鑰壓憲膚鹽憲鏇窪(網醖鏇鹹選憲膚淵鹹衊) = 積膚廠窪餘膚糧齋願鏇廠顧衊醖積鹹淵鏇鏇壓 (膚壓鏇艱蓋鬱淵簾艱鬱, 衊選壓願選觸製餘網鬱 ~ 繭餘構襯繭壓網網積蓋) 更多	-	2017-01-19
				ACP-001 (ACP-001, Dose-level 2)	簾蓋鑰壓憲膚鹽憲鏇窪(網醖鏇鹹選憲膚淵鹹衊) = 鬱憲夢鹽窪膚積網構鹹廠顧衊醖積鹹淵鏇鏇壓 (膚壓鏇艱蓋鬱淵簾艱鬱, 齋窪壓襯積鏇簾簾鹽鹽 ~ 齋膚鑰淵獵鑰廠襯鏇蓋) 更多