Botulinum toxin A(Medytox)

2015年，为布局肉毒素领域，华熙生物与韩国企业Medytox携手，成立合资公司。不过，几年时间过去，二者关系却变了质。今日（8月1日），华熙生物发布公告，子公司向Medytox发出律师函，要求行使权利终止合资协议及相关协议。是什么使得曾经的合作伙伴，如今对簿公堂？对此，华熙生物给出了答案。由于Medytox的肉毒素产品一直未完成产品注册手续，导致Medytox无法通过合法方式向合资公司华熙美得妥提供肉毒素产品。这才使得华熙生物做出此举。恒瑞医药乳腺癌布局迎来好消息。恒瑞医药发布公告表示，泛 ErbB 受体酪氨酸激酶抑制剂马来酸吡咯替尼片联合曲妥珠单抗和多西他赛，一线治疗HER2阳性复发/转移性乳腺癌的III 期临床达到主要终点。此外，不少药企发布上半年业绩公告，包括日本公司盐野义制药，国内公司和黄医药、海特生物等，他们的表现如何？可在下文寻找答案。过去一天，国内外医药市场还有哪些热点值得关注呢？让氨基君带你一起看看吧。PS：每个工作日晚上，「氨基观察」每日“药”闻，准时更新，带你追踪医药市场热点。/ 01 /行业速递1) 华熙生物子公司向Medytox发出律师函8月1日，华熙生物公告，由于Medytox无法通过合法方式向合资公司华熙美得妥提供肉毒素产品，全资子公司已向Medytox发出律师函。2) 海特生物上半年净利1887.2万元，同比增长161.49%8月1日，海特生物公告，上半年实现营业收入3.87亿元，同比增长71.69%；净利润1887.2万元，同比增长161.49%。3) 山河药辅上半年净利6615.9万元，同比增长24.21%8月1日，山河药辅公告，上半年度实现营业收入3.6亿元，同比增长17.82%；净利润6615.9万元，同比增长24.21%。4) 和黄医药上半年总收入增长28%至2.02亿美元8月1日，和黄医药公告，上半年总收入增长28%至2.02亿美元，股东应占净亏损为1.629亿美元，同比扩大约59.05%。5) 九安医疗美国子公司日常经营重大合同履行完毕7月31日，九安医疗公告，国子公司已经收到美国ACC针对本合同支付的17.75亿美元货款，合同履行完毕。6) 太极集团子公司青霉素V钾片抽检不合格7月31日，太极集团公告，公司控股子公司西南药业生产的青霉素V钾片有关物质检测不合格。7) 华润双鹤拟收购神舟生物科技50.11%股权8月1日，华润双鹤公告，拟以5.02亿元收购神舟生物科技有限责任公司50.11%股权。8) 药审中心发布新冠状病毒新药非临床和临床评价标准的问答8月1日，国家药监局药审中心发布《关于新型冠状病毒新流行株感染抗病毒新药非临床和临床评价标准的问与答》通知。9) 沃森生物累计回购200万股，占总股本0.1248%8月1日，沃森生物公告，截至7月31日公司累计回购股份数量为200万股，占公司目前总股本的0.1248%，成交总金额约为9264万元。/ 02 /产品跟踪1) 和黄医药在国内启动达唯珂的桥接研究8月1日，和黄医药表示，在中国启动EZH2甲基转移酶抑制剂达唯珂的桥接研究，首名患者已于2022年7月29日接受首次给药治疗。2) 首药控股SY-3505胶囊获得II期临床试验伦理审批报告8月1日，首药控股公告表示，公司三代ALK抑制剂CT-3505胶囊治疗ALK阳性非小细胞肺癌患者的I/II期临床符合伦理要求，可以在临床研究中使用。3) 恒瑞医药吡咯替尼一线乳腺癌适应症 III 期临床达到终点8 月 1 日，恒瑞医药发布公告，泛 ErbB 受体酪氨酸激酶抑制剂马来酸吡咯替尼片联合曲妥珠单抗和多西他赛，一线治疗HER2阳性复发/转移性乳腺癌的III 期临床达到主要终点。4) 礼来高血糖素鼻用粉雾剂上市申请获得受理8 月 1 日，据 CDE 官网显示，礼来紧急治疗严重低血糖的高血糖素鼻用粉雾剂，上市申请获受理。5) 迈威生物Nectin-4 ADC获批临床8 月 1 日，迈威生物宣布，其自主研发的靶向 Nectin-4 ADC 创新药，临床试验申请获 FDA 批准，用于治疗实体瘤。6) afuresertib+信迪利单抗+化疗三药联合疗法完成首例受试者给药8月1日，来凯医药与信达生物共同宣布，由双方合作的afuresertib+信迪利单抗+化疗三药联合，针对抗PD-1/PD-L1耐药的特定实体瘤患者的1/2期临床研究，已于近日完成首例受试者给药。7) 远大医药放射性核素偶联药物TLX591-CD临床申请获得受理8月1日，远大医药公告，放射性核素偶联药物TLX591-CD临床申请获得受理，用于诊断前列腺癌x。8) 远大医药放射性核素偶联药物TLX250-CDx临床申请获得受理8月1日，远大医药公告，放射性核素偶联药物TLX250-CDx临床申请获得受理，用于诊断透明细胞肾细胞癌。/ 03 /海外要闻1) FDA解除对Celyad公司CyAD-101临床试验的限制8月1日，Celyad宣布，在公司对试验的资格标准进行更改后，FDA解除对同种异体CAR-T与KEYTRUDA联合临床试验CyAD-101的1b临床试验限制。2) 盐野义制药归母净利润347亿日元，同比增长7.7% 8月1日，盐野义制药上半年营收718亿日元，同比增长4.2%；归母净利润347亿日元，同比增长7.7%。3) 日本首相称将讨论下调新冠肺炎的传染病级别7月31日，据朝日新闻，日本首相岸表示，在当前日本第七波疫情过后，将讨论下调新冠肺炎的传染病级别。4) Beam 公司BEAM-201临床申请已被搁置8月1日，Beam Therapeutics宣布，收到FDA消息，公司CAR-T疗法BEAM-201用于治疗复发/难治性T细胞急性淋巴细胞白血病/T细胞淋巴母细胞淋巴瘤的临床申请已被搁置。文／方涛之免责声明:本文（报告）基于已公开的资料信息或受访人提供的信息撰写，但氨基观察及文章作者不保证该等信息资料的完整性、准确性。在任何情况下，本文（报告）中的信息或所表述的意见均不构成对任何人的投资建议。

Los Angeles, USA, June 07, 2021 (GLOBE NEWSWIRE) -- Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight Overactive Bladder therapies with different mechanisms of action are currently being studied with excellent market potential. Ongoing scientific research has provided with greater sophistication and a clearer understanding of the mechanisms of therapeutic interventions, combined with improved outcome measures to assess the efficacy and patient satisfaction, as well as high-quality Overactive Bladder clinical trials with proper design, which would translate into more refined and directed therapies in future years. DelveInsight’s “Overactive Bladder Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Overactive Bladder pipeline landscapes. It comprises Overactive Bladder pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Overactive Bladder therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Overactive Bladder pipeline products. Some of the key takeaways from the Overactive Bladder Pipeline Report Get an overview of pipeline landscape @ Overactive Bladder Clinical Trials Analysis Overactive Bladder (OAB) causes a frequent and sudden urge to urinate that may be difficult to control. One may need to pass urine many times during the day and night and may also experience unintentional loss of urine. There are six antimuscarinic agents available for the OAB treatment worldwide- oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. Overactive Bladder Emerging Drugs Neuronox, an acetylcholine inhibitor is being developed by Medy-Tox for the treatment of the Overactive Bladder. The active ingredients involve Clostridium botulinum toxin type A. It is currently in the phase III stage of development. In September 2020, US drugmaker Allergan entered into a license agreement with South Korea’s Medytox under the terms of which, on closing, Allergan would pay Medytox an upfront of USD 65 million and Medytox would grant Allergan exclusive rights, worldwide outside of Korea, to develop and, if approved, commercialise certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. In May 2020, AbbVie announced that it had finished its acquisition of Allergan plc. following receipt of regulatory approval from all government authorities needed by the transaction agreement and approval by the Irish High Court. Research and DevelopmentPhase III NCT04113941: In August 2019, Medy-Tox initiated a phase III trial, a randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of Meditoxin in subject with Idiopathic Overactive Bladder. This study is for patients who have idiopathic overactive bladder symptoms. This study will assess the efficacy and safety of Neuronox against placebo. The trial is currently in the active not recruiting stage with an estimated enrollment of 216 participants and anticipated to be completed in August 2021. Urovant Sciences is developing URO-902 for the treatment of the Overactive Bladder. URO-902 has the potential to be the first gene therapy for OAB patients. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to existing third-line OAB treatments. It is currently in the phase II stage of development. Research and DevelopmentPhase II NCT04211831: In December 2019, Urovant Sciences GmbH initiated a phase II trial titled “An exploratory phase IIa study evaluating the efficacy and safety of URO-902 in subjects with Overactive Bladder and Urge Urinary Incontinence”. This study will investigate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose. The trial is currently in recruiting stage with an estimated enrollment of 78 participants and expected to be completed in September 2022. Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for Overactive Bladder treatment. Solabegron has been tested in over 800 study subjects in a twice-a-day formulation and demonstrated efficacy in treating OAB and Irritable bowel syndrome (IBS). A once-daily formulation designed to optimise patient convenience and effectiveness has been developed and is currently being evaluated in phase 2b dose-ranging clinical trials. Research and DevelopmentPhase II NCT03594058: In July 2018, Velicept Therapeutics initiated a phase IIb, multicenter, randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of oral solabegron modified-release tablets in the treatment of Overactive Bladder in adult female subjects. The trial enrolled 1413 participants and was completed in May 2019. Results Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients. In the study, twice-daily administration of solabegron showed a statistically major improvement compared to placebo at week 12, as measured by the mean change in the number of micturitions per day, the study’s primary endpoint. Solabegron also showed statistical significance across various secondary endpoints, comprising a percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes. For further information, refer to the detailed report @ Overactive Bladder Pipeline Therapeutics Scope of Overactive Bladder Pipeline Drug Insight Key Questions regarding Current Overactive Bladder Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Overactive Bladder Drugs Pipeline Report Related Reports DelveInsight’s Overactive Bladder Market Insights, Epidemiology and Market Forecast report provides a detailed overview of the disease and a depth understanding of historical data. DelveInsight's Overactive Bladder - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Overactive Bladder in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight's "Interstitial Lung Disease - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Interstitial Lung Disease, historical and forecasted epidemiology. DelveInsight's Interstitial Cystitis - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. DelveInsight's Bronchiolitis Obliterans Syndrome - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. Checkpoint Kinase Inhibitor Pipeline Insights, 2021 report by DelveInsight offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Checkpoint Kinase Inhibitor development. Browse ASCO 2021 Abstracts here:- About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.