Bexagliflozin

MARLBOROUGH, Mass.--( BUSINESS WIRE )--A new study published in JAMA Network Open titled “ Income-Related Disparities in Mortality Among Young Adults With Type 2 Diabetes ” underscores the need for addressing disparities in care and improving access to important therapies for type 2 diabetes. This study further underscores recent data compiled by the American Diabetes Association which states that diabetes is the most expensive chronic condition in the United States, and millions of Americans struggle to afford effective treatment of their type 2 diabetes and associated complications. Seeking to address this critical health issue, BRENZAVVY ® (bexagliflozin) is a safe, effective and affordable option for adults with type 2 diabetes. In the United States, BRENZAVVY is sold at around $50 per month through a network of online and independent pharmacies. BRENZAVVY's low price point makes sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy a more affordable option for uninsured, underinsured, and Medicare patients. This increased affordability can help ensure that patients can initiate and maintain a safe and effective therapy, improving their ability to manage their type 2 diabetes. Adults with type 2 diabetes can easily determine if BRENZAVVY is right for them by visiting www.brenzavvydirect.com and speaking to a doctor quickly and affordably. For healthcare providers, BRENZAVVY can easily be prescribed without insurance plan headaches, such as prior authorizations or step therapy hurdles, that the SGLT2 inhibitor class traditionally faces. “ The findings of this study reinforce that many adults living with type 2 diabetes simply cannot afford to start and stay on their therapy ,” said the TheracosBio CEO, Brian Connelly. “ With BRENZAVVY, TheracosBio is fulfilling our mission to address financial barriers to care. By unlocking wider access to an important class of therapy, more and more people with type 2 diabetes have better access to a safe, affordable and effective treatment option,” Mr. Connelly added. BRENZAVVY is available as 20 mg oral tablets to be taken once daily, in the morning, with or without food. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors or combinations of these agents. Although BRENZAVVY is not approved for weight loss or blood pressure reduction, modest decreases in both weight and blood pressure have been observed in the clinical program. To learn more about BRENZAVVY , please visit https://www.brenzavvy.com . To learn more about TheracosBio, please visit https://theracosbio.com . BRENZAVVY Important Safety Information BRENZAVVY ® (bexagliflozin) is a prescription medicine used along with diet and exercise to improve blood sugar in adults with type 2 diabetes. BRENZAVVY is not recommended to decrease blood sugar in people with type 1 diabetes. Do not take BRENZAVVY if you are allergic to bexagliflozin or any of the ingredients in BRENZAVVY. BRENZAVVY can cause serious side effects including diabetic ketoacidosis that may be fatal. Signs and symptoms of ketoacidosis include nausea, vomiting, stomach pains, tiredness, trouble breathing, and ketones in urine or blood. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. BRENZAVVY may increase the risk of lower limb amputations. Call your doctor if you notice signs or symptoms. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation. BRENZAVVY may cause dehydration, urinary tract or genital yeast infections, and low blood sugar. Symptoms of dehydration include feeling dizzy, faint, lightheaded, or weak upon standing. Yeast infections can occur in women and men. Signs of low blood sugar may include headache, confusion, drowsiness, dizziness, sweating, irritability, hunger, shaking, fast heartbeat, or weakness. A rare life-threatening bacterial infection in the skin of the perineum could occur. Stop taking BRENZAVVY and call your doctor right away if you have symptoms of this infection The perineum is the area between the anus and genitals. Symptoms of this infection include fever, weakness and pain tenderness, redness, or swelling of the genital area. The most common side effects of BRENZAVVY are vaginal yeast infections, urinary tract infections, and changes in urination, including an urgent need to urinate more often, in large amounts, and at night. For additional important safety information about BRENZAVVY, visit www.brenzavvy.com . About TheracosBio TheracosBio was founded in 2000 and develops affordably priced novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases. COM-23118-01

第15届医博会特设宠物新药开发专场，汇聚院士、评审专家及行业精英，共探宠物药创新之路。携手跨国公司，深析MAH制度与VICH机遇，引领宠物医药未来。 上周，药明生物官微发布PawBio品牌，宣告进军动物保健赛道，不禁引发行业热议：此举是战略性主动为之，引领行业新方向？还是，在一片红海的人用药市场实在是找不到出路的无奈之举？ 其实，做腻了人用药之后，总有些躁动的心想尝试扩大适用人群，比如消费健康，或者扩大适用物种，比如动物保健和植物保护，甚至就选择生命健康以外的领域。但，这些跃跃欲试的想法真正付诸实践的却是寥寥无几，原因就在于并不是最初料想那样可以实现降维打击。正所谓隔行如隔山，新领域的生态圈和业务逻辑有着本质差别，前期充分调研还是十分必要的，以前积累的经验只能在有些方面可以迁移使用。 说到药明系，可以说是独一无二的存在，在药物研发链条上基本上属于全面铺开，全方面涉猎，做到无一死角。更厉害的是大多数做得很成功，包括之前风生水起的DDSU虽然现在完成了历史使命，带来了大量CRO业务；即便现在行业不景气，好在也培育出TIDES板块，也已经成为全球第一。更厉害的是孵化出来的药明生物，以及再度孵化出来的药明合联，都是行业领导者，也都成功上市。 此番进军动保，是不是药明系发现的又一个风口呢？又该如何借鉴人用药的经验？以下尝试分析一下药明生物会面临何种局面？ 首先看一下动保市场。 有一则消息有一些劲爆：中国宠物数量首次超过婴幼儿。这是一个严肃的社会问题。这种类比有其道理，但细究之下还是有差别的。相同的是宠物和婴幼儿在表达方面都是欠缺的，但不同的是婴幼儿属于发育不完全，而成年宠物则不是。此外，人种差异相对较小，且主要考虑三四种即可，而宠物物种则是非常繁多，就拿狗来说，犬种有几百种，体型也是相差巨大。 不过，这种类比至少在一定程度上说明了宠物药市场潜力。根据《2021中国宠物医疗白皮书》数据，驱虫药销售额占比约25.1%，宠物疫苗市场占比22.5%，接下来就是抗感染药物，尤其是用于经济动物。直到2022年，勃林格殷格翰的犬用口服驱虫药超可信系列产品全球净销售额为10.64亿欧元，成为兽药史上首个重磅产品。可见，兽药市场远远小于人用药。 此外，考虑到药明生物所涉猎的是抗体和融合蛋白等大分子业务，截止到2023年只有三款兽用抗体药，用于特异性皮炎、瘙痒和骨关节炎，属于刚刚起步。这块市场会风起云涌吗？国内兽药市场是被仿制药主导的，新兽药寥寥无几。前些日子，格格巫和礼蓝联合研发的礼舒替尼用于控制犬过敏性瘙痒，是继2016年欧博方的维他昔布之后的国内第二个一类新兽药，与人用药上市品种的数量根本没法相比。而且，格格巫是广州因明的子公司，属于主营人用药，兼做兽药。 当然，因明的人用药还没有批准的，这么说来还是兽药跑在前面。化学药都如此稀少了，生物药就更别提了。 然后看一下客户群体，也就是生意从哪里来？ 这就需要调研一下动保生态圈的基本情况。相对于人用药而言，动保领域玩家少且竞争格局相对固化。外资品牌主要是硕腾、礼蓝、默沙东和勃林格殷格翰，国内大型兽药企业包括金宇、瑞普、普莱柯等，当然也有一些人兽药兼营企业，如海正、齐鲁、哈药、丽珠等。 借鉴人用药的经验，前些年CRO行业的兴起就是由如雨后春笋般的biotech所推动的。那么，动保biotech会有多少呢？刚刚起步，也多是从人用药转型而来，也在摸索阶段，暂且还远没有到雨后春笋的情形。 接下来，要谈谈兽药法规。 前面提到这么多年才有一款新兽药批准，除了市场动力不足之外，在某种程度上表明新兽药的注册法规相比人用药不见得就宽松。 2020年9月，国内出台了《人用化学药品转宠物用化学药品注册资料要求》，为加快相关药物研发开辟了一条新的道路。但显然，除了分子结构本身之外，大多数工作都需要另外开展，并没能将人用药研究资料直接拿来就用。2022年底，美国批准猫糖尿病的SGLT2药物Bexagliflozin一开始是研发用于人的，只是后来因为研发进度远远落后于人用药同类产品从而改变策略转做动物。 此外，与人用药和医疗器械不同，兽药在国内暂时还没有MAH制度，换句话说就是产品持有人必须是自行生产。此外，兽药GMP有别于人用药GMP，两者是不能共线的，也不便在同一法律主体下。所以，药明生物提到其符合中美法规，但并没有说具体哪些工厂会专注于兽药。如果是现有工厂，那可能就不得不面临抉择：放弃人用药GMP。 法规风险是没法无视的，尤其是对于药明而言。之前，分段生产的法规限制给药明合联独立运营带来不利影响，最终有碍客户项目，而且药明合联也不得不增加投资建设抗体部分产线。 最后再来说说十分敏感和关键的价格问题。 宠物用药可能还有一定价格容忍度，经济动物事关民生保障，必须是价格低廉。如果药物价格没法低廉的话，经济动物一旦得病，最终面临的可能就是人道主义处死以及无害化处理，尤其是鸡蛋和猪肉是十分重要的农产品，涉及到老百姓基本民生问题，特别是猪肉还是国家安全储备物资之一。所以，必须保持低成本。 显然，药明生物盯着宠物用药市场。药物发现阶段所关心的是序列和靶点，而有些靶点是人畜共有的，这部分经验是可以迁移的。而确定了PCC之后，开发阶段就是关注成本了，但宠物用药的价格，显然是不能与人用药的价格拥有相同的承受程度。此外，相对于治疗药物，用量更大的兽用疫苗会不会是主攻业务方向呢？比如，把药明海德拿出来。 以上这些点，不知道药明生物是怎么考虑的？ 同写意媒体矩阵，欢迎关注↓↓↓