MARLBOROUGH, Mass. & KIGALI, Rwanda--(BUSINESS WIRE)--TheracosBio and BAMCO Africa, Inc. today announced they have partnered to bring BRENZAVVY® (bexagliflozin), an FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes, to patients in Sub-Saharan Africa.

马萨诸塞州马尔堡和卢旺达基加利--（商业新闻短讯）--TheracosBio和BAMCO Africa，Inc.今天宣布，他们已经合作将BRENZAVVY®（bexagliflozin），一种FDA批准的用于治疗2型糖尿病的口服钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，带给撒哈拉以南非洲的患者。

BAMCO is a pioneering healthcare company committed to providing access to innovative therapies for patients in Sub-Saharan Africa. BAMCO was carefully selected by TheracosBio due to the two companies’ shared mission and BAMCO’s strong leadership team and depth of experience in the region..

BAMCO是一家开创性的医疗保健公司，致力于为撒哈拉以南非洲的患者提供创新疗法。由于两家公司的共同使命以及BAMCO强大的领导团队和在该地区的丰富经验，TheracosBio精心挑选了BAMCO。。

“The mission of TheracosBio is to bring effective treatments to patients in need at affordable prices and BAMCO is working to do the same for patients in Sub-Saharan Africa,” said Brian Connelly, CEO of TheracosBio. “We are excited to work with BAMCO to provide doctors and their patients in the region with access to BRENZAVVY, a cost-effective therapy to manage type 2 diabetes,” Mr.

TheracosBio首席执行官布莱恩·康奈利（BrianConnelly）表示：“TheracosBio的使命是以可承受的价格为有需要的患者提供有效的治疗，BAMCO正在为撒哈拉以南非洲的患者提供同样的服务。我们很高兴与BAMCO合作，为该地区的医生和患者提供Brenzavvvy，这是一种治疗2型糖尿病的经济有效的疗法。”。

Connelly added..

康奈利补充道。。

“BAMCO’s mission is that all patients in Sub-Saharan Africa deserve better and need to have equitable and timely access to the latest innovative treatments that save and improve their lives.” said Markus Gemuend, CEO of BAMCO Africa. He added, “We are thrilled to partner with TheracosBio to provide access to BRENZAVVY for patients with type 2 diabetes, a fast growing health burden, and engage with medical communities to launch this innovative treatment in Sub-Saharan Africa.”.

“BAMCO的使命是，撒哈拉以南非洲的所有患者都应该得到更好的治疗，并且需要公平及时地获得最新的创新治疗方法，以挽救和改善他们的生活。”BAMCO非洲首席执行官Markus Gemuend说。他补充道：“我们很高兴与TheracosBio合作，为2型糖尿病患者提供Brenzavvvy治疗，这是一种快速增长的健康负担，并与医学界合作，在撒哈拉以南非洲推出这种创新治疗。”。

BRENZAVVY is available as 20 mg oral tablets to be taken once daily, in the morning with or without food. BRENZAVVY treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73 m2. Patients with eGFR between 30 and 59 mL/min/1.73 m2 are said to be in stage 3 chronic kidney disease.

Brenzavvvy有20毫克口服片剂，每天服用一次，早上有或没有食物。Brenzavvvy治疗可以在2型糖尿病患者中开始，估计肾小球滤过率（eGFR）大于或等于30 mL/min/1.73 m2。据说eGFR在30至59 mL/min/1.73 m2之间的患者处于3期慢性肾脏疾病。

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.

3期临床研究表明，Brenzavvvy在24周后显着降低血红蛋白A1c和空腹血糖，无论是作为单一疗法，与二甲双胍联合使用，还是作为由多种方案组成的标准护理治疗的补充，包括二甲双胍，磺脲类，胰岛素，DPP4抑制剂或这些药物的组合。

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..

尽管Brenzavvvy未被批准用于减肥或降压，但在临床计划中观察到体重和血压均适度下降。。

To learn more about BRENZAVVY, please visit https://www.brenzavvy.com.

To learn more about BRENZAVVY, please visit https://www.brenzavvy.com.

To learn more about TheracosBio, please visit https://theracosbio.com.

要了解有关TheracosBio的更多信息，请访问https://theracosbio.com.

To learn more about BAMCO, please visit https://bamcoafrica.com

欲了解更多有关BAMCO的信息，请访问https://bamcoafrica.com

INDICATION AND SAFETY SUMMARY WITH WARNINGS

BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

不建议使用Brenzavvvy来改善1型糖尿病患者的血糖控制。

BRENZAVVY is contraindicated in patients who are hypersensitive to bexagliflozin or any other ingredient in the BRENZAVVY tablet. The most common side effects of taking BRENZAVVY include female genital mycotic infections, urinary tract infections, and changes in urination, but more serious side effects are possible (see below)..

BRENZAVVY禁用于对贝沙格列嗪或BRENZAVVY片剂中任何其他成分过敏的患者。服用brenzavvvy最常见的副作用包括女性生殖器真菌感染，尿路感染和排尿改变，但可能会产生更严重的副作用（见下文）。。

For BRENZAVVY full prescribing information visit https://www.brenzavvy.com. To report suspected adverse reactions, contact TheracosBio at 1-855-BRENZAVVY (1-855-273-6928) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

BRENZAVVY完整处方信息访问https://www.brenzavvy.com.要报告疑似不良反应，请致电1-855-Brenzavvvy（1-855-273-6928）联系TheracosBio或致电1-800-FDA-1088或www.FDA.gov/medwatch联系FDA。

Important Safety Information about BRENZAVVY

关于BRENZAVVY的重要安全信息

Limitation of Use: BRENZAVVY (bexagliflozin) is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.

使用限制：不建议使用Brenzavvvy（bexagliflozin）来改善1型糖尿病患者的血糖控制。它可能会增加这些患者患糖尿病酮症酸中毒的风险。

Contraindications

禁忌症

BRENZAVVY is contraindicated in patients with hypersensitivity to bexagliflozin or any excipient in BRENZAVVY. Anaphylaxis and angioedema have been reported with sodium-glucose cotransporter 2 (SGLT2) inhibitors.

BRENZAVVY禁用于对贝沙格列嗪或BRENZAVVY中任何赋形剂过敏的患者。。

Warnings and Precautions

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis

1型糖尿病和其他酮症酸中毒患者的糖尿病酮症酸中毒

BRENZAVVY increases the risk of life-threatening ketoacidosis in patients with type 1 diabetes. Type 2 diabetes and pancreatic disorders are also risk factors for ketoacidosis and fatal events of ketoacidosis have been reported in patients with type 2 diabetes using SGLT2 inhibitors. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse.

Brenzavvvy增加了1型糖尿病患者危及生命的酮症酸中毒的风险。。糖尿病酮症酸中毒或其他酮症酸中毒的诱发条件包括由于胰岛素剂量减少或胰岛素剂量错过而导致的胰岛素不足，急性发热性疾病，热量摄入减少，生酮饮食，手术，体积消耗和酒精滥用。

Signs and symptoms of diabetic ketoacidosis are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Assess patients who present with signs and symptoms of metabolic ketoacidosis, regardless of blood glucose levels.

糖尿病酮症酸中毒的体征和症状与脱水和严重代谢性酸中毒一致，包括恶心，呕吐，腹痛，全身不适和呼吸急促。评估出现代谢性酮症酸中毒体征和症状的患者，无论血糖水平如何。

If suspected, discontinue BRENZAVVY, treat promptly and monitor for resolution before restarting. Consider ketone monitoring in patients with type 1 diabetes mellitus as well as in others at risk for ketoacidosis. Withhold BRENZAVVY in clinical situations known to predispose to ketoacidosis and resume when clinically stable.

如果怀疑，停止服用Brenzavvvy，立即治疗并在重新开始之前监测解决方案。。在已知易患酮症酸中毒的临床情况下保留Brenzavvvy，并在临床稳定时恢复。

Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue BRENZAVVY and seek medical attention immediately if signs and symptoms occur..

教育所有患者酮症酸中毒的体征和症状，并指示患者停止服用Brenzavvvy，如果出现体征和症状，立即就医。。

Lower Limb Amputation

下肢截肢术

Lower limb amputations have been observed in patients treated with BRENZAVVY in a study of patients with type 2 diabetes who had either established cardiovascular disease (CVD) or were at risk for CVD. Of the 23 BRENZAVVY-treated patients who had amputations, 15 were amputations of the toe and midfoot and 8 were amputations above and below the knee.

在一项针对患有心血管疾病（CVD）或有CVD风险的2型糖尿病患者的研究中，使用Brenzavvvy治疗的患者观察到下肢截肢。在接受Brenzavvvy治疗的23名截肢患者中，15名是脚趾和中足截肢，8名是膝盖以上和以下截肢。

Some patients had multiple amputations. Lower limb infections, gangrene, ischemia, and osteomyelitis were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy..

一些患者多次截肢。下肢感染、坏疽、缺血和骨髓炎是最常见的导致截肢的医疗事件。既往有截肢史、外周血管疾病和神经病变的患者截肢风险最高。。

Before initiating BRENZAVVY, consider factors in the patient’s history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients receiving BRENZAVVY about the importance of routine preventative foot care and monitor for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment..

在开始BRENZAVVY之前，考虑患者病史中可能导致截肢的因素，例如先前截肢史，周围血管疾病，神经病和糖尿病足溃疡。为接受Brenzavvvy治疗的患者提供常规预防性足部护理的重要性咨询，并监测糖尿病足感染（包括骨髓炎）的体征和症状，新的疼痛或压痛，涉及下肢的溃疡或溃疡，并进行适当的治疗。。

Volume Depletion

体积损耗

BRENZAVVY can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics.

Brenzavvvy可引起血管内容量收缩，有时可能表现为症状性低血压或肌酐的急性短暂变化。据报道，接受SGLT2抑制剂的2型糖尿病患者需要住院和透析的急性肾损伤。在开始之前，评估肾功能受损患者（eGFR小于60 mL/min/1.73 m2），老年患者，收缩压低的患者或服用袢利尿剂的患者的体积状态和肾功能。

In patients with volume depletion, correct this condition. After initiating, monitor for signs and symptoms of volume depletion and renal function..

对于容量耗尽的患者，请纠正这种情况。开始后，监测容量消耗和肾功能的体征和症状。。

Urosepsis and Pyelonephritis

Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including BRENZAVVY. Treatment with BRENZAVVY increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat them promptly..

在接受SGLT2抑制剂（包括BRENZAVVY）的患者中，已发现严重的尿路感染，包括需要住院治疗的尿脓毒症和肾盂肾炎。用BRENZAVVY治疗会增加尿路感染的风险。评估患者尿路感染的体征和症状，并及时治疗。。

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues

与胰岛素和胰岛素促分泌剂同时使用的低血糖症

Insulin and insulin secretagogues (e.g., sulfonylureas) are known to cause hypoglycemia. BRENZAVVY may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with BRENZAVVY..

已知胰岛素和胰岛素促分泌剂（例如磺脲类）会引起低血糖。。与BRENZAVVY联合使用时，可能需要较低剂量的胰岛素或胰岛素促分泌剂，以最大程度地降低低血糖的风险。。

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)

会阴坏死性筋膜炎（福尼尔坏疽）

Serious, life-threatening cases requiring urgent surgical intervention have been identified in postmarketing surveillance in both males and females with diabetes mellitus receiving SGLT2 inhibitors. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal areas, along with fever or malaise.

在接受SGLT2抑制剂的男性和女性糖尿病患者的上市后监测中，已经发现需要紧急手术干预的严重危及生命的病例。严重后果包括住院治疗，多次手术和死亡。评估生殖器或会阴区域出现疼痛或压痛，红斑或肿胀以及发烧或不适的患者。

If suspected, start treatment, and discontinue BRENZAVVY..

如果怀疑，开始治疗，停止服用BRENZAVVY。。

Genital Mycotic Infections

生殖器真菌感染

BRENZAVVY increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop genital mycotic infections. Monitor and treat appropriately.

BRENZAVVY增加了生殖器真菌感染的风险。有生殖器真菌感染史或未受割礼的患者更有可能发展为生殖器真菌感染。适当监测和治疗。

MOST COMMON ADVERSE REACTIONS (>5%): Female genital mycotic infections, urinary tract infection and increased urination.

。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy: BRENZAVVY is not recommended during the second and third trimesters.

怀孕：不建议在妊娠中期和晚期使用BRENZAVVY。

Lactation: BRENZAVVY is not recommended when breastfeeding.

哺乳期：母乳喂养时不建议使用BRENZAVVY。

Geriatric patients: There is a higher incidence of adverse reactions related to volume depletion.

老年患者：与体积消耗有关的不良反应发生率较高。

Renal Impairment: There is a higher incidence of adverse reactions related to reduced renal function.

肾功能不全：与肾功能下降有关的不良反应发生率较高。

Hepatic Impairment: BRENZAVVY is not recommended for patients with severe hepatic impairment.

肝功能损害：对于严重肝功能损害的患者，不建议使用Brenzavvvy。

DRUG INTERACTIONS:

药物相互作用：

Inducers of UGT1A9 could result in more rapid clearance of BRENZAVVY by metabolism. Doses of insulin and sulfonylureas may need to be reduced to offset the action of BRENZAVVY. The safety of BRENZAVVY is compromised when it is coupled with insulin or an insulin secretagogue (sulfonylureas and meglitinides – the latter rarely used in the US).

。可能需要减少胰岛素和磺脲类药物的剂量以抵消Brenzavvvy的作用。当Brenzavvvy与胰岛素或胰岛素促分泌剂（磺脲类和美格列奈类药物-后者在美国很少使用）结合使用时，其安全性会受到损害。

Lithium carbonate is used as a mood stabilizer in bipolar disorder. Lithium ions might be preferentially (compared to sodium ions) taken up with glucose in the kidney. Empirical evidence has shown that lithium levels can be lower when SGLT2 inhibitors are administered. SGLT2 inhibitors produce pronounced glucosuria, which makes urine testing for glucose diagnostically useless.

碳酸锂被用作双相情感障碍的情绪稳定剂。锂离子可能优先（与钠离子相比）被肾脏中的葡萄糖吸收。经验证据表明，当施用SGLT2抑制剂时，锂水平可能较低。SGLT2抑制剂会产生明显的糖尿症，这使得尿液葡萄糖检测在诊断上无用。

Measurements of 1,5-anhydroglucitol are also compromised..

1,5-脱水葡萄糖醇的测量也受到影响。。

For additional important safety information about BRENZAVVY, please see the full Prescribing Information.

有关BRENZAVVY的其他重要安全信息，请参阅完整的处方信息。

About TheracosBio

关于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.

TheracosBio成立于2000年，开发价格合理的新型疾病治疗药物，对社会产生重大影响。TheracosBio的使命是扩大常见疾病患者获得新药的机会。

About BAMCO

关于BAMCO

Since our founding in 2023, BAMCO Africa has prioritized oncology and cardio-metabolic diseases, working closely with governments and other partners across select Sub-Saharan African countries. We collaborate to address unique healthcare challenges, co-create sustainable solutions, and implement them for long-term societal and patient benefit.

自2023年成立以来，BAMCO Africa一直将肿瘤学和心脏代谢疾病列为优先事项，并与撒哈拉以南非洲国家的政府和其他合作伙伴密切合作。我们合作应对独特的医疗保健挑战，共同创造可持续的解决方案，并实施这些解决方案以实现长期的社会和患者利益。

The mission of BAMCO Africa is to make standard of care medicines affordable and available in Sub Saharan Africa through partnerships, medical education, and clinical research..

BAMCO非洲公司的使命是通过伙伴关系、医学教育和临床研究，使撒哈拉以南非洲地区的标准护理药物价格合理且可用。。