South San Francisco, CA -- June 16, 2025 --

加利福尼亚州南旧金山 -- 2025年6月16日 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta

基因泰克（罗氏集团成员，SIX: RO, ROG；OTCQX: RHHBY）与艾伯维今天宣布了III期VERONA研究（NCT04401748）中关于Venclexta的结果。

®

®

(venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall survival at the final analysis. The safety profile of the Venclexta combination was consistent with the known risk of the individual study medicines and no unexpected safety signals were observed.

（维奈托克）加阿扎胞苷用于既往未经治疗的高危骨髓增生异常综合征（MDS）患者。该研究在最终分析时未达到总生存期的主要终点。Venclexta组合的安全性与已知的个别研究药物的风险一致，未观察到意外的安全信号。

Full data will be presented at an upcoming medical meeting in 2025..

完整的数据将在2025年即将召开的医学会议上公布。

VERONA is a global, AbbVie-led, Phase III, multicenter, randomized, double-blind study evaluating Venclexta in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve patients with higher-risk MDS. The study includes approximately 500 patients across 220 sites globally who were randomly assigned to either Venclexta plus azacitidine or placebo plus azacitidine.

VERONA 是一项全球性、由艾伯维主导的 III 期多中心、随机、双盲研究，评估维奈克拉联合阿扎胞苷对比安慰剂加阿扎胞苷在初治高危 MDS 患者中的疗效。该研究在全球 220 个研究中心招募了约 500 名患者，随机分配至维奈克拉加阿扎胞苷组或安慰剂加阿扎胞苷组。

Patients who received Venclexta in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician..

通过参与MDS临床试验接受维奈克拉与阿扎胞苷联合治疗的患者将由其主治医生告知相关信息。

The results of the VERONA study have no impact on the approved indications for Venclexta or any ongoing studies.

VERONA 研究的结果对 Venclexta 的已批准适应症或任何正在进行的研究均无影响。

About Venclexta

关于Venclexta

®

®

(venetoclax)

(维奈托克)

Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis..

Venclexta 是一种首创的靶向药物，旨在选择性结合并抑制 B 细胞淋巴瘤 2（BCL-2）蛋白。在某些血液癌症和其他肿瘤中，BCL-2 蛋白积累并阻止癌细胞死亡或自我毁灭，这一过程被称为细胞凋亡。Venclexta 阻断 BCL-2 蛋白，并帮助恢复细胞凋亡的过程。

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers..

Venclexta由艾伯维和罗氏集团成员基因泰克共同开发。该药物在美国由两家公司联合商业化，而在美国以外则由艾伯维负责商业化。两家公司共同致力于Venclexta的研究，目前该药物正在多项临床试验中针对多种类型的血液癌症进行研究。

Venclexta

维奈克拉

®

®

(venetoclax) U.S. Indication

(维奈托克) 美国适应症

Venclexta is a prescription medicine used:

Venclexta 是一种处方药，用于：

It is not known if Venclexta is safe and effective in children.

尚不清楚Venclexta在儿童中是否安全有效。

Important Safety Information

重要安全信息

What is the most important information patients should know about Venclexta?

患者应该了解的关于维奈克拉（Venclexta）的最重要的信息是什么？

Venclexta can cause serious side effects, including:

维奈托克可引起严重副作用，包括：

Tumor lysis syndrome (TLS).

肿瘤溶解综合征 (TLS)。

TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient’s doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. .

TLS 是由癌细胞快速分解引起的。TLS 可能导致肾衰竭、需要透析治疗，并可能引发死亡。患者医生会在他们开始服用 Venclexta 之前进行测试，以评估发生 TLS 的风险。患者在开始使用 Venclexta 治疗前及治疗期间将会接受其他药物，以帮助降低 TLS 的风险。

The patient may also need to receive intravenous (IV) fluids into their vein. The patient’s doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain..

患者可能还需要接受静脉注射 (IV) 液体。患者的医生会在患者开始使用Venclexta治疗时以及治疗期间进行血液检查，以检查是否出现TLS。患者按时进行血液检测是非常重要的。如果患者在使用Venclexta治疗期间出现任何TLS症状，包括发烧、发冷、恶心、呕吐、意识模糊、呼吸急促、癫痫发作、心律不齐、尿液深色或浑浊、异常疲倦或肌肉或关节疼痛，应立即告知医生。

Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS.

患者在使用Venclexta进行治疗时应多喝水，以帮助降低TLS的风险。

Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased.

患者应该每天喝6到8杯水（总共约56盎司），从维奈托克第一次给药前2天开始，并在每次剂量增加时继续。

The patient’s doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient’s doctor may again check for the risk of TLS and change the patient’s dose.

如果患者出现副作用，患者的医生可能会延迟、减少剂量或停止使用维奈托克治疗。在停药一周或更长时间后重新开始使用维奈托克时，患者的医生可能会再次评估TLS风险并调整患者的剂量。

What patients should not take Venclexta?

哪些患者不应服用维奈托克？

Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS.

患者刚开始服用Venclexta且剂量正在缓慢增加时，由于TLS风险增加，某些药物不得同时服用。

Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they:

在服用Venclexta之前，患者必须告诉医生他们的所有健康状况，包括是否他们：

What to avoid while taking Venclexta:

服用Venclexta时应避免的事项：

Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood.

患者在服用Venclexta时不应饮用葡萄柚汁或食用葡萄柚、塞维利亚橙（常用于制作橘子酱）或杨桃。这些产品可能会增加患者血液中Venclexta的含量。

What are the possible side effects of Venclexta?

维奈托克可能有哪些副作用？

Venclexta can cause serious side effects, including:

维奈托克可能会导致严重的副作用，包括：

Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta.

患者在使用Venclexta治疗期间，如果出现发烧或任何感染迹象，应立即告知医生。

The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include

当维奈克拉与奥比妥珠单抗或利妥昔单抗联合使用，或单独用于治疗CLL或SLL患者时，最常见的副作用包括

low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet.

白细胞计数低；血小板计数低；红细胞计数低；腹泻；恶心；上呼吸道感染；咳嗽；肌肉和关节疼痛；疲倦；以及手臂、腿部、手和脚的肿胀。

The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include

维奈克拉与阿扎胞苷或地西他滨或小剂量阿糖胞苷联合使用时，在急性髓系白血病患者中最常见的副作用包括

nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure..

恶心；腹泻；血小板减少；便秘；白细胞减少；伴有白细胞减少的发热；疲倦；呕吐；手臂、腿部、手或脚肿胀；发热；肺部感染；呼吸急促；出血；红细胞减少；皮疹；腹痛；血液感染；肌肉和关节疼痛；头晕；咳嗽；喉咙痛；低血压。

Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.

维奈托克可能会导致男性生育问题。这可能影响生育能力。如果患者对生育能力有疑虑，应咨询医生。

These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects.

这些并非 Venclexta 的所有可能副作用。患者应致电医生咨询有关副作用的医疗建议。

You may report side effects to the FDA at (800) FDA-1088 or

您可以向 FDA 报告副作用，电话号码是 (800) FDA-1088 或者

http://www.fda.gov/medwatch

http://www.fda.gov/medwatch

. You may also report side effects to Genentech at (888) 835-2555.

您也可以通过拨打（888）835-2555向基因泰克报告副作用。

Please see the Venclexta full

请参阅Venclexta完整版

Prescribing Information

处方信息

, including the

，包括

Medication Guide

药品指南

, for additional Important Safety Information.

，以获取更多重要的安全信息。

About Genentech in Hematology

关于基因泰克在血液学领域

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit

二十多年来，基因泰克一直致力于开发药物，旨在重新定义血液学领域的治疗方法。如今，我们正在加大力度投资，努力为血液病患者带来创新的治疗选择。欲了解更多信息，请访问

http://www.gene.com/hematology

http://www.gene.com/hematology

.

。

About Genentech

关于基因泰克

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

成立于40多年前的基因泰克是一家领先的生物技术公司，致力于发现、开发、制造和销售用于治疗患有严重和危及生命疾病的药物。该公司是罗氏集团的成员，总部位于加利福尼亚州南旧金山。

For additional information about the company, please visit .

有关公司的更多信息，请访问 。

http://www.gene.com

http://www.gene.com

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