Osaka and Tokyo, Japan, August 25, 2025 - Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) and Bristol-Myers Squibb K.K. (Headquarters:Tokyo, Japan; President: Hidehito Katsuma; “BMSKK”) today announced that the companies have received a supplemental approval of Ono’s anti-PD-1 antibody, Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”) and BMSKK’s anti-CTLA-4 antibody, Yervoy® (generic name: ipilimumab) Injection (“Yervoy”) in combination therapy in Japan, to expand the use for the treatment of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer.

日本大阪和东京，2025年8月25日 — 小野药品工业株式会社（总部：日本大阪；总裁兼首席运营官：泷野藤一；“小野制药”）与百时美施贵宝日本公司（总部：日本东京；总裁：胜又秀人；“BMSKK”）今日宣布，两家公司已获得小野制药的抗PD-1抗体Opdivo®（通用名：纳武利尤单抗）静脉注射剂（“Opdivo”）与BMSKK的抗CTLA-4抗体Yervoy®（通用名：伊匹木单抗）注射剂（“Yervoy”）联合疗法的补充批准，扩大其在日本用于治疗不可切除的晚期或复发性高微卫星不稳定性（MSI-High）结直肠癌的使用范围。

This approval is related to the additional indication for a partial change in approved items of the manufacturing and marketing approval in Japan..

该批准与日本制造和上市许可中已批准项目部分变更的额外适应症有关。

This approval is based on the results from the CheckMate-8HW study, a global multi-center Phase 3 clinical study (CA209-8HW: ONO-4538-87), evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice of chemotherapy* in patients with unresectable advanced or recurrent MSI-High or mismatch repair deficient (dMMR) colorectal cancer.

该批准基于 CheckMate-8HW 研究的结果，这是一项全球多中心的 3 期临床研究（CA209-8HW：ONO-4538-87），评估了 Opdivo 加 Yervoy 与单独使用 Opdivo 或研究者选择的化疗*在不可切除的晚期或复发性 MSI-High 或错配修复缺陷 (dMMR) 结直肠癌患者中的效果。

In this study, Opdivo plus Yervoy demonstrated a clinically meaningful improvement in one of the dual primary endpoints of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) compared to investigator’s choice of chemotherapy in previously untreated patients with centrally confirmed MSI-High or dMMR colorectal cancer at a pre-specified interim analysis.

在此项研究中，与研究者选择的化疗相比，Opdivo联合Yervoy在预先设定的中期分析中，对于既往未接受治疗且经中心确认为MSI-High或dMMR的结直肠癌患者，根据盲态独立中心审查（BICR）评估，其中一个双重主要终点无进展生存期（PFS）显示出具有临床意义的改善。

In addition, Opdivo plus Yervoy demonstrated a clinically meaningful improvement in another primary endpoint of PFS assessed by BICR, compared to Opdivo alone in patients across all lines of treatment. The safety profile of Opdivo plus Yervoy remained consistent with previously reported data, with no new safety signals identified..

此外，与单独使用Opdivo相比，Opdivo联合Yervoy在所有治疗线的患者中，通过BICR评估的另一个主要终点PFS显示出具有临床意义的改善。Opdivo联合Yervoy的安全性与之前报告的数据保持一致，未发现新的安全性信号。

Any one of the following regimens was selected: mFOLFOX6 (5-fluorouracil, folinic acid, and oxaliplatin), mFOLFOX6 with bevacizumab or cetuximab, FOLFIRI (5-fluorouracil, folinic acid, and irinotecan), or FOLFIRI with bevacizumab or cetuximab.

选择了以下方案之一：mFOLFOX6（5-氟尿嘧啶、亚叶酸钙和奥沙利铂）、加贝伐单抗或西妥昔单抗的mFOLFOX6、FOLFIRI（5-氟尿嘧啶、亚叶酸钙和伊立替康）、或加贝伐单抗或西妥昔单抗的FOLFIRI。

Opdivo and Yervoy were designated as orphan drugs by the Ministry of Health, Labour and Welfare with the indication of unresectable, advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer in September 2024.

2024年9月，Opdivo和Yervoy被厚生劳动省指定为治疗无法切除、晚期或复发性高微卫星不稳定性（MSI-High）结直肠癌的孤儿药。

With respect to the indication of colorectal cancer, Opdivo was approved as monotherapy in February 2020 and in combination with Yervoy in September 2020 for the indication of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer that has progressed following chemotherapy..

关于结直肠癌的适应症，Opdivo于2020年2月被批准作为单一疗法，并于2020年9月与Yervoy联合用于治疗不可切除的晚期或复发性微卫星不稳定性高（MSI-High）结直肠癌，这些患者在接受化疗后病情有所进展。

About CheckMate-8HW Study (CA209-8HW: ONO-4538-87)

关于CheckMate-8HW研究（CA209-8HW：ONO-4538-87）

CheckMate-8HW study is a global multi-center, randomized, open-label Phase III clinical study evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice of chemotherapy (mFOLFOX6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with unresectable advanced or recurrent microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer..

CheckMate-8HW研究是一项全球多中心、随机、开放标签的III期临床研究，评估Opdivo联合Yervoy与单独使用Opdivo或研究者选择的化疗（mFOLFOX6或FOLFIRI，联合或不联合贝伐单抗或西妥昔单抗）在不可切除的晚期或复发性高微卫星不稳定性（MSI-High）或错配修复缺陷（dMMR）结直肠癌患者中的疗效。

Approximately 830 patients were randomized to receive Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), Opdivo monotherapy (Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. Patients were treated until disease progression or unacceptable toxic effects.

大约830名患者被随机分配接受Opdivo加Yervoy（Opdivo 240 mg加Yervoy 1 mg/kg每三周一次，共四剂，随后Opdivo 480 mg每四周一次）、Opdivo单药治疗（Opdivo 240 mg每两周一次，共六剂，随后Opdivo 480 mg每四周一次），或研究者选择的化疗。患者持续接受治疗直至疾病进展或出现不可接受的毒性反应。

The dual primary endpoints of the study are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in previously untreated patients with centrally confirmed MSI-High or dMMR colorectal cancer, and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone in patients across all lines of therapy..

本研究的双重主要终点是：根据盲态独立中心审查（BICR），在既往未经治疗且经中心确认为MSI-High或dMMR结直肠癌患者中，Opdivo加Yervoy对比研究者选择的化疗方案的无进展生存期（PFS）；以及在所有治疗线的患者中，Opdivo加Yervoy对比单独使用Opdivo的PFS（基于BICR）。

About Colorectal Cancer

关于结直肠癌

Colorectal cancer (CRC) is the third most common cancer, with approximately 1,926,000 new cases diagnosed each year worldwide, and approximately 904,000 deaths are reported annually

结直肠癌（CRC）是第三大常见癌症，全球每年约有1,926,000例新发病例，每年报告的死亡人数约为904,000人。

. In Japan, CRC is the most common cancer, with approximately 145,000 new cases per year, and approximately 60,000 deaths are reported each year

在日本，CRC是最常见的癌症，每年大约有145,000个新病例，每年报告的死亡人数约为60,000人。

Approximately 4% of unresectable CRC patients have MSI-High or dMMR tumors

大约4%的不可切除的结直肠癌患者具有MSI-High或dMMR肿瘤。

. For unresectable advanced or recurrent MSI-High or dMMR CRC, conventional chemotherapy has not been effective enough, and the development of new therapeutic drugs is expected.

对于无法切除的晚期或复发性MSI-High或dMMR结直肠癌，传统化疗效果不够理想，期待开发新的治疗药物。

Globocan 2022. Available at:

Globocan 2022。可从以下网址获取：

Japanese Society for Cancer of the Colon and Rectum. JSCCR Guidelines 2024 for the Treatment of Colorectal Cancer

日本大肠癌学会。JSCCR 2024年结直肠癌治疗指南

Overview of Opdivo® Intravenous Infusion

Opdivo®静脉输注概述

Product name

产品名称

Opdivo® Intravenous Infusion 20 mg, 100 mg, 120 mg, and 240 mg

Opdivo® 静脉输注 20 毫克、100 毫克、120 毫克和 240 毫克

Generic name (JAN)

通用名称 (JAN)

Nivolumab (Genetical recombination)

纳武利尤单抗（基因重组）

Indication

适应症

Melanoma

黑色素瘤

Unresectable, advanced or recurrent non-small cell lung cancer

不可切除的晚期或复发性非小细胞肺癌

Neoadjuvant treatment of non-small cell lung cancer

非小细胞肺癌的新辅助治疗

Unresectable or metastatic renal cell carcinoma

不可切除或转移性肾细胞癌

Recurrent or refractory classical Hodgkin lymphoma

复发性或难治性经典霍奇金淋巴瘤

Recurrent or metastatic head and neck cancer

复发性或转移性头颈部癌症

Unresectable advanced or recurrent gastric cancer

无法切除的晚期或复发性胃癌

Unresectable advanced or recurrent malignant pleural mesothelioma

不可切除的晚期或复发性恶性胸膜间皮瘤

Malignant mesothelioma (excluding malignant pleural mesothelioma)

恶性间皮瘤（不包括恶性胸膜间皮瘤）

Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer

微卫星不稳定性高（MSI-High）不可切除的晚期或复发性结直肠癌

that has progressed after chemotherapy

化疗后进展的

Unresectable advanced or recurrent esophageal cancer

无法切除的晚期或复发性食管癌

Adjuvant treatment of esophageal cancer

食管癌的辅助治疗

Cancer of unknown primary

原发灶不明的癌症

Adjuvant treatment of urothelial carcinoma

尿路上皮癌的辅助治疗

Unresectable urothelial carcinoma

不可切除的尿路上皮癌

Unresectable advanced or recurrent malignant epithelial tumors

无法切除的晚期或复发性恶性上皮肿瘤

Unresectable hepatocellular carcinoma

无法切除的肝细胞癌

Dosage

剂量

<Melanoma>

<黑色素瘤>

Usually, for adults, administer at 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In the adjuvant therapy of melanoma, the administration period does not exceed 12 months.

通常情况下，成人每2周给予240 mg纳武利尤单抗（基因重组）或每4周给予480 mg静脉输注。在黑色素瘤的辅助治疗中，给药期不超过12个月。

In combination therapy with ipilimumab (genetical recombination) for unresectable melanoma, usually, for adults, administer 80 mg of nivolumab (genetical recombination) every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion..

在与伊匹单抗（基因重组）联合治疗不可切除的黑色素瘤时，通常成人每3周给予80毫克纳武单抗（基因重组），共4次。之后，每2周给予240毫克纳武单抗（基因重组）或每4周给予480毫克，通过静脉输注。

<Unresectable, advanced or recurrent non-small cell lung cancer, and unresectable advanced or recurrent gastric cancer>

不可切除、晚期或复发性非小细胞肺癌，以及不可切除的晚期或复发性胃癌

Usually, for adults, administer at 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常情况下，成人每2周给予240毫克的尼伏鲁单抗（基因重组）静脉输注，或每4周给予480毫克。

In combination therapy with other anti-tumor drugs, usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 360 mg every 3 weeks as intravenous infusion.

在与其他抗癌药物联合治疗时，通常成人每2周给予240毫克尼伏鲁单抗（基因重组）或每3周给予360毫克，通过静脉输注。

<Neoadjuvant treatment of non-small cell lung cancer>

非小细胞肺癌的新辅助治疗

In combination therapy with other anti-tumor drugs, usually, for adults, administer 360 mg of nivolumab (genetical recombination) every 3 weeks as intravenous infusion. The administration frequency does not exceed 3 doses.

在与其他抗肿瘤药物联合治疗时，通常成人每3周一次静脉输注360毫克纳武利尤单抗（基因重组），给药频率不超过3次。

<Unresectable or metastatic renal cell carcinoma>

<不可切除或转移性肾细胞癌>

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常情况下，成人每2周给予240毫克尼伏单抗（基因重组）静脉输注，或每4周给予480毫克。

In combination therapy with cabozantinib, usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In combination therapy with ipilimumab (genetical recombination) for unresectable or metastatic renal cell carcinoma previously untreated with chemotherapy, usually, for adults, administer 240 mg of nivolumab (genetical recombination) as intravenous infusion every 3 weeks for 4 doses.

在与卡博替尼联合治疗时，通常对于成人，每2周给予240 mg的尼伏鲁单抗（基因重组）或每4周给予480 mg静脉输注。在与伊匹单抗（基因重组）联合治疗既往未接受化疗的不可切除或转移性肾细胞癌时，通常对于成人，每3周一次、共4次剂量，给予240 mg的尼伏鲁单抗（基因重组）静脉输注。

After that, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion..

之后，每2周给予240 mg纳武利尤单抗（基因重组）静脉输注，或每4周给予480 mg。

<Recurrent or refractory classical Hodgkin lymphoma>

复发性或难治性经典霍奇金淋巴瘤

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常，对于成人，每2周给予240 mg的尼伏鲁单抗（基因重组）静脉注射，或每4周给予480 mg。

Usually, for pediatrics, administer 3 mg/kg (body weight) of nivolumab (genetical recombination) every 2 weeks as intravenous infusion. For pediatrics weighing 40 kg (body weight) or more, nivolumab (genetical recombination) can be administered at 240 mg every 2 weeks or 480 mg every 4 weeks as intravenous infusion..

通常情况下，对于儿科患者，每2周以静脉输注方式给予3 mg/kg（体重）的纳武利尤单抗（基因重组）。对于体重40 kg（体重）或以上的儿科患者，可每2周静脉输注240 mg纳武利尤单抗（基因重组），或每4周静脉输注480 mg。

<Recurrent or metastatic head and neck cancer, malignant mesothelioma (excluding malignant pleural mesothelioma), cancer of unknown primary, and unresectable advanced or recurrent malignant epithelial tumors>

复发性或转移性头颈部癌、恶性间皮瘤（不包括恶性胸膜间皮瘤）、原发不明癌症以及不可切除的晚期或复发性恶性上皮肿瘤

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常成人每2周给予240 mg尼伏鲁单抗（基因重组）静脉输注，或每4周给予480 mg。

<Unresectable advanced or recurrent malignant pleural mesothelioma>

<不可切除的晚期或复发性恶性胸膜间皮瘤>

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常情况下，成人每2周给予240毫克尼伏单抗（基因重组）静脉注射，或每4周给予480毫克。

In combination therapy with ipilimumab (genetical recombination), usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 360 mg every 3 weeks as intravenous infusion.

在与伊匹单抗（基因重组）联合治疗时，通常对于成人，每2周给予240毫克纳武单抗（基因重组）或每3周给予360毫克，通过静脉输注。

<Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer

高度微卫星不稳定（MSI-High）的不可切除的晚期或复发性结直肠癌

that has progressed after chemotherapy

化疗后进展的

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常情况下，成人每2周给予240毫克的尼伏鲁单抗（基因重组）静脉输注，或每4周给予480毫克。

In combination therapy with ipilimumab (genetical recombination), usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 3 weeks for 4 doses as intravenous infusion. After that, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion..

在与伊匹单抗（基因重组）联合治疗时，通常对于成人，每3周静脉注射240 mg纳武单抗（基因重组），共4次。之后，每2周静脉注射240 mg纳武单抗（基因重组），或每4周静脉注射480 mg。

In monotherapy with nivolumab (genetical recombination) for microsatellite instability-high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed after chemotherapy, usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion..

在使用纳武利尤单抗（基因重组）单药治疗微卫星不稳定性高（MSI-High）的不可切除晚期或复发性结直肠癌，且患者在接受化疗后病情进展的情况下，通常对于成人，每2周给予240 mg纳武利尤单抗（基因重组）或每4周给予480 mg，通过静脉输注给药。

<Unresectable advanced or recurrent esophageal cancer>

无法切除的晚期或复发性食管癌

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

通常情况下，成人每2周给予240毫克尼伏鲁单抗（基因重组）静脉输注，或每4周给予480毫克。

In combination therapy with other anti-tumor drugs, usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks, 360 mg every 3 weeks, or 480 mg every 4 weeks as intravenous infusion.

在与其他抗肿瘤药物联合治疗时，通常成人每2周给予240毫克尼伏单抗（基因重组），每3周给予360毫克，或每4周给予480毫克，通过静脉输注。

<Adjuvant treatment of esophageal cancer, adjuvant treatment of urothelial carcinoma>

食管癌的辅助治疗，尿路上皮癌的辅助治疗

Usually, for adults, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion. The administration period does not exceed 12 months.

通常情况下，成人每2周给予240 mg尼伏鲁单抗（基因重组）静脉注射，或每4周给予480 mg。给药周期不超过12个月。

<Unresectable urothelial carcinoma>

不可切除的尿路上皮癌

In combination with gemcitabine hydrochloride and platinum-containing anti-tumor drugs, usually, for adults, administer 360 mg of nivolumab (genetical recombination) every 3 weeks for 6 doses as intravenous infusion. After that, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion..

与盐酸吉西他滨和含铂类抗肿瘤药物联合使用时，通常成人每3周一次静脉注射360毫克的纳武利尤单抗（基因重组），共6剂。之后，每2周一次静脉注射240毫克或每4周一次静脉注射480毫克纳武利尤单抗（基因重组）。

<Unresectable hepatocellular carcinoma>

<不可切除的肝细胞癌>

In combination therapy with ipilimumab (genetical recombination), usually, for adults, administer 80 mg of nivolumab (genetical recombination) every 3 weeks for 4 doses as intravenous infusion. After that, administer 240 mg of nivolumab (genetical recombination) every 2 weeks or 480 mg every 4 weeks as intravenous infusion.

在与伊匹单抗（基因重组）联合治疗时，通常对成人每3周静脉注射80毫克纳武单抗（基因重组），共4次。之后，每2周静脉注射240毫克纳武单抗（基因重组），或每4周静脉注射480毫克。

About Opdivo

关于Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014.

Opdivo是一种程序性死亡受体-1（PD-1）免疫检查点抑制剂，旨在通过阻断PD-1与其配体之间的相互作用，独特地利用人体自身的免疫系统来帮助恢复抗肿瘤免疫反应。通过利用人体自身的免疫系统来对抗癌症，自2014年7月在日本获批用于治疗黑色素瘤以来，Opdivo已成为多种癌症的重要治疗选择。

Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, the US and European Union..

Opdivo目前已在65多个国家获得批准，包括日本、韩国、台湾、美国和欧盟。

In Japan, Ono launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma that has progressed after chemotherapy in August 2018, microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020, cancer of unknown primary in December 2021, adjuvant therapy of urothelial carcinoma in March 2022, malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023, unresectable advanced or recurrent malignant epithelial tumors in February 2024, unresectable urothelial carcinoma in December 2024, and unresectable hepatocellular carcinoma in June 2025..

2014年9月，小野制药在日本推出Opdivo用于治疗不可切除的黑色素瘤。此后，Opdivo在2015年12月获得用于不可切除的晚期或复发性非小细胞肺癌的额外适应症批准，2016年8月用于不可切除或转移性肾细胞癌，2016年12月用于复发或难治性经典霍奇金淋巴瘤，2017年3月用于复发或转移性头颈部癌症，2017年9月用于化疗后进展的不可切除的晚期或复发性胃癌，2018年8月用于化疗后进展的不可切除的晚期或复发性恶性胸膜间皮瘤，2020年2月用于化疗后进展的高度微卫星不稳定性（MSI-High）不可切除的晚期或复发性结直肠癌和化疗后进展的不可切除的晚期或复发性食管癌，2021年12月用于原发不明癌症，2022年3月用于尿路上皮癌的辅助治疗，2023年11月用于恶性间皮瘤（不包括恶性胸膜间皮瘤），2024年2月用于不可切除的晚期或复发性恶性上皮肿瘤，2024年12月用于不可切除的尿路上皮癌，以及2025年6月用于不可切除的肝细胞癌。

About Yervoy

关于Yervoy

Yervoy is a recombinant, human monoclonal antibody, and binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells.

Yervoy是一种重组的人源单克隆抗体，能够结合到细胞毒性T淋巴细胞相关抗原4（CTLA-4）。CTLA-4是T细胞活化的负调节因子。Yervoy与CTLA-4结合并阻止CTLA-4与其配体CD80/CD86的相互作用。CTLA-4的阻断已被证明可以增强T细胞的活化和增殖，包括肿瘤浸润T效应细胞的活化和增殖。

Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma.

抑制CTLA-4信号传导还可以降低T调节细胞功能，这可能有助于提高T细胞的总体反应性，包括抗肿瘤免疫反应。2011年3月25日，美国食品药品监督管理局（FDA）批准Yervoy 3 mg/kg单药疗法用于无法切除或转移性黑色素瘤患者。

Yervoy is now approved in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. In Japan, Yervoy was approved for the indication of unresectable malignant melanoma in July 2015..

Yervoy目前已在超过50个国家获得批准。Yervoy有针对多种肿瘤类型的广泛且正在进行的开发计划。在日本，Yervoy于2015年7月获批用于不可切除的恶性黑色素瘤的治疗。

About the Ono and Bristol Myers Squibb Collaboration

关于小野制药和百时美施贵宝的合作

In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS), Ono granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea, and Taiwan, where Ono had retained all rights to Opdivo except the US at the time. In July 2014, Ono and BMS further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea, and Taiwan..

2011年，通过与百时美施贵宝（BMS）的合作协议，小野药品将其在全球范围内开发和商业化Opdivo的领土权利授予BMS，但日本、韩国和台湾地区除外，当时小野药品在这些地区保留了除美国外的所有Opdivo权利。2014年7月，小野药品和BMS进一步扩大了双方的战略合作协议，共同开发和推广多种免疫疗法——包括单药治疗和联合方案——用于日本、韩国和台湾的癌症患者。