生化医药专利中英互译翻译案例展示

生化医药专利中译英（节选自公开文本：CN116462660A）

Translated by ZWX on Jan. 10, 2024, Reviewed by ZHF

中文原文：

一种异喹啉酮类化合物的盐及其晶型

1.式（I）所示化合物的可药用盐，其中所述可药用盐选自对甲苯磺酸盐、甲磺酸盐、磷酸盐、盐酸盐和氢溴酸盐，

式I。

2.根据权利要求1所述的可药用盐，其特征在于，所述式（I）所示化合物与酸分子的化学配比为5:1～1:5，优选3:1、2:1、1:1、1:2、1:3、1:4或1:5，最优选2:1、1:1或1:2。

3.式（I）所示化合物的可药用盐的晶型，其选自：

式I，

式（I）所示化合物对甲苯磺酸盐的a晶型，其特征在于，以衍射角2θ角度表示的X-射线粉末衍射图，在5.787、6.961、9.961、15.756、21.717、23.539和26.272处有特征峰，优选以衍射角2θ角度表示的X-射线粉末衍射图谱如图1所示。

4.一种药物组合物，含有权利要求1或2所述的可药用盐，或权利要求3所述的式（I）所示化合物的可药用盐的晶型，和任选自药学上可接受的载体、稀释剂或赋形剂。

5.一种药物组合物的制备方法，包括将权利要求1或2所述的可药用盐，或权利要求3所述的式（I）所示化合物的可药用盐的晶型，与药学上可接受的载体、稀释剂或赋形剂混合的步骤。

6.权利要求1或2所述的可药用盐，或权利要求3所述的式（I）所示化合物的可药用盐的晶型，或权利要求4所述的药物组合物，或由权利要求5所述方法制备得到的组合物在制备用于治疗和/或预防与CRBN蛋白相关疾病的药物中的用途。

7.权利要求1或2所述的可药用盐，或权利要求3所述的式（I）所示化合物的可药用盐的晶型，或权利要求4所述的药物组合物，或由权利要求5所述方法制备得到的组合物在制备用于治疗和/或预防癌症、与血管生成相关的病症、疼痛、黄斑变性或相关综合征、皮肤病、肺部疾病、石棉相关疾病、寄生虫病、免疫缺陷病、CNS疾病、CNS损伤、动脉粥样硬化或相关病症、睡眠障碍或相关病症、感染性疾病、血红蛋白病或相关病症、或TNFα相关病症的药物中的用途；优选地，在制备用于治疗和/或预防癌症或CNS损伤的药物中的用途。

英文译文

SALT AND CRYTAL FORM OF ISOQUINOLONE COMPOUND

1. A pharmaceutically acceptable salt of the compound shown in Formula (I), wherein the pharmaceutically acceptable salt is selected from the group consisting of p-toluenesulfonate, methanesulfonate, phosphate, hydrochloride, and hydrobromide,

Formula I.

2. The pharmaceutically acceptable salt of claim 1, wherein the chemical ratio of the compound shown in Formula (I) to the acid molecule is 5:1-1:5, preferably 3:1, 2:1, 1:1, 1:2, 1:3, 1:4 or 1:5, most preferably 2:1, 1:1 or 1:2.

3. A crystal form of the pharmaceutically acceptable salt of the compound shown in Formula (I), being selected from the group consisting of:

Formula I,

a crystal form A of p-toluenesulfonate of the compound shown in Formula (I), wherein in the X-ray powder diffraction pattern represented by a diffraction angle 2θ, there are characteristic peaks at 5.787, 6.961, 9.961, 15.756, 21.717, 23.539 and 26.272, preferably the X-ray powder diffraction pattern represented by the diffraction angle 2θ is as shown in Figure 1.

4. A pharmaceutical composition comprising the pharmaceutically acceptable salt of claim 1 or 2, or the crystal form of the pharmaceutically acceptable salt of the compound shown in Formula (I) of claim 3, and optionally a pharmaceutically acceptable carrier, diluent, or excipient.

5. A preparation method of a pharmaceutical composition, comprising a step of mixing the pharmaceutically acceptable salt of claim 1 or 2, or the crystal form of the pharmaceutically acceptable salt of the compound shown in Formula (I) of claim 3 and a pharmaceutically acceptable carrier, diluent, or excipient.

6. Use of the pharmaceutically acceptable salt of claim 1 or 2, or the crystal form of the pharmaceutically acceptable salt of the compound shown in Formula (I) of claim 3, or the pharmaceutical composition of claim 4, or the composition prepared by the method of claim 5 in the manufacturing of a medication for the treatment and/or prevention of CRBN protein related diseases.

7. Use of the pharmaceutically acceptable salt of claim 1 or 2, or the crystal form of the pharmaceutically acceptable salt of the compound shown in Formula (I) of claim 3, or the pharmaceutical composition of claim 4, or the composition prepared by the method of claim 5 in the manufacturing of a medication for the treatment and/or prevention of cancers, angiogenesis related disorders, pains, macular degeneration or related syndromes, skin diseases, lung diseases, asbestos-related diseases, parasitic diseases, immunodeficiency diseases, CNS diseases, CNS injuries, atherosclerosis or related disorders, sleep disorders or related conditions, infectious diseases, hemoglobinopathy or related disorders, or TNFα-related disorders, preferably in the manufacturing of a medication for the treatment and/or prevention of cancers or CNS injuries.

生化医药专利英译中（节选自公开文本：US20230406951A1）

Translated by ZWX on Jan. 10, 2024, Reviewed by ZHF

英文原文：

Anti-TNFR2 antibodies and methods of use thereof

1. An isolated antibody that specifically binds to TNFR2, a heavy chain variable region (VH) and a light chain variable region (VL), comprising one or more selected from the group consisting of

(i) comprising the CDR-H1, CDR-H2, and CDR-H3 sequences of a VH sequence selected from the group consisting of SEQ ID NO: 30, SEQ ID NO: 13, SEQ ID NO: 19, SEQ ID NO: 21, SEQ ID NO: 22, and SEQ ID NO: 29; and the CDR-L1, CDR-L2, and CDR-L3 sequences of a VL sequence selected from the group consisting of SEQ ID NO: 9, SEQ ID NO: 6, SEQ ID NO: 8, and SEQ ID NO: 4;

(ii) a CDR-L1 sequence according to SEQ ID NO: 1; a CDR-L2 sequence according to SEQ ID NO: 7, and a CDR-L3 sequence according to SEQ ID NO: 3, and a CDR-H1 sequence according to SEQ ID NO: 10; a CDR-H2 sequence according to SEQ ID NO: 20; a CDR-H3 sequence according to SEQ ID NO: 12; and

(iii) a CDR-L1 sequence according to SEQ ID NO: 1; a CDR-L2 sequence according to SEQ ID NO: 2, and a CDR-L3 sequence according to SEQ ID NO: 3, and a CDR-H1 sequence according to SEQ ID NO: 10; a CDR-H2 sequence according to SEQ ID NO: 11; a CDR-H3 sequence according to SEQ ID NO: 12.

2. The antibody of claim 1, comprising one or both of

(i) a VH framework sequence derived from a human germline VH sequence selected from the group consisting of IGHV1-46, IGHV4-31, IGHV4-30-4, and IGHV4-4; and

(ii) a VL framework sequence derived from a human germline VL sequence selected from the group consisting of IGKV1-9, IGKV1-33, IGKV1-27, IGKV1-39, IGKV1-9, IGKV1-1, and IGKV1-11.

3. The antibody of claim 1, wherein the VL comprises an amino acid sequence according to a sequence selected from the group consisting of SEQ ID NO: 8 and SEQ ID NO: 4, and wherein the VH comprises an amino acid sequence according to a sequence selected from the group consisting of SEQ ID NO: 21 and SEQ ID NO: 13.

4. The antibody of claim 1, comprising the VH sequence of SEQ ID NO: 21, and the VL of SEQ ID NO: 8.

5. The antibody of claim 1, further comprising an Fc domain, wherein the Fc domain is the Fc domain of an IgA, IgD, IgE, IgM, or IgG.

6. The antibody of claim 1, further comprising one or both of a heavy chain (HC) comprising a sequence in accordance with SEQ ID NO: 22, And a light chain (LC) comprising a sequence in accordance with SEQ ID NO: 9.

7. The antibody of claim 1, comprising a first Fab, second Fab, third Fab, and fourth Fab wherein the first Fab, second Fab, third Fab, and fourth Fab each comprise a CDR-L1 sequence according to SEQ ID NO: 1; a CDR-L2 sequence according to SEQ ID NO: 7, and a CDR-L3 sequence according to SEQ ID NO: 3, and a CDR-H1 sequence according to SEQ ID NO: 10; a CDR-H2 sequence according to SEQ ID NO: 20; a CDR-H3 sequence according to SEQ ID NO: 12.

8. The antibody of claim 7, wherein the first Fab, second Fab, third Fab, and fourth Fab each comprise a VH with a sequence according to SEQ ID NO: 21 and a VL with a sequence according to SEQ ID NO: 8.

中文译文：

抗TNFR2抗体及其使用方法

1、一种特异性结合TNFR2、重链可变区（VH）和轻链可变区（VL）的分离抗体，其包含选自以下中的一种或多种：

（i）包含VH序列的CDR-H1、CDR-H2、和CDR-H3序列，所述VH序列选自SEQ ID NO: 30、SEQ ID NO: 13、SEQ ID NO: 19、SEQ ID NO: 21、SEQ ID NO: 22、和SEQ ID NO: 29；和VL序列的CDR-L1、CDR-L2、和CDR-L3序列，所述VL序列选自SEQ ID NO: 9、SEQ ID NO: 6、SEQ ID NO: 8、和SEQ ID NO: 4；

（ii）根据SEQ ID NO:1所示的CDR-L1序列；根据SEQ ID NO:7所示的CDR-L2序列，和根据SEQ ID NO:3所示的CDR-L3序列，和根据SEQ ID NO:10所示的CDR-H1序列；根据SEQ ID NO:20所示的CDR-H2序列；根据SEQ ID NO:12所示的CDR-H3序列；和

（iii）根据SEQ ID NO:1所示的CDR-L1序列；根据SEQ ID NO:2所示的CDR-L2序列，和根据SEQ ID NO:3所示的CDR-L3序列，和根据SEQ ID NO:10所示的CDR-H1序列；根据SEQ ID NO:11所示的CDR-H2序列；根据SEQ ID NO:12所示的CDR-H3序列。

2、根据权利要求1所述的抗体，包含以下中的一种或两种：

（i）衍生自选自IGHV1-46、IGHV4-31、IGHV4-30-4和IGHV4-4的人类种系VH序列的VH框架序列；和

（ii）衍生自选自IGKV1-9、IGKV1-33、IGKV1-27、IGKV1-39、IGKV1-9、IGKV1-1和IGKV1-11的人类种系VL序列的VL框架序列。

3、根据权利要求1所述的抗体，其中，所述VL包含根据选自SEQ ID NO: 8和SEQ ID NO: 4的序列所示的氨基酸序列，并且其中，所述VH包含根据选自SEQ ID NO: 21和SEQ ID NO: 13的序列所示的氨基酸序列。

4、根据权利要求1所述的抗体，包含SEQ ID NO:21的VH序列和SEQ ID NO:8的VL。

5、根据权利要求1所述的抗体，还包含Fc结构域，其中，所述Fc结构域是IgA、IgD、IgE、IgM、或IgG的Fc结构域。

6、根据权利要求1所述的抗体，还包含重链（HC）和轻链（LC）中的一个或两个，所述重链（HC）包含根据SEQ ID NO:22所示的序列，且所述轻链（LC）包含根据SEQ ID NO:9所示的序列。

7、根据权利要求1所述的抗体，包含第一Fab、第二Fab、第三Fab和第四Fab，其中所述第一Fab、第二Fab、第三Fab和第四Fab各自包含根据SEQ ID NO:1所示的CDR-L1序列；根据SEQ ID NO:7所示的CDR-L2序列，和根据SEQ ID NO:3所示的CDR-L3序列，和根据SEQ ID NO:10所示的CDR-H1序列；根据SEQ ID NO:20所示的CDR-H2序列；根据SEQ ID NO:12所示的CDR-H3序列。

8、根据权利要求7所述的抗体，其中，所述第一Fab、第二Fab、第三Fab和第四Fab各自包含具有根据SEQ ID NO:21所示的序列的VH和具有根据SEQ ID NO:8所示的序列的VL。