Domestic Research and Development Status of Antibody-drug Conjugates and Strategic Layout of Key Enterprises

doi:10.13523/j.cb.2105038

China Biotechnology

2021, Vol. 41

Issue (6): 105-110 DOI: 10.13523/j.cb.2105038

Domestic Research and Development Status of Antibody-drug Conjugates and Strategic Layout of Key Enterprises

CHEN Wen-jie(

),MIAO Xian-feng

Hangzhou Firestone Technology Co. Ltd., Hangzhou 310051, China

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Abstract

Antibody-drug conjugates are immunoconjugates comprised of monoclonal antibodies tethered to a cytotoxic drug via a chemical linker.It has been proven to be a promising technical method in the clinical treatment of hematologic malignancies and solid tumors.Therefore,it has newly become one of the fastest growing areas in the researching and developing of anticancer drugs at home and overseas. Five key requirements of ADCs throughout the research and pharmacuetical manufacturing process were expatiated systematically,and the pipelines and strategic layout of major domestic companies were also analyzed in order to provide a reference for the R&D layout of ADCs for the emerging companies and industrial decision for regional government.

Key words： Antibody-drug conjugates ADC Pipelines Target

Received: 14 May 2021 Published: 06 July 2021

ZTFLH:

R97

Corresponding Authors: Wen-jie CHEN E-mail: chenwj@hsmap.com

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Cite this article:

CHEN Wen-jie,MIAO Xian-feng. Domestic Research and Development Status of Antibody-drug Conjugates and Strategic Layout of Key Enterprises. China Biotechnology, 2021, 41(6): 105-110.

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https://manu60.magtech.com.cn/biotech/10.13523/j.cb.2105038 OR https://manu60.magtech.com.cn/biotech/Y2021/V41/I6/105

Fig.1 Structure and mechanism of action of ADC^[4]

公司名称	药物名称		靶点		适应证		研发状态		审评时间
荣昌生物	注射用纬迪西妥单抗(RC48)		HER2		局部晚期或转移性胃癌		申请上市		2020-08-28
					HER2低表达的局部晚期或转移性乳腺癌		Ⅲ期		2020-05-11
					HER2阴性局部晚期或转移性尿路上皮癌患者		Ⅱ期		2019-12-26
					胆道癌		Ⅱ期		2019-10-17
					HER2过表达尿路上皮癌		Ⅱ期		2019-01-08
					HER2过表达或HER2突变的晚期非小细胞肺癌		Ⅰ期		2019-05-27
	RC88		间皮素		晚期恶性实体肿瘤		Ⅰ期		2019-10-23
	RC108		c-Met		多种实体瘤		IND		2020-09-10
百奥泰	注射用BAT8001		HER2		HER2阳性的晚期乳腺癌有效性和安全性		Ⅲ期		2018-02-22
	注射用BAT8003		Trop2		晚期上皮癌		Ⅰ期		2019-04-01
多禧生物	注射用重组人源化抗Trop2单抗-Tub196偶联剂		Trop2		晚期实体瘤		Ⅰ期		2020-09-15
	注射用重组人源化抗Her2单抗-Tub114偶联剂		HER2		Her2阳性晚期乳腺癌和/或胃癌		Ⅰ期		2019-06-21
东曜药业	注射用TAA013		HER2		局部晚期或转移性HER2阳性乳腺癌患者		Ⅲ期		2020-06-03
浙江医药	ARX788		HER2		HER2阳性乳腺癌		Ⅱ/Ⅲ期		2020-08-27
					HER2阳性晚期胃癌		Ⅰ期		2019-04-18
复星医药产业	重组HER2人源化单克隆抗体单甲基奥瑞他汀F偶联剂注射液		HER2		HER2阳性的晚期乳腺癌和/或晚期恶性实体瘤		Ⅰ期		2019-04-23
科伦博泰	注射用A166		HER2		HER2表达局部晚期或转移性实体瘤		Ⅰ期		2018-08-09
	注射用SKB264		TROP-2		恶性实体瘤		IND获批		2020-10-22
交联药物/ 上海医药	注射用重组抗HER2人源化单克隆抗体-MCC-DM1偶联剂(B003)		HER2		HER2阳性的乳腺癌		Ⅰ期		2019-03-21
	注射用重组人鼠嵌合抗CD30单克隆抗体-MCC-DM1偶联剂		CD30		间变性大细胞淋巴瘤(ALCL)、霍奇金淋巴瘤(HL)和皮肤T细胞淋巴瘤(CTCL)		IND		2018-03-09
美雅珂生物	注射用MRG003		EGFR		晚期实体肿瘤		Ⅱ期		2020-09-28
	注射用MRG002		HER2		晚期实体瘤		Ⅰ期		2018-10-11
	注射用MRG001		CD20		非霍奇金淋巴瘤		IND获批		2019-05-05
石药集团	重组人源化抗HER2单抗-MMAE偶联药物注射液		HER2		HER2阳性晚期实体瘤		Ⅰ期		2019-10-29
公司名称		药物名称		靶点		适应证		研发状态	审评时间
海正药业		注射用重组抗HER2人源化单克隆抗体偶联美登素衍生物DM1		HER2		乳腺癌		Ⅰ期	2019-06-18
		注射用重组抗人表皮生长因子受体人源化单克隆抗体偶联海兔毒素衍生物DUO5		HER2		HER2阳性晚期实体瘤		IND	2018-03-30
浙江特瑞思药业		注射用重组抗CD20单抗-MMAE偶联剂(注射用TRS005)		CD20		复发或难治的CD20阳性B细胞非霍奇金淋巴瘤		Ⅰ期	2018-11-29
恒瑞医药		注射用SHR-A1201		HER2		乳腺癌		Ⅰ期	2019-08-13
		注射用SHR-A1403		c-Met		晚期实体瘤		Ⅰ期	2019-01-31
齐鲁制药		注射用重组抗HER2人源化单克隆抗体-DM1		HER2		乳腺癌		IND获批	2017-01-05
三生国健		注射用重组抗HER2人源化单抗-DM1偶联物		HER2		实体瘤		IND	2017-08-24

Table 1 Antibody-drug conjugate (ADC) pipelines of major domestic companies

Fig.2 Domestic R&D pipelines for popular targets of ADCs

Fig.3 Distribution of indications for domestic ADCs


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