Development of Monoclonal Antibodies in China: Overview and Prospects

Table 3

Clinical trial of mAbs in China.

Number	Registry number and scientific title	mAb	Year	Applicant’s institution	Funding	Target disease	Study phase	Drug combination
1	(ChiCTR-ONC-13003646); Function of ranibizumab intraocular injection in the control of neovascular glaucoma	Ranibizumab	2013	Qilu Hospital of Shandong University	①	Neovascular glaucoma	Post-market	No
2	(ChiCTR-RCS-13003158); VEGF gene polymorphisms predict of bevacizumab in the treatment of advanced breast cancer research	Bevacizumab	2013	South China University of Technology	Chinese Anti-Cancer Association	Breast cancer	Phase II	No
3	(ChiCTR-ONC-12002442); Clinical study of chemoimmunotherapy with fresh frozen plasma, high dose methylprednisolone, and rituximab for ultra-high risk chronic lymphocytic leukemia	Rituximab	2012	The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital	Investigator sponsored	Ultra-high risk chronic lymphocytic leukemia	Phase III	No
4	(ChiCTR-ONRC-12002397); Neoadjuvant chemotherapy of bevacizumab, gemcitabine, and cisplatin in stage III NSCLC	Bevacizumab	2012	The First Affiliated Hospital of Guangzhou	N/A	NSCLC	Phase II	Yes
5	(ChiCTR-ONC-12002130); Open-Label, uncontrolled, multicenter phase II study of cisplatin and 5-Fu combined with nimotuzumab as first-line treatment in patients with untreated metastatic nasopharyngeal carcinoma	Nimotuzumab	2012	Sun Yat-Sen University	Biotech	Metastatic nasopharyngeal carcinoma	Phase II	Yes
6	(ChiCTR-TRC-11001556); Optimization treated clinical research for I-131 metuximab injection combined with chemoembolization for HCC	Metuximab	2011	Chengdu Huasun	Chengdu Huasun	HCC	Post-market	Yes
7	(ChiCTR-TNC-11001145); A phase II study of neoadjuvant chemotherapy and IMRT combined with cetuximab in advanced T stage of nasopharyngeal carcinoma	Cetuximab	2011	Sun Yat-Sen University	Merck	Nasopharyngeal carcinoma	Phase II	Yes
8	(ChiCTR-TRC-10001060); Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: double-blind, randomized, placebo-controlled trial	Infliximab	2010	Shanghai Changzheng Hospital	CPGJ	Rheumatoid arthritis	Phase III	No
9	(ChiCTR-TNC-10000798); Rituximab in the treatment of severe lupus myelopathy: a prospective, open-label pilot trial	Rituximab	2010	Shanghai JiaoTong University, Renji Hospital	Shanghai Jiaotong University, Renji Hospital	Lupus myelopathy	Post-market	Yes
10	(ChiCTR-TNC-09000606); Triple therapy for diabetic macular edema: intravitreal bevacizumab, triamcinolone acetonide, and macular photocoagulation	Bevacizumab	2010	N/A	Hospital of Talmologico de Sorocaba	Diabetic macular edema	Phase III	Yes
11	(ChiCTR-TNC-08000116); Open, multicenter study of cetuximab combined with IMRT and concurrent chemotherapy of cisplatin in nasopharyngeal carcinoma	Cetuximab	2008	Sun Yat-sen University	Merck	Nasopharyngeal carcinoma	Post-market	Yes
12	(ChiCTR-TRC-08000108); Clinical study of MabThera (Rituximab) and chemotherapy for the treatment in NHL	Rituximab	2008	Fujian Tumor Hospital	Self-supported	NHL	Post-market	Yes

Notes: “Primary Sponsor” is the experiment contract organization, “Funding” represents the resource of fund, from which institutions or others. “①” is The Independent Innovation Foundation to Universities and Colleges by Jinan Science and Technology Bureau. “NSCLC” is “non-small-cell lung cancer.” “NHL” is short for non-Hodgkin’s lymphoma. “HCC” is Hepatocellular Carcinoma. “CPGJ” is Shanghai CP Guojian Pharmaceutical Co., Ltd.
Source: http://www.chictr.org/en/.