COMPANY OVERVIEW

Beijing Boxin Nature Biotech Ltd. has the leading R&D strength and scientific research team of new drugs in China, covering the R&D of medical devices and new specific drugs.

The company has successively undertaken the national “863” program, the military “Tenth Five-Year Plan” mandatory project, and the national “Twelfth Five-Year” science and technology major project “AIDS and viral hepatitis prevention and control” special project in 2013.

It has assembled domestic and foreign experts in various disciplines, and has deeply cooperated with the Field Blood Transfusion Institute of the Academy of Military Medical Sciences of the Chinese People‘s Liberation Army, Beijing YouAn Hospital, Capital Medical University and CDC of Henan Shangcai County to successfully develop the AIDS therapeutic apparatus

Milestones

2003
2009
2016
2017
2018
2019
August 2003
JY-1 plasma virus inactivation instrument was successfully developed
December 2009
The medical device registration certificate No.: GSYJX(Z)Z 2009 No. 3451019 was obtained
December 2016
The cooperation agreement was signed with the Infection Center of Beijing YouAn Hospital on "immune reconstitution therapy for HIV drug-resistant patients"
February 2017
In February, the first large-scale clinical trial was conducted in Beijing YouAn Hospital, Capital Medical University
May 2017
In May, the second clinical trial was conducted in the Second People's Hospital of Tianjin
April 2018
In April, the patent for invention of plasma viral inactivation instrument was applied (Patent No.: 201810368896.7)
April 2018
In April, invention patent on photochemical preparation method of autologous plasma inactivated vaccine for treatment of AIDS was obtained(Patent No: 201810368096.5)
May 2018
In May, the project "Study on the efficacy and safety of non-drug fusion blocking therapy in the treatment of HIV/AIDS" passed the acceptance by the famous national expert group on AIDS prevention and control
September 2019
In September, the clinical trials were conducted simultaneously in Chongqing, Tianjin and Beijing
September 2019
In September, the in vitro HIV standard/resistant strain inactivation validation test of BX-I AIDS therapeutic apparatus was completed in State Key Laboratory of Infectious Disease Diagnosis and Treatment (P3 Laboratory), Zhejiang University
2017年 3月
与韩国韩美制药达成战略合作
2017年 5月
PD-1单抗IBI308进入临床III期
2018年 4月
PD-1单抗信迪利注射液提交新药上市申请,并获得优先审评资格
2018年 10月
信达生物制药于香港联交所主板挂牌上市
2018年 11月
国家药品监督管理局接受信达生物的阿达木单抗注射液生物类似药的新药上市申请并获得优先审评资格
2018年 12月
与美国Incyte达成战略合作和独家开发协议
2018年 12月
PD-1单克隆抗体达伯舒®(信迪利单抗注射液)在中国正式获批
2019年 1月
达伯舒®(信迪利单抗注射液)治疗淋巴癌关键研究结果荣登《柳叶刀·血液学》封面
2019年 1月
国家药品监督管理局接受信达生物IBI305 (贝伐珠单抗注射液生物类似药)的新药上市申请并获得优先审评资格
2019年 6月
国家药品监督管理局受理IBI301(利妥昔单抗注射液生物类似药)的新药上市申请并获得优先审评资格
2019年 8月
信达生物与美国礼来制药宣布就新型糖尿病药物在中国的开发和商业化达成授权许可协议
2019年 8月
IBI303在强直性脊柱炎患者中III期关键研究结果荣登《柳叶刀·风湿病学》创刊号,获封面推荐
2019年 11月
信达生物和礼来制药共同开发的创新PD-1抑制剂达伯舒®(信迪利单抗注射液)列入新版国家医保目录