河北道恩药业有限公司（前途汇VIP会员单位、首届一致性评价药交会参会单位）于2014年9月9日正式注册成立，为河北天成药业股份有限公司的全资子公司。河北道恩药业有限公司以打造专业抗肿瘤药的研发、生产、销售为目标，按照欧盟、美国FDA和中国等相关药品生产质量管理标准为依据，高标准设计、建设抗肿瘤药生产车间，采用国际先进的制药设备为技术保障，占地面积7700.4平方米，建筑面积3420平方米。

Hebei Dawn Pharma, as the wholly ownedsubsidiary of HEBEI TIANCHENG PHARMA, was officially established at 9thSeptember 2014. With goal of building a professional enterprise for R&D,manufacturing and sales of oncology drugs, advanced pharmaceutical plant wasdesigned and built according to the requirements of EU GMP, US FDA cGMP andCFDA GMP standards, which is equiped with worldwide advanced pharmaceuticalequipments as technology assurance and covers an area of 7700.4m2 and buildingarea of 3420 m2.

河北道恩药业有限公司建有非无菌原料药、口服固体制剂（片剂、胶囊剂）、注射剂（非终端灭菌注射剂、冻干粉针剂）3个车间，其中包含仓储、QC实验室系统，车间设施及质量控制系统、仓储系统均按照中国cGMP、FDA cGMP和EU GMP要求设计施工，配备的设备设施均来自国内外知名的设施设备生产商，并配备了完善的EU GMP软件系统。

Hebei Dawn Pharma contains 3 workshops:Non-sterile API Workshop, Solid Oral Dosage Form Workshop (Tablets andCapsules) and Injection Workshop (Non-terminal Sterilized Injection / LyophilizedPowder for Injection)  including thewarehousing system and QC system. All workshops & facilities, QualityControl System, Warehousing System were designed and built according to therequirements of FDA cGMP and EU GMP. Advanced facilities & equipment werepurchased from domestic and international famous suppliers, and equiped withcomprehensive EU GMP software system.

河北道恩药业有限公司于2015年7月正式建成。通过自主研发、仿创结合的方式，开发了多种替尼类小分子靶向制剂和脂质体注射剂。公司组建了专业的人才团队正在积极筹备国际认证准备工作，并按照公司制订的“抗肿瘤药走国际化路线、进入国际管制医药市场”的发展战略进行企业转型和产业升级。

Hebei Dawn Pharma was put into use in July2015. By the activities of independent R&D and combination of innovativedrugs and generic drugs, Hebei Dowen Pharma has developed kinds of tinib small moleculetargeting formulation and liposome injection. Professional talents team wasorganized to prepare international certification, and entriprise transformationand upgrading is in progress according to Hebei Dawn Pharma  stragety of “Oncology drugs should realizethe internationalization and enter global regulated markets”.

目前，河北道恩药业有限公司正在紧锣密鼓的进行准备工作，我们在葡萄牙市场的两个上市许可已经完成了生产地址变更手续，并于2018年7月通过欧盟GMP认证，这将为企业的后续发展提供一条新的道路。道恩药业具有素质过硬的研发团队，可以承接委托研发及合作研发项目。盐酸多柔比星脂质体注射液的药学研发部分已接近尾声，后期的BE实验也正在准备当中。同时，我们研发的注射用硼替佐米，也取得了突破性进展。

At present, Hebei Dawn Pharma is in busywith preparation work for GMP certification. We already finished themanufacturer transfer procedure of two MA in Portugal market, and the EU GMPinspection is as planned in July 2018, which shall provide a new way for ourfollowing development. With the professional R&D team, Hebei Dowen Pharmais able to undertake customize R&D project and contract R&D project.The Pharmaceutical study part of Doxorubicin Hydrochloride Liposome Ijection isnearly complete and the following BE study is in preparation. At the same time,we have achieved a significant progress in the R&D work of Bortezomib forInjection.

道恩药业具有先进的设备设施及完善的质量体系。无菌罐装系统采用BOSH自动称量设备及计算机系统，能够做到支支称量及自动调节，从而达到精确装量。质量管理体系已经过多次欧盟、美国和中国GMP专家的审核并得到了充分的肯定。道恩药业可以承接符合欧盟、美国及中国的OEM委托加工订单；具有欧盟、美国及中国的药品注册及GMP认证经验，可以承接MA批件转移及MA批件注册等相关工作。

Hebei Dawn Pharma owns advanced equipment& facilities and complete quality system. The aseptic filling system adoptsBOSH automatic weighing equipment and computer system, which can achieve accuratefilling via realizing the weighing 100% and automatic adjustment. Our qualitymanagement system has been reviewed by EU, US and Chinese GMP experts manytimes and fully comfirmed. Hebei Dowen Pharm can undertake OEM business in linewith EU, US and China. Also, our team has the registration experience in EU, USand China and GMP certification experience, which helps Hebei Dowen Pharma toundertake related work such as MA transfer and MA registration.

道恩药业的企业宗旨是为世界上不同国家的患者生产和供应可负担得起的抗癌药，抗癌药业务范围包括生产和供应、委托加工服务、已有市场许可及其技术转移。道恩药业拥有强大的技术团队，是保障抗肿瘤药进入欧美市场的强大动力！

The enterprise objective of Hebei DawnPharma is to manufacture and supply affordable oncology drugs for patients indifferent countries around the world. The business scope of oncology drugs includesManufacturing and Supplying, Contract Manufacturing Service, Ready MarketAuthorization and Technology Transfer. Hebei Dowen Pharma has a strength technicalteam, which is the powerful driving force to launch oncology drugs into EU andUS markets !