【故事】海康生物：血液制品行业的突围者

在温州市鹿城区里垟新路，很难想象这里还隐立着海康生物这么一家高新技术企业。上世纪八九十年代的厂房外观，与周围崭新的住宅楼盘形成鲜明的对比，也让这家走过近30年风雨的企业，更有时代的印迹。

从温州市中心血站剥离的小企业起家，到现在驰骋于国家高新技术企业之列，同时也是省内唯一一家血液制品生产企业。海康生物的崛起，与其说是时势造就的英雄，不如说是主动求生的突围者。

从原材料的突围到体制机制的突围，从产品研发的突围到工艺提升的突围，在“老血站人”沈荣杰的带领下，海康生物突出重围、异军突起，依托三家单采血浆原料基地，让温州乃至全省的血液制品从无到有、从有到优。

一、艰难原料路，十年建起三家采浆基地

1996年6月，根据市政府相关文件精神，温州市海螺工业集团公司（现为温州海螺集团有限公司，以下简称“海螺集团”）和浙江省血液制品所合资组建成浙江海康生物制品有限责任公司。民企牵手国营事业单位开启了一段道阻且长的新征程，也为我省血液制品行业的发展注入全新动力。CXO UNION CXO联盟 cxounion.cn

“从1996年到2006年，这是海康起步发展的第一个10年，因为还可以依托于原先浙江省血液制品所的资源发展，从原料到人才都有一定的保障，企业得以稳步前进、逐渐成长。但到了2006年3月，浙江省血液制品所完成事业单位改制后，海康生物成为海螺集团全资子公司。彻底告别体制内的安逸，转身投向市场化的激烈，我们一度陷入了发展的低谷。”回忆起企业的发展历程，在公司总经理沈荣杰看来，2006年到2016年这个十年，是海康生物真正艰难的十年。

据沈荣杰介绍，血液制品是由健康人血浆或特异性免疫人血浆为原料，通过分离、提纯、病毒灭活等生物技术制备的血浆蛋白制品，如人血白蛋白、人免疫球蛋白、人凝血因子等，主要用于烧伤、肝病、失血、休克等重症患者的救治和免疫系统缺陷、病毒感染、凝血功能障碍等疾病的诊断、治疗或被动免疫预防。因此说“血液制品是老百姓的救命药”一点也不为过。CXO UNION CXO联盟 cxounion.cn

血浆是海康生物生产血液制品的唯一原材料，且只有通过健康人群捐献这唯一来源途径。“2006年海康生物举步维艰，在浙江省没有自己的原料基地。那时候我真的是天天拿着公文包往省内各个犄角旮旯里跑。记得2008年在金华磐安县建立了海康生物第一家原料血浆基地时，我带领宣传团队几乎是挨家挨户地和村民去沟通，动员和发动他们去捐献血浆。山区的老百姓身体素质好，思想淳朴，加上捐献血浆会得到一定的经济补助，这对于山区百姓来说算是一笔额外收入，所以我们的采浆基地开始都会考虑建在偏远贫困山区。”沈荣杰说。

自身的主动出击加上省政府、省卫生健康委、温州市政府和温州市卫生健康委的大力支持。海康生物终于在这10年时间里，从原来的没有一袋浆、没有一个原料基地，陆续建成了磐安、文成、青田这三家单采血浆原料基地。目前海康生物年血浆采集量达到了70吨以上，公司也逐渐步入了正轨。CXO UNION CXO联盟 cxounion.cn

二、守住安全线，智能化数字化保障品质

对于海康生物来说，保证原料安全、生产安全、产品安全等各个环节的安全，是悬于每个海康人心上的一把利剑，也是企业安身立命的根本。CXO UNION CXO联盟 cxounion.cn

“血液制品是一个特殊行业，对生产环境有非常严苛的消毒程序。”沈荣杰介绍道。透过无菌车间外的监控大屏，记者看到员工进入首道门就要换上隔离服进行严格消毒，生产车间内部不同工序的车间都独立分隔，且进入车间之后还需要更换防护更严密的无菌隔离服，对进入生产车间人数也有严格要求。而从原料的多次消毒杀菌到提取物的分离提纯再到机器代人进行产品灌装的操作，更是无处不体现着海康对品质把控的严谨。

2020年10月，在浙江省卫生健康委的大力支持下，海康生物承建了浙江省单采血浆站管理信息系统，实现了浙江省血站和单采血浆站信息的互联互通。为提升我省单采血浆站管理的标准化、规范化、专业化和精细化作出了应有贡献。

2021年1月，浙江省药监局发出了关于推进浙药链“黑匣子”工程建设的倡议。“黑匣子”工程是落实国家药品智慧监管和浙江省委省政府数字化改革的重要措施，是药监部门依托药品生产企业数字化智能系统，在线采集药品生产、检验等过程中的关键参数和数据储存于特殊介质（即“黑匣子”），利用“黑匣子”终端数据进行风险调查评估，实现药品生产非现场智能化监管的重要手段。海康生物积极响应，率先加入了“黑匣子”工程建设，被省药监局列入温州市“黑匣子”工程建设的试点企业，成为温州首家应用药品“黑匣子”企业。

目前，海康生物已自动收集企业生产源头采集的物料管理、生产工艺、质量检验、产品放行等影响药品质量的关键参数，并做到关键数据自动收集、数据内容智能校验、风险信号及时预警。通过一盒管数据，双向管安全，全程可追溯，进一步推动企业向智能“数字工厂”“未来工厂”转型。CXO UNION CXO联盟 cxounion.cn

“现在我们海康生物生产的每一瓶产品从原料血浆采集到生产全过程再到临床使用的患者，实现了从‘血管-血管’关键数据信息的全程追溯。就是这瓶产品所用的原料是哪一位献浆者所捐献的血浆，这些信息都可从公司关键数据信息管理系统中自动抓取。”沈荣杰强调，公司产品自1998年通过药品GMP认证投放市场以来，20多年以来从未因质量问题受到投诉。如今公司整个产品质量的追踪，每个环节、关键数据，都可以自动上传到省药监的药品“黑匣子”监管系统当中去，这对海康生物的品质把控而言，无异于锦上添花。”

三、恒久创新功，改进工艺开发新品两不误

2016年12月，海康生物又迎来企业历史性的一刻，公司完成股权重组，成为上市企业上海莱士血液制品股份有限公司旗下同路生物制药有限公司和温州海螺集团有限公司合资的股份公司。在上市公司的助力下，海康生物迈入了新品研发的快车道。不管在资金投入、工艺技术对接还是公共资源共享方面，上市公司都对海康生物提供了大力支持。作为海康生物的老股东，海螺集团亦大力支持海康生物的技术研发工作，特别腾出300平方米面积的办公楼作为海康生物实验动物中心使用，进一步赋能企业发展。

提高企业的竞争力关键靠科技创新，海康生物非常重视新产品的研发工作，每年的研发经费投入逐年增长。通过加大科技投入，提高原料血浆的综合利用率，改善和提升产业结构，提高企业核心竞争力。海康生物现拥有专利15项,其中发明专利2项、实用新型专利13项和1项软件著作权。目前生产的主要产品有：人血白蛋白、静注人免疫球蛋白、乙型肝炎人免疫球蛋白、肌注人免疫球蛋白，其中人血白蛋白、静注人免疫球蛋白还是浙江省高新技术产品。

静注人免疫球蛋白作为治疗新冠肺炎的特需药品，在防御抗击新冠疫情中发挥了重要作用，被纳入浙江省重要医疗物资监管。值得一提的是，海康生物还是新冠肺炎疫情防控的抗病毒药品重点生产企业。自疫情爆发以来，海康生物及上级公司（上海莱士、同路生物）将近100万瓶静注人免疫球蛋白和人血白蛋白发往湖北武汉、浙江、贵州、重庆、江苏等全国一线医院，为这场战“疫”做出贡献。CXO UNION CXO联盟 cxounion.cn

近几年，随着生产规模的扩大，海康生物除了生产人血白蛋白、静注人免疫球蛋白以外，还充分利用上海莱士、同路生物的技术研发优势，加大 “破伤风人免疫球蛋白”和“狂犬人免疫球蛋白”的产品研发力度，并创造条件着手凝血因子类产品(人纤维蛋白原、人凝血因子Ⅷ、人凝血酶原复合物等)开发，提高海康生物的核心竞争力。海康为此成立了技术研发小组，希望在未来的3到5年，把因子类产品开发出来并投入临床使用。CXO UNION CXO联盟 cxounion.cn

据悉，新的海康生物园区建设也已经在规划之中，目标建成一个投浆300吨以上，生产三大类12个品种，年产300万瓶（支）血液制品，年产值8亿元，创税利3亿元以上的现代化血液制品生产园区，为浙江省生物医药产业做出更大贡献。

翻译：

Hikang Biology: Breakthrough in the blood products industry

In Wenzhou Lucheng District Li Yang Xin Road, it is difficult to imagine that there is still a hidden Haikang biological such a high-tech enterprise. The appearance of the factory in the 1980s and 1990s is in stark contrast to the new residential buildings around it, which also makes this enterprise that has gone through wind and rain for nearly 30 years, more of the imprint of The Times.

From the small business of Wenzhou downtown blood station, to now gallop in the ranks of national high-tech enterprises, but also the only blood products production enterprise in the province. The rise of Haikang creatures is not so much the hero created by The Times as the breakout of active survival.

From the breakthrough of raw materials to the breakthrough of system and mechanism, from the breakthrough of product research and development to the breakthrough of process improvement, under the leadership of Shen Rongjie, the “old blood station man”, Haikang Bio-prominent and sudden rise, relying on three single-collection plasma raw material bases, so that the blood products in Wenzhou and even the province from scratch, from there to excellent.CXO UNION CXO联盟 cxounion.cn

First, the difficult raw material road, ten years to build three pulp mining bases

In June 1996, according to the spirit of the relevant documents of the municipal government. Wenzhou Conch Industry Group Co., LTD. (now Wenzhou Conch Group Co., LTD., hereinafter referred to as “Conch Group”) and Zhejiang Blood Products Institute jointly established Zhejiang Haikang Biological Products Co., LTD. Private enterprises hand in hand with state-owned institutions to open a long and difficult new journey. But also for the development of blood products industry in our province into a new impetus.

“From 1996 to 2006, this is the first 10 years of Haikang’s development. Because it can also rely on the original resource development of Zhejiang blood products. From raw materials to talents have a certain guarantee, the enterprise can steadily advance and gradually grow.” However, in March 2006, after Zhejiang Blood Products Institute completed the restructuring of public institutions. Haikang Biological became a wholly-owned subsidiary of Conch Group. Completely bid farewell to the comfort of the system, turned to the fierce market, we once fell into the trough of development.” Recalling the development process of the enterprise, in the view of Shen Rongjie, the general manager of the company. The decade from 2006 to 2016 is a really difficult decade for Haikang Biology.

According to Shen Rongjie, blood products are plasma protein products

According to Shen Rongjie, blood products are plasma protein products. Such as human blood albumin, human immunoglobulin and human clotting factor, prepared by biotechnology such as separation, purification and virus inactivation, which are made from healthy human plasma or specific immune human plasma. It is mainly used for the treatment of severe patients such as burns, liver disease, blood loss and shock. And the diagnosis, treatment or passive immune prevention of diseases such as immune system deficiency, viral infection and coagulation dysfunction. Therefore, it is not too much to say that “blood products are life-saving drugs for ordinary people”.CXO UNION CXO联盟 cxounion.cn

Plasma is the only raw material for the production of blood products by Hikon. And the only source is donations from healthy people. “In 2006, Haikang biology was struggling and did not have its own raw material base in Zhejiang Province. At that time, I literally carried a briefcase to every corner of the province. I remember that in 2008, when I established the first raw plasma base of Haikang Biology in Panan County, Jinhua, I led the publicity team to communicate with villagers almost door-to-door to mobilize and motivate them to donate plasma. People in mountainous areas have good physical fitness and simple thinking, plus they will get certain economic subsidies for donating blood plasma. Which is an additional income for people in mountainous areas. So our pulp extraction base will consider building in remote and poor mountainous areas.” Shen Rongjie said.

Its own initiative and strong support from the provincial government, the Provincial Health Commission, the Wenzhou Municipal government and the Wenzhou Municipal Health Commission.

Haikang Biological finally in this 10 years, from the original no bag of pulp. No raw material base, has built Panan, Wencheng, Qingtian three single collection of plasma raw material base. At present, Hikang biological plasma collection volume has reached more than 70 tons. And the company has gradually stepped into the right track.

Shen Rongjie, general manager of Zhejiang Haikang Biological Products Co., LTD

Second, hold the security line, intelligent digital guarantee quality

For Haikang biology, ensuring the safety of raw materials, production safety, product safety and other aspects of safety is a sword hanging on the hearts of each Haikang. And it is also the foundation of the enterprise.

“Blood products are a special industry with very strict disinfection procedures for the production environment.” Shen Rongjie introduced. Through the monitoring screen outside the aseptic workshop. The reporter saw that the staff entered the first door to change into isolation clothing for strict disinfection. The workshops of different processes in the production workshop are independently separated. And after entering the workshop, it is also necessary to replace the sterile isolation clothing with more strict protection. And the number of people entering the production workshop also has strict requirements. From the multiple disinfection of raw materials to the separation and purification of extracts to the operation of product filling by machines on behalf of people. Haikang’s rigorous quality control is reflected everywhere.CXO UNION CXO联盟 cxounion.cn

In October 2020, with the strong support of the Zhejiang Provincial Health Commission. Haikang Biological undertook the construction of the Zhejiang Province plasma Collection Station management information system. Which realized the interconnection of information between blood stations and plasma collection stations in Zhejiang Province. It has made due contributions to the standardization, standardization, specialization and refinement of the management of plasma collection station in our province.

In January 2021, the Zhejiang Provincial Food and Drug Administration issued an initiative on promoting the construction of the “black box” project of Zhejiang pharmaceutical chain.

The “black box” project is an important measure to implement the national smart drug supervision and the digital reform of Zhejiang Provincial Party Committee and provincial government. Relying on the digital intelligent system of drug production enterprises. The drug regulatory department collects key parameters and data in the process of drug production and testing online and stores them in special media (namely “black box”). And uses the “black box” terminal data to conduct risk investigation and assessment. An important means to realize off-site intelligent supervision of drug production. Haikang Biological responded positively, took the lead in joining the “black box” project construction. And was included in the pilot enterprise of the “black box” project construction in Wenzhou by the Provincial Food and Drug Administration. Becoming the first enterprise in Wenzhou to apply the “black box” of drugs.

At present, Hikang Biological has automatically collected key parameters affecting drug quality

At present, Hikang Biological has automatically collected key parameters affecting drug quality such as material management, production process, quality inspection, and product release collected from the production source of enterprises, and achieved automatic collection of key data, intelligent verification of data content, and timely warning of risk signals. Through a box of tube data, two-way tube security, the whole process can be traced to further promote the transformation of enterprises to intelligent “digital factory” and “future factory”.CXO UNION CXO联盟 cxounion.cn

“Now every bottle of our products produced by Hikang Biology from raw plasma collection to the whole process of production and clinical use of patients, to achieve the full traceability of key data information from ‘vaso-vascular’.” This information is automatically captured from the company’s key data information management system, “he said. Shen Rongjie stressed that since the company’s products were put on the market through the pharmaceutical GMP certification in 1998. There have been no complaints about quality problems for more than 20 years. Now the company’s entire product quality tracking, each link, key data, can be automatically uploaded to the provincial drug “black box” regulatory system. Which is the icing on the cake for the quality control of Haikang biology.”

Third, permanent innovation, improve the process and develop new products

In December 2016, Hikang Biology ushered in a historic moment of the enterprise. The company completed the equity restructuring, and became a joint venture company of Tonglu Biopharmaceutical Co., LTD. A subsidiary of Shanghai Raishi Blood Products Co., LTD., and Wenzhou Conch Group Co., LTD. With the help of listed companies, Haikang Biology has entered the fast lane of new product research and development. Whether in terms of capital investment, process technology docking or public resource sharing, listed companies have provided strong support for Haikang Biological. As an old shareholder of Hikang Biology, Conch Group also strongly supports the technology research and development work of Hikang Biology, and especially vacates an office building with an area of 300 square meters to use as the laboratory animal center of Hikang Biology to further empower the development of the enterprise.

The key to improve the competitiveness of enterprises depends on scientific and technological innovation. Haikang biological attaches great importance to the research and development of new products. And the annual research and development investment increases year by year. By increasing scientific and technological investment, improve the comprehensive utilization rate of raw material plasma. Improve and enhance the industrial structure, and improve the core competitiveness of enterprises. Haikang Biological currently has 15 patents, including 2 invention patents, 13 utility model patents and 1 software copyright. At present, the main products are: human blood albumin, intravenous injection of human immunoglobulin, hepatitis B human immunoglobulin, intramuscular injection of human immunoglobulin, of which human blood albumin, intravenous injection of human immunoglobulin are high-tech products in Zhejiang Province.CXO UNION CXO联盟 cxounion.cn

As a special drug for the treatment of the novel coronavirus pneumonia

As a special drug for the treatment of the novel coronavirus pneumonia, intravenous human immunoglobulin has played an important role in the defense and fight against the novel coronavirus epidemic. And has been included in the supervision of important medical materials in Zhejiang Province. It is worth mentioning that Haikang Bio is also a key manufacturer of antiviral drugs for the prevention and control of the novel coronavirus pneumonia epidemic. Since the outbreak of the epidemic, Hikang Bio and its parent companies (Shanghai Raishi, Tonglu Bio) have sent nearly 1 million bottles of human immunoglobulin and human blood albumin for intravenous injection to first-line hospitals in Wuhan, Hubei, Zhejiang, Guizhou, Chongqing, Jiangsu and other provinces, making contributions to the fight against the epidemic.

In recent years, with the expansion of the production scale, in addition to the production of human blood albumin and intravenous injection of human immunoglobulin

In recent years, with the expansion of the production scale. In addition to the production of human blood albumin and intravenous injection of human immunoglobulin. Haikang Biology also makes full use of the technological research and development advantages of Shanghai Laiss and Tonglu Biology. And increases the product research and development of “tetanus human immunoglobulin” and “Rabies human immunoglobulin”. And create conditions to start the development of coagulation factor sub-products (human fibrinogen, human coagulation factor Ⅷ, human prothrombin complex, etc.), improve the core competitiveness of Haikang biology. For this reason, Hikang has set up a technology research and development team, hoping to develop and put into clinical use in the next 3 to 5 years.CXO UNION CXO联盟 cxounion.cn

It is reported that the construction of the new Haikang biological Park has also been planned. And the goal is to build a modern blood products production park with more than 300 tons of plasma, 12 varieties of three categories. An annual output of 3 million bottles (branches) of blood products, an annual output value of 800 million yuan. And a tax profit of more than 300 million yuan, making greater contributions to the biomedical industry in Zhejiang Province.

本文由CXO UNION-CXO联盟（cxounion.cn）转载而成，来源于温州商报，作者：张晨；编辑/翻译：CXO UNIONCXO联盟小U。

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