【故事】浙江华海药业股份有限公司总裁陈保华：让中国制药走向世界

中国首家制剂通过美国FDA认证、首家获得美国ANDA文号、首家制剂规模化销售美国市场、首家挑战美国药品原研专利，这是华海药业在中国制药行业获得的四个“第一”。

成绩背后，是企业对“以高效率创造新优势，以高质量实现新跨越”的不懈追求。在高层次人才的引领下，华海药业现已形成对标世界一流的研发能力、覆盖国内外的全球销售体系、通过欧美认证的规模化产能，综合实力持续领跑中国制药行业。美国《华尔街日报》称赞“华海药业是中国制药企业进军欧美发达国家市场的一个缩影”。

一、一路峥嵘，敢想敢闯

1989年1月，陈保华毅然辞去了国企岗位，选择了创办企业这条充满风险与艰辛的人生之路。他带领着与他同样年轻的怀揣梦想的创业者们以筹借的2万元资金，租用村里的小屋做厂房，以玻璃器皿、电热套等为主要设备，开始了医药中间体的生产，也开始了华海药业艰苦而辉煌的创业征程。

“刚开始创业时，什么都没有，唯一的交通工具就是停在厂门口的一辆摩托车，换个灯泡都是自己动手。”陈保华既当掌柜又当伙计，当时他主要的任务是到全国各地跑业务。第一年，以加工和销售“舒胆通”中间体起步，销售额30万元，利润14万元，陈保华淘到了第一桶金。到1994年，华海药业基本完成原始积累。

2004年，时任浙江省委书记习近平来到华海药业视察，勉励华海药业走国际化道路。同年，陈保华首次赴美国考察药品市场。

在美国FDA考察时，美国FDA官员告诉陈保华，“在美国、印度现在已经有36家企业通过了美国FDA认证（美国FDA认证，是世界公认的最严苛的质量管理标准，是药品进军国际高端市场的通行证），有38个制剂品种获得了美国FDA的批准文号，而你们中国这么大一个国家至今一个都没有”。这句话令深深触动了陈保华，下定决心，华海药业要瞄准美国市场，做首个“勇吃螃蟹的人”，华海药业的产品一定要率先通过美国FDA认证，一定要达到FDA的质量标准，并拿到进入美国制剂市场的通行证，实现中国制造的药品在美国市场的零的突破。

历经四年艰苦奋斗，2007年9月10日，华海药业终于完成了中国第一个FDA认证，当时美国的华尔街日报和CNN电视台都争相来到浙江台州临海汛桥镇来采访华海药业，美国用华尔街日报大半版的篇幅刊登了：US opens  the door to Chinese phills，美国向中国打开了大门。 CXO UNION-CXO联盟（cxounion.cn）

2009年，苯那普利片作为中国首个登陆美国零售市场的产品在美国上市。陈保华回忆道：“当时美国的药店说不敢卖，因为是中国制造的，他们没有卖过中国造的药，上升到董事会去讨论，并在没有通知我们的情况下把我们的产品送去第三方质量检测，最后测出来我们的产品质量比美国同类产品还要高，所以我们的产品才得以在美国上市。现在，这个产品在美国的市场份额排名第一。”据美国 IQVIA统计（2022年12月数据），华海药业在美国市场销售被纳入统计的54个产品中，有31个产品的市场份额占有率位居前三（其中有5个产品市场份额位居第一）。

34年来，从中间体、原料药、仿制药到生物药、新药的大力研发，陈保华时时将“以不息为体，以日新为道”的观念贯彻到底，以创新领航全局，脚踏实地带领华海一步一个脚印稳步向前发展。

二、品质+创新”是华海永恒的追求

“守正创新，科技是第一生产力不会错。”华海药业的核心竞争力就体现在“品质+创新”，仅2022年研发投入占营业收入比例14.54%。

华海药业从创业之初就确立了“重视质量就是对生命负责”的质量理念，这正奠定了华海创业立业的根本。从创业初期生产中间体舒胆通到1997年成为临海市第一家顺利通过ISO质量体系的企业；从1998年紧跟行业发展，启动GMP提升计划，到原料药、固体制剂产品通过国家GMP认证；从历经四年，华海完成了中国第一个FDA认证，到相继的“四个首家”，无一不是品质领先为华海奠定的坚强基础。 CXO UNION-CXO联盟（cxounion.cn）

对制药企业来说，“创新”二字至关重要。目前，华海药业生物药板块在研项目超过20个，其中11个在临床试验阶段。在贯彻创新驱动发展的实践中，华海药业依靠技术创新、市场创新、资本运作创新、管理创新、人才工作创新、文化建设创新 “六个创新”，推动华海高质量发展。

在创新的道路上，华海药业建立的与国际接轨的创新研发体系，十分亮眼。据悉，该体现包含全球注册中心、集团科技管理中心、创新研发体系、工艺开发体系和临床研究体系，形成以华海（美国）为前沿技术信息平台、以上海张江研发中心为自主仿创平台、以临海总部技术中心为基础技术创新和科技转化平台、以湖北武汉研发中心为抗病毒药物研发平台、以杭州、南京研究院为复杂制剂和改良型新药的开发平台，具备固体缓控释、复杂注射剂、难溶药物增溶、首仿和挑战专利产品等高端仿制药以及生物药、创新药的研发能力，有效实现了信息、人才、技术等研发资源的互动与整合。

 如今，华海药业已建立20多个科技开发应用服务平台，同时与20多家科研院所建立长期协作关系，努力解决一些“卡脖子”技术难题，推动生产工艺改进，推动设备、技术和产品迭代更新。

“员工是华海最宝贵的财富”，以事业引才、以平台聚才、以项目用才、以待遇留才。在人才团队的带动下，华海药业自主创新能力不断提升。当前，华海药业设有“国家级企业技术中心”“国家级博士后科研工作站”“浙江省外国专家工作站”，先后在中国浙江、上海、江苏、湖北及美国多地构建了立体互动的研发体系，有效实现信息、人才、技术等研发资源的互动与整合。 CXO UNION-CXO联盟（cxounion.cn）

三、“八八战略”在华海打造立足中国、辐射全球的垂直一体化医药产业格局

“八八战略”在浙江大地生动实施20年，正是华海药业高速发展的20年。可以说，华海药业一直都是“八八战略”的实践者、受益者。

在“八八战略”第一个十年，华海药业从拉长产业链到原料药向制剂转型、按国际高标准要求进军美国市场；在“八八战略”第二个十年，华海药业二次转型，在获得了美国主流市场认可后，高起点布局生物药、新药板块，积极构建原料药、制剂两大产业链，打造立足中国、辐射全球的垂直一体化医药产业格局。

谈及华海药业与“八八战略”的二十载故事，陈保华表示：“华海药业践行“八八战略”的核心就是要在制药领域进一步做精、做大、做强，从重生产的制造型企业向重研发、重销售的综合型企业发展升级，从现有的化学原料药、制剂制造企业向综合性、国际化、高技术的大型制药企业迈进。” CXO UNION-CXO联盟（cxounion.cn）

2003年以来，“先人一步”是华海药业决胜市场的制胜法宝。当别人看到做中间体能赚钱，开始做中间体参与国内市场竞争时，华海已转做原料药，挺进印度、南美市场；当别人开始做原料药，涌入非规范市场时，华海开始做欧洲COS认证，跻身规范市场；当别人开始做COS时，华海又携制剂FDA认证，进军美国高端市场；而当别人开始做制剂FDA认证时，华海药业已将制剂产品销往美国市场和世界各地。就这样在激烈的市场竞争中，华海药业始终保持领先一步。

“要让中国人民吃上进口品质、国产价格的好药” ，是华海制药人的不懈追求。华海药业的产能建设，目前已经形成了年产近8000吨的原料药产能、年产220亿片（境内）的固体制剂产能。在产品系列上，现已逐步形成了心血管、中枢神经类、抗感染类等几大系列产品，成为全球最主要的心血管、中枢神经类医药产品供应商。

四、向世界展示中国制药的窗口

在“八八战略”的指引下，浙江的民营企业在持续的政策鼓励与良好生态中茁壮成长，无论应对全球经济风云变幻，还是适应把握国内经济调速换挡，都让民营经济方向更明、信心更足、目标更清。

“十四五”期间，华海药业将通过战略、规划、措施、计划体系方案的实施，重塑组织体系和运营管控，强化人才引进和梯队培养，优化产业结构和创新规划，全面深入拓展国内和国际市场。成为拥有良好技术积淀、完整产业布局、巨大成长潜力、核心竞争优势的持续快速增长的医药先进制造的头部企业。 CXO UNION-CXO联盟（cxounion.cn）

谈及华海药业的未来，陈保华充满信心。他表示，华海药业在构建原料药、制剂、生物药、新药的产业布局方面将持续发力，坚定“关爱生命、报效中华”的企业使命，以“国际品质、国产价格”惠及国内患者。

翻译：

Chen Baohua, president of Zhejiang Huahai Pharmaceutical Co., LTD. : Let Chinese pharmaceutical go to the world

China’s first preparation passed the US FDA certification, the first to obtain the ANDA document number in the US, the first large-scale sales of the preparation in the US market, and the first to challenge the original research patent of the US drug, which are the four “firsts” obtained by Huahai Pharmaceutical in the Chinese pharmaceutical industry.

Behind the achievements, is the enterprise’s unremitting pursuit of “creating new advantages with high efficiency and achieving new leaps with high quality”. Under the guidance of high-level talents, Huahai Pharmaceutical has formed world-class research and development capabilities, global sales system covering both domestic and foreign countries, large-scale production capacity certified by Europe and the United States, and comprehensive strength continues to lead the Chinese pharmaceutical industry. The Wall Street Journal praised “Huahai Pharmaceutical is a microcosm of Chinese pharmaceutical companies entering the developed markets in Europe and the United States.” CXO UNION-CXO联盟（cxounion.cn）

One, all the way lofty, dare to dare to break

In January 1989, Chen Baohua resolutely resigned from his position in a state-owned enterprise and chose a life path full of risks and hardships. He led entrepreneurs with the same young dream with him to borrow 20,000 yuan of funds, rent the cottage in the village as a workshop, with glassware, electric heating sets and other main equipment, began the production of pharmaceutical intermediates, but also began the arduous and brilliant entrepreneurial journey of Huahai Pharmaceutical.

A corner of Huahai Synthetic Chemical Plant in 1994

“When I started the business, I had nothing, the only means of transportation was a motorcycle parked in front of the factory, and I had to change the light bulb myself.” Chen Baohua was both a shopkeeper and a clerk, and his main task at that time was to run business around the country. In the first year, in order to process and sell “Shu Dan Tong” intermediates, sales of 300,000 yuan, profit of 140,000 yuan, Chen Baohua amoted the first bucket of gold. By 1994, Huahai Pharmaceutical had basically completed the original accumulation. CXO UNION-CXO联盟（cxounion.cn）

In the same year, Chen Baohua visited the United States for the first time to investigate the drug market.

In the United States FDA inspection, FDA officials told Chen Baohua, “In the United States, India now has 36 companies through the United States FDA certification (FDA certification, is the world’s most stringent quality management standards, is the drug to enter the international high-end market pass), there are 38 preparation varieties obtained the United States FDA approval number, In a country as big as China, we still have none.” This sentence deeply touched Chen Baohua, determined that Huahai Pharmaceutical should aim at the US market, be the first “brave crab”, Huahai Pharmaceutical’s products must be the first to pass the US FDA certification, must meet the quality standards of the FDA, and get the pass to enter the US preparation market, to achieve zero breakthrough of Chinese-made drugs in the US market.

After four years of hard work, on September 10, 2007, Huahai Pharmaceutical finally completed China’s first FDA certification. At that time, the Wall Street Journal and CNN television in the United States rushed to Zhejiang Taizhou Linhai Xinqiao Town to interview Huahai Pharmaceutical, and the United States used the Wall Street Journal to publish the following: US opens the door to Chinese phills, US opens the door to Chinese phills, CXO UNION-CXO联盟（cxounion.cn）

Wall Street Journal
US opens the door to Chinese phills

In 2009, Benazepril tablets became the first Chinese product to hit the US retail market. Chen Baohua recalled: “At that time, the pharmacies in the United States said that they did not dare to sell, because it was made in China, they had not sold Chinese-made drugs, went to the board of directors to discuss, and sent our products to the third party quality testing without notifying us, and finally measured that the quality of our products was higher than similar products in the United States, so our products were listed in the United States.” Now it’s number one in market share in the United States.” According to IQVIA statistics (December 2022 data), among the 54 products that Huahai Pharmaceutical sold in the US market, the market share of 31 products ranked in the top three (of which 5 products ranked first in market share).

Paroxetine hydrochloride tablets

In the past 34 years, from intermediates, apis, generics to biological drugs, and new drugs, Chen Baohua always carries out the concept of “ceaselessly as the body, and daily new as the way” to the end, and leads the overall situation with innovation, and down-to-earth leads Huahai to steadily develop step by step.

Quality + Innovation “is the eternal pursuit of Huahai

“Adhere to innovation, science and technology is the first productive force will not be wrong.” Huahai Pharmaceutical’s core competitiveness is reflected in the “quality + innovation”, only 2022 R & D investment accounted for 14.54% of the operating income. CXO UNION-CXO联盟（cxounion.cn）

Huahai Pharmaceutical has established the quality concept of “paying attention to quality is responsible for life” from the beginning of its business, which is laying the foundation for Huahai’s business. From the initial stage of the production of intermediates to 1997, Linhai became the first company to successfully pass the ISO quality system; From 1998 to follow the development of the industry, launched the GMP upgrading plan, to the raw drug, solid preparation products through the national GMP certification; After four years, Huahai completed the first FDA certification in China, to the “four first” successively, none of which is the strong foundation laid by the quality leadership for Huahai.

Huahai Pharmaceutical headquarters gate

For pharmaceutical companies, the word “innovation” is crucial. At present, there are more than 20 projects under research in the biopharmaceutical sector of Huahai Pharmaceutical, of which 11 are in the clinical trial stage. In the practice of implementing innovation-driven development, Huahai Pharmaceutical relies on the “six innovations” of technological innovation, market innovation, capital operation innovation, management innovation, talent work innovation, and cultural construction innovation to promote the high-quality development of Huahai.

On the road of innovation, the innovative research and development system established by Huahai Pharmaceutical in line with international standards is very bright. It is reported that the embodiment includes the global registry, the group science and technology management center, the innovation research and development system, the process development system and the clinical research system, The formation of Huahai (USA) as the frontier technology information platform, Shanghai Zhangjiang R&D Center as the independent imitation and innovation platform, Linhai Headquarters technology center as the base of technology innovation and technology transformation platform, Hubei Wuhan R&D Center as the antiviral drug research and development platform, Hangzhou and Nanjing Research Institute as the development platform of complex preparations and improved new drugs, With solid slow and controlled release, complex injections, insoluble drug solubilization, first imitation and challenge patent products and other high-end generic drugs as well as biological drugs, innovative drugs research and development capabilities, effectively realize the interaction and integration of information, talent, technology and other research and development resources. CXO UNION-CXO联盟（cxounion.cn）

Chen Baohua and Huahai Pharmaceutical research personnel exchange

At present, Huahai Pharmaceutical has established more than 20 science and technology development application service platforms, and has established long-term cooperative relationships with more than 20 research institutes, striving to solve some “stuck neck” technical problems, promote production process improvement, and promote the iterative update of equipment, technology and products.

“Staff is the most valuable wealth of Huahai”, to cause talent, to gather talent by platform, to use talent by project, to retain talent by treatment. Driven by the talent team, Huahai Pharmaceutical’s independent innovation ability continues to improve. At present, Huahai Pharmaceutical has set up “State-level Enterprise Technology Center”, “State-level post-doctoral research workstation” and “Zhejiang Foreign Expert Workstation”, and has successively built a three-dimensional interactive R & D system in Zhejiang, Shanghai, Jiangsu, Hubei and many places in the United States, effectively realizing the interaction and integration of information, talent, technology and other R & D resources.

Third, the “88 Strategy” creates a vertically integrated pharmaceutical industry pattern based on China and radiating the world in Huahai

The “88 Strategy” has been implemented vividly in Zhejiang for 20 years, which is exactly the 20 years of rapid development of Huahai Pharmaceutical. It can be said that Huahai Pharmaceutical has always been the practitioner and beneficiary of the “88 Strategy”. CXO UNION-CXO联盟（cxounion.cn）

Aerial photo of Huahai Pharmaceutical Industrial Park

In the first decade of the “88 Strategy”, Huahai Pharmaceutical industry from the extension of the industrial chain to the transformation of raw materials to preparations, according to international high standards to enter the US market; In the second decade of the “88 strategy”, Huahai Pharmaceutical has made a second transformation. After gaining recognition from the mainstream market in the United States, Huahai Pharmaceutical has laid out biological drugs and new drugs from a high starting point, actively built two industrial chains of apis and preparations, and created a vertical integrated pharmaceutical industry pattern based on China and radiating the world.

Talking about the 20-year story of Huahai Pharmaceutical and the “88 Strategy”, Chen Baohua said: “The core of Huahai Pharmaceutical’s implementation of the” 88 strategy “is to further refine, enlarge and strengthen in the pharmaceutical field, develop and upgrade from a manufacturing enterprise that focuses on production to a comprehensive enterprise that focuses on research and development and sales, and move from the existing chemical raw materials and preparations manufacturing enterprises to a comprehensive, international and high-tech large pharmaceutical enterprise.”

Chen Baohua spoke at the annual meeting of Huahai Pharmaceutical in the first half of 2023

Since 2003, “One step ahead” has been the magic weapon for Huahai Pharmaceutical to win the market. When others see that being an intermediary can make money and begin to compete in the domestic market as an intermediate, Huahai has turned to be a raw material drug and entered the Indian and South American markets; When others began to do apis and poured into the non-standard market, Huahai began to do European COS certification and entered the standardized market; When others began to do COS, Huahai entered the high-end market of the United States with FDA certification; When others began to do FDA certification, Huahai Pharmaceutical has sold its pharmaceutical products to the US market and around the world. In this way, in the fierce market competition, Huahai Pharmaceutical has always been one step ahead. CXO UNION-CXO联盟（cxounion.cn）

“To let the Chinese people eat imported quality, domestic prices of good medicine” is the unremitting pursuit of Huahai Pharmaceutical people. The production capacity construction of Huahai Pharmaceutical has formed an annual production capacity of nearly 8,000 tons of raw materials and an annual production capacity of 22 billion tablets (domestic) of solid preparations. In terms of product series, it has gradually formed several series of cardiovascular, central nervous, anti-infection and other products, and has become the world’s most important supplier of cardiovascular and central nervous medicine products.

Fourth, the window to show China’s pharmaceutical industry to the world

Under the guidance of the “88 Strategy”, private enterprises in Zhejiang thrive in the continuous policy encouragement and good ecology, whether to cope with the global economic changes, or adapt to grasp the speed shift of the domestic economy, so that the direction of the private economy is clearer, more confident, more clear goals. CXO UNION-CXO联盟（cxounion.cn）

During the “14th Five-Year Plan” period, Huahai Pharmaceutical will reshape the organizational system and operation control, strengthen talent introduction and echelon training, optimize the industrial structure and innovation planning, and comprehensively expand the domestic and international markets through the implementation of strategies, plans, measures and planning systems. To become a leading pharmaceutical advanced manufacturing enterprise with good technical accumulation, complete industrial layout, huge growth potential and core competitive advantages.

Talking about the future of Huahai Pharmaceutical, Chen Baohua is full of confidence. He said that Huahai Pharmaceutical will continue to make efforts in building the industrial layout of apis, preparations, biological drugs and new drugs, firmly adhere to the corporate mission of “caring for life and serving China”, and benefit domestic patients with “international quality and domestic prices”.

由CXO UNION-CXO联盟（cxounion.cn）转载而成，来源于浙商之家；编辑/翻译：CXO UNIONCXO联盟小U。

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