The parent company of Beijing Minhai Biotechnology Co., Ltd., Shenzhen Kangtai Biological Products Co., Ltd. (hereinafter referred to as Kangtai Bio), is a publicly listed enterprise whose primary business is the research, development, production, and sales of biological vaccines, with the stock code 300601 The company is headquartered in Shenzhen and maintains R&D centers and industrial bases in both Shenzhen and Beijing, making it one of China’s leading hepatitis B vaccine manufacturers. Its product portfolio covers both routine and non‑routine immunization vaccines, with its flagship offering currently being the recombinant hepatitis B vaccine. ( Brewing yeast )、 b Haemophilus influenzae type b conjugate vaccine, measles–rubella combined live attenuated vaccine, acellular pertussis–diphtheria–tetanus vaccine b Haemophilus influenzae type b conjugate vaccine, 23 Pneumococcal polysaccharide vaccine Waiting for products. The Shenzhen Special Economic Zone Daily provided a detailed report on this matter.

Shenzhen is an international, innovation-driven city brimming with charm, dynamism, vitality, and creativity. Its prosperity is a vivid testament to the spirit of pioneering, innovation, and fearless determination.

1988 In that year, it was precisely on the fertile ground of innovation in Shenzhen that a company was nurtured—one that has made outstanding contributions to the nation’s immunization efforts. —— Shenzhen Kangtai Biological Products Co., Ltd.

After 30 After years of development, Kangtai Biological has transitioned from relying on foreign vaccine technologies to... “ Successor ” , gradually becoming a company with robust R&D capabilities “ Chaser ”。30 Over the years, Kangtai Biological has remained firmly aligned with the overarching theme of technological innovation, continuously increasing its investment in vaccine R&D to build an even stronger safeguard for the health and well-being of the people.

■   square Victory

Bearing the mission

Undertaking hepatitis B vaccine technology “ Spark of fire ”

Last century 90 In the early years of the decade, the hepatitis B virus remained an inescapable shadow over public health. According to the Ministry of Health, 1992 The annual survey results show that , National Hepatitis B Virus Surface Antigen (HBsAg) The proportion of positive cases among the total population is 9.75% , among which the prevalence of hepatitis B virus carriage in children is also as high as 9.67% . To address this issue, 1989 In [year], the U.S. company Merck transferred recombinant hepatitis B vaccine technology to China, and Kangtai Biological assumed the mission of taking over this technology transfer.

1991 In that year, Kangtai Biological dispatched a dedicated team across the ocean to the United States, where they underwent a training program lasting 1 A year-and-a-half technical training program. Confronted with an unfamiliar environment and profound differences in culture and daily habits, the pioneers at Kangtai Biological overcame numerous challenges, successfully fulfilled their mission, and brought recombinant hepatitis B vaccine technology back to China.

Pioneering and diligent in forging new paths, tirelessly striving for the cause of human health. “ Pioneering Ox ” This spirit is vividly embodied in the people of Kangtai during the early stages of its entrepreneurial journey. A senior executive at Kangtai Biotech who was involved throughout the entire technology‑import process at the time candidly admitted: “ At the time, everyone was driven by a shared determination to help Chinese vaccines catch up with the world’s cutting edge as quickly as possible. Being able to contribute to such a project and generate such significant social value fills us with immense pride. ”

1994 In [year], thanks to the tireless efforts of the first generation of Kangtai employees, the hepatitis B vaccine production facility was successfully completed and entered trial production. 10 The batch of qualified products also marked the successful introduction of China’s first genetic engineering vaccine project. Subsequently, … 20 Over the years, Kangtai Biological has steadily expanded the production capacity of its hepatitis B vaccine, with cumulative production and sales reaching… 10 More than 100 million doses, enabling 3 More than hundreds of millions of people have been immunized, reducing… 4000 The risk of hepatitis B virus infection among ten thousand children has helped the country reduce public health expenditures by more than… 1600 One hundred million yuan.

At present, by implementing a comprehensive prevention and control strategy that prioritizes vaccination while integrating prevention and treatment, China… 5 The prevalence of hepatitis B surface antigen carriage among children under the age of … has decreased from … 1992 year's 9.7% Drop to 2014 year's 0.3% . According to the “China Health Statistics Yearbook ( 2019 )》，截止 2018 In [year], the incidence of hepatitis B in China was [rate]. 0.07% During this period, Kangtai Biological has assumed an increasingly important role in the fight against disease, helping China to soon shed… “ A country with a high prevalence of hepatitis B ” of the hat, made outstanding contributions.

Research and Development Innovation

Improve vaccine accessibility and affordability

Although the introduction of hepatitis B vaccine technology has yielded significant social and economic benefits, Kangtai Biological has not stopped there. A path of sustainable development driven by continuous R&D and innovation has become increasingly clear throughout the company’s growth.

“ The vaccine industry is a matter of great national and public importance, touching on the well-being of generations to come. My wish is that all Chinese people can access vaccines that are technologically advanced, affordable, and safe and effective; if I can accomplish this in my lifetime, that would be more than enough. ” Du Weimin, Chairman of Kangtai Biological, said that after years of dedicated work in the vaccine industry, he has remained true to his original aspirations. “ To achieve this goal, our vaccines must not only meet world-class quality standards but also make a leap in innovation by building on the introduction and assimilation of advanced technologies. ”

2010 In the year, Kangtai Biological in “ Introduction, absorption, and innovation ” In the process, it delivered its first results in enhancing vaccine accessibility and affordability. From… 2000 Starting in [year], after ten years of arduous research and development, Kangtai Biological launched a product targeted at individuals who exhibit low or no immune response to conventional hepatitis B vaccines. 60 The microgram‑dose hepatitis B vaccine, the world’s first of its kind, has been launched, promptly filling a critical gap in the market.

From 60 Starting with the microgram‑dose hepatitis B vaccine, Kangtai Biological’s quadrivalent vaccine, 23 pneumococcal vaccine, measles–rubella combined vaccine, Hib New products, including vaccines, are being launched one after another. Among them, the quadrivalent vaccine is another exclusive product pioneered by the company and represents the domestically produced combination vaccine with the largest number of antigens. It can significantly improve vaccination compliance among infants and young children and has received national… “863” Specialized ” Major scientific and technological achievements also confer a significant competitive advantage in the market.

In addition, Kangtai Biological also has projects currently under development. 30 Remaining items, among which 12 The item has entered the registration process. 13 Pneumococcal conjugate vaccine, lyophilized b Haemophilus influenzae type b conjugate vaccine, ACYW135 Meningococcal polysaccharide vaccines, among others 3 Products in this category have applied for drug registration approval and have entered the review stage. Industry analysts generally believe that a diversified, tiered product portfolio is likely to consolidate Kangtai Biological’s industry-leading position over the medium to long term.

2019 In [year], Kangtai Biological invested... 20 The first phase of the Beijing Minhai Biotechnology’s new‑generation vaccine internationalization industrial base, built with an investment of several billion yuan, has been launched, aiming to develop and manufacture urgently needed next‑generation vaccines, including combination and multivalent vaccines. “ In the past 10 This year, we are still keeping pace with international developments; in the future… 10 This year, we will align ourselves with international standards and even strive to surpass them by developing globally leading innovative vaccines. ” With such robust R&D capabilities and substantial R&D investment as its foundation, “ Confidence ” Du Weimin is fully confident about the company’s future.

A person has joined Kangtai Biological. 20 For many years, a senior official who has been involved in the R&D of several key company projects stated: “ The research and development of innovative projects is typically characterized by long cycles. In scientific research, one must avoid seeking quick results; the challenges encountered during the R&D process often stem not from the technology itself, but from the ability to endure solitude and persistence. ”

Becoming comfortable with solitude, dedicating oneself to painstaking research and development, and selflessly giving one’s all have long been the shared guiding principles of Kangtai Biological’s entire R&D team. It is precisely through decades of relentless, round-the-clock dedication and unwavering perseverance that Kangtai Biological has established and continuously refined its scientific‑research framework, positioning itself as one of China’s vaccine companies with the most robust pipeline of innovative products. On the one hand, a steadfast and tenacious R&D team provides a solid talent base for the company’s future growth; on the other hand, the company has steadily increased its investment in R&D, with total R&D spending rising year after year over the past three years, reaching… 2019 The year has reached 2.15 hundred million yuan, accounting for more than of operating revenue 10% It ranks among the top among publicly listed companies in the biopharmaceutical industry.

Quality First

Building a Solid Barrier for Life and Health

“ The people come first; life comes first. ” Kangtai Biological has always regarded “ Quality is life. ” As a core principle of production and operations, vaccines serve as a robust safeguard for the health and well-being of the people. By doing everything possible to ensure the quality and safety of its vaccines, Kangtai Biological provides a powerful embodiment of this principle.

“ At present, the state has implemented the strictest regulatory framework for the vaccine industry, and the media and the general public are continuously monitoring it. The vaccine sector can thus be said to be under close scrutiny. ‘ Microscope ’ In the industries we operate in, even the slightest oversight in quality is simply unacceptable. While we continue to strengthen R&D and maintain rigorous quality control, we must also convey to society and the market our unwavering confidence in product quality. ” Regarding the requirements for vaccine quality, Du Weimin stated as follows.

From 1994 Since the successful trial production of the first batch of hepatitis B vaccine in [year], at Kangtai Biological, nearly… 30 Throughout years of vaccine production, no adverse events attributable to vaccine quality have ever occurred. This is attributable to the company’s unwavering commitment to rigorous quality management. “ Quality is life. ” This philosophy has been deeply ingrained in the hearts of every member of Kangtai.

Kangtai Biological according to GMP The requirements mandate the establishment of a rigorous quality management system to ensure that products comply with their intended use and registration standards throughout all stages of research and development, manufacturing, and distribution. The quality management system encompasses… QA (Quality Assurance) and Quality Control (Quality Control) As two critical components, Kangtai Biological employs quality risk management throughout the product lifecycle to mitigate potential quality issues in the manufacturing process, thereby further ensuring and enhancing the quality of both products and processes, and guaranteeing the provision of high‑quality, safe, and effective vaccine products to the public.

In practice, from raw material inspection upon arrival at the facility, through process control during vaccine production, to ensuring the cold-chain logistics for vaccine distribution, quality and safety leave no room for compromise—every regulation must be strictly adhered to without exception. This meticulous, even rigorous, attention to every detail has provided an ironclad guarantee for康泰生物’s products entering the market. “ Pass permit ” , as of 2019 By year-end, Kangtai Biological had cumulatively produced over 10 Billions of vaccine doses, with a batch-release approval rate of 100%。

In addition, in response to the national call to optimize the structure of the vaccine industry, Kangtai Biological has… 2011 In [year], a new vaccine R&D and production base was approved for construction, and in... 2018 The company was the first to complete its transition to a new‑generation vaccine business model, successfully transferring hepatitis B vaccine production to a new manufacturing site, and simultaneously advancing multiple novel vaccine candidates into clinical development, thereby steadily strengthening its core competitiveness.

Kangtai Biological’s achievements in quality management have been recognized by both official authorities and the industry. 2019 year 7 In [Month], Kangtai Biological, in collaboration with the National Institute for Food and Drug Control’s Advanced Research Institute, hosted a specialized training workshop on vaccine manufacturing processes and product quality control at Kangtai Biological’s new production facility, successfully providing training to vaccine inspectors from across China’s provinces. 2019 year 9 In [month], Kangtai Biological and the company’s quality officer were each awarded by the Guangdong Provincial Pharmaceutical Production Quality Authorization Professional Committee. “ Outstanding Group Committee Member ” and “ Excellent Quality Authorizer ” Honorary medals and certificates; 2019 year 12 In [month], the company was designated by the Chinese Society of Preventive Medicine as the nation’s first vaccine science education base.

Looking ahead, Kangtai Biological will continue to… “ Developing better vaccines to benefit human health. ” Taking responsibility as our mission, grounding ourselves in quality and safety, and driving progress through research and innovation, we strive to build a large-scale, internationally renowned biopharmaceutical multinational corporation that ranks among the best in China, as Shenzhen moves toward… “ Healthy Bay Area ” We will forge ahead with unwavering determination, making even greater contributions to safeguarding the lives and health of our people.