Detailed Personal Achievements

Nie Xiaoqi is the Deputy General Manager of Beijing Minhai Biotechnology Co., Ltd. and currently serves as the company’s Head of Quality Management. He has previously held the positions of Director of the Diphtheria–Tetanus Vaccine Workshop in Vaccine Department II, Director of Vaccine Department IV, and Head of Production Management. During his tenure in the production system, he successfully spearheaded… Hib- Diphtheria–tetanus–pertussis–polio quadrivalent vaccine, 23 pneumonia, 13 Pneumococcal pneumonia, human diploid cell rabies vaccine, etc. 8 the successful market launch of the product. During my tenure as Head of Quality Management, by inviting WHO Inspectors visit the company to provide consultation, recommend quality personnel to attend major international quality management conferences, and organize… GMP Relevant personnel have participated in a series of training sessions on international regulations, and various measures have been continuously implemented to enhance the quality management system. At the same time, efforts to promote the export of already-marketed products have been actively advanced, and notifications have been received from the drug regulatory authorities of multiple countries, including Indonesia. GMP Factory audit passed via letter. The organization has established a Quality Compliance Department, which is dedicated to… WHO PQ preparatory work, to achieve early approval WHO Pre-certification has laid a solid foundation.

At Beijing Minhai Biotechnology Co., Ltd. 2008-2012 During my years of employment, I served as the Director of the Diphtheria-Tetanus Vaccine Workshop in Vaccine Department II at Beijing Minhai Biotechnology Co., Ltd., and was fully involved in… “863” Major Special Project on Vaccines and Antibodies: DTaP-hib Participated in the industrialization of the quadrivalent vaccine project. DTaP-hib Throughout the entire industrialization process of the quadrivalent vaccine, I assumed full responsibility for the workshop’s establishment, technical operations, and management. During this period, the workshop… 2012 year 6 Passed in the month Hib On-site process verification by the National Medical Products Administration for single-dose vaccine projects and GMP Certification, 2012 year 8 Passed in the month DTaP-hib The National Medical Products Administration’s on-site process inspection of the quadrivalent vaccine and GMP Certification has enabled the achievement of the industrialization goal, from zero to product launch.

Combination vaccines represent the current trend in global vaccine development, and their unique advantage of protecting against multiple diseases with a single dose is expected to drive broad market demand. Minhai Company DTaP-hib The quadrivalent vaccine is China’s first combination vaccine; upon full-scale production, it is planned to manufacture an acellular pertussis–diphtheria–tetanus–Haemophilus influenzae type b (Hib) vaccine. Dtap/hib ) Combined vaccine (commonly referred to as the quadrivalent vaccine) 500 Ten thousand units; annual sales revenue to be achieved after stabilization. 54000 Ten thousand yuan, total tax paid (corporate income tax) 4200 Ten thousand yuan, annual net profit 24000 Ten thousand yuan. This has yielded substantial economic and social benefits. Comrade Nie Xiaoqi, as the principal project leader of this initiative, has made due contributions to the development of novel vaccines and disease prevention and control in China.

2013 In [year], after completing the company’s Phase I industrialization project, he was transferred to Minhai Biotechnology Co., Ltd. as the Director of Vaccine Department IV, assuming full responsibility for the company. 23 pneumococcal polysaccharide vaccine and 13 Industrialization efforts for the pneumococcal polysaccharide conjugate vaccine are underway. The Vaccine Unit 4 (the production workshop for the pneumococcal vaccine bulk) has completed the installation of facility infrastructure and equipment commissioning in accordance with EU standards, and has already… 2019 year 1 Achieved the month 23 Pneumococcal polysaccharide vaccine GMP Certification certificate, and 2021 year 9 Achieved the month 13 the drug registration certificate for the pneumococcal polysaccharide conjugate vaccine and GMP Certificate of compliance.

 23 Pneumococcal polysaccharide vaccine can cover 23 The serotypes that frequently cause pneumococcal infections, approximately 90% Pneumonia is caused by this. 23 Caused by the serotype. 23 Pneumococcal vaccines can effectively prevent pneumonia and are already used in the United States, the United Kingdom, Canada, and other countries. 30 Used in multiple countries and regions 14 For more than years, the post-vaccination protective efficacy can reach 92% , with good safety and sustained immune efficacy 5 Year. 13 The pneumococcal polysaccharide conjugate vaccine is primarily administered as active immunization in infants and young children to prevent disease caused by pneumococcal serotypes. 1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F and 23F It causes invasive diseases, including bacteremic pneumonia, meningitis, sepsis, and bacteremia. Streptococcus pneumoniae is the most common cause of invasive disease in children, as well as pneumonia and upper respiratory tract infections; currently, in China, there are only… 2 A domestic vaccine manufacturer has already obtained marketing approval for this vaccine product, and under the leadership of Comrade Nie Xiaoqi, our company has completed… 13 The pneumonia‑industrialization project features a dual‑vector product developed exclusively in China, which is safer to use and elicits a more robust, long‑lasting immune response; therefore, it… 2021 Since the product’s launch this year 4 Over the past year and more, while generating substantial economic benefits for the company, this effort has also significantly advanced the development and refinement of China’s disease‑prevention and immunization system, thereby improving the quality of life of the Chinese people and contributing to global efforts in disease prevention and control.

Vaccine industrialization is a complex, end-to-end process that spans from initial development to product launch. It encompasses activities such as product registration and regulatory approval; design and installation of cleanroom facilities; engineering and installation of utility systems; selection of large-scale equipment; scale-up and optimization of vaccine manufacturing processes; establishment of production facilities and recruitment of personnel; organizational management and training; drafting of documentation systems; selection, commissioning, and validation of equipment and infrastructure; process validation; and, finally, inspection by the drug regulatory authority during product registration. GMP Compliance inspections and other such tasks require extensive specialized expertise to produce qualified vaccine products. It demands not only a thorough understanding of engineering and construction, CAD Design also requires expertise in vaccine manufacturing processes, product quality control, the design and operation of vaccine production equipment, cleanroom management, and other specialized skills. Comrade Nie Xiaoqi has demonstrated outstanding performance in industrialization projects, possessing these competencies and qualities. His primary responsibilities include: DTaP-hib The quadrivalent vaccine has been approved for market launch and sales, yielding significant economic and social benefits.

In order to strengthen vaccine management, ensure vaccine quality and supply, standardize immunization practices, promote the development of the vaccine industry, safeguard public health, and uphold public health security, 2019 year 12 month 1 In 2019, the Vaccine Administration Law of the People’s Republic of China was enacted. The law explicitly stipulates that “the marketing authorization holder shall establish a comprehensive production quality management system, continuously strengthen deviation management, and use information technology to accurately record all data generated during production and testing, thereby ensuring that the entire production process consistently complies with statutory requirements.” To effectively implement this provision, at the suggestion of Comrade Nie Xiaoqi, the company established a dedicated “Information Center” department, solely responsible for advancing information‑technology initiatives, in… 2021 Since the beginning of the year, we have already completed MES (Manufacturing Execution System), SCADA (Monitoring and Control System), ERP (Enterprise Resource Planning System), DMS( Document Management System), LIMS( Laboratory Information Management System), QMS (Quality Management System) ,TMS( The development of the training management system has been completed, and all of the aforementioned systems have now been successfully launched and are operating stably. This advancement in information technology has significantly elevated our company’s management standards. During inspections conducted by both the National Medical Products Administration and the Beijing Municipal Medical Products Administration, inspectors consistently expressed high praise and recognition for our company’s IT infrastructure, citing it as a best‑practice case that has helped drive the adoption of similar digital solutions across the industry. The establishment of an information‑based system for vaccine production represents both a challenge and an opportunity. Minhai has proactively prepared for this transformation and has already set sail. Comrade Nie Xiaoqi has played a pivotal leadership role in this IT‑driven initiative; his visionary approach has not only led to groundbreaking improvements in our quality management but has also actively propelled progress within the vaccine manufacturing sector.

Following the COVID‑19 pandemic, China’s domestic economy experienced a downturn, and the vaccine industry was significantly impacted. At his suggestion, the company proactively expanded into overseas markets, striving to realize its ambitious goal of bringing Chinese vaccines to the world. To date, the company has obtained regulatory approvals in multiple countries, including Indonesia, the Philippines, Pakistan, and Uzbekistan, making a substantial contribution to its profit growth.

2023 Year and 2024 In [year], during Comrade Nie Xiaoqi’s tenure as Head of Quality Management, the company’s independently developed lyophilized human rabies vaccine (human diploid cell‑derived) and live attenuated varicella vaccine respectively obtained drug registration approvals and… GMP The product successfully obtained market approval after passing the compliance inspection. This achievement was made possible thanks to Comrade Nie Xiaoqi’s proactive spirit and tireless efforts, as he led the production and quality teams to approach the inspection with determination and meticulous attention. Following the inspection, they promptly and effectively addressed all issues raised by the inspectors, ensuring the product’s smooth clearance. The company’s lyophilized human rabies vaccine (human diploid cell‑derived) is the second such vaccine in China to be approved for marketing; it is produced using human diploid cells, which are of human origin. Compared with other types of vaccines, this formulation carries a lower risk of adverse reactions. This is particularly important for vulnerable populations—such as children, the elderly, and individuals with compromised immune systems—since it helps minimize discomfort and potential risks associated with vaccination. Moreover, the vaccine elicits a robust immune response, effectively preventing the onset of rabies. Although the live attenuated varicella vaccine has not yet been included in the national immunization program, national regulations require that children complete vaccination before entering primary school. 2 The vaccination coverage for this injectable vaccine is 100% Accordingly, the launch of the two aforementioned products has not only boosted the company’s profitability but also demonstrated to international audiences the rapid pace of China’s vaccine development.

In summary, it is precisely because of outstanding young professionals like Comrade Nie Xiaoqi that enterprises and the entire industry can continuously advance and innovate, driving more Made-in-China products onto the global stage.

Receive honors ：

l 2019 In [year], he was awarded the title of “Director of the New Social Strata Representatives’ Association of the Daxing Biomedical Industry Base of the Zhongguancun National Independent Innovation Demonstration Zone” by the same association.

l 2022 In [year], it was awarded the “Beijing Daxing District” honor by the CPC Beijing Daxing District Committee. “ New National Gate ” “Outstanding Young Talents”;

l 2023 In [year], was selected for the Daxing District Pool of Outstanding Science and Technology Professionals.