On January 12, 2026, the National Medical Products Administration (NMPA) officially issued a Clinical Trial Approval Notice (Acceptance No.: CXSL2500917, Registration Category 3.3) to Beijing Baihui Biotechnology Co., Ltd. and Bohui Biopharmaceutical Co., Ltd. for their jointly submitted freeze-dried human rabies vaccine (human diploid cell). This vaccine, incorporating multiple technological innovations, has successfully entered the clinical trial stage, marking a key breakthrough for Baihui Biotechnology in the field of viral vaccine development and providing a new localized solution for rabies prevention and control in my country.

pictureRabies has a near 100% mortality rate, making prevention and control an urgent need.

Rabies, an acute infectious disease of the central nervous system caused by the rabies virus, is a public health nightmare due to its lethality. Data shows that approximately 59,000 people die from the disease globally each year, with the majority of deaths occurring in developing countries. After onset, patients exhibit typical symptoms such as hydrophobia, photophobia, and aerophobia. Once symptoms appear, death typically occurs within 3 to 6 days due to respiratory or circulatory failure, with a mortality rate approaching 100%.

Although rabies is "preventable but not curable," proper post-exposure prophylaxis can effectively reduce the risk of infection—timely wound treatment, standardized rabies vaccination, and the rational use of passive immunization agents are key means of preventing viral infection. Against this backdrop, the development of safer and more stable vaccine products has become an important issue in improving rabies prevention and control in my country.

With the support of three core technologies, a balance is achieved between security, efficiency, and scale.

The freeze-dried human rabies vaccine (human diploid cell) that has been approved for clinical trials relies on three scientifically validated core technologies to build a product advantage of "safety first, while taking into account efficiency and scale," breaking through many limitations of traditional vaccine production processes.

Regarding the choice of production matrix, this vaccine uses human diploid cells recommended by the World Health Organization (WHO). Compared to traditional animal-derived cells, these cells have higher homology with human cells, eliminating the potential risk of tumorigenesis at its source. This is hailed as the "gold standard" for safety in viral vaccine production. This choice not only efficiently supports the proliferation of the rabies virus and ensures the immunogenicity of the antigen, but also reduces the introduction of foreign proteins, significantly lowering the incidence of adverse reactions such as local reactions after vaccination, thus further enhancing the safety of the vaccine.

In terms of process optimization, the vaccine employs low-serum cell culture technology, significantly reducing serum usage through improved culture medium formulation. Simultaneously, recombinant trypsin is used for cell digestion, a dual approach that reduces the risk of introducing animal-derived substances at the source. Notably, the reduction in serum usage also effectively controls production costs, laying the foundation for the vaccine's future widespread accessibility.

In terms of large-scale production capacity, this vaccine employs a closed bioreactor system combined with microcarrier culture technology. By dynamically controlling the culture environment, it significantly increases cell density and virus yield per unit volume. Compared to traditional planar culture, this technology can maintain production conditions more stably, supporting continuous harvesting of viral fluid and providing core technological support for subsequent large-scale production and ensuring market supply.

The 2.4 billion yuan industrialization base has been completed, and production capacity assurance has been put on the agenda.

While achieving breakthroughs in vaccine research and development, Baihui Biotechnology is also accelerating its industrialization layout. The intelligent vaccine production base, located in the Yanjiao High-tech Development Zone in Hebei Province, represents a total investment of 2.4 billion yuan and has a planned total construction area of approximately 88,000 square meters. Positioned as a modern vaccine factory meeting Chinese, WHO, and EU GMP standards, it serves as the core platform for the company's digital transformation in the pharmaceutical industry.

Currently, the main structure of the base has been completed, and it is expected to be completed and put into operation by the end of 2026. At that time, this intelligent factory will work in synergy with the advanced vaccine production process to provide a solid guarantee for the large-scale supply of products and effectively alleviate the supply pressure in my country's rabies vaccine market.

The rise of domestic innovation forces is evident in the acquisition of three clinical trial approvals in a short period of time.

This approval for a rabies vaccine to undergo clinical trials marks the third vaccine clinical trial approval Baihui Biotechnology has received in a short period. Previously, its trivalent influenza virus subunit vaccine and other products had successively entered the clinical stage. The rapid achievement of these results not only demonstrates the company's rapid rise in the vaccine research and development field, but also showcases its efficient ability to connect early technology reserves with clinical translation.
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As a rising force in China's vaccine industry innovation, Baihui Biotechnology adheres to the core value of "doing its utmost to produce every vaccine," driving its vaccine product portfolio through a dual-engine approach of technological innovation and capacity expansion. Looking ahead, the company will continue to focus on building core capabilities in vaccine R&D and manufacturing, meeting clinical needs with higher-quality, localized products, strengthening my country's vaccine defense system for major diseases, and contributing to a more robust national health protection network.
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