China Hepatitis B Vaccine Using Hansenula Polymorpha Expression Technology Manufacturer, Supplier, Factory

AIM Honesty Biopharmaceutical Co., Ltd., a trusted Chinese vaccine factory under the listed AIM Vaccine Group, independently develops and produces high-performance Hepatitis B Vaccine Hansenula Polymorpha. Built on the world-class Hansenula Polymorpha expression platform and patented adjuvant technology, this human immunization vaccine delivers stable, superior immune response, exceeding conventional yeast and cell-based hepatitis B vaccine products. With over 20 years of market validation and nearly 500 million cumulative doses used nationwide, it serves as a core preventive solution for HBV infection control for newborns, medical staff and high-risk groups worldwide.

Core Profile

This advanced yeast-derived immunization product is formally branded as RECVAX®, professionally manufactured and exported by AIM Honesty Biopharmaceutical Co., Ltd. Different from traditional Saccharomyces cerevisiae and CHO cell vaccine routes, Hepatitis B Vaccine Hansenula Polymorpha adopts a cutting-edge recombinant yeast expression system with zero antibiotic and zero bovine serum albumin addition throughout production. It effectively avoids exogenous contamination risks and achieves industry-leading purity and safety standards, making it a preferred long-term immune protection vaccine for global public health procurement.

As a key commercial product of AIM Vaccine Group, this vaccine benefits from the group’s five validated vaccine technology platforms and strict GMP standardized production systems. It maintains consistent batch stability and excellent clinical performance, supporting large-scale bulk export and cross-border medical project cooperation.

Product Function

Hepatitis B virus infection is one of the leading causes of chronic liver diseases, cirrhosis and primary liver cancer globally. Statistical data shows that chronic HBV infection affects over 296 million people worldwide, causing approximately 820,000 annual deaths from liver failure and malignant liver lesions. Effective vaccination remains the most economical and reliable public health intervention to block viral transmission and reduce long-term liver disease risks.

Hepatitis B Vaccine Hansenula Polymorpha is designed specifically for HBV infection prevention. It induces the human body to produce targeted hepatitis B surface antibodies, establishing a stable immune barrier against viral invasion. Standard immunization can effectively block mother-to-child transmission, occupational exposure infection and daily contact transmission, significantly reducing the incidence of chronic hepatitis B and subsequent liver cancer risks.

Applicable Crowds

This optimized recombinant hepatitis B immunization vaccine is suitable for all HBV-susceptible populations, covering pediatric and adult groups with differentiated protection demands. It provides targeted immune defense for high-risk groups with frequent exposure risks.

1. Newborn infants, especially babies delivered by HBsAg and HBeAg double-positive mothers, effectively blocking vertical mother-to-child HBV transmission.

2. Clinical healthcare workers, laboratory researchers and medical staff who are regularly exposed to human blood and bodily fluid samples with high viral exposure probability.

3. Adults living in high-incidence areas, personnel engaged in high-risk public health positions, and individuals requiring long-term regular immune protection against hepatitis B virus.

Tech Standards

AIM Honesty Biopharmaceutical implements stricter internal pharmacopoeia standards than industrial norms for Hepatitis B Vaccine Hansenula Polymorpha. Every batch undergoes rigorous testing on endotoxin, residual chemical content and impurity indicators, ensuring higher safety thresholds than traditional vaccine technical routes. The following comparison table clearly reflects the quality advantages of Hansenula Polymorpha yeast technology over Saccharomyces cerevisiae and CHO cell processes.

Immune Advantages

Different from conventional hepatitis B vaccines, Hepatitis B Vaccine Hansenula Polymorpha adopts exclusive patented adjuvant and in-situ adsorption technology. After inoculation, it forms a stable antigen bank inside the human body, realizing sustained and slow antigen release. This mechanism prolongs immune stimulation duration and significantly enhances overall immune response, bringing more durable and reliable protective effects.

Clinical academic research led by academician institutions has verified its outstanding performance. In comparative booster immunization trials covering children aged 5 to 15, the 10μg Hansenula Polymorpha yeast vaccine achieved an 83.4% anti-HBs seropositive rate within eight years after booster vaccination, ranking the highest among four mainstream vaccine groups. Its long-term immune persistence far exceeds traditional products.

With two decades of stable market promotion, the RECVAX® vaccine series has covered all 31 provincial-level administrative regions in China, serving nearly 80% of domestic newborn immunization programs. The cumulative clinical dosage has reached nearly 500 million doses, proving stable and safe mass application capacity.

Production Strength

Product quality stability relies on standardized industrial production systems. As a core subsidiary of the listed AIM Vaccine Group, AIM Honesty Biopharmaceutical operates fully compliant GMP-grade clean workshops and adopts closed automated production processes for Hepatitis B Vaccine Hansenula Polymorpha. The whole production link strictly abides by international biopharmaceutical manufacturing specifications to eliminate cross-contamination risk and ensure uniform batch quality.

The group owns complete industrial chain capabilities including independent R&D platforms, professional vaccine research institutes and standardized purification workshops. It is one of the few Chinese human vaccine enterprises with complete multi-technology platform layout and P3 laboratory strategic resources, providing solid technical and production guarantees for long-term stable supply of high-quality yeast-derived hepatitis B vaccines.

Supply Service

AIM Honesty Biopharmaceutical supports global bulk procurement and stable cross-border delivery of Hepatitis B Vaccine Hansenula Polymorpha. Relying on the group’s mature international supply chain system, it provides one-stop supporting services including official qualification documents, batch test reports, customs clearance files and cold-chain transportation solutions, meeting the registration and procurement standards of different countries and regions.

All exported vaccines adopt standardized export packaging and professional low-temperature cold-chain logistics to ensure activity stability during long-distance transportation. The enterprise maintains sufficient inventory reserves and flexible order cycles, which can meet the batch procurement demands of international medical institutions, public health projects and vaccine distributors.

FAQ

Q1: Why is Hansenula Polymorpha yeast technology better for hepatitis B vaccine production?

A1: Compared with traditional Saccharomyces cerevisiae and CHO cell technical routes, Hansenula Polymorpha expression technology features higher genetic stability, stronger antigen expression efficiency and ultra-high product purity. It eliminates animal-derived additive risks, tumorigenic hidden dangers and residual chemical impurities, delivering safer injection experience and more durable immune protection. It is currently recognized as the optimal technical route for recombinant hepatitis B vaccines in the industry.

Q2: Which age groups can take this hepatitis B vaccine?

A2: This yeast-derived hepatitis B immunization vaccine adapts to full-age susceptible populations. The 10μg specification is suitable for all children and adults, while the 20μg specification is approved for people aged 16 and above. It can be used for routine newborn immunization, high-risk adult supplementary vaccination and postoperative booster immunization, covering all mainstream clinical vaccination scenarios.

Q3: Is the vaccine safe for newborns of HBV-positive mothers?

A3: Completely safe and highly recommended. This vaccine is widely applied in maternal and infant HBV blocking programs. Combined with standardized immunization procedures, it can effectively block vertical mother-to-child transmission, greatly reducing the newborn HBV infection rate, and has been verified by decades of large-scale clinical application data.

Q4: What supporting documents can be provided for overseas registration?

A4: As a formal Chinese vaccine manufacturer, we can provide complete official documents including GMP certification, manufacturing license, batch COA test report, product registration certificate, packing list and commercial invoice. All files comply with international customs clearance and medical product registration requirements, supporting customers’ local market access and project bidding.

Q5: What are the advantages compared with imported hepatitis B vaccines?

A5: With internationally leading Hansenula Polymorpha expression technology and patented adjuvant process, our vaccine achieves immune effects equal to or even better than imported products. Meanwhile, it has more stable batch consistency, higher cost performance and larger domestic and global clinical usage data, with more sufficient real-world safety and effectiveness verification.

Product Summary

Hepatitis B Vaccine Hansenula Polymorpha from AIM Honesty Biopharmaceutical Co., Ltd. represents the advanced level of global recombinant hepatitis B vaccine technology. With unique yeast expression system advantages, strict quality control standards and long-term clinical market verification, it solves the safety and efficacy pain points of traditional vaccines. Suitable for full-age population prevention and high-risk crowd immune intervention, it is a reliable long-term HBV prevention solution for global public health institutions and bulk purchasers.