China Hepatitis B Vaccine For Newborn And Adult Protection Manufacturer, Supplier, Factory

AIM Honesty Biopharmaceutical Co., Ltd., a professional China-based manufacturer of recombinant vaccines, offers the Hepatitis B Vaccine For Newborn And Adult Protection—a product developed using the first domestically adopted and internationally leading recombinant Hansenula polymorpha expression technology platform. As a national key technology research program of the 863 Program undertaken by AIM Honesty, this vaccine features a production workshop covering over 11,000 square meters with a maximum production capacity reaching 45 million doses per year. With nearly 500 million doses administered across China and 20 years of market presence, this vaccine provides immunization plans for nearly 80% of the country's newborns. Hepatitis B affects approximately 296 million people worldwide, with about 820,000 deaths annually from HBV-related liver failure, cirrhosis, or primary liver cancer—making this vaccine a critical tool in global disease prevention efforts.

Understanding the Hepatitis B Threat

Hepatitis B is a viral liver disease that poses a significant global health burden. Without prevention, approximately 5% to 10% of infected individuals will develop chronic liver disease, increasing their lifelong risk of cirrhosis or liver cancer. Chronic HBV infection is the most important cause of liver cancer in China, with about 85% of liver cancer patients carrying HBV. Globally, there are approximately 296 million people with chronic HBV infection. The "Expert Consensus on Primary Prevention of Liver Cancer in China" (2018) pointed out that after excluding factors such as age and gender, compared with those who are both HBsAg and HBeAg negative, the relative risk of liver cancer for those who are HBsAg positive is 9.6, and for those who are both HBsAg and HBeAg positive, the relative risk is 60.

● Hepatitis B vaccination has few side effects and effectively protects recipients, so timely vaccination is recommended.

● Immunization is the most economical and effective means to control and even eradicate infectious diseases.

● Hepatitis B vaccination is a primary preventive measure for the etiology of liver cancer.

Newborn Protection: The Critical First Line of Defense

Newborns represent the most vulnerable population for hepatitis B infection, particularly those born to HBsAg-positive mothers. The Hepatitis B Vaccine For Newborn And Adult Protection is specifically indicated for newborns, especially those whose mothers are HBsAg and HBeAg positive. Timely vaccination within 24 hours of birth, combined with hepatitis B immunoglobulin when indicated, can reduce mother-to-child transmission by over 95%. The vaccine is administered intramuscularly into the deltoid muscle of the upper arm, with a standard immunization schedule of three doses at 0, 1, and 6 months.

● Nearly 80% of China's newborns receive immunization plans through this vaccine.

● The 10 μg formulation is suitable for all age groups, including newborns.

● Each human dose contains 10 μg or 20 μg HBsAg, with 0.5 ml per vial.

Adult Protection: Comprehensive Coverage for High-Risk Groups

Adults also require reliable hepatitis B protection, particularly those in high-risk categories. The Hepatitis B Vaccine is indicated for hepatitis B susceptible individuals, especially medical staff engaged in medical work and laboratory personnel exposed to blood. Additional high-risk groups include individuals with high-risk sexual behavior, injection drug users, household contacts of chronic carriers, patients with chronic liver disease, renal failure patients on hemodialysis, and travelers to endemic regions. The vaccine's superior immunogenicity ensures that even adults with suboptimal immune responses achieve protective antibody levels.

● The vaccine is suitable for people of all ages, effectively protecting against hepatitis.

● Healthcare workers and laboratory personnel benefit from reliable occupational protection.

● The 10 μg dose is applicable to all populations, unlike some competing products where 10 μg is only applicable to children.

Advanced Hansenula Polymorpha Expression Platform

The Hepatitis B Vaccine is manufactured using an internationally advanced recombinant Hansenula polymorpha expression technology platform, which is the first of its kind in China. This platform is characterized by high output and high antigen presentation purity. Unlike first-generation Saccharomyces cerevisiae expression systems or CHO cell-derived alternatives, the Hansenula polymorpha platform eliminates the need for antibiotics, bovine serum albumin, or thiocyanate during production, substantially reducing the risk of allergic reactions and adventitious agent contamination.

● The production workshop covers over 11,000 square meters with a maximum production capacity reaching 45 million doses per year.

● RECVAX® patented adjuvant technology creates an "antigen bank" in the body after administration, steadily releasing antigens and extending the duration of antigen action.

● The vaccine has achieved excellent immune effects, even surpassing the same dose of imported products and domestic multiple-dose products.

Comparative Quality and Purity Advantages

When evaluating hepatitis B vaccines, purity and safety parameters are critical considerations. The Hepatitis B Vaccine For Newborn And Adult Protection demonstrates superior quality across multiple pharmacopoeia parameters compared to other expression systems. The Hansenula polymorpha platform consistently achieves the highest purity standards with fewer additives and lower impurity levels.

Proven Immunogenicity and Long-Term Protection

Clinical evidence demonstrates the superior immunogenicity of the Hepatitis B Vaccine. A landmark study led by Academician Li Lanjuan evaluated booster immunization in 5- to 15-year-old children with four different hepatitis B vaccines. After a 0-1-6-month booster series with 10 μg RECVAX® (Hansenula-yeast) vaccine, the anti-HBs seropositive rates at 1, 5, and 8 years post-booster reached 83.4%—the highest among all four vaccines evaluated.

● The vaccine achieves high seroconversion rates, with over 98% of healthy recipients achieving protective antibody levels after a complete three-dose series.

● Protective antibody levels persist for at least 10 years in the majority of recipients, reducing the need for frequent boosters.

● The Hansenula polymorpha platform induces stronger T-cell activation, which is critical for clearing virus-infected cells and providing sterilizing immunity.

Manufacturing Excellence and Quality Assurance

AIM Honesty Biopharmaceutical Co., Ltd. was established in September 1993 and is one of the earliest Chinese high-tech enterprises specializing in vaccine production, R&D and sales. With a registered capital of RMB 250 million, AIM Honesty is among the first batch of enterprise technology centers of Liaoning Province and an enterprise with a national postdoctoral workstation. Located in Dalian, the company's employees with backgrounds in medicine or related fields account for more than half of its staff. The Hepatitis B Vaccine is manufactured under GMP-certified conditions, with production workshops covering over 11,000 square meters. The company holds drug manufacturing licenses and business licenses for honest operation.

● The vaccine has been on the market for 20 years, covering 31 provinces, cities, and autonomous regions in China.

● Total market usage has reached nearly 500 million doses.

● The company is strengthening production-education-research cooperation with world-renowned and domestic famous institutes.

Global Market Presence and Supply Reliability

As a subsidiary of AIM Vaccine Co., Ltd. (Stock Code: 06660.HK)—the largest global manufacturer of hepatitis B vaccines and the second-largest global rabies vaccine manufacturer—AIM Honesty benefits from a robust global supply chain. The company's products have been exported to South America, Central Asia, South Asia, Africa and other regions. AIM Vaccine has established cooperation with the relevant governments of Pakistan, Kenya and Egypt. Main sales markets include Southeast Asia (20%), Africa (20%), West Asia (20%), South Asia (15%), Central Asia (15%), and South America (10%).

● The company is both a manufacturer and trading company.

● Delivery time is typically 30 working days after payment receipt.

● Vaccines require cold chain transportation within 2-8 degrees range.

Frequently Asked Questions

Q: What is the recommended vaccination schedule for newborns?

A: The standard schedule is three doses administered at 0, 1, and 6 months. For newborns of HBsAg-positive mothers, the first dose should be given within 24 hours of birth, preferably combined with hepatitis B immunoglobulin. The vaccine is administered intramuscularly into the deltoid muscle of the upper arm.

Q: Is the 10 μg dose sufficient for adults?

A: Yes, the 10 μg formulation of the Hepatitis B Vaccine For Newborn And Adult Protection is applicable to all populations, including adults. This is due to the superior immunogenicity of the Hansenula polymorpha expression platform, which achieves excellent immune effects even at this dose level.

Q: How long does the vaccine provide protection?

A: Protective antibody levels persist for at least 10 years in the majority of recipients. A study led by Academician Li Lanjuan showed that anti-HBs seropositive rates at 1, 5, and 8 years post-booster reached 83.4%—the highest among all four vaccines evaluated.

Q: What are the storage requirements for the vaccine?

A: The vaccine requires cold chain transportation and storage within 2-8 degrees Celsius range. It should be protected from light and never frozen. The vaccine has a shelf life of 36 months under proper storage conditions.

Q: Does the vaccine contain any preservatives or animal-derived components?

A: No. The Hansenula polymorpha platform eliminates the need for antibiotics, bovine serum albumin, or thiocyanate during production. The vaccine is preservative-free, reducing the risk of allergic reactions and making it safer for all recipients.

Q: What is the total number of employees at AIM Vaccine?

A: The total number of employees in the Group and its holding companies is 1,501. This workforce supports the company's comprehensive operations across R&D, manufacturing, and commercialization.

Q: Has the manufacturing facility been inspected by PIC/S member countries?

A: The company hasn't undergone inspections by any PIC/S member countries to date, but is actively advancing this process.

Partnering for Global Hepatitis Prevention

Choosing the right hepatitis B vaccine is a strategic decision with lasting public health impact. The Hepatitis B Vaccine For Newborn And Adult Protection offers a unique combination of advanced technology, proven immunogenicity, and exceptional safety, supported by 20 years of real-world experience and nearly 500 million doses administered. AIM Honesty Biopharmaceutical Co., Ltd. stands ready to assist procurement agencies with comprehensive documentation, cold-chain support, and flexible packaging options. The company provides dedicated service, with marketing managers available to respond to inquiries and support export arrangements. By partnering with AIM Honesty, you gain access to a reliable manufacturer with a track record of delivering high-quality vaccines to over 31 provinces and multiple countries worldwide. Contact the international sales team for technical data, sample requests, or to discuss customized supply arrangements.