China Reliable Hepatitis B Vaccine Manufacturer

AIM Honesty Biopharmaceutical Co., Ltd., which owns the RECVAX® brand, is a Recombinant Hepatitis B Vaccine Hansenula Polymorpha manufacturer from China. We use advanced technology to provide safe and reliable vaccine products for people of all ages, effectively protecting against hepatitis.

What is Hepatitis B?

Hepatitis B is a viral liver disease. Without prevention, approximately 5% to 10% of infected individuals will develop chronic liver disease, increasing their lifelong risk of cirrhosis or liver cancer. It is a very threatening disease. Hepatitis B vaccination has few side effects and effectively protects recipients, so timely vaccination is recommended.

Liver Cancer Prevention

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

Chronic HBV infection is the most important cause of liver cancer in our country, with about 85% of liver cancer patients carrying HBV. According to WHO, in 2019 there were approximately 296 million people worldwide with chronic HBV infection, and about 820,000 people died from liver failure, cirrhosis, or primary liver cancer caused by HBV infection.

The "Expert Consensus on Primary Prevention of Liver Cancer in China" in 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.

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

Our Product

Subsidiary of AIM Vaccine, AIM Honesty Biopharmaceutical Co., Ltd. independently developed RECVAX® Recombinant Hepatitis B Vaccine (Hansenula Polymorpha).

Due to the adoption of the first domestic and internationally leading recombinant Hansenula Polymorpha expression technology platform and patented adjuvant technology, it has achieved excellent immune effects, even surpassing the same dose of imported products and even the domestic multiple-dose products.

Product Introduction

AIM Honesty RECVAX®

[Composition and Description]

This product is prepared by purifying hepatitis B virus surface antigen (HBsAg) expressed by recombinant Hansenula Polymorpha yeast and adding aluminum adjuvant. It is a milky white suspension that can be layered due to precipitation and easily shaken and dispersed.

Active ingredient: hepatitis B virus surface antigen.

Excipients: aluminum hydroxide, sodium chloride.

[Vaccinated subjects]

This vaccine is indicated for hepatitis B susceptible individuals, especially those who: (1) Newborns, especially mothers, are HBsAg and HBeAg positive. (2) Medical staff engaged in medical work and laboratory personnel exposed to blood.

[Actions and Usage]

Vaccination stimulates immunity against the hepatitis B virus. Used for prevention of hepatitis B.

[Regulation]

0.5 ml per vial (vial), 0.5 ml per human dose, containing 10μg or 20ug  HBsAg.

[Immunization procedures and doses]

(1) was injected intramuscularly into the deltoid muscle of the upper arm.

(2) The immunization schedule is three doses, administered at 0, 1, and 6 months, and newborns receive the first dose of vaccine within 24 hours of birth, one dose each time.

[Adverse reactions]

Common adverse reactions: Pain and tenderness may be felt at the injection site within 24 hours after vaccination and disappear spontaneously within 2 to 3 days in most cases.

Rare adverse reactions:

(1) Transient febrile reactions may occur in vaccinees within 72 hours after vaccination and generally persist for 1 to 2 days and resolve spontaneously.

(2) Mild to moderate redness, swelling and pain at the inoculation site. Generally, it lasts for 1 to 2 days and resolves spontaneously without treatment.

Very rare adverse reactions:

(1) Induration may occur at the inoculation site and is generally absorbed spontaneously in 1 to 2 months.

(2) Local aseptic suppuration: Pus is generally repeatedly aspirated with a syringe, and in severe cases (ulceration) it is necessary to expand the wound to remove necrotic tissue, which lasts longer and can finally be absorbed and healed.

(3) Allergic reactions: allergic rash, Arthur reaction. Arthur reaction generally appears about 10 days after inoculation, local redness and swelling lasts for a long time, and solid alcohols can be used for systemic and local treatment.

(4) Anaphylactic shock: It generally occurs within 1 hour after injection of the vaccine and should be treated with timely injection of epinephrine and other rescue measures.

[Do not avoid]

(1) Known hypersensitivity to any component of the vaccine, including excipients, formaldehyde, and yeast.

(2) Patients suffering from acute diseases, severe chronic diseases, acute attacks of chronic diseases and fever;

(3) Pregnant women.

(4) For uncontrolled epilepsy and other progressive neurological diseases;

[Precautions]

(1) Use with caution in patients with the following conditions: family and individual history of convulsion, chronic diseases, history of epilepsy, and allergic constitution.

(2) It should be shaken well when used, and should not be used if there are clots that do not disperse, foreign bodies, cracks in the vaccine bottle, or unclear labels.

(3) Vaccine bottles should be used immediately when opened.

(4) Drugs such as epinephrine should be available for emergency use in case of occasional severe allergic reactions. Those receiving the injection should be observed in the field for at least 30 minutes after the injection.

(5) If abnormal conditions such as high fever and convulsion occur after the first injection, the second injection is generally no longer injected, and for infants with maternal and fetal blocking, the second and third injections should be followed by the doctor 's advice.

(6) Freezing is strictly prohibited.

[Package and Storage]

Store and transport at 2-8℃, protected from light.

Package Container: The inner packing materials are vials, ampoules and prefilled syringes, vials: 0.5 ml × 1 vials/box, 0.5 ml × 3 vials/box, 0.5 ml × 30 vials/box; ampoules: 0.5 ml × 3 vials/box, 0.5 ml × 9 vials/box; prefilled syringes: 0.5ml × 1 vial/box.

Effective period: Vials: 36 months, ampoules: 24 months, prefilled syringes: 36 months.

Product Specification

Compared to other technical routes, RECVAX® were produced with a more rigorous pharmacopeia standard, which improve the quality and safety of the product.

Characteristic Comparison

Product Application

RECVAX® patented adjuvant technology, through in situ adsorption technology, creates an "antigen bank" in the body after the product enters, steadily releasing antigens, extending the duration of antigen action, playing a role in enhancing the stimulation of the immune response, and improving immunogenicity.

The RECVAX® series Hepatitis B Vaccine Hansenula Polymorpha has been on the market for 20 years, covering 31 provinces, cities, and autonomous regions in the country, with a total market usage of nearly 500 million doses, providing immunization plans for nearly 80% of the country's newborns.

A 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.

Professional and modern production workshops are the cornerstone of high-quality products!