Shanghai Securities News, www.cnstock.com, On March 4, Amy Vaccine announced on the Hong Kong Stock Exchange that the company's R&D of the 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal polysaccharide vaccine have all completed the on-site work of Phase III clinical trials and are carrying out various preparations before the new drug application for market launch, planning to complete the application and launch in 2024. In addition, the company has completed the construction of production workshops for the above three vaccines and has completed the production of Phase III clinical trial samples in the completed workshops.

Previously, on March 1, Amy Vaccine announced that the 13-valent pneumococcal conjugate vaccine had submitted a pre-application for market registration. In addition, the company announced the start of Phase II clinical trials for the quadrivalent meningococcal conjugate vaccine. With the submission of the tetanus vaccine for clinical trials, the company has initiated the R&D of the adsorbed acellular pertussis-diphtheria-tetanus-Haemophilus influenzae type b (HIB) combination vaccine (referred to as the "quadrivalent vaccine").

According to Amy Vaccine's 2023 performance forecast, based on the premise that its sales revenue is essentially the same as in 2022, due to significant changes in the COVID-19 pandemic, the company has made substantial impairment provisions for intangible assets and goodwill, and five major core products are all in phase III clinical status, this has led to a significant year-on-year increase in R&D expenses for the year, resulting in a forecasted loss.

Despite the forecasted loss, the company has three blockbuster iterative upgrade products applying for market launch in 2024, showing a positive signal. "Amy is in a leading position in global innovation in the field of rabies vaccine products, and the pneumonia series of vaccines benchmark international giants Pfizer, with continuous upgrade and iteration capabilities, is expected to enhance the company's new quality production force in the vaccine industry and enhance new development momentum." said Amy Vaccine.

Pneumonia vaccines, as billion-dollar major varieties, have been proven by the market for their commercial value. Amy Vaccine has developed a series of pneumonia vaccine products using the advantages of the polysaccharide conjugate vaccine technology platform.

Among them, the 13-valent pneumococcal conjugate vaccine has completed the on-site work of Phase III clinical trials and has submitted a pre-application for market launch; the 23-valent pneumococcal polysaccharide vaccine has also completed Phase III clinical trials and is expected to complete the application and launch in 2024; the 20-valent pneumococcal conjugate vaccine has submitted a pre-application for clinical trials; the globally synchronized first research of the 24-valent pneumococcal conjugate vaccine has completed pre-clinical research work.

In addition, the company's pneumonia series vaccine GMP workshop has been completed in batches, meeting international standards, and the Phase III clinical samples of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine are all produced in the above workshops.

Not only pneumonia vaccines, as the world's second-largest supplier of rabies vaccines, Amy Vaccine is rapidly promoting the launch process of the upgraded iterative rabies vaccine series. According to the announcement, the on-site work of the Phase III clinical trial of the serum-free iterative rabies vaccine has been completed, and various preparations before the new drug application for market launch are underway, planning to complete the application and launch in 2024; the novel process human diploid cell rabies vaccine is expected to submit a pre-application for clinical trials in the first half of 2024; the mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine product accepted domestically.

In addition, the company's serum-free iterative rabies vaccine workshop and the novel process human diploid cell rabies vaccine workshop have been completed, and equipment debugging and verification work are being carried out.

"So far, there has been no serum-free rabies vaccine approved and launched globally. The serum-free iterative rabies vaccine developed by the company does not contain animal serum, significantly improving safety and reducing the probability of adverse reactions." said relevant persons of Amy Vaccine.

Amy Vaccine stated that although the company's hepatitis B vaccine and rabies vaccine have taken a leading position in the domestic market, the company does not stop at being a traditional vaccine company but also layouts a number of globally innovative products.

At present, the company's five major technology platforms have laid out 23 innovative vaccines, with 5 in Phase III clinical trials, and there are 3 globally synchronized first research innovative vaccines, including EV71-CA16 bivalent hand-foot-mouth disease vaccine, 24-valent pneumococcal conjugate vaccine, mRNA iterative rabies vaccine, etc.

"The company's strategic intention is very clear, hoping to become the leader of innovation from the follower of innovation. In the future, we will accelerate the realization of new quality production forces and release the surging momentum of the company's innovative development." said relevant persons of Amy Vaccine.