On October 17th, Aimei vaccines announced that the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (referred to as the 13-valent pneumococcal vaccine) is about to enter the stage of statistical unblinding. As of now, the trial results obtained indicate that the vaccine has good safety and immunogenicity.

This also means that domestic 13-valent pneumococcal vaccines are expected to gain an edge. An industry insider responsible for clinical registration told reporters that the clinical data for the 13-valent pneumococcal vaccine will have to wait for the unblinding results before any conclusions can be drawn. "If the unblinding data meets expectations, the company can initiate a new drug application for marketing, which means the product's launch is imminent," the source said.

If all goes well, Aimei vaccines will become the third domestic enterprise after Watson Biotechnology and Kangtai Biotechnology to possess this major category of 13-valent pneumococcal vaccine.

The speed of listing may become one of the competitive advantages in this category

The 13-valent pneumococcal vaccine is a major pharmaceutical category and is known as the "golden variety" in the vaccine industry. According to Frost & Sullivan's report, the Chinese vaccine market is expected to reach 383.5 billion yuan by 2031, with a compound annual growth rate of 15.95% from 2020 to 2031.

Based on this, the 13-valent pneumococcal vaccine has become a "must-have" product for vaccine companies. According to the WiseSearch database, apart from Aimei vaccines, there are currently several other companies, including Consino Biotechnology, An Tejin Biotechnology, Bowo Biotechnology, Weichao Biotechnology, Kexin Biotechnology, and Oulin Biotechnology, among others, progressing with related products, with Consino Biotechnology and An Tejin Biotechnology both in phase III clinical trials.

Zhao Xilong, Senior Investment Advisor at Jufeng Securities, told Securities Daily, Looking at the overall situation, more and more domestic vaccines are entering the market, which is expected to further reduce vaccine prices, increase vaccine sales and vaccination rates. For domestic vaccines, "the earlier they are listed, the earlier they can compete with foreign brands, giving them a first-mover advantage. If they are late to the domestic market, their sales may be affected." Zhao Xilong said.

Company production lines have been completed

Based on this, Aimei vaccines is racing against time.

Reporters further learned from Aimei vaccines that the company expects the vaccine to reach the unblinding stage at the end of this year or early next year, and obtain a new drug market approval in 2024. "We are very optimistic about the market space for the 13-valent pneumococcal vaccine and will spare no effort in advancing the listing process for this vaccine," Aimei vaccines told Securities Daily.

Previously, during a visit to the front lines, it was learned that the vaccine will be produced by Aimei Weixin, a factory located in Ningbo. Zhu Nan, the factory manager, told reporters that the 13-valent pneumococcal vaccine is a flagship product for Aimei Weixin, marking its transformation from a minor to a major variety, and the company has made every effort to expand production capacity.

"To meet the production requirements of new products, Aimei Weixin's old factory area started reconstruction in 2019 and has completed construction. The designed production capacity of the vaccine is 30 million doses," Zhu Nan said. The production line has also completed production verification, "and the samples of the 13-valent pneumococcal vaccine for the Phase III clinical trial were produced on this production line." It is reported that if the 13-valent pneumococcal vaccine is approved for market launch in the future, the subsequent bridging trial process can be omitted, expediting the listing process.

Potential supply gaps may still exist in the market

Currently, there may still be a certain supply gap in the domestic 13-valent pneumococcal vaccine market.

"Calculated based on the quantity of approvals issued, the cumulative penetration rate of five years covering age groups from 2018 to 2022 was 18.5%. Considering the 80% penetration rate in the United States, we believe that the market is still in a state of undersupply," Zhu Nan told reporters.

Zhao Xilong also told reporters that the fact that many pharmaceutical companies are developing and promoting the 13-valent pneumococcal vaccine indicates that the potential demand in the market is considerable. Currently, only 3 to 4 million vaccines are launched for use in the Chinese market each year, and supply is inadequate, which keeps prices relatively high, largely due to the monopoly of foreign brands.

Simultaneously, Securities Daily reporters noted that Aimei vaccines has planned to return to A-shares. On October 8th, Aimei vaccines announced that in order to promote business development, enhance overall competitiveness, and ensure the realization of the company's business goals and future development strategies, it had decided to initiate an A-share listing plan. Additionally, according to information from the China Securities Regulatory Commission's online service platform, Aimei vaccines' A-share listing advisory has been accepted as of October 16th, with CITIC Securities as the advisory institution.