Clinical trial application for the second-generation mRNA COVID-19 vaccine is scheduled to be submitted in the fourth quarter of this year.
This article is an original IPO Early Know
Author | Robin
According to IPO Early Know, Amy Vaccine Co., Ltd. (hereinafter referred to as "Amy Vaccine") submitted a listing application to the Hong Kong Stock Exchange again on September 12, with Goldman Sachs, CICC, CICC and Macquarie being the joint sponsors.
Emira vaccine has received multiple rounds of investment from institutions such as Meihua Bio (600873.SH), Saifu Equity Investment, China Merchants Bank International, Langmafeng Venture Capital, Hillhouse Venture Capital, Zhengxingu Capital, Yizhuang Guotou and other institutions.
prospectus shows that the Amy vaccine issued a total of 60 million doses in China in 2020, accounting for 9.5% of the market share. It is China's largest private vaccine group in the entire industry chain and the second largest domestic vaccine manufacturer after China Biologics (CNBG).
Emirati vaccine product portfolio includes eight commercial vaccine products for six vaccines that can prevent infectious diseases (hepatitis B, hepatitis A, rabies, mumps, nephrotic syndrome hemorrhagic fever and meningococcal disease). There are also 23 vaccines under development in the pipeline targeting 13 disease fields.
Source: Prospectus
Based on the batch issuance in 2020, Aimee vaccine is the largest hepatitis B vaccine supplier and the second largest rabies vaccine supplier in China.
vaccine under development mainly includes three types of vaccine under development, including DTP (including diphtheria, tetanus, pertussis) vaccine under development, (DTaP, DTcP and DTP-Hib), , , (including a global innovative mRNA rabies vaccine under development, a vaccine under development using serum-free Vero cells that is being prepared for clinical trial applications, and a vaccine under development based on human diploid cells), , a MC V4 Meningococci vaccine under development , , two influenza vaccines under development , , two HPVs under development (including HPV2 and HPV9), , one herpes vaccine under development , and , one RSV, respiratory syncytial virus infection vaccine under development .
For COVID-19, Amy vaccine has laid out candidate pipelines based on four technology platforms, namely mRNA, inactivated virus, recombinant adenovirus vector and recombinant protein. Among them, mRNA COVID-19 vaccine under development, is a self-developed product of the company. has entered the Phase I clinical trial stage, and has made the fastest progress among the four COVID-19 pipelines. The above phase I clinical trial was conducted at Shulan Hospital. The adult group completed enrollment at low and medium doses. The preliminary trial results showed that it was safe and well tolerated after vaccination.
The first generation of the inactivated COVID-19 vaccine (for the original strain) has obtained the clinical trial application approval. This clinical trial is expected to accelerate the company's second-generation mRNA COVID-19 vaccine under development and the second-generation inactivated COVID-19 vaccine against the Delta strain. Emmy vaccine is scheduled to submit a clinical trial application for the second generation mRNA COVID-19 vaccine in the fourth quarter of 2021, and is expected to start the Phase II clinical trial of the product in 2022. 's second-generation inactivated COVID-19 vaccine against Delta strain was developed by the company in cooperation with the Zhejiang Provincial Center for Disease Control and Prevention; Amy's vaccine is also jointly developing two new broad-spectrum COVID-19 vaccines based on recombinant adenovirus vectors with the Shanghai Public Health Center.
Aimi Vaccine now operates four certified factories of Rong'an Bio, Aimi Hanxin, Aimi Kanghuai and Aimi Weixin, with an annual designed production capacity of 25 million doses, 45 million doses, 5.3 million doses and 16 million doses respectively, totaling 91.3 million doses).
Aimee vaccine's biosafety third-level protection (P3) production workshop of the inactivated COVID-19 vaccine located in Ningbo Bonded Zone has been completed, with an estimated annual production capacity of 500 million doses.
From 2018 to 2020 and the first half of 2021, Amy's vaccine revenue recorded 1.111 billion yuan, 952 million yuan, 1.638 billion yuan and 673 million yuan. The revenue mainly comes from rabies vaccine (Vero cells) and hepatitis B vaccine sales revenue. From 2018 to 2020, the company's net profit was RMB 101 million, RMB 120 million and RMB 400 million, respectively, with an annual compound growth rate of 98.7%, and net profit margins were 9.1%, 12.6% and 24.4%. In the first half of 2021, due to the significant increase in one-time non-operating share remuneration expenses and R&D expenses, the company's net profit recorded a loss.
