Recbio Announces Interim results for the Fiscal Year 2022 and Company Progress

The nine-valent HPV vaccine and other blockbuster varieties have been advanced efficiently.

Cash reserve was nearly RMB 1.5 billion,which provided support to sustainable innovation and commercialization.

The novel adjuvants vaccine will create a strong growth engine.

TAIZHOU,China,Aug. 29,2022 --Recbio (HKEK:02179),an innovative vaccine company,released its interim result for the fiscal year 2022 in the evening of August 25. During the reporting period,the company efficiently advanced its core products,including nine-valent HPV vaccine and multiple vaccine candidates,and made significant progress. Therefore,the R&D expenses increased by 73.05% to RMB 354 million on a year-on-year basis.

Phase III clinical trials of nine-valent HPV vaccine have been advancing rapidly. The demand for import substitution was strong.

HPV vaccines currently comprise the largest component of Recbio pipeline portfolio,including five bivalent,newly adjuvant-based quadrivalent and nine-valent HPV vaccines. The Phase III clinical trial of recombinant 9-valent HPV vaccine REC603 in China was composed of three parts: main efficacy test,immune bridging test in young age groups,and immunogenicity comparison test with Gardasil 9. The trial was multicenter,randomized,blind and parallel controlled,with a total sample size of 16,050 subjects. This was the largest sample size of nine-valent HPV vaccine in Phase III clinical practice in China. At present,REC603 main efficacy trial is in the follow-up stage according to the protocol,and all subjects have been enrolled and inoculated in the bridging trials in the younger age group and head-to-head immunogenicity bridging trials with Gardasil 9.

Phase I clinical data of REC603 showed that REC603 was safe and well tolerated with good immunogenicity. The high yield and stable expression of HPV virus-like particles can be satisfied by using the Humphrey's yeast expression system,which makes this vaccine candidate more suitable for commercial production.

The demand for HPV vaccines,especially high-end HPV vaccine products,remains strong in China. The total volume of HPV products Gardasil and Gardasil 9 by MSD issued in China in 2021 reached 8.8 million and 10.2 million,respectively. Global sales of Gardasil/Gardasil 9 increased 40% to $5.673 billion,driven by the Chinese market.

At present,no domestic nine-valent HPV vaccine has been approved for sale in China. China continues to face a manufacturing capacity bottleneck for HPV vaccines. It is estimated that 234 million women aged 9 to 45 years will remain unvaccinated by the year of 2025,leaving a gap of 702 million doses assuming a three-dose regimen. Based on the leading Phase III clinical progress,the largest sample size of nine-valent vaccine subjects in China,and the clinical trial site with higher incidence,REC603 is expected to become the first domestic nine-valent HPV vaccine approved for sale,realizing the domestic substitution of imported HPV vaccines and alleviating the situation of " supply falls short of demand ".

In addition to the nine-valent products,REC601,a bivalent HPV vaccine (type 16/18) from Regbio,has completed Phase I clinical trials with data showing good safety and immunogenicity. The bivalent HPV vaccine (type 6/11) REC602 has been in Phase I clinical data analysis. REC602 is the most effective medical intervention for HPV-induced genital warts (male market),which cause high disease burden and have no effective treatment. In addition,Recbio new adjuvant quadrivalent HPV vaccine REC604a has completed preclinical studies and will file an IND in the second half of this year.

With efficient and sustainable business development,the new adjuvant platform has huge potential.

As a whole,the pipeline also covers COVID-19 vaccines,shingles vaccines and other major disease areas which bring great global public health burden. During the reporting period,the recombinant COVID-19 vaccine ReCOV made steady progress. Equipped with BFA03,a new adjuvant independently developed by the company,ReCOV can induce high-titer broad-spectrum neutralizing antibodies and Th1-biased T-cell immune response,which has good cross-neutralizing effect and immune persistence against Omicron,Delta and other variant viruses. At present,the company has carried out international Phase II/III clinical studies in the Philippines and the United Arab Emirates,and obtained clinical approval from China Food and Drug Administration. The Phase II study of the basic immunization of ReCOV in the Philippines is in the data analysis phase. Preliminary data showed that the overall safety and tolerability were pleasing,and no serious vaccine-related adverse reactions occurred. In the Phase II booster immunization study in the Philippines,the immunogenicity study of ReCOV versus Pfizer mRNA vaccine as a positive control took only 2 weeks from the receipt of approval to the completion of vaccination in all subjects. The company plans to submit the EUA simultaneously in China and overseas markets in the second half of 2022 to contribute to the global containment of COVID-19.

During the reporting period,the company's vaccine quality management system also achieved rapid development. The ReCOV production base located in Taizhou has obtained the conformance statement issued by the EU Quality Authorizer (QP),which indicates that the company's Taizhou production base and quality management system comply with the EU GMP standard,and lays a solid foundation for the high-quality development and future international commercialization of ReCOV.

The subsidiary company Recogen took the lead in breaking through the lyophilization process of mRNA vaccines. The world's first lyophilized dosage form mRNA vaccine R520A was designed against Omicron variant and has been approved clinical trails by the Philippines and New Zealand. Preclinical research papers have been published on the preprint platform bioRxiv,and the data show that R520A can be stored and transported at 2-8 degrees Celsius,and has extensive cross-neutralization effect.

New adjuvants have increasingly become an important bottlenecking technology in China's vaccine industry.Through its novel adjuvant development platform,Recbio is able to develop and iterate on FDA-approved adjuvants (AS01,AS03,AS04,MF59,and CpG1018). With this capability,Recbio is not dependent on any specific adjuvant supplier and is able to develop the next generation of novel vaccines with more clinical value. Its recombinant shingles vaccine candidate REC610 uses a novel adjuvant with AS01,which greatly improves cellular immunity. Head-to-head studies have shown that its immunogenicity is not inferior to GSK's Shingrix.

During the reporting period, the company has continuously recruited high-quality talents in an orderly manner,and the staff has rapidly expanded to 478 people. Ms. Wang Jing,Chief Quality Officer,Ms. Feng Yanfei,Chief Business Officer,and other industry experts with rich experience in quality management and global business cooperation have joined Recbio,laying a solid foundation for efficiently promoting the market access and commercialization of candidate vaccines,including nine-valent HPV vaccine REC603 and COVID-19 vaccine ReCOV.

At present,the company's cash reserve is nearly RMB 1.5 billion,which provide support to the company's research and development innovation and sustainable development.

In terms of the execution of the R&D pipeline,cash reserves and the layout of high-end talents,Recbio has made full preparations to realize the commercialization and localization of high-end HPV vaccines and the technical landing of other major diseases.

"In the context of the huge global demand for innovative vaccines,we will accelerate the commercialization process of products in the global market through continuous innovation and international cooperation,and promote the innovation of the whole value chain of product pipeline from R&D to commercialization,so as to create more value for shareholders and investors," said Dr. Yong Liu,founder,Chairman of the Board and general manager of Recbio.

About Recbio

Founded in 2012,Recbio is an innovative vaccine company. With the vision of "Become the Leader of Innovative Vaccine in the Future," Recbio takes "Protect Human Health with Best-in-Class Vaccines" as its mission. It has established three major cutting-edge technology platforms including novel adjuvants platform,protein engineering platform,immunological evaluation platform and mRNA vaccine platform. Recbio has a high-value vaccine portfolio consisted of HPV vaccine candidates,COVID-19 vaccine candidates,shingles vaccine candidates,influenza vaccine candidates,adults TB vaccine candidates etc. The core management team has more than 20 years of experience in the development and commercialization of innovative vaccines. For more information,please visit https://www.recbio.cn/.

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