Recbio plans to offer 30,854,500 H Shares (subject to the Over-allotment Option), of which 27,769,000 H Shares will be International Placing Shares (subject to reallocation and the Over-allotment Option), representing approximately 90% of the initial Offer Shares; the remaining 3,085,500 H Shares will be Hong Kong Offer Shares (subject to reallocation), representing approximately 10% of the initial Offer Shares. Recbio will open for Hong Kong Public Offering in Hong Kong at 9:00 a.m., 21 March 2022 (Monday), and close at 12:00 noon, 24 March 2022 (Thursday). Dealings in H Shares of Recbio on the Main Board of the Hong Kong Stock Exchange is expected to commence on 31 March 2022 (Thursday). The H Shares will be traded in board lot of 500 H Shares each. The Company’s stock code is 2179.HK.
— Morgan Stanley Asia Limited, CMB International Capital Limited and CLSA Capital Markets Limited are the Joint Sponsors; and Morgan Stanley Asia Limited, CMB International Capital Limited and CLSA Limited are the Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers.
— China Industrial Securities International Capital Limited, Haitong International Securities Company Limited, GF Securities (Hong Kong) Brokerage Limited, Essence International Securities (Hong Kong) Limited and Valuable Capital Limited (in relation to the Hong Kong Public Offering only) are the Joint Bookrunners and Joint Lead Managers.
— Livermore Holdings Limited is the Joint Lead Manager.
A Vaccine Pipeline Driven by Novel Adjuvant Technology
Recbio is the vaccine company with a high-value vaccine portfolio driven by in-house developed technologies. The Company is primarily focus on the R&D of HPV vaccine candidates. Its vaccine portfolio consists of 12 vaccines, including the Core Product, REC603, a recombinant HPV 9-valent vaccine under phase III clinical trial, and the Company is one of the few domestic vaccine companies to have phase III stage HPV 9-valent vaccine candidate.
In recent years, vaccinology field has entered into a new era. Advanced technologies and breakthroughs in immunology have largely reshaped the vaccinology by creating opportunities for safer and more effective vaccine solutions. According to Frost & Sullivan, subunit vaccines accounted for approximately 55.4% of China’s vaccine market in 2020, which is expected to further grow to 86.6% in 2030. Driven by the growing number of subunit vaccines and technology breakthroughs, China’s vaccine market is expected to grow from RMB75.3 billion in terms of production value in 2020 to RMB333.3 billion in 2030 at a CAGR of 16.0%. With its strong R&D capabilities in developing subunit vaccines, the Company believe it is well-positioned to further benefit from the overall growth of China’s vaccine market.
With years of dedication in developing vaccines and leveraging its in-house developed technology platforms, the Company has been built a comprehensive vaccine portfolio consisting of 12 candidates, covering a broad disease spectrum including cervical cancer, COVID-19, adult tuberculosis, shingles, HFMD and influenza. Its vaccine portfolio extends to five of the ten diseases with the greatest burden under the 2019 Global Burden of Diseases assessed by DALYs issued by the WHO and covers disease areas of the three of the top five globally bestselling vaccine products in 2020. The Core Product, REC603, is a recombinant HPV 9-valent vaccine candidate, which is currently under phase III clinical trial in China. The Company plan to submit the BLA application in 2025 for REC603 and commence commercialization once the BLA application is approved. In addition, its COVID-19 vaccine, ReCOV, has commenced a phase I clinical trial in New Zealand in June 2021 and obtained the initial partially unblinded data in October 2021. Based on the major safety and immunogenicity data and the partially unblinded efficacy data from the phase I trial, the Company subsequently obtained the clinical trial approval from the Philippines FDA to conduct the global phase II/III trial for ReCOV in January 2022. To date, the Company has initiated subject enrollment for the global phase II/III trial for ReCOV in the Philippines. In January 2022, the Company also obtained the unblinded clinical data for the remaining three cohorts and has been finalizing data analysis and clinical trial report. It plans to file the EUA/BLA application in 2022.
A Pipeline of Vaccine Candidates Covering Diseases With Significant Unmet Needs
The Company has adopted a vaccine development strategy aimed to firmly position itself at the vanguard of the vaccine industry. In light of overarching vaccine industry trends, it has strategically developed a pipeline that extends from preventative to post-exposure prophylaxis. In addition to HPV and COVID-19, its comprehensive pipeline also includes a recombinant shingles vaccine, two TB vaccines for adults, an influenza quadrivalent vaccine, and an HFMD quadrivalent vaccine.
HPV vaccines are one of the most commercially valuable vaccines in the world, with a global market size of US$4.2 billion in 2020, accounting for approximately 11.5% of the global vaccine market in terms of production volume. Therefore, the Company has strategically developed a comprehensive HPV pipeline to address the unmet urgent need for HPV vaccines. To date, the Company is advancing clinical trials of three key vaccine candidates namely a recombinant HPV 9-valent vaccine, REC603, and two recombinant bivalent vaccines, REC601 and REC602, targeting different countries and populations. At present, the Company is also developing REC604a and REC604b with a potentially fewer dose regimen, employing a self-developed novel adjuvant benchmarking AS04, and plans to submit INDs filing in 2022 and 2023, respectively.
What is noteworthy is that, its recombinant HPV 9-valent vaccine, REC603, is expected to be the one of the first of domestic vaccines of its kind to be approved and commercialized in China. The Company is currently conducting a phase III clinical trial and has completed 12,500 subjects enrollment for the potency tests in October 2021. The first subject was enrolled on June 26, 2021 and the Company is actively working with industry leading PIs and highly-qualified CROs to accelerate its trial progress. The Company expects to complete three-shot dosing by the first half of 2022 and plans to reach primary endpoints for its phase III clinical trial and submit BLA to the NMPA in 2025.
Self-Developed Advanced Technology Platforms that Support and Drive the Development of Next Generation Vaccine Candidates
Through years of dedication and focus on vaccinology field, the Company has developed a comprehensive vaccine innovation engine consisting of a novel adjuvant platform, protein engineering platform and immunological evaluation platform. The Company is the one of the few companies that are capable of developing novel adjuvants, benchmarking all of the FDA-approved novel adjuvants to date. The technology platforms form a solid trifecta, creating synergies among the design and optimization of antigens, the development and production of adjuvants and the identification of the optimal combinations of antigens and adjuvants. Supported by these platforms, the Company is constantly upgrading its technology to further enrich its R&D toolbox so that to drive its vaccine development going forward.
In addition to the technology platforms, its IPD System lays a solid foundation for the R&D activities. The IPD system governs the entire life cycle of vaccine candidates. Empowered by the IPD System, the Company is able to advance multiple vaccine development projects simultaneously.
Continuously Expand Production Capacity, Strengthen Competitive Advantage
The company has started to build up its manufacturing capabilities at an early stage to ensure the vaccine candidates can be smoothly transferred into successful commercial vaccine products. The manufacturing and quality control system is built in compliance with the industry leading GMP standard. It also has recruited many talents in charge of production and quality, who has gained abundant industry insights and profound understanding from their commercialization experience in vaccine companies.
Currently, the Company is constructing its HPV vaccine manufacturing facility in Taizhou, Jiangsu province, the first phase of which has a designed capacity of five million doses of HPV 9-valent vaccines or 30 million doses of HPV bivalent vaccines per year. The construction of the first phase of its HPV manufacturing facility is expected to be completed by the end of 2022. In addition, the Company has obtained a drug production license from ReCOV and completed the construction of the GMP-standard manufacturing facility for ReCOV in November 2021. The manufacturing facility, which can also be used for the manufacturing of recombinant shingles vaccines, has a total GFA of approximately 17,000 sq.m. and has the potential to support an annual manufacturing capacity of 300 million doses of ReCOV.
High Performance Management and Scientific R&D Team, Supported by Leading Investors in the Healthcare Industry
R&D is crucial to the continuous success. The vaccine industry has been rapidly evolving with various scientific advancement and innovative technologies to constantly reshape the vaccinology field. The Company is led by an experienced management and elite scientific team consisting of industry-leading scientists with extensive experiences in academic studies of immunology and development of vaccine products and industry-leading experts who are familiar with bringing vaccine candidates from concept to market.
The Company has also received strong support from its shareholders, including leading investors in healthcare industry as well as major institutional investor such as Lake Bleu Capital, Temasek, Legend Capital and Sequoia Capital, representing recognition from its shareholders on the market position and growth potential. The Company believe its diversified shareholder base will fuel the future growth with financial support and industry insights.
The Chairman of the Board, Executive Director and General Manager of Jiangsu Recbio Technology Co., Ltd., Dr. LIU Yong said, “As the vaccinology field enters a new era driven by novel vaccine technologies and significant expansion in disease and population coverage, we expect that China’s vaccine market will grow significantly. With our strong R&D capabilities, we expect to further benefit from the overall growth in China’s vaccine market. Looking ahead, we plan to continuously accelerate R&D, clinical trial and commercialization of our vaccine candidates, including rapidly advancing the development of our HPV vaccines, COVID-19 vaccines as well as the development and commercialization of our other vaccine candidates. We also intend to boost our market penetration and profitability by encouraging continuous innovation, streamlining our organization structure, company culture, and talent recruiting system, commercializing our technologies and products in the global market, and expanding vaccine candidates and technologies internationally through collaboration. At the same time, we will continue to explore opportunities to acquire advanced technologies and recruit international talent to supplement our in-house R&D capabilities. We are also evaluating establishing an overseas R&D center to closely collaborate with academic institutes and scientists abroad and to advance our R&D activities. Finally, driven by our strong R&D capabilities, we are focusing on complete value chain innovation from R&D to commercialization in the vaccine industry, to maximize value for our shareholders and investors.”
Use of Proceeds:
The Company estimates that it will receive net proceeds of approximately HK$672.4 million from the Global Offering, after deducting the underwriting commissions and other estimated offering expenses payable by the Company, assuming the Over-allotment Option is not exercised and assuming the Offer Price is fixed at HK$24.80 per H Share. The Company intends to use the net proceeds for the following purposes:
— Approximately 47.3%, or HK$317.9 million, will be allocated to continue to optimize, develop and commercialize HPV vaccine pipeline, including the Core Product, the recombinant HPV 9-valent vaccine REC603
— Approximately 17.7%, or HK$119.3 million, will be used for the preclinical and clinical studies, registration of the COVID-19 vaccine, namely ReCOV
— Approximately 21.1%, or HK$142.0 million, will be used for the preclinical and clinical studies, registration of other vaccine candidates, including recombinant shingles vaccine, REC610; TB vaccines, REC606; and REC607, recombinant quadrivalent influenza vaccine, REC617; and recombinant HFMD quadrivalent vaccine, REC605
— Approximately 6.7%, or HK$44.7 million, will be used to further enhance the R&D capabilities and enhance its operating efficiencies
— Approximately 7.2%, or HK$48.5 million, will be used for working capital and general corporate purposes
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