World-First Inhaled COVID-19 Vaccine, Developed in Partnership Between Aerogen® and CanSinoBIO, First Public Booster Immunization in China.

Late in 2021, Aerogen® (Galway, Ireland) and CanSinoBIO (SSE: 688185, HKEX: 06185) (Tianjin, China) announced a development and commercial supply partnership for the inhaled delivery of CanSinoBIO’s Recombinant Novel Coronavirus Vaccine Convidecia Air™ utilizing Aerogen’s proprietary aerosol drug delivery technology.

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In 2022 Convidecia Air™ was granted Emergency Use Authorization as a booster dose by the National Medical Products Administration of China (“NMPA”). On October 25^th, Shanghai became the first city to initiate booster vaccination by inhalation for adults aged 18 and above, who have previously been primed with two shots of inactivated vaccines or one shot of Convidecia™.

The aerosolised vaccine is directly inhaled via a cup dispenser into the patient’s airway. This route mimics the natural infection pathway of the respiratory virus COVID-19 and may create additional benefits through generating mucosal immunity.

According to a Phase III clinical trial published in December 2021 in the journal The Lancet, the injected Convidecia™ vaccine was 91.7% effective at preventing severe disease after four weeks or longer following a single administered dose.¹

Further clinical trials on delivery by inhalation, published in the Lancet in December 2021 and August 2022, demonstrated the inhaled vaccine Convidecia Air™ as a heterologous booster generated much stronger immune responses than those induced by a homologous inactivated vaccine booster. Convidecia Air™ has proven to be an innovative solution that provides safe and effective protection for people through a needle-free, painless and non-invasive delivery without any serious adverse events observed. ^2,3

Inoculation by the inhaled aerosol route requires a considerably smaller volume of vaccine to be used and therefore provides the capacity to allow a much larger number of patients to cost-effectively access the CanSinoBIO vaccine than would have been possible using an injectable approach.⁴

Further clinical trials of the inhaled vaccine are progressing in Asia and Latin America to support other country approvals for this innovative technology.

John Power, Aerogen CEO & Founder said “T he world has an urgent need for an effective, low-cost, globally scalable, and globally accessible solution to mass vaccination. The pioneering development undertaken by Aerogen and CanSino has resulted in a system that meets all these requirements and with the capacity to vaccinate in the billions. We are delighted with the news of approval and public rollout in China and look forward to further approval of inhaled vaccines around the world.”

Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO commented; “We are delighted that our collaborative efforts with Aerogen on the innovative inhaled delivery of COVID-19 vaccine is recognized by the market. This significant breakthrough in vaccination has the potential of blocking transmission through an added layer of mucosal immunity. We look forward to expanding global access to our innovative needleless vaccine to accelerate the pace of bringing society back to life.”

Leo Clancy, CEO, Enterprise Ireland said: “Aerogen has an exceptional track record, delivering game-changing disruptive technology to MedTech and pharma companies throughout the world to optimise and accelerate the development and production of medicines, including vaccines. The innovative technologies pursued by the company continue to push boundaries and transform treatments, in this case with respect to Covid-19, positively impacting the well-being of people worldwide. Today’s announcement is hugely significant and further strengthens Ireland’s position in the global value chain of vaccine development and manufacturing. We look forward to continuing to work with Aerogen as it continues to transform product offering for healthcare through innovation, underpinning the company’s continued growth in world markets.”

Additional information:

About CanSinoBIO:

CanSinoBIO (SSE: 688185, HKEX: 06185) is a leading biopharmaceutical company committed to research, production, and commercialization of innovative vaccines for global public health security. It possesses five integrated platform technologies including viral vector-based technology, synthetic vaccine technology, protein structure design and recombinant VLP technology, mRNA vaccine technology as well as formulation and delivery technology. As of today, it has established a rich portfolio of pipeline products preventing 12 diseases, including Asia’s innovative vaccine for Ebola virus disease Ad5-EBOV, the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) recognized by the WHO, and our global innovative inhaled COVID-19 vaccine Convidecia Air^TM. Additional information can be found online at www.cansinotech.com.

About Aerogen:

Aerogen is the world leader in acute care aerosol drug delivery. The Aerogen Solo is a closed-system, single-patient-use aerosol drug delivery technology⁵ that mitigates the transmission of patient-generated infectious aerosol during ventilation^6-11. As the only globally available closed-circuit system, Aerogen technology has been used to treat over 16 million patients in 75 countries worldwide, playing a critical role in emergency departments and intensive care units¹².

References

1. Halperin SA, Ye L, MacKinnon-Cameron D, Smith B, Cahn PE, Ruiz-Palacios GM, Ikram A, Lanas F, Guerrero ML, Muñoz Navarro SR, Sued O, Lioznov DA, Dzutseva V, Parveen G, Zhu F, Leppan L, Langley JM, Barreto L, Gou J, Zhu T, for the CanSino COVID-19 Global Efficacy Study Group. Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial. Lancet 2022 399: 237-248, DOI: doi.org/10.1016/S0140-6736(21)02753-7
2. Li JX, Wu SP, Guo XL, Tang R, Huang BY, Chen XQ, Chen Y, Hou LH, Liu JX, Zhong J, Pan HX, Shi FJ, Xu XY, Li ZP, Zhang XY, Cui LB, Tan WJ, Chen W, Zhu FC. Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial. Lancet Respir Med 2022, 10: 739-48. doi.org/10.1016/S2213-2600(22)00087-X
3. Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis 2021, 21: 1654-64. doi.org/10.1016/ S1473-3099(21)00396-0
4. Heida R, Hinrichs WL, Frijlink HW. Inhaled vaccine delivery in the combat against respiratory viruses: a 2021 overview of recent developments and implications for COVID-19 [published online ahead of print, 2021 Aug 25]. Expert Rev Vaccines. 2021;1-18
5. Aerogen Solo System Instruction Manual. Aerogen Ltd. P/N 30-354, Revision U.
6. Ari A. Practical strategies for a safe and effective delivery of aerosolized medications to patients with COVID-19. Respir. Med. 2020; 167. doi:10.1016/j.rmed.2020.105987.
7. Miller A, Epstein D. Safe bronchodilator treatment in mechanically ventilated COVID19 patients: A single center experience. J. Crit. Care. 2020; 58: 56–57.
8. Fink JB, Ehrmann S, Li J, Dailey P, McKiernan P, Darquenne C et al. Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine. J Aerosol Med Pulm Drug Deliv 2020. doi:10.1089/jamp.2020.1615.
9. Halpin DMG, Criner GJ, Papi A, Singh D, Anzueto A, Martinez FJ et al. Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: The 2020 GOLD Science Committee Report on COVID-19 & COPD. Am J Respir Crit Care Med 2020. doi:10.1164/rccm.202009-3533SO.
10. O’Toole C, McGrath JA, Joyce M, Bennett G, Byrne MA, MacLoughlin R. Fugitive Aerosol Therapy Emissions during Mechanical Ventilation: In Vitro Assessment of the Effect of Tidal Volume and Use of Protective Filters. Aerosol Air Qual Res 2020; 20. doi:10.4209/aaqr.2020.04.0176.
11. Joyce M, McGrath JA, Mac Giolla Eain M, O’Sullivan A, Byrne M, MacLoughlin R. Nebuliser Type Influences Both Patient-Derived Bioaerosol Emissions and Ventilation Parameters during Mechanical Ventilation. Pharmaceutics 2021; 13: 199.
12. Aerogen internal data on file.

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Contact information

For further information on Aerogen technology please contact:

D eclan Slemon, dslemon@aerogen.com

For further information about Aerogen in China please contact

D an Han, DHan@aerogen.com

For further information on CanSinoBIO please contact:

J unhong Jing, junhong.jing@cansinotech.com