Etana and CanSinoBIO Announce Indonesian EUA for Inhaled COVID-19 Booster Vaccine Convidecia Air®

Jakarta, March 3, 2023 – Indonesian biotechnology company PT Etana Biotechnologies Indonesia (“Etana”) and CanSinoBIO (Stock Codes: SSE: 688185, HKEX: 06185) jointly announced today that the National Agency of Drug and Food Control (BPOM) of Indonesia has granted Emergency Use Authorization (EUA) for its recombinant COVID-19 vaccine (adenovirus type 5 vector), Convidecia Air®, as an inhaled heterologous booster. Under the existing license agreement with CanSinoBIO, Etana will commercialize Convidecia Air® in Indonesia. This sequential booster is indicated for all individuals aged 18 years and older. This marks another significant milestone for CanSinoBIO’s inhaled COVID-19 vaccine, which has previously received emergency use authorization in China and Morocco.

Nathan Tirtana, President of Etana, stated: “Etana appreciates BPOM’s approval of Convidecia Air®. With the emergency use authorization granted, we can provide the public with a more convenient inhaled booster vaccine targeting COVID-19. We are committed to producing biologics and vaccines that are vital for Indonesia and essential for improving the nation’s hygiene and health standards.”

Dr. Zhu Tao, Chief Scientific Officer of CanSino Biologics, stated, “In the face of the COVID-19 pandemic, vaccine technologies are undergoing rapid iteration, and vaccines with enhanced safety and immunogenicity will soon be deployed. The emergency use authorization for its use as a booster in Indonesia will provide an innovative solution for local COVID-19 prevention.” Furthermore, CanSino Biologics’ bivalent inhaled COVID-19 vaccine is also approaching market launch. This vaccine can elicit immune responses against both the original SARS-CoV-2 strain and the Omicron variant, offering more comprehensive and effective protection.

The latest research findings indicate that CanSino Biologics' inhaled COVID-19 vaccine is safe and immunogenic when used as a sequential booster. No serious adverse reactions were reported with this vaccine. Administering one dose of the inhaled COVID-19 vaccine after three doses of inactivated vaccines resulted in neutralizing antibody levels against the Omicron variant (BA.5) that were 19 times higher than those observed after four doses of inactivated vaccines, with the neutralizing antibody response persisting for more than 12 months. Furthermore, adding one dose of the inhaled COVID-19 vaccine after two doses of inactivated vaccines led to neutralizing antibody levels against the Omicron variant that were six times higher than those achieved with three doses of recombinant protein vaccines. In addition, the unique CD8+ T cell immune response elicited by the inhaled COVID-19 vaccine can significantly reduce the risk of severe disease and death while alleviating symptoms. This suggests that, under the current epidemic situation, selecting innovative vaccine technologies such as the inhaled COVID-19 vaccine as boosters will be safer and more effective.

As early as during the G20 Leaders’ Summit last November, CanSino Biologics and the Indonesian biopharmaceutical company Etana signed an agreement on cooperation in inhaled vaccine technology, as well as for the prevention and treatment of tuberculosis, on behalf of their respective countries. As a leading biopharmaceutical company in Indonesia, Etana boasts state-of-the-art local manufacturing facilities that comply with both international and Indonesian FDA standards, along with an experienced commercialization team, positioning it as a leader in Southeast Asia’s biopharmaceutical industry. With the support of bilateral cooperation, this inhaled COVID-19 vaccine has received emergency use authorization in Indonesia, which will further promote technological advancement in Indonesia’s vaccine industry and the continuous development of public health.

In addition, Etana also produces an mRNA platform-based COVID-19 vaccine, which has received Emergency Use Authorization (EUA) from the Indonesian Food and Drug Authority, Halal certification from LPOM of the Indonesian Ulema Council (MUI), and a Halal certificate from the Halal Product Assurance Organizing Agency (BPJPH) under the Indonesian Ministry of Religious Affairs.

ETANA, established in 2014, is a leading biopharmaceutical company in Indonesia, dedicated to the research and development, manufacturing, and sales of biopharmaceutical products for the Southeast Asian (ASEAN) market. Committed to providing patients with high-quality, affordable innovative medicines, ETANA has built the most advanced local production facilities that comply with international standards and the regulations of the Indonesian Food and Drug Authority (BPOM). These facilities have also obtained Halal certification from the Indonesian Ulema Council (MUI), a recognized authoritative body in Indonesia. Focusing on oncology and vaccines, ETANA has established an integrated system for the R&D, manufacturing, and commercialization of antibodies, mRNA, and other biological therapies. Through active collaborations to expand its product pipeline and increase production capacity, ETANA aims to become the premier biopharmaceutical enterprise in Southeast Asia.

ETANA’s management team comprises professionals with international educational backgrounds and extensive experience in the biopharmaceutical industry. The company has secured investment and collaborative support from international institutional investors and leading biopharmaceutical companies. ETANA is committed to supporting the Indonesian government’s industrial development plans and meeting the region’s growing market demand by locally producing high-quality, innovative, and affordable biopharmaceutical products.

CanSino Biologics Inc. (CanSinoBIO -B 06185.HK; CanSino 688185.SH), founded in Tianjin, China in 2009, is dedicated to providing solutions for the prevention and treatment of infectious diseases worldwide. The company currently possesses five innovative vaccine platform technologies, including viral vector vaccine technology, synthetic vaccine technology, protein structure design and VLP assembly technology, mRNA vaccine technology, and formulation and delivery technology. Currently, the company has established a pipeline of dozens of vaccine candidates covering more than ten infectious diseases, including the WHO-listed recombinant novel coronavirus vaccine (adenovirus type 5 vector) Convidecia, the world’s first inhaled COVID-19 vaccine Convidecia Air (adenovirus type 5 vector), China’s first quadrivalent meningococcal conjugate vaccine against serogroups A, C, W, and Y (CRM197 carrier) Menhixia, the bivalent meningococcal conjugate vaccine against serogroups A and C (CRM197 carrier) Menaixi, and the recombinant Ebola virus disease vaccine (adenovirus type 5 vector), which was the third globally and the first in Asia to enter clinical trials.