ETANA AND CANSINO LAUNCH PHASE I CLINICAL TRIAL OF THE WORLD’S FIRST INHALED TUBERCULOSIS VACCINE IN INDONESIA

Jakarta, November 13, 2025 – PT Etana Biotechnologies Indonesia (Etana), together with CanSino Biologics Inc., has officially initiated the Phase I Clinical Trial of an inhaled Tuberculosis (TB) vaccine in Indonesia. This inhaled TB booster vaccine is a recombinant human adenovirus type 5–based vaccine and represents an innovative global TB booster designed for individuals who have previously received the Bacillus Calmette-Guérin (BCG) vaccine.

The inauguration of the clinical trial took place at Jakarta Islamic Hospital Cempaka Putih, attended by the Deputy Minister of Health, Dr. Benyamin Paulus Octavianus, Sp.P, FISR, and the Head of the National Agency of Drug and Food Control (BPOM), Prof. Dr. Taruna Ikrar, M.Biomed., MD., Ph.D.

“Through this collaboration, we aim to introduce a new generation of tuberculosis vaccines designed to prevent the spread of TB in Indonesia. Conducting this Phase 1 clinical trial marks an important step in developing an innovative TB vaccine that will later be produced locally. This initiative aligns with our commitment to delivering high-quality, affordable, and innovative vaccines and biological products for the people of Indonesia,” said President Director of Etana, Nathan Tirtana.

The Deputy Minister of Health of the Republic of Indonesia, Dr. Benyamin Paulus Octavianus, Sp.P(K), emphasized that tuberculosis (TB) eradication is one of the national priorities receiving direct attention from President Prabowo. The government is strengthening cross-ministry and cross-agency collaboration to accelerate TB elimination in Indonesia. This Phase I clinical trial of the inhaled TB vaccine is a strategic step toward achieving a TB-free Indonesia by 2030.

“The full support from BPOM for this inhaled TB vaccine clinical trial demonstrates the government’s strong commitment to accelerating TB elimination efforts in Indonesia. We want to ensure the process runs quickly and efficiently while still prioritizing scientific rigor. Our hope is that by 2029, this vaccine can be widely used, allowing more people to be protected and bringing Indonesia closer to achieving a TB-free future,” stated Dr. Benyamin Paulus Octavianus, Sp.P(K).

Meanwhile, the Head of the National Agency of Drug and Food Control (BPOM), Prof. Dr. Taruna Ikrar, M.Biomed., Ph.D., stated that BPOM fully supports the implementation of the Phase I clinical trial of the inhaled TB vaccine as part of its commitment to achieving a TB-free Indonesia. Approval for the clinical trial was granted following a comprehensive scientific evaluation, including in vitro and in vivo preclinical studies that demonstrated the vaccine’s safety and quality.

Prof. Taruna also emphasized that BPOM conducted an on-site inspection of the vaccine production facility in China to ensure that all quality and safety standards were met. “We have granted approval for the Phase I clinical trial as a concrete form of support for this vaccine innovation. Based on preclinical results, both in vitro and in animals, the vaccine has shown a strong safety profile. This first clinical phase is crucial to ensuring safety in humans, and if the results are positive, we are ready to support progression to Phase II and Phase III,” said Prof. Taruna Ikrar.

CEO of CanSino Biologics Inc., Dr. Xuefeng Yu, added that as a developing country with a high burden of tuberculosis, Indonesia faces challenges similar to many other nations, including China. Recognizing this, CanSino Biologics Inc. is committed to providing innovative solutions to global public health issues, one of which is through the development of TB vaccines. Based on preclinical findings, the inhalation-based vaccine approach is considered to have greater potential compared to injectable methods. Through collaboration with PT Etana Biotechnologies Indonesia, the development of this inhaled TB vaccine is expected to be a concrete step toward more effective and widely impactful TB prevention.

“Tuberculosis remains one of the biggest public health challenges, especially in developing countries. From our research, inhaled vaccine approaches show the potential for stronger protection. Through our collaboration with Etana, we aim to accelerate innovation and deliver this vaccine to those who need it most—moving toward a future where TB is no longer a threat,” said Dr. Yu.

For information, this clinical trial is led by Prof. Dr. dr. Erlina Burhan, M.Sc., Sp.P(K), and conducted at two hospitals: Jakarta Islamic Hospital Cempaka Putih and Persahabatan General Hospital. A total of 36 healthy participants aged 18–49 will receive the vaccine through inhalation using a nebulizer, an innovative method targeting mucosal immunity in the respiratory tract—the main entry point of TB infection.

To date, the BCG vaccine remains the only available vaccine for tuberculosis. While it offers protection against severe TB in infants and young children, it is not effective in protecting adults or older children from pulmonary TB.

Tuberculosis continues to be one of the world’s greatest global health challenges. Eight countries, including Indonesia, account for around 68% of total global TB cases. Without innovation and new preventive measures, the target of eliminating TB by 2030 will be difficult to achieve. Through the implementation of this clinical trial, Etana and CanSino reaffirm their commitment to enhancing innovation, collaboration, and the independence of Indonesia’s health industry, supporting efforts to accelerate TB elimination and improve public health outcomes.

About Etana

Established in 2014, Etana is an Indonesian biopharmaceutical company that researches, manufactures and markets biological therapies for the Southeast Asian market. With a mission to serve patients by providing high quality, affordable, and innovative therapies, the company has built state-of-the-art local production facility that meet international and Indonesian FDA standards. The facility are able to produce biological therapy with halal certification from the Indonesian Ulama Council (MUI). Etana aspires to become the leading biopharmaceutical company in the ASEAN region through aggressive expansion in production capacity and product development, with a primary focus on oncology and vaccine products.

Etana is led by a local management team who come from various international and domestic educational backgrounds and have strong experience in the biopharmaceutical industry and are supported by a team of international investors and leading biopharmaceutical companies. Etana aims to provide innovative yet affordable therapies through local production, to support Indonesian government programs and larger market demands. Etana is currently a leading biotech company in Indonesia committed to the research and manufacture of monoclonal antibodies, mRNAs and other biological platforms. For more information on Etana, visit: www.id.etanabiotech.com

About CanSinoBIO

Incorporated in 2009, CanSino Biologics Inc. (SSE: 688185, HKEX: 06185) commits to providing high-quality, innovative, and affordable vaccines for global public health security. It possesses five integrated platform technologies upon which the company has established a rich portfolio of pipeline products preventing more than ten diseases, including the world's initial vaccine for Ebola virus disease Ad5-EBOV, the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) approved in over 10 countries and granted EUL by the WHO, the Group A and Group C Meningococcal Conjugate Vaccine (CRM197) Menphecia® and the Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) Menhycia® approved by NMPA in China. The world's first inhaled COVID-19 vaccine Convidecia Air® has been approved as a booster dose in China, Morocco, and Indonesia. Additional information can be found online at www.cansinotech.com