April 10th, 2026, CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) announced today that its self-developed adsorbed diphtheria, tetanus and pertussis(acellular, three component)combined vaccine for infants ("DTcP", trade name: Tripecia®) has been officially approved by China's National Medical Products Administration ("NMPA") through an accelerated approval pathway.

Pertussis, an acute respiratory infectious disease caused by Bordetella pertussis, can affect individuals of all ages. Its typical symptom is paroxysmal spasmodic coughing, and it is highly contagious, significantly more so than influenza, second only to measles^1,2. In recent years, numerous countries worldwide have faced the serious challenge of "pertussis resurgence"³. In 2024, China reported 476 690 pertussis cases, an approximate 12-fold increase from 2023^4,5.

Pertussis has a prolonged course; coughing in infected infants can last 2 to 3 months⁶. Reported pertussis cases in China are predominantly in young infants, with those under 1 year old accounting for 31% of cases⁷. Among these, infants under 3 months of age are at high risk for severe illness and death⁵. To further strengthen childhood immunization against pertussis, China optimized and adjusted the national immunization schedule for diphtheria, tetanus, and pertussis (DTP) vaccines in January 2025, notably changing the vaccine for 6-year-old children from diphtheria-tetanus (DT) vaccine to DTaP vaccine⁸.

As the first approved adsorbed diphtheria, tetanus and pertussis(acellular, three component)combined vaccine  in China⁹, Tripecia® not only contains pertussis toxin (PT) antigen and filamentous hemagglutinin (FHA) antigen but also the key antigen pertactin (PRN), providing more comprehensive protection¹⁰. Results from a large-scale Phase III clinical trial demonstrated that Tripecia® elicits a more potent immune response, achieving superior priming immunogenicity for PT compared to the control group⁹. Furthermore, it does not contain thimerosal, antibiotics, or animal-derived components. The incidence of fever after the booster dose was reduced by over 50%, indicating a favorable safety and tolerability profile¹¹.

Prof. Liang Xiaofeng, Vice Chairman of the Chinese Preventive Medicine Association

Prof. Liang Xiaofeng, Vice Chairman of the Chinese Preventive Medicine Association, pointed out that currently, vaccination with the DTP vaccine is one of the most effective means of preventing pertussis. In recent years, the government has placed high importance on related efforts, public health awareness has significantly increased, medical services have continuously improved, and childhood vaccination programs have been effectively implemented. China's current DTP vaccine primarily uses acellular co-purification technology, while mainstream developed countries generally apply more advanced acellular component purification technology^6,12. Component purification technology offers advantages such as more precise antigen ratios and the ability to induce a robust and stable immune response. The approval of the first adsorbed diphtheria, tetanus and pertussis(acellular, three component)combined vaccine marks a significant step in aligning China's capabilities with international advanced standards in this field and holds important public health significance for establishing and strengthening herd immunity.

Prof. Zeng Mei, Children's Hospital of Fudan University & Children's National Medical Center

Prof. Zeng Mei, Children's Hospital of Fudan University & Children's National Medical Center, stated that pertussis remains one of the major infectious diseases contributing to morbidity and mortality among children worldwide¹³. Unvaccinated infants are particularly susceptible and face a higher risk of complications such as pneumonia and pertussis encephalopathy. With resistance rates to macrolide antibiotics, the traditional first-line treatment, exceeding 90%¹⁴,once infected, children not only suffer from severe coughing, but clinicians also face difficulties in selecting appropriate medications and administering effective treatment, potentially missing the optimal treatment window. Given this serious situation, age-eligible children should receive the DTaP vaccine as early as possible and complete the full vaccination schedule. Children who have not completed the vaccination schedule should receive catch-up immunization as soon as possible. Parents should prioritize vaccination and choose safe and effective vaccines early to reduce infection risk.

Dr. Zhu Tao, Chief Scientific Officer of CanSinoBIO

Dr. Zhu Tao, Chief Scientific Officer of CanSinoBIO, stated that, to date, no domestically developed component pertussis vaccine has been approved in China. After 16 years of dedicated research, CanSinoBIO has successfully overcome multiple key technical challenges. In addressing the highly technically challenging detoxification of PT, the R&D team, after prolonged systematic research and repeated validation, successfully achieved a key technological breakthrough. The vaccine does not contain thiomersal, antibiotics, or animal-derived ingredients, ensuring high purity and a favorable safety profile with fewer adverse reactions. CanSinoBIO's independent breakthrough in component purification technology filled a gap in this field for domestic companies and was granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in February 2025.

Dr. Yu Xuefeng, Chairman and Chief Executive Officer of CanSinoBIO

Dr. Yu Xuefeng, Chairman and Chief Executive Officer of CanSinoBIO, stated that Tripecia®, as China's first approved adsorbed diphtheria, tetanus and pertussis(acellular, three component)combined vaccine , contains three antigens—PT, FHA, and PRN—offering more comprehensive protection. Following primary immunization in two-month-old children, it elicits a more potent immune response, with good safety and tolerability. The successful approval of Tripecia® marks another significant milestone in CanSinoBIO's innovation-driven vaccine development.

CanSinoBIO is currently actively advancing the development of component pertussis combination vaccines for adolescents and adults, aiming to further expand its vaccine portfolio and provide high-quality innovative solutions for disease prevention and control. These efforts will support the establishment of a comprehensive life-course immunization system and contribute to the "Healthy China" initiative.

Disclaimer:

Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.

References:

1.Chinese Center for Disease Control and Prevention. Pertussis prevention and control [Internet]. 2024 Dec 11 [cited 2026 Mar 27]. Available from: https://www.chinacdc.cn/jkkp/crb/ycr/202412/t20241211_303248.html

2.Kim JH, Marks F, Clemens JD. Looking beyond COVID-19 vaccine phase 3 trials. Nat Med. 2021 Feb;27(2):205-211.

3.Hua CZ, Wang CQ, Yang ZN, et al. New insights into the pathogen of pertussis and strategies for antibacterial infection. Journal of Clinical Pediatrics. 2024;42(6):480-484, 508. [Chinese]  

4.World Health Organization. Pertussis reported cases and incidence: China [Internet]. [cited 2026 Mar 27]. Available from: https://immunizationdata.who.int/global/wiise-detail-page/pertussis-reported-cases-and-incidence?CODE=CHN&YEAR=

5.Liu J, Lu G, Qiao J. Global resurgence of pertussis in infants. BMJ. 2025 Oct 20;391: r2169.

6.Chinese Preventive Medicine Association, Vaccine and Immunology Branch of the Chinese Preventive Medicine Association. Expert consensus on the China Pertussis Initiative. Chinese Journal of Epidemiology. 2021;42(6):955-965. [Chinese]

7.Zhang Q, Wu D, Zheng H, et al. Epidemiological characteristics of pertussis in China,2022. Chinese Journal of Vaccines and Immunization. 2024;30(1):34-38. [Chinese]

8.National Disease Control and Prevention Administration, et al.Notice on the adjustment of the national immunization program regarding the diphtheria, tetanus, and pertussis (DTaP) vaccine and the diphtheria-tetanus (DT) vaccine [Internet]. 2024 Dec 25 [cited 2026 Mar 27]. Available from: https://www.gov.cn/zhengce/zhengceku/202412/content_6994724.htm

9.Zhang W, Wei C, Wan P, et al. Safety and immunogenicity of diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed after three-dose priming in 2 months age infants: a randomized, blinded, controlled phase III clinical trial in China. Emerg Microbes Infect. 2026 Feb;15(1):2625556.

10.Dai H, Sui X, Che J, et al. Pathogenicity and vaccine protection of circulating pertactin- and filamentous hemagglutinin-deficient Bordetella pertussis strains. Emerg Microbes Infect. 2026 Feb;15(1):2640283.

11.CSR data on file

12.Liu Y, Yu D, Wang K, et al. Global resurgence of pertussis: A perspective from China. J Infect. 2024 Nov;89(5):106289.

13.GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222.

14.Pediatric Infection Group, Chinese Society of Infectious Diseases, Chinese Medical Association, et al. Guidelines for diagnosis and management and prevention of pertussis of China (2024 edition). Chinese Medical Journal. 2024;104(15):1258-1279.[Chinese]