core product registration in Indonesia and Egyptian technology transfer project both approved

April 1, 2025  Source: drugdu 49

"/On March 29, Chengda Bio (688739.SH)'s official website reported that in March 2025, the company's freeze-dried human rabies vaccine (Vero cells) downstream production process technology transfer project (hereinafter referred to as: Egyptian technology transfer project) was officially approved by the Egyptian Food and Drug Administration (EDA). Chengda Bio's rabies vaccine can be exported to Egypt in two categories: finished products and semi-finished products; at the same time, the company's freeze-dried human rabies vaccine (Vero cells) also officially obtained the registration approval and on-site inspection approval for the finished product issued by the Indonesian Food and Drug Administration (BPOM). Access to Indonesia marks that the company has achieved new breakthroughs in the Southeast Asian market after Thailand, the Philippines, Vietnam and other countries, and has penetrated into the core market of ASEAN.

Egypt's technology transfer project approved, overseas localized production enters a new stage

Despite the rapid development of the global vaccine industry, some parts of Africa still face challenges such as weak infrastructure and shortage of professional talents in vaccine acquisition, distribution and vaccination. As early as 2012, Chengda Bio's freeze-dried human rabies vaccine (Vero cell) finished product obtained the registration certificate from the Egyptian Food and Drug Administration (EDA) and officially entered the Egyptian market. Over the past decade, the company has supplied more than 10 million doses of high-quality vaccines to Egypt.

In order to help Egypt and neighboring countries improve their independent vaccine supply capabilities, Chengda Bio and the Egyptian government officially launched the freeze-dried human rabies vaccine (Vero cell) downstream production process technology transfer project in 2023, and in 2024, reported the project progress to the Egyptian government at the Egyptian Vaccine Manufacturers Alliance (EVMA) meeting, and deeply participated in the construction of the African vaccine industry ecosystem.

In March 2025, the project was officially approved by the Egyptian Drug Administration (EDA), marking a further step forward in the internationalization of Chengda Biopharmaceuticals, which has effectively promoted the development of the Egyptian government's "localized vaccine production" public health cause. After the project is put into production, it can meet the basic needs of rabies vaccines in Egypt and neighboring countries, significantly improve regional disease prevention and control capabilities, and provide a demonstration case for technical cooperation and localized production in the global vaccine industry.

Product quality management is in line with international standards, helping to deepen the internationalization strategy

Indonesia (abbreviated as: Indonesia), as the world's fourth most populous country (281 million), ASEAN's largest economy and the country with the largest Muslim population, carries the core mission of building a public health system in Southeast Asia. As a member of PIC/s, its strict drug regulatory system is not only an entry threshold, but also a touchstone for testing the international competitiveness of vaccine companies. The registration certificate for finished preparations in Indonesia is a strong proof that Chengda Biopharmaceuticals' products meet the strict quality standards in the ASEAN region.

By establishing a quality management system in line with international standards, the company has successively obtained registration certificates in more than 20 overseas countries. As the company's core product, rabies vaccine has performed well in overseas market sales. By 2024, the cumulative sales volume will reach 18 million doses, firmly establishing the company's global leading position in the field of human rabies vaccine.

Chengda Bio said that the company's continued expansion in overseas markets will help effectively alleviate the local rabies vaccine supply pressure. Based on a new starting point, the company will continue to optimize vaccine production processes and promote more high-quality biological products to land in overseas markets; at the same time, it will continue to deepen cooperation with international organizations and governments of various countries, empower the global epidemic prevention system with innovative technologies, and contribute China's strength to building a human health community.

https://finance.eastmoney.com/a/202503303360236887.html

By editor
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