Edit | Zhang Shuo
According to ANVISA's statement, the above-mentioned events affecting clinical research occurred on June 29th, 10. ANVISA did not disclose the details of the incident in this statement.
On June165438+1October 10, Kexing Bio released the Notes on the Suspension of Clinical Research on Inactivated Vaccine in COVID-19, Brazil, and responded that "after communicating with the Brazilian partner Butan Institute, the person in charge of the institute thought that this incident had nothing to do with the vaccine".
According to public information, the coronavirus vaccine (Kelefu) is an inactivated novel coronavirus vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. (hereinafter referred to as "Kexing Zhongwei"), a subsidiary of Kexing Bio. Clinical research was approved in April this year. In July this year, ANVISA approved Clover to conduct phase III clinical research in Brazil.
It is understood that the aforementioned Butan Institute is a Brazilian manufacturer of immune biological products and vaccines. According to the introduction of the third phase of clinical research published by Kexing Bio, the research is sponsored by the Butan Institute and will be carried out in 12 research centers in six Brazilian states. It is planned to recruit nearly 9,000 volunteers.
According to official website data, Kexing Holding Biotechnology Co., Ltd. is headquartered in Beijing and currently listed on NASDAQ: SVA. Through its wholly-owned subsidiary, Kexing Holdings (HK) Co., Ltd., it owns four enterprises: Beijing Kexing Biological Products Co., Ltd., Kexing (Dalian) Vaccine Technology Co., Ltd., Beijing Kexing Zhongwei Biotechnology Co., Ltd. and Beijing Kexing Zhong Yi Biomedical Co., Ltd., and the COVID-19 vaccine is developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. 。
Kexing Bio said in the earlier blind evaluation and open meeting of Kleef/Phase I clinical research (0, 14 scheme) that the preliminary results showed that the vaccine had good safety and immunogenicity.
Kexing Bio said that the safety data of this unblinding showed that the main adverse reaction of the vaccine was 1, mainly manifested as mild pain at the inoculation site, fatigue and low fever in individual subjects, and no serious adverse reaction was reported. The results of phase I clinical study showed that the positive conversion rate of neutralizing antibody exceeded 90% after 4 days of full immunization/kloc-0, indicating that the vaccine had good immunogenicity.
After the "Brazil Phase III Clinical Research Suspension" incident, Kexing Bio said today that it will continue to communicate with Brazil on this matter. Clinical research in Brazil will continue to carry out relevant work in strict accordance with the requirements of GCP. We have confidence in the safety of the vaccine.
Related Questions and Answers: Why did Beijing Kexing suspend the consultation record Answer 202 1- 12-22: Why did Beijing Kexing suspend the marriage? Kexing Holdings suspended trading because of abnormal trading fluctuations. Kexing Holdings suspended trading in the middle of the transaction, which did not conform to the normal suspension process, but at the beginning of the transaction. Regarding the suspension of Kexing Holdings, the Exchange did not provide detailed information to the public. The public should keep a rational view and judgment on this, and do not make rumors, believe in rumors and make rumors.