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July 16 (NBD) -- Chinese vaccine maker, Changchun Changsheng, a wholly-owned subsidiary of Shenzhen-listed Changsheng Bio-tech Co Ltd (Changsheng Bio-tech, 002680.SZ), was found having medicine manufacturing irregularities, including fabricating production records of rabies vaccines for human use, during an inspection by the State Drug Administration (SDA).

A source acknowledging the matter told NBD that upon receiving the notification from the SDA, Changsheng Bio-tech immediately required its marketing team to inform the centers for disease control and inoculation in local communities to stop using such vaccines.

An employee at Changsheng Bio-tech confirmed the matter when reached by NBD.

The SDA ordered the local drug regulator in Jining province to withdraw Changchun Changsheng's Good Manufacturing Practice (GMP) certificate, which has been done. In addition, further investigations were under way as an investigation team was assigned to the company.

According to Changsheng Bio-tech's announcement, Changchun Changsheng is by far the second largest rabies vaccine manufacturer in China. In 2017, sales of rabies vaccines of Changchun Changsheng totaled 734 million yuan (110 million U.S. dollars), contributing 47.26 percent to the listed company's revenue in that year.

According to the National Institutes for Food and Drug Control, NBD found that the sale of over 3.67 million doses of freeze-dried rabies vaccine for human use of Changsheng Bio-tech was approved from December 21 of 2017 to July 8 of 2018.

Nevertheless, the SDA said that no products involved in this inspection were on sale and all vaccines involved were under control.

The vaccine sector constitutes the major revenue contributor for Changsheng Bio-tech. For instance, the vaccine sales accounted for 99.1 percent for the listed company's revenue of 1.55 billion yuan (232 million U.S. dollars) in 2017.

In sharp contrast, Changsheng Bio-tech only invested 122 million yuan (18 million U.S. dollars) in R&D in that year, taking up about 7.87 percent of the company's revenue.

 

 

Email: tanyuhan@nbd.com.cn