China's Zhifei Halts Meningitis-Pneumonia Vaccine Pipeline as Permit Is Pending
Lin Zhiyin
DATE:  Apr 03 2019
/ SOURCE:  yicai
China's Zhifei Halts Meningitis-Pneumonia Vaccine Pipeline as Permit Is Pending China's Zhifei Halts Meningitis-Pneumonia Vaccine Pipeline as Permit Is Pending

(Yicai Global) April 3 -- Chinese drug firm Zhifei Biological Products' combination vaccine against meningitis, sepsis and pneumonia is facing a production pause due to a delay in licensing.

Zhifei has not received a permit for its AC-Hib vaccine from Beijing Municipal Drug Administration after waiting for nearly five months for the regulator to go through its paperwork, the Chongqing-based firm said in a statement. 

The company's existing five-year permit for the drug expired on April 1. The AC-Hib vaccine is given to children above the age of two and it decreases the number of visits to a hospital by preventing multiple infectious diseases, such as those caused by meningococcal groups A and C, as well as Haemophilus influenza type b.

Qin Fei, the board secretary of Zhifei, did not immediately reply to Yicai Global's inquiry yesterday about the reason behind the delay. The postponement may mean that the firm needs to add more documents for its application, a person from a vaccine firm told Yicai Global.

Zhifei's timing may be unfavorable. The Chinese government drafted a new tighter law for vaccine administration in January after the nation was shaken by a scandal that exposed Changsheng Biotechnology forging production documents to make substandard rabies vaccines for as young as three-month-old babies. 

The new rules will implement the strictest supervision on the whole process of development, production, and circulation of vaccines, Jiao Hong, the director of the China Food and Drug Administration, said in a political conference last month.

Zhifei has tapped a lucrative market with its combination vaccine, the type of which is so far rare in the national immunization program. In 2015, AC-Hib sales made up almost 33 percent of the firm's total revenue of CNY713 million (USD106.2 million). The company turned a net profit of CNY197 million during the year.

Editor: Emmi Laine

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Keywords:   Drug,Zhifei Biological Products