21st Jan 2016 16:40
LONDON (Alliance News) - Chinese pharmaceutical company Taihua PLC Thursday said it has been granted a Chinese Good Manufacturing Practice certificate, but said the issue of a Drug Production permit has been delayed, forcing the company to retain its halt on production.
The manufacturing certificate means Taihua can resume production of traditional Chinese medicines and of homoharringtonine, otherwise known as omacetaxine mepesuccinate, a pharmaceutical drug substance that is indicated for treatment of chronic myeloid leukemia.
Taihua develops and sells pharmaceuticals products, and produces active pharmaceutical ingredients, including raw materials for the traditional Chinese medicine industry.
However, authorities have delayed issuing the company a Drug Production permit, which would allow the company to sell its products in China. The delay is being caused by "longer than expected" procedures, it said.
As a result, the temporary halt to sales of homoharringtonine and traditional Chinese medicines, originally announced in early August, will continue until that permit is issued. Taihua said the delayed permit will not affect sales of pacliataxel, which is sold outside China, or Forsythia, which is not covered by the permit.
Paclitaxel is a drug used to treat ovarian, breast, lung, pancreatic and other cancers and Forsythia is a type of plant used to treat a series of ailments including bronchiolitis, inflammation, heart disease and tonsillitis.
Securing the certificate and permit has taken longer than expected, as Taihua said back in August that it expected production of the traditional Chinese medicines to restart before the end of September, with homoharringtonine and paclitaxel production to have restarted by the end of the year.
Taihua did not clarify whether or not production of paclitaxel, as it is unaffected by the delayed permit, has restarted or not.
Taihua has previously said the delay would not have an immediate effect on its trading, as it had sufficient stock to fulfil its anticipated orders for a few months, but conceded Thursday that the effect of the delay is now unknown.
"The issue of the Drug Production permit is a priority for the directors of the company, and it is anticipated that this will be issued before the end of March 2016. The impact on overall trading of the group is unknown at this stage, and further updates will be provided in due course," said Taihua.
For the half year to end-June the company reported a pretax profit of CNY1.2 million, swung from a pretax loss of CNY423,000 a year before, as revenue rose to CNY5.4 million from CNY4.3 million.
Taihua shares were flat at the close on Thursday at 1.25 pence per share.
By Joshua Warner; [email protected]; @JoshAlliance
Copyright 2016 Alliance News Limited. All Rights Reserved.
Related Shares:
TAIH.L