WuXi PharmaTech subsidiaries hit regulatory and manufacturing milestone

Published: 21-Mar-2019

Big moves at the pharma giant this week include WuXi Biologics becoming the first biologics company in China to be approved by both the US FDA and the EMA, and a biotech partnership for WuXi STA

Two branches of the WuXi family have made announcements this week. WuXi Biologics has become the first biologics company in China to be approved by both the US FDA and the European Medicines Agency (EMA), while WuXi STA made a strategic partnership with Beta Pharma.

Good Manufacturing Practices

WuXi Biologics the biologics technology platform branch of WuXi has received GMP certificates from the EMA. The certification specifically covers the production of Trogarzo at its cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities in Wuxi city and its cGMP cell banking facilities in Shanghai.

Trogarzo is developed by TaiMed Biologics and marketed in the US and EU by Theratechnologies.

Commenting on the certification, Luc Tanguay, President and CEO of Theratechnologies, said: “This is yet another important milestone towards the potential launch of Trogarzo in Europe. More than ever, we are actively preparing for approval in this territory to ensure that key markets will be receptive to this unique breakthrough treatment for patients with multidrug-resistant HIV."

Strategic partnership

As a CDMO for the parent company, WuXi STA has formed an alliance with biotech firm, Beta Pharma in the UK.

Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of the oncology-focused Beta Pharma, leveraging its platform to accelerate process R&D and manufacturing of later phase and commercial production. The deal will utilise the Marketing Authorization Holder (MAH) scheme.

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