As the year draws to a close, the pharmaceutical industry receives another “big news.” Leading CXO company WuXi AppTec announced that it will transfer all equity interests in its U.S. and U.K. operating entities of WuXi ATU to Altaris, a U.S.-based private equity fund focused on the healthcare industry. The completion of all deliveries is expected in the first half of 2025.
For WuXi AppTec and its painstakingly cultivated WuXi ATU over more than a decade, this outcome seems somewhat regrettable. However, for the vast number of cell and gene therapy (CGT) innovators and entrepreneurs, as well as patients worldwide, this is akin to giving them a “reassuring pill.”
Deeply Rooted in the CGT Industry for Over a Decade
CGT is a field full of opportunities and challenges. In 2012, Emily Whitehead, who had leukemia, became the world’s first patient to receive CAR-T cell therapy and has been cancer-free for 12 years. Since then, this field has attracted many innovators, and the industry as a whole has developed rapidly. Just this year, out of the 48 new drugs approved by the U.S. FDA’s Center for Drug Evaluation and Research (CDER), cell and gene therapies account for 8.
Among them are many “first-of-their-kind” approved therapies that patients have been waiting for, including the first T-cell therapy approved for solid tumors, Amtagvi, the first FDA-approved mesenchymal stromal cell (MSC) therapy, Ryoncil, and the first gene therapy for children with the rare disease metachromatic leukodystrophy (MLD), Lenmeldy, bringing real hope to these patients.
Following industry trends, over the past nearly 10 years, WuXi ATU has also been continuously developing. In 2016, the new base for innovative cell and gene therapy research and development and production in Philadelphia, USA, officially commenced operations, covering an area of about 14,000 square meters, marking WuXi AppTec’s third cell therapy production facility in Philadelphia.
In 2021, the expanded Philadelphia base began operations, with a laboratory area of 13,000 square meters, which, upon completion, could triple the company’s high-end testing capacity. Around the same time, WuXi AppTec also completed the acquisition of OXGENE, a UK gene therapy technology company, which, with its innovative technology, R&D services, and large-scale production systems, became the “innovation center” of WuXi ATU.
This year, Amtagvi, enabled by WuXi ATU from Iovance, received the U.S. FDA BLA (Biologics License Application), and the Philadelphia base also became the first third-party contract testing, development, and manufacturing organization (CTDMO) in the U.S. approved by the FDA for supporting the commercial production and release of personalized T-cell therapies for solid tumors.
According to public information, WuXi ATU has been cooperating with Iovance for nearly ten years and is deeply trusted and recognized.
WuXi ATU Philadelphia Base
“Letting Go” for a Better Tomorrow
In 2024, WuXi ATU should have reaped more rewards, but unfortunately, the emergence of the “Biological Security Act” draft put it under undue pressure. For example, WuXi ATU provides GMP production and testing services required for cell therapy for WU-NK-101, a development by Wugen. In other words, if WuXi ATU’s services are affected, the progress of WU-NK-101 will inevitably be hindered.
Wugen is committed to conquering “off-the-shelf” cell therapies, and its executives have stated that more and more service providers have indicated that they can offer the same services, but they may not necessarily produce equivalent products. “It’s like making soufflé; even if everyone uses the same ingredients, it doesn’t mean everyone can make the same thing.”
Furthermore, for breakthrough therapies like Amtagvi, if supply is unstable, the impact on patients is immeasurable. The essence of the pharmaceutical industry is not to pursue profits but to save patients’ lives. If the act were to be implemented, the ultimate victims would not only be WuXi AppTec but the entire pharmaceutical industry and patients.
For WuXi AppTec, “letting go” is a more responsible choice for customers and patients after weighing the pros and cons. After this “change of ownership,” WuXi ATU’s business will no longer be affected by geopolitical influences, allowing it to fully leverage its strengths. More importantly, customer projects can continue, and patients can receive better treatment.
As stated in WuXi AppTec’s announcement, the main purpose of this transaction is to “ensure that all clients and patients in urgent need of WuXi ATU’s cell therapy services receive uninterrupted services and timely treatment.” WuXi AppTec’s decision is significant for the industry and patients.
Today, the CGT field still carries the hopes of countless patients, and the pace of global innovation and cooperation will not stop. It is believed that both WuXi AppTec and WuXi ATU will continue to exert greater energy for more innovators and patients in need in the future.
【Editor’s note】The above content (~4500 words) is a quick translation of a Chinese article (posted on 2024-12-30) by DrugTimes team. To read the original article, please click here. All comments are warmly welcome. Many thanks!
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