Gilead recruiting employees for China expansion
Back in September 2016, Gilead Sciences (GILD) hired a former Shanghai Roche Pharmaceuticals executive, Rogers Luo, to help build its operations in China. Although the company hasn’t announced it officially, a recent tweet trying to recruit staff for its China operations indicated it is building a manufacturing facility in China.
The tweet shared a link to a Gilead website that stated, “Today, we have a Regulatory team in Beijing and a Chemical Manufacturing Outsourcing group at the Hongqiao Business Center in Shanghai. Gilead is constructing a new manufacturing site in the Hanagzhou Economic Development Area. This will be the first manufacturing site constructed by Gilead outside of the U.S. and it has the potential to grow in the future. Working in close collaboration with the new Hangzhou site, Gilead has also recently established a new affiliate in Shanghai, which will play a critical role in building commercial and access relationships to deliver our innovative medicines to patients across China.”
Other global pharmaceutical companies have manufacturing facilities in China, including Pfizer (PFE), Merck & Co. (MRK), Merck KgaA (MKGAF.PK), Johnson & Johnson (JNJ) and others. In 2016, Pfizer indicated it was having GE build a modular manufacturing plant for biosimilars costing $350 million.
Gilead’s China ventures appear to be focused on hepatitis drugs. Gilead’s Sovaldi and other treatments for hepatitis C are not available in China due to a lengthy drug approval process. Luo’s job is to head the building of Gilead’s commercial activities across China in its China launch for its hepatitis C and B therapies.
In September, Bloomberg wrote, “Getting approval in China would open a vast new market for Gilead. China’s government has sought to revamp its regulatory process for medicines and the China Food and Drug Administration announced in April (2016) that Sovaldi and another of Gilead’s therapies called Harvoni were both included in a list of drugs that would receive priority review. The CFDA did not specify how long the process would take and when they might receive approval.”
Gilead has been criticized for its pricing of Sovaldi and Harvoni, which when launched ran around $1,000 per pill. Gilead manufactured low-priced versions of the drugs and made them available to about 80 developing countries via licensing deals with generics makers. China was not included in those deals.
FiercePharma notes that, “In its fourth-quarter 2016 earnings call, executives said only that Gilead was ‘thinking about a small build-out in China for the private market,’ something that really would be a 2018 and beyond effect.”
Meanwhile, the Gilead China website indicates, in both English and Chinese, that it is recruiting for positions in China. The site states: “Gilead is looking for talented professionals to help us transform and simplify care for people with life-threatening diseases. We are seeking self-driven individuals who thrive in an agile, fast-paced environment where you see the tangible results of your contributions, where every individual matters, and everyone has an opportunity to enhance their skills through on-going development.”
China appears to be accelerating its approvals, as well. Recent approvals by the CFDA have included AstraZeneca (AZN)’s Tagrisso for lung cancer, Roche (RHHBY)’s Zelboraf for melanoma, and Boehringer Ingelheim’s Gilotrif for lung cancer.
The CFDA also dramatically increased the number of drug application reviewers. In 2015, the agency had 120 reviewers. At the end of 2016, it had 600.
In a March 28 Bloomberg article, when asked on the timing of Sovaldi and Harvoni in China and its pricing strategy, a spokeswoman for Gilead said, “Our goal is to collaborate with the government, commercial payers and the broader healthcare community to delivery sustainable access to our medicines.”
Franck Le Deu, a senior partner with McKinsey & Co., a consulting firm, told Bloomberg, “Market approval is only step one of market access. Pricing and reimbursement is still a major unknown, although some positive signs are emerging.”