Welcome to this week’s FiercePharmaAsia report. China’s been in the spotlight these days as the country plots a major foreign drug policy overhaul, while Johnson & Johnson and Lilly chiefs made clear their support for globalization while attending a conference there. Meanwhile, Singapore biotech Tessa bought Euchloe and India’s USV got a second FDA warning letter.
China's FDA published a slate of suggested amendments to its foreign drug registration rules, to eliminate hurdles that slow approvals of Western drugs. If finally approved, foreign drug candidates will no longer need to have entered phase 2 before a clinical trial application in China, and data from multiregional clinical trials that include China as a study site can be directly used for an NDA in the country.
Singapore’s Tessa Therapeutics has completed acquisition of Euchloe, a recent spinoff of A*STAR’s Singapore Immunology Network. The takeover gives Tessa a suite of checkpoint inhibitors against PD-1, PD-L1, CTLA-4 and other targets that it sees complementing its own virus-specific T cells. The area has attracted other players like Merck, Bristol-Myers Squibb, Tesaro and others.
Johnson & Johnson CEO Alex Gorsky, while in China for an international business conference along with several other Big Pharma CEOs, told CNBC that globalization is “critical” for J&J, a comment that could be viewed as in contradiction to Trump's more protectionist stance on foreign trade. The company plans to invest $500 million in R&D operations in China.
Eli Lilly CEO David Ricks’ comment sounds stronger. Ricks, while attending the same event in China, told the country’s state news agency Xinhua that deglobalization moves are “dangerous” and “troubling.” “Certainly our company has been consistently in favor of free trade and liberalization of all trade rules,” he said.
The FDA posted a warning letter on Tuesday for USV Private’s finished pharmaceutical plant in Dabhel, India. The Indian drugmaker’s Mumbai plant was hit by a warning letter in 2014, but some of the same issues, including concerns over data integrity, emerged again.