Japan's health ministry has sent out global first nods to drugs from Roche, Daiichi Sankyo and AstraZeneca. Two years after penning the licensing deal, Celgene has returned PD-1 tislelizumab to BeiGene along with a $150 million breakup fee. Multinational biopharma companies' older medicines in China are under threat as authorities have made a list of 34 drugs and are offering priority review to drugmakers who develop copycats to them. And more.
Japan’s Ministry of Health, Labor and Welfare handed out at least three global first approvals this week. Roche’s Rozlytrek, a rival to Bayer’s Vitrakvi, has won a Japanese nod to treat patients with NTRK fusion-positive advanced recurrent solid tumors regardless of their locations. A month after being voted down by an FDA cancer advisory committee, Daiichi Sankyo’s FLT3 inhibitor Vanflyta (quizartinib), a challenger to Astellas’ Xospata, has been cleared in Japan for relapsed/refractory FLT3-ITD acute myeloid leukemia. AstraZeneca also secured its first global approval for Breztri Aerosphere, a three-in-one chronic obstructive pulmonary disease inhaler that will go up against GlaxoSmithKline’s Trelegy Ellipta.
As the Bristol-Myers Squibb merger moves ahead, Celgene has handed back its rights to BeiGene’s PD-1 drug tislelizumab and paid a $150 million termination fee. BeiGene Chief Adviser Eric Hedrick recently said the Chinese biotech “fully" expected that the transfer-back would happen. At that time, he said taking back the rights would have a “marginal” effect on clinical development and a be “modest” financial hit.
China’s health authority has published its first list of drugs for which the government is soliciting copycats. To sweeten the deal, those who follow will be put under the drug regulator’s priority review pathway. The 34 drugs cover originators from many foreign pharmas and span a wide range of therapeutic areas. Some prominent names include Teva’s Copaxone, Actelion’s Tracleer and AstraZeneca’s Faslodex.
AstraZeneca is committing $630 million to R&D in South Korea over the next five years. Outlined in a letter of intent with a Korean trade promotion agency and industry group, AstraZeneca will help with new drug development, offering mentoring for biotech startups and the advance of artificial intelligence and other emerging technologies.
China is turning up an ocean of healthcare data. Some 89% of doctors in China are equipped for telemedicine, 44% of Chinese said they’d prefer a remote doctor visit and 94% of healthcare professionals use digital health tech or tracking apps. That spells opportunity for pharmas that can figure out how to work best within digital healthcare, a Lions Health panel figured.
Bayer’s for-sale animal health business has reportedly attracted high interest. China’s Fosun International, parent of Fosun Pharma, is considering teaming up with private equity firms or other investors for a joint offer for the franchise, according to Bloomberg. If successful, the takeover would mark another major deal for Fosun since taking a majority stake in Gland Pharma in 2017.