China's new requirements for scientific data sharing might cause trouble for drug R&D collaboration, experts argue. As expected, after a manufacturing snag, Mylan and Biocon's Lantus biosimilar was turned down by the FDA. In a first, Eisai and Biogen's BACE drug managed to lower amyloid beta levels in Alzheimer's patients. And more.
China recently passed a new scientific data management regulation. It requires researchers to receive government approval before sharing or exchanging information abroad, including data submissions for foreign academic papers and journals. Experts interviewed by the Financial Times said they worry it could stem drug R&D collaboration and raise the cost of entry into the Chinese pharma market.
Three months ago, the FDA noted manufacturing problems at a Biocon plant in Malaysia where Biocon and partner Mylan plan to produce a copycat to Sanofi’s Lantus. As expected, the Form 483 has led to a complete response letter rejecting the insulin. The disclosure came the same day that the partners received FDA approval to a biosimilar of Amgen’s Neulasta.
Top-line phase 2 results showed Eisai and Biogen’s elenbecestat was able to reduce amyloid beta levels in patients with Alzheimer’s disease—the first time a BACE inhibitor was able to do so. The study didn’t show statistically significant decline of clinical symptoms, but Eisai said it would require recruiting hundreds more patients to demonstrate efficacy.
Eisai, together with partner Purdue Pharma, reported encouraging results from a phase 3 trial of its sleep disorder drug lemborexant. The drug beat out widely used zolpidem at keeping patients over the age of 55 asleep throughout the night. Two new phase 1 studies examining the drug’s effects on postural instability and impairment on driving ability also returned positive readouts.
Roche recently ran into a Herceptin shortage in China. The reason is the fast implementation of the country’s new national insurance drug list shot up demand that overwhelmed Roche’s production capacity. Roche has received approval to change manufacturing site supplying China the cancer therapy to one with higher capacity, but expects the shortage to last for some time.
Novo Nordisk currently holds the lead in China’s diabetes market—one that accounts for a quarter of the world’s total diabetic population—but the country’s contribution to Novo’s sales has been stagnant at about 11%. Bernstein analysts predict Novo’s insulin products, plus newer GLP-1 drugs like Victoza and Ozempic could grow the number from about $1.67 billion to $3 billion in 2025.
Zai Lab is about to enter the commercial stage with Tesaro’s PARP inhibitor Zejula—dubbed ZL-2306 at Zai, which owns the China rights, and it’s brought on William Liang, recently AstraZenecas oncology sales chief in China to lead the charge. Liang oversaw the successful launch of Tagrisso in China, and has also served stints at Bristol-Myers Squibb and Roche, focused on oncology, a key focus of Zai’s.
Founded by Eli Lilly’s former VP of oncology, Laura Benjamin, immuno-oncology startup Oncologies has opened shop in Boston and Shanghai with $16.5 million in seed funding. The biotech intends to leverage China’s recent drug regulation improvements to conduct development simultaneously in the U.S. and China, with the hope to shorten the time needed to launch drugs in both markets.
Two Indian companies, Syngene International and Zumutor Biologics, have formed a partnership. CRO Syngene will screen target antigens against Zumutor’s human antibody libraries, with the goal of discovering and characterizing novel antibody clones.
After acquiring Shire’s oncology unit for $2.4 billion, Servier has opened a site in Cambridge, Massachusetts' Kendall Square and hired people from Biogen and the University of Massachusetts to help find R&D and licensing opportunities. Its global expansion plan also includes a new office in Beijing.