Welcome to this week’s FiercePharmaAsia weekly wrap-up. Takeda has teamed up with VC Lightstone in forming a new neuroscience company, Cerevance, as the company refocuses. Chinese researchers are publishing more than three times as many cancer research papers than they were a decade ago, closing the gap with their U.S. counterparts. Sun Pharma’s Halol plant was hit by another FDA Form 483 after the company put a lot of effort into improving the site to resolve issues listed in a warning letter. China’s healthcare reforms are affecting domestic and international pharmas in both promising and worrisome ways. China fined Medtronic $17 million for price-fixing as the company plans to expand business further in the country. Takeda put €40 million into a new plant in Ireland to produce promising cancer drug Ninlaro. South Korea biotech Eutilex has rounded up $18.9 million in a Series A funding to push its lead cancer med into midstage testing.
Takeda has partnered with VC Lightstone in forming a new company, Cerevance, focused on R&D for neurological and psychiatric disorders. Besides a $21.5 million Series A injection put together with Lightstone, Takeda is also sending 25 neuroscience researchers from its Cambridge, U.K., site to start the company. The move is regarded as part of a major shift in the Japanese pharma’s R&D philosophy, which has seen it cut back in some areas and buy into others in GI, oncology, vaccines and CNS. Geographically speaking, the company is putting more efforts in its home country and the U.S.
China is catching up on research in the most-discussed and probably the most lucrative disease field for the next few decades: cancer. Chinese researchers are publishing more than three times as many research papers on cancer topics than they were 10 years ago, constituting about 17% of the world’s entire cancer research publications and gradually eating away at the U.S. lead, a recent report by science publisher Elsevier shows. The country’s researchers most recent eye-catching moves in the field include the first CRISPR test in human.
Looks like Sun Pharma’s effort put into its revenue-driving Halol plant to overcome FDA concerns did not do what was needed. A reinspection of the plant only led to more citations. The FDA slapped Sun Pharma’s cornerstone plant with a warning letter last year. As the site produces about 15% of the company’s revenues in the U.S., the Indian drugmaker is anxious to get operations back up to speed, and all bets were on the reinspection which was completed Dec. 1. Sun’s sales in the U.S. were up 17% to about $1.2 billion for the first half of this fiscal year, but mainly because of a Gleevec generic, the production of which the company had to move out from Halol to another facility.
The Chinese pharma market remains the world’s second largest, with forecasts that it will grow to $167 billion by 2020. But a series of recent government reform efforts is likely to shake up the landscape. Eliminating financial incentives of selling drugs for public hospitals and a tougher stance against corruption in the healthcare system will pose a blow to the pharma industry. The country’s drug sales are primarily for generics, about 85%. A decree that requires generics to undergo equivalence tests side by side with their formerly patented ones will probably remove low-quality drugs and small-sized domestic companies from the market. But an opaque drug approval process is still a barrier for international innovators who seek fast approvals for their new formulas.
Medical devices maker Medtronic was recently found guilty of price-fixing by Chinese regulators, which quoted evidence that Medtronic quashed competition by setting minimum prices for its products with distributors. The $17 million fine refers to Medtronic’s cardiovascular and diabetes devices sold in China. The company enjoyed $1.5 billion in revenues from Greater China in fiscal 2016 and is also planning further expansion in the country.
Takeda expects that its new multiple myeloma drug Ninlaro will be a big performer, so it is expanding API production for it with a €40 million new plant in Ireland and adding 40 jobs at the site. Ninlaro is the first orally active proteasome inhibitor to reach the market after approval in the U.S. and from the EMA.
South Korean biotech Eutilex has gathered a $21 billion KRW ($18.9 million) Series A funding and can now move its autologous T-cell therapy, 4-1BB CTL, into phase 2 testing, as well as expand its R&D capabilities by building a new GMP facility in Seoul.