Welcome to this week's FiercePharmaAsia report, which includes stories about a recent Alzheimer's study fail, Shanghai Pharma's overseas expansion plan, WuXi NeCODE CEO's thoughts on the company and the genomics industry, plus more need-to-know news from Asia's pharma industry.
Another disappointment in Alzheimer’s saw Takeda and partner Zinfandel cancel testing of diabetes medicine Actos (pioglitazone) as a potential Alzheimer’s therapy after an interim futility analysis showed no promise. Some researchers believe that antidiabetics could help stave off the effects of AD—Novo Nordisk’s GLP-1 analogue liraglutide is also being tested for that indication.
Shanghai Pharma, already a big player in the domestic Chinese market, is planning to open an R&D site in San Diego later this year. It has been looking for acquisitions or partnerships in the U.S. and Europe in recent years. The companies previously made moves on Stada and Arbor, and successfully took over Cardinal Health’s China business for $557 million in cash.
In a recent interview with FiercePharma, WuXi NextCODE CEO Hannes Smárason said the company plans to build its genomics database from half a million people to about 5 million by 2020. It will also focus on cementing its leadership position as the global platform for genomic data, while significantly growing its direct-to-consumer products in China to constitute over half of its entire business.
Speaking to a Senate panel, Sanofi Pasteur Asia-Pacific head Thomas Trimphe said the company will shoulder the cost of any Dengvaxia adverse events only if they’re scientifically linked to vaccination. The vaccine maker previously agreed to refund the Philippines for unused Dengvaxia shots.
U.S. biotech Tmunity, which focuses on T-cell immunotherapies against cancer, secured $100 million in series A backed by a group of investors including China’s Ping An Ventures. Lilly Asia Ventures was one of the company’s seed round investors. Ping An Ventures' managing partner said it was attracted to T-cell therapies’ potential in oncology in China.
After a preapproval inspection of a Daewoong Pharma plant in South Korea, the FDA issued a Form 483 with 10 observations. Those manufacturing concerns could delay the approval of a Botox copycat, which U.S. biotech Evolus contracted Daewoong to produce. The contractor assured Evolus it expects no further actions from the agency, but Evolus said there are no guarantees of that.
Founded in 2014 by a group of physicists at MIT, China biotech XtalPi just secured a $15 million series A funded by high-profile tech investors Sequoia, Google and Tencent. The company combines artificial intelligence, quantum physics and cloud computing to predict drugs’ crystal structures, which could affect drugs’ potential safety, stability and efficacy.
China’s FDA has approved Amoy Diagnostics’ EGFR mutation liquid biopsy, the first of its kind cleared in the country. Traditionally, doctors test tumor samples to identify patients most likely to respond to EGFR inhibitors, but Amoy’s product is able to identify EGFR gene mutations in plasma samples.
Astellas licensed a cytomegalovirus vaccine candidate from Vical in 2011. The vaccine had previously failed a phase 2 kidney transplant study, and now also missed both the primary and secondary endpoints in a phase 3 in hematopoietic stem cell transplant recipients.
General Electric will help China’s Clover Biopharmaceuticals build a biologics manufacturing facility, which will include two 2,000-leter bioreactors and is expected to be up and running the second half of 2018. The company plans to produce an Enbrel biosimilar there for the Chinese market.