Welcome to this week's FiercePharmaAsia report, which includes stories about Shionogi's Roche-partnered flu powerhouse Xofluza, manufacturing issues at Sun's Halol plant, EpimAb's new CMO hire from Novartis China and more.
1. Shionogi’s flu drug wins green light in Japan, but U.S. approval not likely until 2019
Shionogi’s one-time, single-dose flu drug Xofluza, which bettered Roche’s popular Tamiflu in a phase 3, has won approval in Japan. Roche nabbed its commercialization rights outside of Japan and Taiwan through a deal in 2016. The pair plan to file for U.S. approval later but expects a decision no earlier than 2019.
2. Sun says FDA again faults plant that is its key launch site for U.S. drugs
The FDA’s issues with Sun Pharma’s key manufacturing site in Halol, India, date back to 2014. The facility is responsible for most of its new products for the U.S. After a warning letter in 2015 and a disappointing reinspection in 2016, the plant is once again the subject of a Form 483.
3. I-O biotech EpimAb poaches Novartis China cancer chief as CMO
Bin Peng, M.D., Ph.D., was global head of oncology translational medicine at China Novartis Institutes for BioMedical Research. Now, he is the first CMO at EpimAb Biotherapeutics. Founded in 2015 with a bispecific antibody platform called FIT-Ig, the Chinese biotech secured $25 million in a series A last year, and it is now preparing to move its lead candidate into the clinic this year.
4. Grail said to be planning IPO in Hong Kong to raise $500M
Cancer liquid biopsies developer Grail merged with Hong Kong-based Cirina last May. Now, as the Hong Kong exchange is proposing changes to its listing rules to attract early-stage biotech firms, Grail is looking to raise $500 million through an IPO there.
5. Takeda to add plant, 70 jobs in Ireland as it builds on deal for TiGenex
After announcing a plan to build a new plant in Ireland to produce oral multiple myeloma drug Ninlaro, Takeda is once again investing in its manufacturing site there. This time, it will spend about €25 million to build a standalone facility to manufacture the stem cell therapy it is getting from the acquisition of TiGenix.
6. Fujifilm building a plant in Japan to produce liposomes
Fujifilm said it will invest about $37.5 million to build a plant to produce liposomes that can act as delivery vehicles for the drugs the company develops. First up to use the technology will be an anticancer drug candidate slated to enter clinical trials this year.
7. Median, CMIC join forces on oncology clinical trials in East Asia
Medical imaging software developer Median Technologies will help CRO pioneer CMIC’s clients run oncology clinical trials in East Asia. The deal followed a strategic oncology study collaboration Median formed with Syneos Health last year and its recent expansion in Asia.
8. Biosensorix pens pact to develop rapid dengue, stroke tests
Through a deal with BGN Technologies, Singapore-based Biosensorix is gaining access to an electrochemical lateral flow immunosensor developed at Ben-Gurion University. The company hopes the technology will enable the cheap, rapid testing of dengue and stroke.
9. Indonesia's Kalbe Farma opens $35M plant near Jakarta to produce biologics
Indonesia's largest pharmaceutical company, Kalbe Farma, has opened a $35 million biologics drug facility on an 11,000-square-meter site in an industrial zone near Jakarta. The plant is expected to begin commercial production of hormone treatment erythropoietin at the end of the year.
10. FDA warning thrashes Indian drugmaker for filthy plant, data falsification
An FDA warning letter sent to Indian drugmaker Alchymars ICM cited a host of problems including filthy areas, equipment in poor condition and a quality control unit that had failed to inspect customer complaints. The company had agreed to halt production of a couple of APIs for the U.S.