Fierce Pharma Asia—BeiGene's flagship U.S. hub, Brukinsa win; Takeda's tax bill, regulatory delays

BeiGene is making the U.S. its second home with the construction of a new R&D and manufacturing hub in New Jersey. The news comes just as the Chinese biotech trumpets a phase 3 win in newly diagnosed chronic lymphocytic leukemia. Takeda didn't overturn a €398 million Irish tax bill tied to AbbVie's failed takeover bid for Shire. The Japanese pharma is also facing regulatory delays in the U.S. and EU. And more.

1. BeiGene lays plans for 'flagship' biologics plant and R&D center in New Jersey

BeiGene has signed a deal to purchase about 42 acres of land at the Princeton West Innovation Park in Hopewell, New Jersey, to build a new R&D and manufacturing center. Phase 1 of the project “calls for hundreds of jobs,” Michael Garvey, BeiGene’s global head of technical operations, said. The site will initially make biologics and then potentially small-molecule cancer drugs.

2. BeiGene tees up 3-way leukemia competition against J&J-AbbVie, AstraZeneca with Brukinsa win

News of the U.S. hub came on the heels of BeiGene touting an important phase 3 win for Brukinsa. The BTK inhibitor beat the combination of bendamustine and Roche's Rituxan at staving off cancer progression or death in newly diagnosed patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The Sequoia trial win adds onto Brukinsa’s previous success over AbbVie and Johnson & Johnson’s Imbruvica in previously treated patients.

3. Takeda still on the hook for €398M tax linked to distant AbbVie-Shire breakup fee

After an appeal from Takeda, Ireland’s tax authorities still think the Japanese pharma owes €398 million ($472.9 million) in tax that stemmed from a breakup fee AbbVie paid Shire in 2014 after a failed takeover bid. Takeda bought Shire in 2019. Takeda says it plans to challenge the ruling possibly through an appeal in Irish courts.

4. The curious case of Eohilia: Takeda drug hit with mysterious FDA delay as company leans on launches for growth

Meanwhile, two Takeda pipeline drugs are facing regulatory delays. The FDA missed its original target action date for Eohilia, an oral suspension of the corticosteroid budesonide, for use in eosinophilic esophagitis. Plus, an assessment of the company’s dengue vaccine candidate, TAK-003, has been converted from accelerated review to regular process at the European Medicines Agency.

5. Zai Lab to pay Schrödinger up to $338M in biobucks for oncology R&D collab

Zai Lab has signed on Schrödinger to work on an oncology program that targets DNA damage response. The Chinese firm is paying the computer-based drug discovery specialist an undisclosed upfront payment, with potential $338 million agreed in milestones. While Zai will take lead on global development and commercialization, Schrödinger shares rights in the U.S. 

6. Astellas to pay Minovia $20M upfront, with $420M on the table per product, for mitochondrial cell therapies

Astellas is paying Minovia Therapeutics $20 million upfront to develop cell therapies for diseases caused by mitochondrial dysfunction. Astellas will contribute induced pluripotent stem cells, and Minovia will offer its mitochondrial augmentation therapy platform. Astellas has also promised up to $420 million in biobucks for each successfully commercialized product.

7. Another day, another billion-dollar deal for PeptiDream, this time with Alnylam

Shortly after a neurodegenerative disease pact with Takeda, PeptiDream has inked a collaboration with Alnylam worth up to $2.2 billion. The Japanese peptide-based drug discovery specialist will help Alnylam develop peptide-small interfering RNA conjugates that can deliver RNAi therapeutics to tissues outside the liver.

8. Insilico Medicine's AI engines continue to churn out new drug candidates, now in kidney fibrosis

Hong Kong-based Insilico Medicine has used its artificial intelligence programs to generate a drug candidate for kidney fibrosis. The drug has shown desirable medicinal profiles and showed promising results in lab dishes and animal studies. The company plans to complete IND-enabling studies in 2022.

Other News of Note:

9. Takeda allies with Frazier to spin out late-phase norovirus vaccine

10. Aptar inks deal to target Chinese injectable drug delivery field

11. Social media mavens join SK Life Science's latest epilepsy awareness campaign to promote zero seizures goal