Fierce Pharma Asia—Astellas CEO's 'aggressive' strategy; Leqembi's adcomm win; BeiGene's legal hurdle

Astellas' new CEO Naoki Okamura talked to Fierce Pharma about the company's business plans. Eisai and Biogen's Leqembi looks set to win a full approval after a positive advisory committee recommendation. AbbVie has brought a patent infringement lawsuit against BeiGene over their rival BTK inhibitors. And more.

1. With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company's mantra to be 'aggressive'

Naoki Okamura recently took over as Astellas’ CEO to “go on the aggressive.” Speaking to Fierce Pharma about the recent $5.9 billion buyout of Iveric Bio, Okamura said the target asset, geographic atrophy candidate Zimura, will open a new area for the company. The C5 inhibitor is expected to help Astellas weather the upcoming generic erosion of scanning agent Lexiscan as well as Xtandi’s patent cliff in 2027.

2. Astellas adds Cullgen to parade of protein degrader pacts, paying $35M upfront to access tech

Astellas has signed on Cullgen to work on protein degraders. For $35 million upfront, Astellas gets to combine its own protein degrader capabilities with the Sino-American biotech’s uSMITE platform, which features novel E3 ligands. Astellas will have an exclusive option to license assets coming out of the collaboration, while Cullgen has the option to co-promote its lead program in the U.S. The deal value could eventually swell to $1.9 billion.

3. Eisai, Biogen's Alzheimer's drug Leqembi wins over FDA experts in unanimous vote

Eisai and Biogen look even more likely to secure a full FDA approval for their Alzheimer’s disease drug Leqembi. An FDA advisory committee voted 6 to 0 that the drug’s phase 3 study, Clarity AD, has verified the med's clinical benefit. The experts described the trial results as “robust,” “meaningful,” “consistent” and “significant.” The FDA staffers also gave Leqembi a positive review.

4. AbbVie sues BeiGene over brand-new Imbruvica patent as blood cancer rivalry heats up

AbbVie secured a new patent for its Johnson & Johnson-shared BTK inhibitor Imbruvica and immediately sued Brukinsa developer BeiGene for patent infringement. The patent in question covers the method of using a BTK inhibitor developed under a certain chemical structure for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa beat Imbruvica in a head-to-head study in previously treated CLL/SLL.

5. China rejects Genor’s homegrown PD-1 in rare lymphoma type (Yicai)

Having approved more than a dozen PD-1/L1 inhibitors, China’s drug regulators decided to take a more cautious stance on Genor Biopharma’s anti-PD-1 antibody geptanolimab (GB226). Chinese authorities have rejected the drug in previously treated peripheral T-cell lymphoma, making it the first PD-1 inhibitor that was denied entry in China. Genor used a single-arm phase 2 trial for its application. But drug reviewers were concerned because no PD-1 inhibitor has been approved for the rare non-Hodgkin lymphoma subtype anywhere in the world, local media reported.