The FDA will convene an advisory committee to discuss a China-made PD-1 by Innovent Biologics and partner Eli Lilly in front-line non-small cell lung cancer. Takeda and Bayer settled their hemophilia patent infringement lawsuit two years after the initial $173 million verdict in favor of Bayer. Novo Nordisk's investment arm led a $125 million series C in Singapore precision medicine developer Hummingbird Bioscience. And more.
The FDA accepted Innovent Biologics and Eli Lilly’s application for their PD-1 inhibitor, Tyvyt, in newly diagnosed nonsquamous non-small cell lung cancer and set the decision date for next March. The agency intends to convene an advisory committee meeting to discuss the filing, which is based on tumor progression data from a China-only phase 3 trial dubbed ORIENT-11.
Takeda and Bayer have put behind them a hemophilia patent infringement lawsuit. Two years ago, Bayer won a case in which it accused Takeda subsidiary Baxalta—then part of Shire—for infringing its patent on recombinant factor VIII technology. It came with a judgement of $155 million in damages and an additional $18 million in supplemental damages. Baxalta appealed but failed in March.
Singapore’s Hummingbird Bioscience has collected $125 million in an oversubscribed series C led by Novo Holdings, the investment arm of Novo Nordisk. The new financing will help Hummingbird develop precision therapies for cancers and autoimmune diseases, including its lead candidate, HMBD-001, a HER3 antibody. Novo recently created a chapter in Singapore to focus on Asian life sciences investment.
The pandemic has created a massive backlog of facility inspections at the FDA. The agency’s now slowly getting the reviews back on track. It plans to tap international partners to help with on-site inspections, and if the disease situation worsens, it “would focus on oversight work most critical to its mission and limit inspection activities,” it said in a report.
Chinese biotech I-Mab will report positive early results for its CD73 antibody uliledlimab at ASCO next month. In a combination with Roche’s Tecentriq, the drug triggered a response in 23% of 13 treatment-naïve or refractory patients with various types of cancers in a phase 1 trial. Analysts at Jefferies called the showing as a “favorable outcome” when compared with other candidates.
Californian biotech Kinnate Biopharma highlighted the opportunity of the Chinese market for its RAF inhibitor KIN-2787 at the time of its $276 million IPO late last year. Now aiming to realize that potential, the company has teamed with OrbiMed Asia Partners and other investors to create a Chinese joint venture and closed a $35 million series A for it.
Antibody-drug conjugates (ADCs) such as AstraZeneca and Daiichi Sankyo’s Enhertu are gaining traction. Aiming to ride a rising demand for ADC manufacturing, WuXi Biologics and WuXi STA are creating a $200 million CDMO called WuXi XDC to focus on supporting the production of bioconjugates.
LianBio has licensed two of Landos Bioparma’s inflammatory bowel disease candidates, omilancor and NX-13, for greater China and select Asian markets. The Chinese licenser paid $18 million upfront and committed $200 million in biobucks and will help enroll patients in future global phase 3 trials.
Other news of note:
9. Roche launches first in-house accelerator in Shanghai (release, PDF)