PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).
HONG KONG – New data from Beigene Ltd. recently presented at the ESMO Virtual Congress 2020 showed its PARP inhibitor pamiparib helped shrink tumors in almost 65% of people with platinum-sensitive ovarian cancer treated with the candidate during a pivotal trial.
Favorable conditions in China encouraged biotech veterans Jerry Wang, Bing Yan and Lihua Zheng to co-found Anheart Therapeutics Co. Ltd. in November 2018 to focus on oncology. On Monday, the Chinese startup in-licensed a mIDH-1 inhibitor and an AXL inhibitor from Daiichi Sankyo Co. Ltd. to expand its pipeline, less than two years after it obtained the global rights of its first asset, AB-106 (taletrectinib), from the Japanese firm to establish its footing.
A nearly $2 billion global development and commercialization deal with Abbvie Inc. and a $418 million private placement have bolstered I-Mab Biopharma Co. Ltd.’s position globally. I-Mab framed the deal as being the largest out-licensing and global partnership transaction ever executed by a China-based biotech. Abbvie and I-Mab plan to develop and commercialize the anti-CD47 monoclonal antibody lemzoparlimab for treating multiple cancers globally, with the exception of China. Lemzoparlimab, also called TJC-4, is Shanghai-based I-Mab’s discovery and its lead cancer therapy. The company will get an up-front $180 million by licensing the highly differentiated antibody to Abbvie, along with a $20 million milestone payment based on phase I results.
DUBLIN – Shares in Polyphor AG gained as much as 12% during early trading Aug. 31 on news of a deal in China for its lead drug, balixafortide, which is currently undergoing a phase III trial in HER2-negative locally recurrent or metastatic breast cancer.
LONDON – Ion Beam Applications SA (IBA) has taken a giant step into China, sealing a €100 million-plus (US$118.2 million) licensing deal with a local company to manufacture, install and maintain its proton beam cancer therapy systems.
Innovent Biologics Inc., of Suzhou, has out-licensed ex-China rights for its PD-1 drug Tyvyt (sintilimab) to Eli Lilly and Co. in an expanded license deal. The Chinese firm will receive $200 million upfront in the deal, the value of which could approach up to $1.03 billion. Innovent’s CEO Michael Yu called this “the first solid step in getting Innovent's innovative portfolio into the global market.” With the ex-China rights of Tyvyt, Lilly plans to seek approval for the PD-1 drug in the U.S. and other markets.
HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.
HONG KONG – China’s Lianyungang-based Jiangsu Hengrui Medicine Co. Ltd. has obtained approval from Korea’s Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for a combination therapy of its PD-1 inhibitor candidate camrelizumab and VEGFR-2 inhibitor rivoceranib.