A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.
BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.
BEIJING – Suzhou-based Alphamab Oncology Co. Ltd. (HK:9966), which aims to bring the first PD-L1/CTLA4 bispecific antibody to China, saw its share prices jump almost 30% on its debut on the Hong Kong Stock Exchange (HKEX) on Dec. 12, 2019, ending the year on a positive note for the pre-revenue biotech.
HONG KONG – Israel-based Biolinerx Ltd. has unveiled the latest data from its ongoing phase IIa COMBAT/KEYNOTE-202 study at the European Society of Medical Oncology Immuno-Oncology Congress 2019 which evaluates Biolinerx’s BL-8040.
HONG KONG – Singapore and U.S.-based Hummingbird Bioscience Pte Ltd. has raised $19 million in a series B financing round. Proceeds will be used to support the discovery of new disease targets and to fuel the work of co-discovery projects that are part of an agreement valued with Amgen Inc.
HONG KONG – Rapt Therapeutics Inc., of San Francisco, and Seoul, South Korea-based Hanmi Pharmaceutical Co. Ltd. entered a license agreement for Rapt’s FLX-475 in Asia. FLX-475 is an oral, small-molecule CCR4 antagonist for cancer treatment.
Targeting prostate cancer (PCa) neuroendocrine (NE) cells via inhibition of the C-X-C motif chemokine receptor 2 (CXCR2) is an androgen receptor (AR)-independent therapeutic strategy that can improve the efficacy of treatment for PCa, a leading cause of male cancer mortality.
BEIJING – EOC Pharmaceutical Group, of Shanghai, completed a series C financing round, bagging $71 million to advance its lead programs EOC-103 and EOC-315 for breast and gastric cancers. The round was led by Hangzhou Tigermed Consulting Co. Ltd. and its affiliated funds, TF Capital and Yingke PE.