Tamra Sami

Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab).

Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties.

Wuxi Biologics Co. Ltd. is licensing a preclinical trispecific T-cell engager to Candid Therapeutics Inc. in a deal worth up to $925 million plus royalties.

Women with endometriosis may soon be able to have a simple blood test to diagnose their disease thanks to a breakthrough by Proteomics International Ltd. that has developed a plasma protein biomarker panel that identifies all stages of endometriosis.

Mountainfield Venture Partners and Chengdu, China-based Keymed Biosciences Co. Ltd have partnered to form San Diego-based Timberlyne Therapeutics, which will progress Keymed’s CD-38 monoclonal antibody globally excluding China.

Cornerstone Robotics Ltd. raised more than $70 million in a series C round to expand its international footprint and accelerate R&D efforts for its robotic surgery solutions. The funds will allow the Hong Kong-headquartered company to accelerate commercialization of new surgical robotic products, conduct clinical trials, obtain regulatory approvals and promote global adoption of advanced robotic surgical solutions.

China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.

China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.

Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy. The approval came more than a week ahead of the Jan 29 PDUFA date.

George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination.