China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors.
Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance.
Immuneoncia Therapeutics Inc., a joint venture between South Korea’s Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., is looking to list on the Korea Exchange, having recently passed local technology evaluation.
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
The U.S. FDA granted fast track designation to Telix Pharmaceutical Ltd.’s TLX101-CDx for glioma imaging as the firm prepares to file its NDA in the first half of 2024, a Telix spokesperson told BioWorld.
Prior to this year’s Annual Meeting of the American Association for Cancer Research (AACR), it had been 14 years since metastasis had been the subject of a plenary session. So, the Tuesday session on “Evolution of the genome, microenvironment, and host through metastasis” had plenty of new insights to share.
A day after investing $40 million in China’s D3 Bio Inc., London-based venture capital firm Medicxi is investing $25 million to co-found a new U.K.-based company called Petalion Therapeutics Ltd. that will focus on an early stage oncology asset from Australia’s Starpharma Holdings Ltd. to develop novel dendrimer-based treatments.
The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Sino Biopharmaceutical Ltd. and Boehringer Ingelheim International GmbH are partnering to develop innovative cancer therapies in mainland China. They will jointly develop and commercialize three clinical Boehringer assets, including brigimadlin, zongertinib, BI-764532, and other unnamed early stage assets.
After reviewing data from its phase II trial of farnesoid X receptor agonist ASC-42 in primary biliary cholangitis, Ascletis Pharma Inc. said it was quitting development of the molecule in all indications.
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