The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
Merck Sharp & Dohme Corp. (MSD), known as Merck & Co. Inc. in the U.S. and Canada, terminated its potential $1.86 billion deal with San Diego-based Artiva Biotherapeutics Inc. for novel chimeric antigen receptor-natural killer cell therapies. GC Cell disclosed news of the terminated deal on the Korea Exchange near market close of June 25, saying it was notified by Artiva after the decision was reached by MSD’s internal decision makers.
The annual Companies to Watch report, which was just released, looks closely at seven companies flying under the radar that are developing antibody-drug conjugates (ADCs) for treating cancer. Companies examined in the new report are Adcendo ApS, Araris Biotech AG, Go Therapeutics Inc., Heidelberg Pharma AG, Pheon Therapeutics Ltd., Tallac Therapeutics Inc. and Tubulis GmbH.
Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
Shanghai Fosun Pharmaceutical Co. Ltd announced it will buy out partner Shanghai Henlius Biotech Inc. for up to HKD$5.4 billion (US$691.7 million), according to a joint announcement on the Hong Kong Stock Exchange.
Suzhou, China-headquartered Ascentage Pharma Group Corp. Ltd. has filed plans for a confidential IPO to the U.S. SEC for a potential dual listing on both the U.S. and Hong Kong stock exchanges. News of the U.S. IPO came just a few days after Ascentage drew a $75 million equity investment from Osaka, Japan-headquartered Takeda Pharmaceutical Co. Ltd. with the issuance of about 24.3 million shares at a purchase price of HK$24.09 (US$3.08) per share.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
Fledgling biotech Ternarx Pty Ltd. has emerged from stealth mode and is the first of its kind in Australia to develop targeted protein degrader technology to destroy disease-causing proteins that cannot be targeted by conventional drugs. The Melbourne-based company will initially develop targeted protein degraders against currently undrugged transcription factors in cancers with significant unmet need, starting with neuroblastoma and prostate cancer.
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