New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point. Read More
Beigene Ltd. unveiled positive interim results from its Alpine phase III trial comparing its small-molecule BTK inhibitor, Brukinsa (zanubrutinib), to Abbvie Inc.’s Imbruvica (ibrutinib), lending validity to one of the company’s most important development programs. Read More
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies. Read More
Genhouse Bio Co. Ltd. closed a series A financing round to raise more than ¥200 million (US$31 million) to support phase I studies of KRAS inhibitor GH-35 and SHP2 inhibitor GH-21 in China. The startup expects to enroll patients in trials testing the two compounds in the second half of this year, CEO Wang Kuifeng told BioWorld in an exclusive interview. Read More
With Pharmabcine Inc.’s anti-angiogenic antibody TTAC-0001 (olinvacimab) already in testing against recurrent glioblastoma multiforme (GBM) and metastatic triple negative breast cancer, CEO Jin-San Yoo is now giving serious thought to starting trials to test it in children with brain tumors. Plans to begin four additional trials between the end of 2021 and the beginning of 2022 are also underway. Read More
At the 2021 virtual annual meeting of the American Society for Clinical Oncology (ASCO), results of the VISION trial testing the addition of Novartis AG’s radiopharmaceutical Lutetium-177-PSMA-617 (Lutetium-PSMA) to individualized standard-of-care regimens in metastatic castration-resistant prostate cancer improved both overall survival and radiographic progression-free survival. Read More
Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries. Read More
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept). Read More
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Ambrx, Cygenica, Heartseed, Hifibio, Novocodex, Regencell Bioscience. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Adamis, Astrazeneca, Azurrx, Bio-Thera Solutions, Celltrion, Daiichi Sankyo, Glenmark, Iaso, Icosavax, Immvira, Innovent, Kazia, Kyowa Kirin, Mei, Molecular Partners, Novavax, Redhill, Takeda. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Ascletis, Beigene, Direct Biologics, Iaso, Kiniksa, Kyowa Kirin, Moderna, Ocugen, RDIF, Takeda, Vicore. Read More
