The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
China’s National Medical Products Administration (NMPA) approved Kechow Pharma Inc.’s MEK inhibitor, tunlametinib, for treatment of patients with NRAS-mutated advanced melanoma who were previously treated with PD-1/PD-L1 inhibitors. The Center for Drug Evaluation granted tunlametinib a priority review. The approval marks the first targeted therapy for this patient population and the first product that originated from Kechow, a privately held firm founded in 2014 to develop small-molecule therapeutics against cancer.
PYC Therapeutics raised AU$40 million of an anticipated AU$74 million (US$48.6 million) capital raise to advance three candidates, including lead candidate VP-001, which could potentially be the first treatment for retinitis pigmentosa type 11 (RP11), which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age.
The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
Shanghai Fosun Pharmaceutical Co. Ltd has formed a partnership with seven other investors to form an investment fund partnership that plans to invest ¥5 billion (US$695M) in local biotech and med-tech companies in Shenzhen, China. The target fund will concentrate on local biotechs, including cell and gene therapy companies, as well as other industries, with 70% to be invested in the biomedical industry.
After spending 20 years at Novartis, Radiopharm Theranostics Ltd. CEO Riccardo Canevari told BioWorld that when he joined Radiopharm he wanted to focus on something different within radiopharmaceuticals where no one was playing. “I believe these new modalities are at the beginning of their potential, much like in the immuno-oncology space years ago. That’s a nice place to be,” he said, but it’s not only about competition, it’s also about understanding what other companies are doing and if there is a disease area or a mechanism of action that is not being explored, he said.
As geopolitical tensions mount, bipartisan legislation introduced in both the U.S. Senate and the House is calling to prohibit government contracts with certain Chinese biotechs such as BGI (formerly known as Beijing Genomic Institute) and Wuxi Apptec, because they are increasingly seen as national security threats.
