With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
As geopolitical tensions rise between the U.S. and China, building cross-border relationships is more important than ever, said panelists during the Chinabio Partnering Forum in Shanghai Sept. 10.
Jacobio Pharmaceuticals Group Co. Ltd. out-licensed rights for two lung cancer assets in China to Shanghai Allist Pharmaceuticals Co. Ltd. through a potential ¥900 million (US$126.4 million) deal. Beijing-headquartered Jacobio said Aug. 30 that it signed off development, regulatory and commercial milestone rights to both glecirasib, a KRAS G12C inhibitor first targeting non-small-cell lung cancer, and a SHP2 inhibitor called JAB-3312.
Yoltech Therapeutics Co. Ltd. licensed its PCSK9-targeting gene editing therapeutic, YOLT-101, to Shenzhen Salubris Pharmaceuticals Co. Ltd. for mainland China rights in a deal worth ¥1.035 billion (US$145 million).
Highfield Biopharmaceuticals Inc. has filed an IND application with China’s National Medical Products Administration (NMPA) to conduct a clinical trial of HF-50, an immunoliposome that directs T cells to attack solid tumors and enhances anticancer activity with an immune modulator.
During a webinar arranged by Demy-Colton, panelists discussed a wide range of potential outcomes that might occur depending on which political party ends up in power next year. From tweaks to the Inflation Reduction Act to new laws to the Federal Trade Commission's regulation of M&As, there’s potential for the government to have substantial effects on the drug development industry.
Yoltech Therapeutics Co. Ltd. licensed its PCSK9-targeting gene editing therapeutic, YOLT-101, to Shenzhen Salubris Pharmaceuticals Co. Ltd. for mainland China rights in a deal worth ¥1.035 billion (US$145 million).
TYK Medicines Inc. made a strong debut on the main board of the Hong Kong Stock Exchange (HKSE), raising HK$579 million (US$74.32 million) to commercialize its lead compound, EGFR inhibitor TY-9591, now in pivotal trials in patients with EGFR mutation-positive lung cancer.
Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.