Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Innovent Biologics Inc. and Ascentage Pharma Group Corp. Ltd. inked a three-component collaboration that comes with joint commercialization of an NDA-stage Bcr-Abl inhibitor and co-development of combination therapies, as well as Innovent taking a stake in Ascentage. The collaboration involves a deal worth up to $145 million and a $50 million investment.
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock shoot up nearly 44% on the heels of an oversubscribed AU$3.65 million (US$2.71 million) capital raise after acquiring a new invariant natural killer T (iNKT) cell therapy platform for oncology.
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices.