It also empowers domestic precision immunotherapy for tumours and promotes the high-quality development of China's biopharmaceutical industry
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
Phase II trial will evaluate the safety and efficacy of ASC40 in patients with moderate to severe acne
This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
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