Drug Approval | June 12, 2022
China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer
Tislelizumab is now approved in nine indications in China
Tislelizumab is now approved in nine indications in China
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
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis
This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets
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