China NMPA Approves Tislelizumab in Non-Small Cell Lung Cancer and Hepatocellular Carcinoma

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has granted its anti-PD-1 antibody tislelizumab approval for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) and conditional approval for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy.

“With today’s approvals, tislelizumab is now available in China in five indications covering lung, liver, bladder, and lymphoma, and is becoming an important immunotherapy in the world’s most populous country,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. “This remarkable achievement, which began approximately 18 months ago with tislelizumab’s initial approval, was made possible through BeiGene’s integrated global clinical development approach. We hope to make tislelizumab available broadly in China through our science-based commercial team and globally through our collaboration with Novartis, in furtherance of our goal of expanding access to innovative, quality cancer treatments for more people worldwide.”

“We are pleased about the concurrent approvals for tislelizumab in China – in first-line non-squamous NSCLC following the previous approval for NSCLC patients with squamous histology earlier this year, and in second- or third-line HCC, which was based on the results from the largest global single-arm pivotal trial of any anti-PD-1 antibody in this indication,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “The pivotal clinical program of tislelizumab has seen tremendous progress lately, including two positive Phase 3 trials, one in esophageal cancer and the other in nasopharyngeal cancer. We credit our accomplishment to the dedication of our BeiGene team, and most importantly, the trust from participating patients and their loved ones, as well as investigators leading these clinical trials.”

NMPA Approval in First-Line Advanced Non-Squamous NSCLC

“NSCLC comprises the most common form of lung cancer, although diagnoses are usually delayed with most patients diagnosed at advanced stage. In the Phase 3 RATIONALE 304 trial, tislelizumab in combination with pemetrexed and platinum chemotherapy demonstrated a clinically significant improvement in progression-free survival along with a high response rate, and was generally well-tolerated for treatment-naïve patients with advanced non-squamous NSCLC,” commented Shun Lu, M.D., Ph.D., Professor of Shanghai Chest Hospital at Jiao Tong University and lead investigator for the trial. “I believe that this approval could help meet the significant demand in the front-line care of NSCLC, and I also look forward to the overall survival data readout.”