Beijing, China - October 21, 2024- BeiGene Limited (NASDAQ: BGNE; Hong Kong Stock Exchange code: 06160; Shanghai Stock Exchange code: 688235), a global cancer treatment innovation company, announced today that its PD-1 inhibitor BeiGene An ® Teralizumab has been officially approved by the China National Medical Products Administration (hereinafter referred to as "NMPA") for use in combination with platinum based chemotherapy as neoadjuvant therapy, and continues to be used as monotherapy for resectable stage II or IIIA non-small cell lung cancer patients after surgery. As the first PD-1 drug approved for neoadjuvant and adjuvant immunotherapy of stage II-III non-small cell lung cancer (NSCLC) in China, Trastuzumab provides a new option for perioperative treatment of operable lung cancer patients, helping them achieve longer survival benefits.

This approval is based on clinical trial data of RATIONALE 315 (NCT04379635). This study is a multicenter, randomized, placebo-controlled, double-blind phase 3 study evaluating the efficacy and safety of trastuzumab combined with platinum based dual agent chemotherapy as neoadjuvant therapy, followed by trastuzumab adjuvant therapy, in patients with resectable stage II or IIIA NSCLC. The research results showed that the dual primary endpoints of event free survival (EFS) and major pathological response rate (MPR rate) have been achieved, confirming that the combination of perioperative trastuzumab and neoadjuvant chemotherapy can significantly reduce the risk of perioperative progression or recurrence and metastasis in patients.

Compared with placebo combined with neoadjuvant chemotherapy during the perioperative period, the combination of trastuzumab and neoadjuvant chemotherapy significantly increased MPR rate (56.2% vs 15.0%) and pathological complete response rate (pCR rate, 40.7% vs 5.7%), and significantly prolonged EFS (HR: 0.56, 95% CI: 0.40-0.79), and a good trend of overall survival (OS) extension has been observed (HR: 0.62, 95% CI: 0.39-0.98); The overall tolerability of this treatment regimen is good, and no new safety signals have been found. The results of this study were also presented at the ESMO Plenary session held in February 2024.

Lung cancer is a common malignant tumor worldwide, with the highest mortality rate in the world. In China, lung cancer is also the largest cancer, and its incidence rate and mortality rate rank the "double top" of malignant tumors. NSCLC accounts for approximately 85% of all lung cancer cases. Although there is a chance for curative surgical resection in early and mid stage NSCLC, more than half of patients will experience local recurrence or distant metastasis within 5 years after surgery. Previous perioperative chemotherapy has limited improvement in survival for surgical patients, with a five-year survival rate increase of only 5%.

At present, surgery is still the main treatment method for early, mid, and locally advanced non-small cell lung cancer. Neoadjuvant and adjuvant therapy before and after surgery play a key role in reducing the risk of cancer recurrence and helping to further improve the cure rate. We believe that the approval of the new indication for Trastuzumab will further enhance the confidence of perioperative immunotherapy clinical practice, thereby bringing more hope for cure to lung cancer patients.

As of now, Trastuzumab has been approved by the National Medical Products Administration for 14 indications in China, of which 11 indications have been included in the national medical insurance drug catalog. It is currently the PD-1 inhibitor with the largest number of approved and included indications in the national medical insurance drug catalog.

Globally, Trastuzumab has been approved in countries and regions such as the European Union, the United Kingdom, the United States, South Korea, Switzerland, and Australia, including the European Commission's approval in April of this year for first-line and second-line treatment of three NSCLC indications. The application for new indications for first-line treatment of gastric or gastroesophageal junction cancer and the application for new indications for first-line treatment of esophageal squamous cell carcinoma are currently under review by the US Food and Drug Administration (FDA) and the European Commission (EC).