In late October, BeiGene's self-developed PD-1 inhibitor, Trastuzumab (English trade name: TEVIMBRA), was launched ®， Chinese product name: Baize An ®） The first prescription was issued in the United States, officially entering the American market and bringing new treatment options to local patients. This milestone also marks the beginning of a new chapter for BeiGene's own commercialization team for solid tumors in the United States.Teralizumab was approved by the US Food and Drug Administration (FDA) in March 2024 for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). In October 2024, BeiGene announced the commercial launch of Trastuzumab in the United States, benefiting this patient population at a price 10% lower than other PD-1 therapies approved for this indication.

The first prescription of Trastuzumab in the United States has become another important milestone in the company's globalization process, confirming that BeiGene's drugs are bringing positive changes to more patients worldwide, which is the driving force behind all employees' unremitting progress. Meanwhile, as a company dedicated to global innovation in cancer treatment, BeiGene has always been focused on building a global operational model of independent innovation. The approval and commercialization of Trastuzumab in the United States only took 8 months, fully demonstrating the company's team's commercialization capabilities in the US market.

Eu Lei Qiang shares TEVIMBRA with employees of BeiGene ® Outlook after listing in the United States

Internationally, Trastuzumab has been approved in countries and regions such as the European Union, the United Kingdom, the United States, South Korea, Switzerland, and Australia. This includes the EU's new approval in April of this year for its use as a first-line and second-line treatment for three indications of non-small cell lung cancer. The application for marketing authorization for new indications in the first-line treatment of gastric or gastroesophageal junction (G/GEJ) cancer and esophageal squamous cell carcinoma (ESCC) is currently under review in the United States and the European Union. Recently, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval to expand these two indications.

In China, there are currently 14 indications for Trastuzumab approved by the National Medical Products Administration, of which 11 indications have been included in the national medical insurance drug catalog, making it the PD-1 inhibitor with the highest number of approved and included indications in the national medical insurance drug catalog. The latest approved indications for neoadjuvant and adjuvant immunotherapy for stage II or IIIA non-small cell lung cancer provide a new option for perioperative treatment of operable lung cancer patients, helping them achieve longer survival benefits.

As of August 2024, BeiGene has conducted clinical trials on Trastuzumab in over 30 countries and regions, with more than 14000 participants enrolled and approved indications benefiting over 1.2 million patients worldwide. By promoting international scientific research and talent exchange, gathering high-quality global medicine and medical resources to jointly explore more innovative treatment methods, we believe that more cancer patients worldwide will benefit in the future.