BeiGene's PD-1 Inhibitor Tislelizumab Receives EMA Marketing Authorization Application Acceptance, Accelerating Global Expansion

　　【Pharmaceutical Network Industry DynamicsFollowing the formal acceptance of BeOne Medicines' PD-1 inhibitor, BeiGene's BLA (Biologics License Application) by the U.S. FDA in September 2021, the product has recently received further positive news with the acceptance of its marketing authorization application by the European Medicines Agency (EMA), indicating that BeiGene is accelerating its globalization process.
 

The indication accepted by EMA this time is: for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy, as well as patients with non-small cell lung cancer (NSCLC).
 

Among them, the relevant indications for NSCLC submission include: monotherapy for adult patients with locally advanced or metastatic NSCLC previously treated with chemotherapy; as a first-line therapy, in combination with carboplatin and paclitaxel (or albumin-bound paclitaxel) for the treatment of adult patients with locally advanced or metastatic squamous NSCLC; as a first-line therapy, in combination with pemetrexed and platinum-based chemotherapy for adult patients with locally advanced or metastatic non-squamous NSCLC without EGFR or ALK positive mutations.
 

Tislelizumab is a humanized IgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody designed to minimize binding to the Fcγ receptor on macrophages. Preclinical data suggest that binding to the Fcγ receptor on macrophages can activate antibody-dependent cell-mediated killing of T cells, thereby reducing the anti-tumor activity of PD-1 antibodies.
 

The MAA submission for BeOne Medicines' BeiGene in ESCC is based on the results of a randomized, open-label, multicenter global Phase 3 trial, RATIONALE302 (NCT03430843), which demonstrated favorable safety characteristics.
 

According to reports, this marketing authorization application was submitted by Novartis. In January 2021, BeOne Medicines and Novartis announced a "partnership," with Novartis co-developing, manufacturing, and commercializing BeiGene's Tislelizumab in North America, Europe, and Japan. Previously, both parties also jointly pushed for the FDA to accept the new drug marketing authorization application for Tislelizumab.
 

As of now, BeOne Medicines' product has been approved for 7 indications in China, with two additional new indication applications accepted by the National Medical Products Administration (NMPA) and currently under review.
 

It is reported that BeOne Medicines is also accelerating the global layout and clinical research of BeiGene's product, tislelizumab. To date, over 20 potential registrational clinical trials of tislelizumab have been initiated or completed in China and globally, including 17 Phase 3 clinical trials and 4 pivotal Phase 2 clinical trials.
 

In addition, clinical trials of BeOne Medicines in combination with other drugs are also underway, including ociperlimab, sitravatinib, and zanidatamab.
 

Currently, PD-1 has become one of the most competitive markets in the pharmaceuticals industry. According to analysis data from Frost & Sullivan, the global PD-(L)1 inhibitor market size reached 38.1 billion US dollars in 2021 and is expected to reach 63.9 billion US dollars by 2023. In China, the market size of PD-(L)1 inhibitors is projected to reach 66.4 billion yuan in 2023 and will grow to 98.8 billion yuan by 2030.
 

Industry insiders say that in the fierce competition for market share, in order to boost corporate performance growth, new indications, drug quality, production capacity, distribution channels, sales teams, and medical insurance have all become key areas of competition. In 2021, BeOne Medicines' product,百泽安 (Tislelizumab), had three new indications approved for inclusion in the updated National Reimbursement Drug List (NRDL), including first-line treatment for non-squamous non-small cell lung cancer (NSCLC). With the expanded scope of medical insurance reimbursement, the market penetration and market share of this product have also been continuously growing. Data shows that in 2021, the sales revenue of 百泽安 in China reached approximately 1.6 billion yuan, representing a year-on-year increase of 56%.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.