Junshi Biosciences Gets EU Nod for Toripalimab Marketing

On September 24, 2024, Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences) and its wholly-owned subsidiary, TopAlliance Biosciences Inc., announced the European Commission’s (EC) approval of toripalimab (marketed in Europe as LOQTORZI®) for treating two specific cancer indications.

The first approval allows toripalimab to be used alongside cisplatin and gemcitabine for the initial treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) that cannot be addressed via surgery or radiotherapy. The second approval authorizes toripalimab in combination with cisplatin and paclitaxel for treating adults with advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC).

Earlier in July, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on these treatments' marketing authorization applications. This approval extends across all 27 European Union member states, Iceland, Norway, and Liechtenstein. Toripalimab thus becomes the first medication in Europe specifically approved for treating NPC and the sole first-line treatment for advanced or metastatic ESCC, irrespective of PD-L1 status.

NPC is a type of malignant tumor found in the nasopharyngeal mucosal epithelium and is among the most common head and neck cancers worldwide. According to GLOBOCAN 2022, there were over 120,000 newly diagnosed NPC cases globally in 2022. Due to the tumor’s primary location, surgery is often not feasible. The European Society of Medical Oncology (ESMO) Guidelines now recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC.

The JUPITER-02 study primarily supports the EC’s NPC approval. This study is the first international, multi-center, double-blind, randomized Phase III clinical trial in NPC immunotherapy with the largest sample size. It demonstrated a significant survival advantage when combining toripalimab with chemotherapy compared to chemotherapy alone. Results were highlighted at the 2021 American Society of Clinical Oncology (ASCO) annual meeting and published in prestigious journals like Nature Medicine and the Journal of the American Medical Association (JAMA). The study indicated that combining toripalimab with chemotherapy reduced disease progression risk by 48% and mortality risk by 37%, with median progression-free survival extending by 13.2 months.

EC is a prevalent malignant tumor in the alimentary tract. GLOBOCAN 2022 data reports that esophageal cancer ranks as the 11th most diagnosed cancer, causing over 445,000 deaths worldwide in 2022. ESCC and esophageal adenocarcinoma are the main subtypes. ESMO Guidelines endorse PD-1 blocking antibodies combined with chemotherapy for treating advanced or metastatic ESCC with PD-L1 positive status.

The JUPITER-06 study underpins the EC’s ESCC approval. This Phase III clinical trial evaluated toripalimab’s efficacy and safety when combined with paclitaxel and cisplatin for treating advanced ESCC. The study's findings were initially shared at the ESMO Congress 2021 and subsequently published in leading oncology journals. Results showed that the combination therapy significantly improved progression-free survival and overall survival, extending median overall survival by 6 months and reducing disease progression or death risk by 42%, regardless of PD-L1 status.

Professor Ruihua XU of Sun Yat-sen University Cancer Center emphasized the significance of these approvals, noting the high prevalence of NPC and EC in Asia and the slow development of effective treatments in Europe and the Americas. He praised the pioneering work of Chinese researchers in these studies and expressed hope that these innovations would offer new survival prospects to patients worldwide.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, highlighted the significance of this approval as part of their global commercial strategy. He noted that the approval in Europe underscores the international recognition of the company’s research and production quality. Dr. Patricia Keegan, Chief Medical Officer of TopAlliance Biosciences, echoed these sentiments, emphasizing their ongoing commitment to providing innovative therapies globally.

Toripalimab, an anti-PD-1 monoclonal antibody, is designed to block PD-1 interactions with its ligands, enhancing the immune system's capacity to attack and eliminate tumor cells. Junshi Biosciences has conducted over forty company-sponsored clinical studies for toripalimab, covering more than fifteen indications worldwide.

Founded in December 2012, Junshi Biosciences has developed a diverse R&D pipeline with more than 50 drug candidates. The company’s mission is to provide world-class, innovative, and affordable drugs, underscoring its strategic goal of “In China, For Global.”