Junshi Biosciences Receives Positive CHMP Opinion for Toripalimab

On July 26, 2024, Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading biopharmaceutical company focused on innovative therapies, along with its subsidiary TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced a significant milestone. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization application (MAA) for toripalimab (European trade name: LOQTORZI®). CHMP's recommendation includes approval for toripalimab for two specific indications:

1. In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, non-surgical, or metastatic nasopharyngeal carcinoma (NPC).
2. In combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

The European Commission will consider CHMP’s positive opinion when making the final decision on toripalimab's marketing authorization. If approved, toripalimab will be the first drug in Europe specifically for NPC, as well as the first-line treatment for advanced or metastatic ESCC irrespective of PD-L1 status. This decision will affect all 27 EU member states, plus Iceland and Norway.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, stated that Junshi Biosciences aims to address clinical needs locally and globally. He emphasized that patients with NPC and ESCC currently have limited effective treatment options and that toripalimab could offer significant improvements. Dr. Patricia Keegan, CMO of TopAlliance Biosciences, added that the CHMP’s positive opinion is grounded in strong clinical evidence showing that toripalimab improves overall survival rates when combined with chemotherapy.

NPC is a malignant tumor common in the head and neck region. According to GLOBOCAN 2022, over 120,000 new cases were diagnosed worldwide in 2022. The tumor's location makes surgery a non-viable option, and ESMO Guidelines recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC. The positive opinion on NPC indications is based on the JUPITER-02 study, a Phase III clinical trial. Results from this study were presented at the 2021 ASCO annual meeting and published in prestigious journals like Nature Medicine and JAMA.

Esophageal cancer (EC) is another significant health issue, being the 11th most diagnosed cancer and the 7th leading cause of cancer death globally. In 2022, over 511,000 new cases and over 445,000 deaths were reported worldwide. ESCC is a primary subtype of esophageal cancer. The positive opinion for toripalimab in treating ESCC is backed by the JUPITER-06 study, also a Phase III clinical trial. Findings were first presented at the 2021 ESMO Congress and later published in Cancer Cell and Journal of Clinical Oncology.

Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2. This action enables the immune system to target and destroy tumor cells more effectively. Junshi Biosciences has conducted over forty clinical studies for toripalimab across various indications globally. Currently, toripalimab has ten approved indications in China, including treatments for melanoma, NPC, urothelial carcinoma, and several other cancers.

In the US, the FDA has approved toripalimab for similar uses, and the drug has received various designations such as Breakthrough Therapy and Orphan Drug for treating multiple conditions. Beyond the US and China, toripalimab's marketing applications are under review in Europe, Australia, and Singapore.

Founded in December 2012, Junshi Biosciences focuses on developing and commercializing innovative drugs, with over 50 drug candidates in its pipeline. The company has around 3,000 employees across its facilities in the US and China, remaining committed to delivering world-class, affordable, and innovative treatments globally.

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