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Shanghai Junshi Biosciences Co., Ltd., a leading innovation-driven biopharmaceutical company, announced that the company has received a notice from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) that the marketing authorization application (MAA) for toripalimab (project code: TAB001/JS001) combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC), toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) has been accepted.
The MAA submission for NPC is based on the study results from JUPITER-02 (a randomized, double-blinded, placebo-controlled, international multi-center phase III clinical study, NCT03581786). The JUPITER-02 results were first presented in the plenary session of the American Society of Clinical Oncology (ASCO) 2021 annual meeting (#LBA2) and subsequently published as the cover article of the September 2021 issue of Nature Medicine (IF: 87.241). The study results showed that for patients with recurrent or metastatic NPC who had not received systemic treatment, the toripalimab plus chemotherapy arm had a significantly longer progression free survival (PFS) than the placebo plus chemotherapy arm with median PFS of 21.4 months and 8.2 months, respectively, extended by 13.2 months, and toripalimab plus chemotherapy can reduce the risk of disease progression or death by 48% (HR=0.52, 95%CI: 0.37-0.73, two-sided p<0.0001). In February 2023, positive results have been achieved in the final analysis of overall survival (“OS”) from the JUPITER-02 study. Compared with the placebo plus chemotherapy arm, the OS in NPC patients treated with toripalimab plus chemotherapy achieved a statistically significant and clinically meaningful improvement. As of the date of this announcement, two indications for toripalimab for the first-line and later-line treatment of advanced NPC have been approved by the National Medical Products Administration (the NMPA), thereby making toripalimab the world’s first immune checkpoint inhibitor approved for the treatment of NPC.
Internationally, toripalimab has been granted two Breakthrough Therapies and one Orphan-Drug Designation by the US Food and Drug Administration for the treatment of NPC. The Biologics License Application (the “BLA”) for toripalimab, which is expected to be the first and only drug for the treatment of NPC in the country, is under review in the US.
The MAA submission for ESCC is based on the study results from JUPITER-06 (a randomized, double-blinded, placebo-controlled, multi-center phase III clinical study, NCT03829969). The results from JUPITER-06 were first presented in a mini-oral session during the 2021 European Society for Medical Oncology (ESMO) Congress, and later published in Cancer Cell (IF: 38.585), a world-leading oncology journal. The study results showed that for patients with advanced or metastatic ESCC who had not received systemic chemotherapy, comparewith chemotherapy alone, toripalimab plus chemotherapy provided more patients with better survival benefits. In particular, the median OS was significantly prolonged to 17 months, which was six months longer compared with the control group with chemotherapy alone, with a 42% reduction in the risk of disease progression or death (HR=0.58, p<0.0001), and patients benefiting regardless of their PDL1 expression. Based on the above results, the supplemental new drug application of toripalimab for the first-line treatment of advanced ESCC was approved by the NMPA in May 2022. In addition, the FDA has also granted an Orphan-Drug Designation to toripalimab for the treatment of ESCC.
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China, and has won the “Chinese Patent Gold Award, the top award in China’s patent field. Over thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and Europe. As of the date of this announcement, there are six approved indications for toripalimab in China. In December 2020, toripalimab injection was successfully negotiated into the National Reimbursement Drug List for the first time. At present, three indications have been included in the NRDL (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL fro the treatment of melanoma.
In terms of international layout, the BLA for toripalimab in combination with gemcitabine/cisplatin, for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum containing chemotherapy is under review by the FDA. In December 2022, the European Medicines Agency (EMA) accepted the MAA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC, and toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC.
Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Such stages are susceptible to uncertainties and therefore, investors are advised to make cautious decisions and pay careful attention to investment risks. The company will actively pursue the above research and development project and fulfill its information disclosure obligations in a timely manner for subsequent progress in strict compliance with relevant regulations.
Established in 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company committed to developing first-in-class and best-in-class drugs through original innovation.
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