Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Smal

SHANGHAI, June 18, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab (product code: JS001) in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

Lung cancer is currently the most prevalent malignant tumor with the highest mortality rate in China. Small cell lung cancer (SCLC) is the most aggressive subtype of lung cancer, accounting for approximately 15%-20% of all lung cancer cases with characteristics including rapid progression, early metastasis and poor prognosis. SCLC is divided into limited-stage small cell lung cancer (LS-SCLC) and ES-SCLC. For patients with LS-SCLC, an objective response rate of approximately 90% and a five-year survival rate of approximately 25% could be achieved through standard chemotherapy and radiotherapy. However, most patients have already been diagnosed with ES-SCLC when seeking medical treatment, with a median survival time of less than one year and a two-year survival rate of less than 10%, and thus ES-SCLC remains a major unmet clinical problem.

The approval of the supplemental new drug application is mainly based on data from the EXTENTORCH study (NCT04012606), a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study, aiming to compare the efficacy and safety of toripalimab or placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. Led by principal investigator Professor Ying CHENG from Jilin Cancer Hospital, the study was conducted across 51 clinical centers nationwide.

In May 2023, the primary endpoints of EXTENTORCH met their pre-defined efficacy boundary, and toripalimab thus became the first PD-1 inhibitor in the world to meet the primary endpoints of both overall survival (OS) and progression-free survival (PFS) in a Phase 3 study for the first-line treatment of ES-SCLC.

At the European Society for Medical Oncology (ESMO) Congress held in October 2023, the EXTENTORCH data was released in the form of an oral presentation for the first time. The study results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy could significantly prolong the PFS and OS of patients and demonstrated a favorable safety profile. This suggests that toripalimab may be an optimal immunotherapy for ES-SCLC. In particular, the median PFS of the toripalimab group reached 5.8 months, and the risk of disease progression or death was reduced by 33.3% (P=0.0002). The one-year PFS was nearly four times higher in the toripalimab group compared with the chemotherapy group (18.1% vs. 4.9%). The median OS of the toripalimab group reached 14.6 months, the risk of death was reduced by 20.2% (P=0.0327), and the one-year OS reached 63.1%.

“SCLC is highly invasive, mestastasizes early, and has a poor prognosis. For a long time, the standard treatment of ES-SCLC has been platinum-based chemotherapy. Although patients are responsive to the initial stage of treatment, they are prone to drug resistance. Immunotherapy, however, has opened a new chapter,” said Professor Ying CHENG from Jilin Cancer Hospital. “The double primary endpoint design of PFS and OS in EXTENTORCH followed a higher statistical standard and achieved positive results for both endpoints. This means that compared to mono-chemotherapy, toripalimab combined with chemotherapy can significantly improve patients’ PFS and OS. The approval of toripalimab’s new indication for the first-line treatment of ES-SCLC will provide a new, effective, safe and affordable treatment option for SCLC patients in China!”

“With the highest number of new cases and deaths, lung cancer has always been the archenemy of tumor treatment,” said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences. “Junshi Biosciences has continuously invested in the research and development of new drugs for lung cancer. To date, three indications have been successfully approved, covering the main subtypes of non-small cell lung cancer and SCLC, as well as patients at all stages from early to advanced. More products and indications are currently in development, and we look forward to bringing better treatment options to lung cancer patients!”

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are nine approved indications for toripalimab in Chinese mainland:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
7. in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
8. in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
9. in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In April 2024, the Drug Office at the Department of Health in the Government of the Hong Kong Special Administration Region (DO) accepted the NDA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

In the United States, the US FDA has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.

In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (HSA) in January 2024. The HSA has also granted priority review designation for the NDA.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs”, Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com.

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