Junshi Biosciences Announces the sNDA Approval of Toripalimab for the 1st-line Treatment of Melanoma

SHANGHAI, April 25, 2025 (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 supplemental new drug application (“NDA”) for toripalimab (trade name: TUOYI®) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration (“NMPA”). This marks the approval of toripalimab’s 12th indication in the Chinese mainland.

Melanoma is the most malignant type of skin cancer. According to GLOBOCAN 2022 statistics, approximately 332,000 new melanoma cases and 59,000 deaths were recorded globally that year. Though melanoma is relatively uncommon in China, its mortality rate is high (approximately 5,000 deaths amongst approximately 9,000 new cases in 2022) and its incidence rate is rising year by year. Since 2018, anti-PD-1 monoclonal antibodies have been approved for the second-line or later treatment of advanced melanoma in China and are widely used clinically. However, the first-line standard treatment for advanced melanoma is still dominated by traditional chemotherapy or targeted therapy (limited to patients with BRAF V600 mutation). Until now, no domestic anti-PD-1 monoclonal antibody had been approved for advanced melanoma in China, creating an urgent clinical need for first-line immunotherapy options.

The supplemental NDA approval is based on data from the MELATORCH study (NCT03430297). MELATORCH is a multicenter, randomized, open-label, positive-controlled Phase 3 clinical study, and is also the first pivotal registrational clinical study of a PD-(L)1 inhibitor as the first-line treatment for advanced melanoma that has yielded positive results. Led by Professor Jun GUO from Peking University Cancer Hospital as the Principal Investigator, the study was conducted in 11 clinical centers across the country. The study was designed to compare the efficacy and safety of toripalimab versus dacarbazine for the systemic anti-tumor treatment-naive patients with unresectable or metastatic melanoma.

Prior to this, the results of the MELATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. The results showed that compared with the dacarbazine group (N=128), the progression-free survival (“PFS”) assessed by Blinded Independent Central Review (BICR) of the toripalimab group (N=127) was significantly prolonged, with the median PFS of the two groups being 2.3 months vs. 2.1 months respectively, and the disease progression or mortality risk was reduced by 29.2% (hazard ratio [HR]=0.708, 95% CI: 0.526-0.954; P=0.0209). The sensitivity analysis of median overall survival (“OS”), corrected for the impact of subsequent anti-tumor treatment, showed that compared with the dacarbazine group, the toripalimab treatment group showed a significant trend towards survival benefit, with the median OS being 15.1 months vs. 9.4 months (HR=0.680, 95% CI: 0.486-0.951) respectively. Toripalimab has a good safety profile that is consistent with previous studies with no new safety signals identified.

Professor Jun GUO from Peking University Cancer Hospital said, “Melanoma is a highly aggressive cancer. Due to its low sensitivity to traditional radiotherapy and chemotherapy, patients are often faced with poor survival outcomes. However, thanks to melanoma’s high immunogenicity, immunotherapies such as toripalimab have significantly improved patient survival in recent years. In China, advanced melanoma patients—including those in second-line and later—have gained broad access to these treatments through national medical insurance. Now, toripalimab has been extended to first-line treatment of advanced melanoma. Compared to traditional chemotherapy, toripalimab has demonstrated significant advantages in PFS, ORR, and DoR, as well as a clear trend toward improved OS. Notably, this approval was based on the MELATORCH study, which exclusively enrolled Chinese patients. The trial design aligned closely with clinical practice in China, and thus the findings were more relevant to Chinese melanoma patients. We hope that China’s independently developed immunotherapies like toripalimab can provide a comprehensive treatment solution for advanced melanoma and offer new hope to more patients.”

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, also shared her enthusiasm: “Within a month, toripalimab has secured approvals for two new indications—liver cancer and melanoma. This milestone achievement was, without a doubt, made possible by the selfless and dedicated collaboration of researchers, participating patients, and R&D teams. Seven years ago, toripalimab had just pioneered breakthroughs in second-line melanoma treatment, becoming China’s first domestically developed anti-PD-1 monoclonal antibody and starting a new era of immunotherapy in China; today, toripalimab is again reaching new heights as it becomes the first Chinese-developed first-line immunotherapy for melanoma. Not only does this demonstrate toripalimab’s exceptional clinical value, it also reflects China’s growing strength and innovation in immuno-oncology. Moving forward, we will remain committed to advancing world-class therapies to benefit patients across the world!”

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 to induce PD-1 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, Europe and Southeast Asia. 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 the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland:

unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;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);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);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;in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;first-line treatment for unresectable or metastatic melanoma.

The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China.

Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe.

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. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. 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 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800


Junshi Biosciences Announces the sNDA Approval of Toripalimab for the 1st-line Treatment of Melanoma


THỦ THUẬT HAY

7 ứng dụng dành cho iOS trị giá 11 USD đang được miễn phí

Tiếp tục làm mới chủ đề miễn phí hằng ngày, TCN xin gửi tới các bạn danh sách ứng dụng bản quyền dành cho thiết bị iOS đang được miễn phí trên cửa hàng App Store. Mời các bạn cùng xem và nhanh tay tải về trước khi thời

7 mẹo tận dụng lại smartphone cũ chuẩn không cần chỉnh

Chiếc smartphone của bạn rồi sẽ trở nên lỗi thời. Đó là một điều tất yếu không thể tránh khỏi. Tuy nhiên thì nếu chiếc máy của bạn vẫn bền bỉ và...

Hướng dẫn tải toàn bộ ảnh trong Album từ Facebook về điện thoại Android

Thông thường, để tải về nhiều hình ảnh cùng lúc từ Facebook chắc chắn bạn sẽ mất khá nhiều thao tác và cần sử dụng đến máy tính để bàn. Tuy nhiên, ở bài viết này mình sẽ chia sẻ với các bạn cách tải về toàn bộ ảnh đã

Hướng dẫn khắc phục lỗi "Some Update Were Cancelled" khi cập nhật Windows 10 thất bại

Không ít người dùng Fast Ring đã từng hoặc đang phải đối mặt với lỗi 'Some update were cancelled' khi nâng cấp lên những build mới, nhiều người dùng đang muốn cập nhật lên Windows 10 Redstone 3 build 16170 bị dính phải

Hướng dẫn tải video TikTok không có nút lưu

Người dùng mạng xã hội trẻ tuổi bây giờ dành rất nhiều thời gian cho TikTok – một nền tảng chứa rất nhiều video thú vị ở nhiều chủ đề khác nhau. Vậy khi tải video TikTok không có nút lưu thì phải giải quyết như thế nào?

ĐÁNH GIÁ NHANH

Trên tay và đánh giá nhanh camera quan sát Yi Dome 720 kết nối app Yi Home

Hiện nay, các loại camera quan sát, camera an ninh trên thị trường có rất nhiều mẫu mã, chủng loại khác nhau. Việc lựa chọn một chiếc camera có thể đáp ứng được các nhu cầu và giá tiền của mỗi người rất khó khăn nếu

Đánh giá MINI One 2016: “Mình thích thì mình mua thôi!”

Không chỉ đặc trưng với cảm giác lái go-kart lanh lẹ trong giao thông chật hẹp nơi phố thị, lái MINI One đi khám phá du ngoạn đây đó cũng có rất nhiều điều thú vị.

Honda Goldwing 2018 giá 1,2 tỷ: Đem đến những trải nghiệm hoàn toàn mới

Đặt lốp tới đất Mỹ lần đầu vào năm 1975, Honda Goldwing được ví như bài hát ca ngợi sức mạnh, sự thoải mái và đáng tin cậy của một chiếc mô tô. Phiên bản cập nhật năm 2018 là cuộc cải tổ đầu tiên của Honda dành cho