First-Line, Innovative Treatment for Extensive-Stage Small Cell Lung Cancer: Junshi Biosciences’ Toripalimab Approved!

Junshi Biosciences, a globally recognizied biopharmaceutical company, is pleased to announce its Supplemental New Drug Application for toripalimab – an anti-PD-1 monoclonal antibody – has been accepted for review by the National Medical Products Administration. This drug is potentially able to revolutionize the treatment of patients with extensive-stage small cell lung cancer, offering them a potential lifeline in the form of first-line combination therapy with etoposide plus platinum.

Lung cancer is the most prominent form of malignant tumor in China, unfortunately leading to the most deaths. Small cell lung cancer (SCLC) is the most aggressive and dangerous subtype, affecting between 15-20% of all lung cancer patients.

As if this weren’t enough, those diagnosed with the locally advanced form, ES-SCLC, present with a heartbreaking median survival time of less than one year and a two year survival rate of below 10%. It is very much an unresolved medical challenge, one that needs to be addressed urgently.

EXTENTORCH, an exciting Phase 3 clinical study headed by Professor Ying CHENG of Jilin Cancer Hospital, seeks to answer the vital questions surrounding toripalimab and its efficacy when used in conjunction with etoposide plus platinum as a first-line treatment for ES-SCLC. This randomized, double-blind, placebo-controlled, multi-center study – NCT04012606 – will provide a more comprehensive understanding to determining the safety and efficacy of toripalimab.

Professor Ying CHENG, who is also the vice president of the Chinese Society of Clinical Oncology (CSCO), is dedicated to uncovering the truth behind this revolutionary new treatment.

EXTENTORCH, a combination of the immunotherapy toripalimab and standard chemotherapy, recently launched at 51 centers across the US. Patients were randomly assigned to receive either the treatment or a placebo, along with etoposide plus platinum, for four to six cycles.

After this, patients were given either toripalimab or placebo for maintenance until their disease progressed, toxicity became unbearable, or other criteria called for discontinuation of the treatment, as per the protocol.

In May 2023, history was made as toripalimab became the first ever PD-1 inhibitor to exceed the primary endpoints of both overall survival (“OS”) and progression-free survival (“PFS”) for the first-line treatment of ES-SCLC, as confirmed by the successful completion of the EXTENTORCH study. This was a major breakthrough in the field of oncology, bringing a glimmer of hope to people suffering from this form of cancer.

Results from a study indicate that combining toripalimab with chemotherapy as the first line of treatment for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) could significantly prolong Patient Progression-Free Survival (PFS) as well as Overall Survival (OS).

The safety profile of toripalimab proved to be on par with previous studies, with no untoward safety signals identified. Further details of this groundbreaking study will be unveiled at an upcoming international conference.

The average survival time for patients who are diagnosed with ES-SCLC is unfortunately only about a year due to the rapid tumor proliferation and high malignancy of the condition, which can often present with minimal or no early symptoms.

Thankfully, the EXTENTORCH trial has provided hope by showing that combining toripalimab with chemotherapy as a first-line treatment for ES-SCLC can improve patient outcomes significantly, offering a brighter future for those affected by this disease. According to Professor Ying CHENG of Jilin Cancer Hospital, these results may offer a broader range of more effective treatments for ES-SCLC patients.

Today was a momentous occasion for Junshi Biosciences. After its clinical approval in 2015, our dedicated team of researchers and developers worked diligently to successfully submit our tenth indication for toripalimab – the latest in our list of innovative therapies designed to address unmet medical needs for patients in China and around the world.

With over 40 registered clinical trials thus far and 3 successful large-scale phase 3 clinical trials for lung cancer alone, toripalimab has consistently demonstrated reliable and significant anti-tumor activity.

We are committed to ensuring a smooth application process for the applicable marketing of this indication in order to provide as many cancer patients as possible with our leading-edge therapies.

About Toripalimab

Toripalimab has been developed as a breakthrough anti-cancer therapy. It is an anti-PD-1 monoclonal antibody that works by blocking PD-1 interactions with its ligands, PD-L1 and PD-L2, as well as enhancing receptor internalization (endocytosis) – allowing the immune system to better detect and kill cancer cells. This novel approach to immunotherapy is seen as a major step forward in the fight against cancer, offering an innovative and promising treatment solution.

With more than fifteen indications and forty studies spanning the globe, Junshi Biosciences has been busy at work conducting pivotal trials evaluating the safety and efficacy of toripalimab for an impressive range of cancer types, including lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin cancers.

Its clinical studies have taken place in China, the United States, Southeast Asia, and Europe – a testament to the company’s commitment to providing life-saving care around the world.

China recently approved the first domestic anti-PD-1 monoclonal antibody for marketing in the form of TUOYI® – toripalimab. With six approved indications, toripalimab is one of the most promising therapeutics in the market today, helping to provide relief to patients across a range of conditions, from cancer to autoimmune and more.

The NRDL 2022 Edition is the latest guide for patients and physicians, featuring Toripalimab – the only anti-PD-1 monoclonal antibody – for treating melanoma. This is amongst the first three indications from the National Reimbursement Drug List that have made it in the latest edition, providing hope for those suffering from this life-threatening disease.

The U.S. Food and Drug Administration (FDA) is currently reviewing the Biologics License Application (BLA) for toripalimab in combination with gemcitabine/cisplatin for the first-line treatment of patients with advanced recurrent or metastatic NPC, and for toripalimab as a monotherapy for subsequent second-line or later treatment of NPC following a platinum-containing chemotherapy regimen.

Moreover, the FDA has designated toripalimab as a Breakthrough Therapy for both first- and second-line treatments of recurrent or metastatic NPC, and has further awarded it with Fast Track designation for the treatment of mucosal melanoma, and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, and soft tissue sarcoma, as well as small cell lung cancer (SCLC).

The European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made history in December 2022 and February 2023 by approving the marketing applications for two novel cancer treatments – toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of locally recurrent or metastatic NPC, and toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of unresectable locally advanced or recurrent ESCC. These approvals mark a major milestone in the fight against cancer and offer new hope for patients facing these diseases.

About Junshi Biosciences

Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company founded in December 2012, is dedicated to the discovery, development, and commercialization of innovative therapeutics. It has built a large, diversified R&D pipeline with over 50 drug candidates targeting five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases.

Junshi was the first company in China to obtain approval for an anti-PD-1 monoclonal antibody and its anti-BTLA monoclonal antibody was the first in the world to be approved for clinical trials by the FDA and NMPA. Moreover, its anti-PCSK9 monoclonal antibody was first in China to be approved for clinical trials by the NMPA. We look forward to the exciting developments that lie ahead.

In response to the novel coronavirus pandemic, Junshi Biosciences has gone above and beyond their duties, teaming up with both Chinese and international scientific research institutions and enterprises in order to develop an array of drug candidates to combat COVID-19, demonstrating their unwavering commitment to their social responsibility.

In 2021, their breakthroughs led to the discovery of JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody administered with bamlanivimab, and VV116 (deuremidevir hydrobromide), an oral nucleoside analog anti-SARS-CoV-2 drug which aids in reducing virus replication.

Both programs have been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide and have been approved for marketing in China and Uzbekistan respectively; A remarkable accomplishment in the bid to explore innovative strategies in preventing and controlling the global pandemic.

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