Breakthrough! Junshi Biosciences' First Domestic PD-1 Drug Approved for Launch, Set to Compete Head-to-Head with Merck

On December 17, VCBeat (WeChat ID: vcbeat) learned from the official website of the National Medical Products Administration (NMPA) that the NMPA had granted conditional approval for the market launch of the first domestically produced PD-1 monoclonal antibody, toripalimab injection (brand name: Tuoyi). This innovative biologic product, independently developed by a Chinese enterprise with full independent intellectual property rights, is indicated for the treatment of locally advanced or metastatic melanoma in patients who have failed prior standard therapies.

In June this year, Bristol-Myers Squibb’s (BMS) PD-1 monoclonal antibody nivolumab (commonly known as “Opdivo”) was approved for marketing in China, becoming the first immune checkpoint inhibitor to enter the Chinese mainland market, with its approved indication being non-small cell lung cancer. Subsequently, BMS announced the sales price of nivolumab in the Chinese mainland, which was only half that of the U.S. market and significantly lower than those in other countries and regions. Two months later, nivolumab officially went on sale. In addition, in July this year, Merck’s pembrolizumab injection was approved for marketing in the Chinese mainland, with melanoma as its indicated condition.

Currently, research hotspots in the field of cancer immunotherapy are mainly focused on immune checkpoint inhibitors such as anti-programmed death-1 (PD-1) receptor agents. Unlike traditional chemotherapy and targeted therapy, these agents primarily work by overcoming immunosuppression within the patient’s body and reactivating the patient’s own immune cells to kill tumor cells, representing a completely new concept in anti-tumor treatment. The toripalimab approved this time is a fully human monoclonal antibody against the PD-1 receptor, developed by Suzhou Zhonghe Biopharmaceutical Co., Ltd. (hereinafter referred to as “Suzhou Zhonghe”). It works by blocking PD-1 on T lymphocytes, thereby preventing its binding to PD-L1 on the surface of tumor cells, relieving tumor cell-induced immunosuppression of immune cells, and enabling immune cells to regain their anti-tumor immune function to kill tumor cells.

In recent years, melanoma has shown a rapidly increasing trend in China, becoming one of the malignant tumors with the fastest-growing incidence rate. There are approximately 20,000 new cases annually, and the mortality rate is also rising rapidly year by year, making it one of the diseases that seriously endanger the health of the Chinese population. In terms of treatment, there is currently a lack of effective standard treatment options for melanoma patients who have failed first-line therapy. Clinical trial results of this product show that the objective response rate (ORR) is 17.3%, the disease control rate (DCR) is 57.5%, and the 1-year survival rate is 69.3% in patients with unresectable or metastatic melanoma who have previously failed systemic therapy. The approval of this product for marketing has positive significance for addressing the clinical medication choices available to cancer patients in China.

Toripalimab, the first domestically produced monoclonal antibody drug targeting PD-1 approved for marketing in China, has received support from the National Major Science and Technology Project. Clinical development of this product commenced in early 2016, and to date, more than twenty clinical trials are underway, including those conducted concurrently in the United States. In March 2018, the National Medical Products Administration (NMPA) formally accepted the marketing registration application for this product and included it in the priority review and approval list to expedite the evaluation process. The Center for Drug Evaluation (CDE), the Center for Food and Drug Inspection (CFDI), and the National Institutes for Food and Drug Control (NIFDC), among other relevant entities, collaborated closely, proactively communicated with and provided guidance to the applicant, promptly addressed technical issues encountered during the review, and prioritized technical evaluation, on-site inspections, and laboratory testing. Based on the efficacy data from the applicant’s completed Phase II study in Chinese patients with advanced melanoma and safety data from seven clinical studies, the NMPA granted conditional marketing approval for this product on December 17.

It is understood that Suzhou Zhonghe, established in October 2013, is an independent subsidiary of Shanghai Junshi Biosciences Co., Ltd. (hereinafter referred to as “Shanghai Junshi”). Suzhou Zhonghe is primarily dedicated to the industrialization of monoclonal antibody biosimilars and innovative monoclonal antibodies using cutting-edge technologies. Its products currently in production mainly cover areas such as oncology and autoimmune diseases. The toripalimab recently approved for marketing is one of the biological drugs under development by Suzhou Zhonghe, with the other being the biosimilar adalimumab.

Shanghai Junshi Biosciences is the first Chinese company to submit both an Investigational New Drug (IND) application and a New Drug Application (NDA) for an anti-PD-1 monoclonal antibody to the National Medical Products Administration (NMPA). It is also the first domestic company to receive NMPA approval for IND applications targeting anti-PCSK9 and anti-BLyS monoclonal antibodies.Previously, Shanghai Junshi Biosciences entered into a collaboration agreement with Hutchison MediPharma in October this year. The two parties will launch international cooperation on the combination therapy of toripalimab and surufatinib, Hutchison MediPharma’s novel oral angiogenesis and immuno-modulatory kinase inhibitor, for the treatment of various solid tumors. It is anticipated that toripalimab will be indicated in combination regimens for a broader range of solid tumors beyond melanoma.

Shanghai Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery and development of innovative drugs, as well as global clinical development and commercialization. The company’s mission is to provide patients with more effective and affordable treatment options. In China, leveraging its exceptional capabilities in innovative drug discovery, advanced biotechnology R&D, large-scale production technologies across the entire industry chain, and the rapid expansion of a highly promising pipeline of investigational drugs, Shanghai Junshi Biosciences has established a leading position in the fields of oncology immunotherapy, autoimmune diseases, and metabolic disorder treatments.

As its product pipeline expands and exploration of combination drug therapies deepens, Shanghai Junshi’s innovative scope is expected to extend to the development of a broader range of drug modalities, including small-molecule drugs and antibody-drug conjugates (ADCs), as well as to the exploration of next-generation innovative therapies for cancer and autoimmune diseases.Aims to develop first-in-class or best-in-class drugs through source innovation and become a pioneer in the field of translational medicine.