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Envafolimab, The World’s First Subcutaneously Injected PD-L1 Antibody Approved by NMPA! Simcere Partners with Alphamab Oncology and 3DMed to Innovate Immunotherapy

Release time:2021-11-26

On 26 November 2021, Simcere Pharmaceutical Group Limited (stock code: 2096.HK), 3D Medicines (Beijing) Co., Ltd. ("3DMed") and Alphamab Oncology ("Alphamab") jointly announced that ENWEIDA (恩维达®, generic name: Envafolimab), the world's first single-domain PD-L1 antibody formulated for subcutaneous injection (SC) co-developed by the three companies, has received marketing authorization from the Chinese National Medical Products Administration(国家药品监督管理局)(the "NMPA"). 

The approved indication for Envafolimab is for adult patients with advanced solid tumors who have unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair gene-deficient (dMMR), including those patients with advanced colorectal cancer who have experienced disease progression after being treated with fluorouracil, oxaliplatin and irinotecan previously, as well as other patients with advanced solid tumors who have experienced disease progression after previous treatment and no satisfactory treatment alternatives.

Currently, over a dozen of PD-1 and PD-L1 antibody drugs are being marketed as intravenous injection (IV) in China and globally. The average time for administration is 0.5-2 hours. As the world's first SC PD-L1 antibody, Envafolimab significantly shortens treatment time, while sparing the patients from various adverse reactions arising from intravenous infusion. It provides an alternative treatment option for the cancer patients who are intolerant to IV injection and have otherwise no accessibility to immunotherapy. The nature of SC injection makes it possible to be administered in community hospitals or even at home, therefore reserving healthcare resources in China and promoting the implementation of hierarchical diagnosis and treatment policy.  

A pivotal phaseⅡclinical study, led by Professor Lin Shen from Peking University Cancer Hospital and Institute,has evaluated the efficacy and safety of Envafolimab in patients with advanced dMMR/MSI-H tumors. The updated clinical data presented at CSCO 2021 showed that the Objective Response Rate (ORR) of patients who received Envafolimab as second or later-line treatment is 44.7%, including 12 (11.7%) cases of Complete Response (CR). The responses were durable, and the rates of durable response at 12 months in patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.2%, respectively. The median progression-free survival (PFS) was 11.1 months, 12-month overall survival (OS) rate was 73.6%. Envafolimab was well tolerated in this study with no cases of immune-related pneumonitis, immune-related colitis, immune-related nephritis, or infusion related reactions reported.

Mr. Jinsheng REN, Chairman and CEO of Simcere, commented: "Our mission is providing today's patients with medicines of the future, namely, new drugs with greater clinical significance and better patient compliance. As the first subcutaneous PD-L1 antibody approved globally, Envafolimab brings to the world a brand-new method of administrating PD-L1 antibody that has the potential of changing the game in immunotherapy. Subcutaneous injection is safer and more convenient than traditional IV infusion, therefore providing a new therapy option to patients with better treatment experiences and quality of life. I wish to thank our partners and the dedicated clinical experts for their fruitful efforts. We will accelerate the commercialization of this innovative drug and make it available to the patients sooner."

Dr. Zhaolong GONG, Chairman and CEO of 3DMed, commented: "Envafolimab is our first product reaching commercial stage. We have built a robust pipeline based on our belief that cancer is increasingly being managed as a chronic disease. The launch of Envafolimab proves our capabilities from preclinical discovery, to IND and NDA. Through strategic cooperation with our partners, we will deliver the world’s first subcutaneous PD-L1 antibody to cancer patients, and help them live longer and better."

Dr. Ting XU, Chairman and CEO of Alphamab, commented: "Since discovering Envafolimabwe have been driven by the clinical needs of patients and the differentiated advantages to develop and launch the world’s first and only subcutaneously injected PD- L1 inhibitor with our partners, and continue to develop this product that has a global competitive advantage. We will continue committing to the mission of the company, to make cancer manageable and curable, leveraging the competitive advantages of our integrated proprietary biologics platforms, and keep on developing breakthrough next generation therapies for cancers, so that more patients can benefit from biotechnology progress."

About Envafolimab (ENWEIDA)

Envafolimab (ENWEIDA) is invented by Alphamab Oncology,and co-developed with 3DMed since 2016. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of the product in mainland China. Based on its unique design that allows rapid subcutaneous injection, Envafolimab has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion, which lowers medical costs. 

At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phaseⅢclinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of MSI-H or dMMR advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.