On 26 November 2021, 3D Medicines (Beijing) Co., Ltd. (3DMed) , Alphamab Oncology (stock code: 9966.HK)，and Simcere Pharmaceutical Group Limited (Simcere) jointly announced that Envafolimab (Enweida^®), the single-domain PD-L1 antibody formulated for subcutaneous injection (SC) co-developed by the three companies, has received approval from the Chinese National Medical Products Administration (NMPA) to be commercialized in China. The approved indication for Enweida^® is for adult patients with  microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options. This represents the  tissue-agonistic indication granted to an immune checkpoint inhibitor by NMPA. 

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 to administer the drug is 0.5-2 hours.

As the SC PD-L1 antibody, Envafolimab can be administered within 30 seconds—significantly shortening treatment time, while sparing the patients from various adverse reactions arising from intravenous infusion. It has provided an alternative treatment opportunity for the cancer patients who have no access to immunotherapy due to  intolerance  to IV injection.. The simplified treatment process associated with envafolimab is expected to  reduce the burden of care to the healthcare system, broaden the accessibility of immunotherapy to lower tier health centers, and improve the compliance and convenience of cancer patients. 

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  in patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.4%, respectively.  The median progression-free survival (PFS) was 11.1 months, 12-month overall survival (OS) rate was 74.6%. 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.

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 subcutaneous PD-L1 antibody to cancer patients, and help them live longer and better." 

Dr. Ting XU, Chairman and CEO of Alphamab Oncology, commented, “Since discovering Envafolimab, we have been driven by the clinical needs of patients and the differentiated advantages to develop and launch the 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  therapies for cancers, so that more patients can benefit from biotechnology progress.

Mr. Jinsheng REN, Founder and Chairman of Simcere, commented: "Simcere's mission is ‘Providing Today’s Patients with Medicines of the Future’, namely, new drugs with greater clinical significance, including 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 patients sooner."

About Envafolimab （KN035）

Envafolimab is a fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc  independently invented by Alphamab Oncology. Envafolimab was in pre-clinical stage when the Co-Development Agreements were first entered into between the Company and Alphamab in February 2016. Since then, we took full responsibility for global clinical development of envafolimab, which has undergone clinical trials across for multiple tumor types in the U.S., China and Japan. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.

At present, Envafolimab (KN035) is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) 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 previously treated MSI-H/dMMR advanced solid tumors.  

About 3D Medicines

3D Medicines, Inc. is a commercial-stage biopharmaceutical company with a mission to help people with cancer live longer and better. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines focuses on the development of differentiated immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with both  biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.

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