December 22, 2020 - 3D Medicines Inc. announced the New Drug Application (NDA) of Envafolimab (KN035), a recombinant humanized PD-L1 single-domain antibody has been accepted by the National Medical Products Administration (NMPA) on December 17, with the registration number CXSS2000060 for the indications of previously treated microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) advanced colorectal cancer, gastric cancer and other advanced solid tumors. 3D Medicines, Alphamab Biopharmaceuticals Co., Ltd. (9966.HK) and Simcere Pharmaceutical Group Ltd. (2096.HK) reached the strategic collaboration on Envafolimab (KN035), the  PD-L1 inhibitor formulated for subcutaneous injection, which can fill the unmet clinical needs after the marketing approval.

Microsatellite instability-high (MSI-H) is widely present in several solid tumors, and the incidence of MSI-H is relatively high in solid tumors such as gastric cancer and colorectal cancer, bile tract cancer, prostate cancer and endometrial cancer. Numerous clinical trials have demonstrated that MSI-H/dMMR is an important predictive biomarker for immuno-oncology, and patients with MSI-H/dMMR tumors are more likely to benefit from PD-L1 and other treatments using immune checkpoint inhibitors. Envafolimab (KN035) is expected to be the PD-1/PD-L1 single-domain antibody as a pan-cancer immunotherapy for the indication of MSI-H/dMMR solid tumor approved by the NMPA.

Envafolimab (KN035) was independently developed by Alphamab, and 3D Medicines initiated its clinical trials for multiple tumor indications worldwide. The results have demonstrated favorable safety and efficacy. This NDA filing is based on the pivotal phase II clinical trial evaluating Envafolimab (KN035) monotherapy for the treatment of MSI-H/dMMR advanced solid tumors. 103 Chinese patients with MSI-H/dMMR advanced solid tumors who failed first-line and above systemic therapy were enrolled in the study. The confirmed objective response rate (ORR) was 42.7% in the overall population, 43.1% in patients with colorectal cancer (CRC), and 44.4% in patients with gastric cancer (GC), and 40.0% in the patients with other tumors assessed by Blinded Independent Review Committee (BIRC).

Professor Lin Shen from Beijing Cancer Hospital, the principal investigator in the clinical trial of Envafolimab (KN035), commented, “Envafolimab (KN035), administered subcutaneously, has demonstrated durable efficacy with a favorable safety profile in pivotal clinical trials, which can bring a brand-new safe, effective and convenient treatment option for patients with MSI-H/dMMR advanced solid tumors who have previously failed at least standard first-line therapy. We are excited about the marketing of Envafolimab (KN035) and the clinical benefits for patients."

John Gong, M.D., Ph.D., Chairman and CEO of 3D Medicines Inc., commented, “The acceptance of NDA filing for Envafolimab (KN035) by the National Medical Products Administration (NMPA) is a significant milestone in the history of our company, proving our capabilities in clinical development and regulatory registration. We will work closely with our partners to bring Envafolimab to the market as early as possible. We believe the differentiated advantages of Envafolimab will provide better treatment options for cancer patients in China.”

Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented, “KN035 is the subcutaneous PD-L1 inhibitor. After approval, it will fill the gaps for relevant indications immunotherapy in China. Thanks to the support of the researchers and patients participating in the clinical trials, partners and all employees for their work, we look forward to the early approval of KN035 for marketing, benefiting more patients and their families. Alphamab Oncology will take this as the cornerstone, continue to develop cutting-edge tumor immunotherapy, and use our innovative products to lighten the life of patients and their families around the world.”

Ren Jinsheng, Board Chairman and CEO of Simcere commented, “Simcere has a portfolio of innovative drugs and first-to-market products in the field of tumor treatment. We look forward to Envafolimab with unique and differentiated advantages to bring better treatment options to clinical trials and patients. At the same time, with the support of relevant policies for accelerating review and approval, we are confident in working with strategic partners and clinical research institutions to accelerate the clinical development and commercialization of this innovative product, so as to work together to allow patients to use more effective drugs as soon as possible.”

About Envafolimab (KN035)

Envafolimab (KN035) is a PD-L1 single-domain antibody Fc fusion protein independently developed by Alphamab. Based on the unique design, KN035 has advantages in safety, convenience and compliance, and can be used for patients who are not suitable for intravenous infusion with a lower medical cost. On March 30, 2020, Alphamab, 3D Medicines and Simcere reached a three-way strategic collaboration. Alphamab, as the original research party, is responsible for production and quality, 3D Medicines is responsible for global clinical development in the field of oncology, registration and commercialization abroad, and Simcere is responsible for the exclusive commercial promotion of the product in mainland China. At present, KN035 is being evaluated in clinical trials for multiple cancer indications in China, the United States and Japan, and the research for multiple indications have entered the registration/clinical Phase III. KN035 has been awarded orphan drug designation (ODD) by FDA in the United States for the treatment of advanced biliary tract cancer. On December 17, 2020, the NMPA officially accepted the NDA of Envafolimab (KN035).

About 3D Medicines

3D Medicines, Inc. is a clinical-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.

About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platform in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan.

The Company also has proprietary CRIB and CRAM platforms for bi-specifics and antibody mixtures, and state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards. With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.

About Simcere

Simcere is a research and development-driven Chinese pharmaceutical company with a State Key Lab for Translational Medicine and Innovative Drug Development. It is committed to delivering highly effective treatment to patients. Simcere achieves this by focusing its efforts on therapeutic areas of oncology, neurology, inflammation/immunology diseases and more. By leveraging its commercial capability, all of the company’s best products have achieved leading market shares in China. Simcere continues to promote the advancement of international scientific and medical breakthroughs through a collaborative R&D strategy and extensive strategic partnership with several multinational companies.

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