January 19, 2021 – 3D Medicines Inc. announced that the NDA of Envafolimab (KN035), the recombinant humanized PD-L1 single-domain antibody on which 3D Medicines has established a strategic collaboration with Alphamab Oncology (9966.HK) and Simcere Pharmaceutical Group Limited (2096.HK), was granted Priority Review by the Center for Drug Evaluation (CDE) under National Medical Products Administration (NMPA). The NDA was submitted for the treatment of microsatellite instability-high (MSI-H) colorectal cancer, gastric cancer, and advanced mismatch repair deficient (dMMR) solid tumors with failure of previous standard treatment.

With the development of immuno-oncology and combination therapy, many types of cancer will hopefully become “chronic illnesses” in the future, which can be controlled or even cured. Also, the demand for home or community medication for cancer patients will increase, and subcutaneous injection is expected to become the future trend of PD-1/PD-L1 treatment. As the subcutaneous PD-L1 inhibitor, Envafolimab (KN035) has demonstrated favorable safety and efficacy in clinical trials carried out worldwide for multiple indications. Compared to other PD-L1 antibodies on the market or in development, Envafolimab (KN035) has differentiated advantages including stability at room temperature, smaller injection volume per single dose, quicker dosing process, and fewer limitations at the injection site, providing novel treatment options to tumor patients under the trend of cancer chronicization and improving their quality of life.

Priority review is a program aimed to encourage the research and development of new drugs, and expedite the NDA review and approval of new drugs with significant clinical value and urgent clinical need. According to the following announcements by the NMPA, the Measures for the Administration of Drug Registration (No. 27 of the Order of the State Administration for Market Regulation) shall come into force on July 1, 2020 and the Working Procedures for Drug Priority Marketing Authorization Review and Approval (Trial) (No.182, 2020) on July 7, 2020, and the drugs with priority review are granted optimized review process and resource allocation by the NMPA, which shorten the time limit for review.

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. In China, the NDA of Envafolimab (KN035) was officially accepted and granted priority review by the NMPA.

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 next-generation 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 next-generation biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.

For more information, please visit: www.3d-medicines.com

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. In China, the NDA of Envafolimab (KN035) was officially accepted and granted the priority review by the NMPA.

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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