Suzhou, China, May 22, 2026 - Alphamab Oncology (stock code: 9966.HK) today announced that patient enrollment has been completed for its Phase III clinical trial (study code: KN035‑CN‑017) of Envafolimab (KN035) as neoadjuvant/adjuvant treatment of resectable non‑small cell lung cancer (NSCLC). This milestone marks significant progress for Envafolimab in the perioperative treatment of early‑stage lung cancer and is expected to provide a more convenient and safer subcutaneous immunotherapy option for lung cancer patients.
KN035‑CN‑017 is a randomized, controlled, double‑blind, multicenter Phase III clinical study. It is led by Professor Wang Changli of Tianjin Medical University Cancer Institute & Hospital, with the participation of approximately 60 centers across China. The study planned to enroll 390 patients with resectable NSCLC, and the actual number of enrolled patients meets the protocol requirements. The trial aims to evaluate the efficacy and safety of Envafolimab combined with platinum‑based doublet chemotherapy versus placebo combined with platinum‑based doublet chemotherapy as neoadjuvant/adjuvant treatment of patients with resectable NSCLC. The primary endpoints include event‑free survival (EFS), major pathological response (MPR) rate, and complete pathological response (pCR) rate.
As the world’s first subcutaneously injected PD‑(L)1 inhibitor, Envafolimab offers distinctive clinical advantages: it can be administered in 30 seconds, making it particularly suitable for frail, elderly, or IV-intolerant patients. Since its market approval in 2021, Envafolimab has been available in 30 provinces across China, has been included in multiple authoritative domestic and international guidelines, and is widely recommended in the global clinical community.
About Envafolimab (KN035)
Envafolimab (KN035) is independently invented by Alphamab Oncology, and co-developed with 3D (Beijing) Medicines 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, 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.
Envafolimab is a subcutaneous PD-L1 single-domain antibody Fc fusion protein. It was approved for marketing in China in November 2021, for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors.
Envafolimab efficiently blocks the binding of PD-1 and PD-L1, thereby activating an immune response against tumors. With a molecular weight half that of a conventional antibody, it exhibits enhanced tissue penetration and reaches tumor tissues via the lymphatic circulation system. Envafolimab offers significant advantages in convenience and compliance by avoiding intravenous infusion and can be administered in just 30 seconds, making it particularly suitable for frail, elderly, or IV-intolerant patients.
Multiple clinical trials for Envafolimab are currently underway to further expand its indications. The New Drug Application (NDA) for Envafolimab in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC) has been accepted by the National Medical Products Administration (NMPA).
Envafolimab has been granted three Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) for the treatment of advanced biliary tract cancer, soft tissue sarcoma, and gastric cancer and gastroesophageal junction cancer; it has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic solid tumors with high tumor mutation burden (TMB-H).
About Alphamab Oncology
Alphamab Oncology (Stock Code: 9966.HK) is an innovative biopharmaceutical company focused on oncology. Leveraging proprietary platforms-including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payloads, dual-payload ADCs, and high-concentration subcutaneous formulations, the Company has built a differentiated and globally competitive pipeline, covering cutting-edge candidates in ADCs, bispecific antibodies, and single-domain antibodies.
One product has received market approval: Envafolimab (KN035, brand name: 恩维达®), the world's first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment. The new drug application for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer, is currently under review. Five bispecific ADC candidates have entered clinical stages, and next-generation ADC pipelines—such as dual-payload ADCs—are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms.
Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, enabling patients to achieve long-term, high-quality survival and delivering China-innovated cancer therapies to benefit patients worldwide.
Alphamab Oncology Forward-Looking Statements
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