Recently, Affinity (Shanghai) Biopharmaceutical Co., Ltd. ("Affinity") announced that it has formally entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (Merck & Co., Inc., Rahway, NJ, USA). This collaboration marks that the potential value of Affinity’s proprietary Tumor Microenvironment-Activated (TMEA) platform has been recognized by a leading global pharmaceutical enterprise.

Pursuant to the agreement, the two parties will conduct a multicenter, open-label, Phase Ib/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of Legubicin (QHL-108) in combination with pembrolizumab (Keytruda^®), MSD’s anti-PD-1 therapy, with or without chemotherapy, as first-line treatment in participants with Stage IV non-squamous non-small cell lung cancer, aiming to deliver novel potential therapeutic options for cancer patients with unmet clinical needs. This clinical study will be led by Affinity; MSD will provide pembrolizumab as the investigational product.

Based on Affinity’s proprietary TMEA platform, Legubicin (QHL-108) was developed as the first legumain-activated conjugate. It has completed its first registrational clinical trial and if approved, will become the first conjugate utilizing a Topo II inhibitor (doxorubicin) as its payload. Its primary planned indications currently include soft tissue sarcoma, non-small cell lung cancer, ovarian cancer, and breast cancer, among others.

Pembrolizumab (Keytruda^®) is a PD‑1 immune checkpoint inhibitor developed by MSD. It can increase the ability of the body’s immune system to help detect and fight tumor cells, and has been approved for the treatment of a variety of malignancies worldwide.

Dr. Cheng Liu, Founder, Chief Executive Officer & Chief Medical Officer of Affinity, stated: “We are honored to enter this clinical collaboration with MSD. The core strength of our TMEA platform lies in precise in-situ drug activation and reduced systemic toxicity, enabling substantial potential for combination therapy alongside a wide range of targeted and immunotherapeutic agents. The goal of this joint clinical study is to further expand the clinical application scope of legubicin (QHL-108). Recognition from a global top-tier pharmaceutical enterprise underscores the clinical potential of our proprietary foundational technology platform and core pipeline. Moving forward, the Company will continue advancing the development of diverse combination therapies and actively pursue clinical and industrial collaboration opportunities worldwide.”

About Affinity (Shanghai) Biopharmaceutical Co., Ltd. ("Affinity")

Leveraging its globally first-in-class and proprietary Tumor Microenvironment-Activated (TMEA) technology platform, Affinity develops and advances highly selective, low-toxicity innovative anti-cancer drugs. The company is dedicated to solving the toxicity challenges of traditional chemotherapy and targeted therapies, focusing on unmet medical needs in oncology, with the potential to transform traditional treatment approaches and reshape the cancer care paradigm. Looking ahead, Affinity aims to become a fully integrated biopharmaceutical company with robust manufacturing and commercialization capabilities.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Risk Disclaimer

The CTCSA collaboration focuses on joint clinical trial development and does not currently involve product‑rights transfer or commercial licensing. Like all innovative‑drug development programs, clinical trials entail inherent uncertainties. Clinical endpoints of the combination regimen are subject to validation by subsequent study data. Please view the project’s R&D progress objectively and rationally.