Multiple Innovative Drugs Receive Clinical Trial Approvals in China, Involving Kanghong Pharma, Kelun-Biotech and Others

　　【Pharmaceutical Network Industry DynamicsAccording to the review, last week (December 29, 2025 - January 4, 2026), multiple product clinical trials were approved, involving Juventas, Kanghong Pharmaceutical, and Kelun-Biotech. These products cover several key treatment areas including autoimmune diseases, post-stroke sequelae, diabetic complications, and advanced solid tumors, utilizing cutting-edge technologies such as CAR-T, iPSC-derived cells, gene therapy, and ADC, showcasing the robust innovation and diversified strategies in China's biopharmaceutical R&D sector.
 

On January 4, 2026, cStem's "Human Anterior/Midbrain Neural Progenitor Cell Injection" (R&D code: ACT121) received tacit approval from the National Medical Products Administration for a new drug clinical trial application. The indication focuses on hemiplegia sequelae caused by ischemic stroke.
 

This is the first clinical trial approval for cStem's iPSC-derived cell product. As an off-the-shelf cell product, the core component of ACT121 is human anterior/midbrain neural precursor cells. These cells are differentiated through allogeneic induced pluripotent stem cell (iPSC) technology, aiming to provide cell replacement therapy for stroke and traumatic brain injury. cStem is committed to leveraging cutting-edge cell technology to develop therapies that can effectively alleviate hemiplegia symptoms, bringing new hope for rehabilitation to millions of stroke patients worldwide. Through the innovative application of human anterior/midbrain neural precursor cells, ACT121 is expected to become a significant breakthrough in the field of cell therapy and offer a new solution for stroke treatment.
 

On January 4, Kanghong Pharmaceutical announced that its subsidiary, Chengdu Hongji Biotechnology Co., Ltd., had received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The drug involved in the approval notice is KH631 Ophthalmic Injection, indicated for the treatment of Diabetic Macular Edema (DME), and has been granted permission to conduct relevant clinical trials.
 

KH631 Ophthalmic Injection is an innovative gene therapy product independently developed by Hongji Bio, classified as a Class 1 therapeutic biological product. The product utilizes a proprietary adeno-associated virus (AAV) delivery system with characteristics such as tissue specificity, low immunogenicity, controllable expression, and high infection efficiency, demonstrating sustained efficacy in preclinical disease models.
 

On January 4, the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the investigational new drug, SKB105 Injection, developed by Kelun-Biotech, has been approved for clinical trials. It is intended for the treatment of advanced solid tumors.
 

SKB105 is a differentiated ADC targeting ITGB6, with a topoisomerase I inhibitor as its payload. ITGB6 is highly expressed in various solid tumors but shows low or no expression in most normal tissues, offering the potential to reduce systemic toxicity and off-target risks. SKB105 consists of a fully human IgG1 monoclonal antibody targeting ITGB6 conjugated with a stable and clinically validated cleavable linker, utilizing Kthiol irreversible conjugation technology. This design aims to enhance drug stability and tumor-specific payload delivery while minimizing adverse effects. Preclinical studies demonstrate that SKB105 exhibits favorable characteristics in terms of efficacy, safety, and pharmacokinetic (PK) profiles.
 

On December 19, 2025, Juventas announced that the Investigational New Drug (IND) application for its self-developed innovative product HY001N Cell Injection had received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of autoimmune hemolytic anemia (AIHA) patients who have failed at least three prior lines of therapy.
 

Autoimmune Hemolytic Anemia is a group of hemolytic anemias that affect the lifespan of patients due to abnormal immune function leading to hyperactive B lymphocytes producing antibodies against their own red blood cells. The adsorption of red blood cells by autoantibodies and/or complements results in accelerated destruction of red blood cells. HY001N Cell Injection is a product developed on Juventas' innovative rapid preparation NexT technology platform. Compared with the traditional autologous CAR-T technology platform process, the rapid preparation NexT process technology reduces the expansion and culture operation steps of CAR-T cells in vitro, shortening the production time of CAR-T cells in the workshop from 9-14 days to less than 2 days, cutting patient waiting time by 50%, up to 10 days, and significantly reducing production costs based on existing preparation technologies. Meanwhile, the proportion of T naïve cells in the final rapidly prepared CAR-T product is increased, laying a foundation for its efficacy and safety.
 

Multiple Innovative Drugs Approved for Clinical Trials Within a Week, Reflecting China's Pharmaceutical Companies' Continued Efforts in Innovation and Development, as well as the Strong Support from the State for Biomedical Innovation. The advancement of these products in clinical trials will further enrich China's drug pipeline for the treatment of major diseases, offering patients more high-quality treatment options.
 

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