BLA Supports NovaSpira’s Bispecific Antibody NS-342 in Securing Phase I Clinical Trial Approval from South Korea’s MFDS
BLA Regulatory
September 12, 2026
Gaithersburg, Maryland, U.S. (September 12, 2026) — Recently, NS-342, a next-generation GPC3×4-1BB bispecific antibody and the core pipeline of U.S. innovative biopharmaceutical company NovaSpira Biotherapeutics, has successfully passed the review of the Ministry of Food and Drug Safety (MFDS) of South Korea and been approved for a Phase I clinical trial. The trial is intended for the treatment of refractory advanced hepatocellular carcinoma (HCC) and various GPC3-expressing advanced solid tumors.
As NovaSpira’s external regulatory team for this South Korean Investigational New Drug (IND) application, BLA was responsible for the drafting, integration and translation of core filing documents, and provided ongoing support for issue analysis, document revision and response preparation throughout the review process.
NS-342: An Innovative Bispecific Antibody Addressing Unmet Needs in Solid Tumor Treatment
NS-342 is a next-generation bispecific immune-activating agent targeting GPC3 and 4-1BB, featuring “precise targeting + conditional immune activation”. By specifically binding to the GPC3 target on tumor surfaces, it precisely locks onto solid tumors such as liver cancer; meanwhile, it selectively activates the 4-1BB costimulatory pathway to awaken T-cell-mediated anti-tumor immunity, effectively enhancing tumor infiltration and killing efficacy.
Compared with conventional immunotherapies, NS-342 has a lower off-target risk and a more favorable safety profile. Preclinical data have demonstrated its potent anti-tumor activity, making it a highly promising innovative candidate for advanced refractory solid tumors. The approved Phase I trial will focus on evaluating its safety, tolerability, pharmacokinetics and preliminary clinical efficacy.
Significant Unmet Clinical Needs Remain in Advanced Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the third leading cause of cancer death worldwide. According to GLOBOCAN 2024 statistics, there were approximately 843,000 new cases of liver cancer and 732,000 related deaths globally in 2024.
While current PD-1/PD-L1 inhibitors combined with anti-VEGF agents have improved first-line treatment outcomes, the vast majority of patients eventually develop disease progression. For patients with advanced HCC who have failed standard systemic therapy, effective treatment options are very limited, and there is an urgent clinical need for innovative agents with novel mechanisms to break the impasse.
Dr. Han Li, CEO of NovaSpira Biotherapeutics, stated: “The MFDS approval of the Phase I protocol is a significant milestone for both NovaSpira and patients with advanced HCC who are in urgent need of new treatment options. Refractory HCC is a highly challenging solid tumor worldwide. With limited efficacy of existing systemic therapies and poor long-term prognosis for patients, NS-342 is developed precisely to fill this clinical gap.”
BLA’s Core Support: From Core Dossier Preparation to Regulatory Response
Bispecific antibodies are highly complex innovative biologics. South Korea’s MFDS applies stringent review standards for CMC (Chemistry, Manufacturing and Controls), non-clinical data, clinical protocols, risk assessment and data logic, with detailed scrutiny and a high risk of supplementary information requests. The efficient approval of this project is largely attributed to BLA’s one-stop regulatory filing capabilities.
During the project, BLA undertook the following key responsibilities:
- Professional Assessment of Complex Technical Issues
Regarding key regulatory and technical issues involved in bispecific antibody applications, BLA’s senior experts conducted comprehensive assessments based on product mechanism, R&D data and MFDS regulatory requirements, and proposed targeted and actionable solutions to provide professional support for critical project decisions. - Regulatory Strategy and Dossier Planning
Based on MFDS regulations, guidelines and the characteristics of NS-342, we systematically sorted out existing R&D data, identified key regulatory concerns, clarified data requirements and preparation strategies for each filing module, and established a clear regulatory pathway for the South Korean IND application. - Core IND Dossier Writing and Integration
We completed the integration, compilation, data alignment and compliance optimization of the full Common Technical Document (CTD) package, including CMC, non-clinical, clinical, risk assessment and Investigator’s Brochure, ensuring the dossier is logically sound, rigorous and fully compliant for direct submission. - Analysis and Response to Review Comments
During the MFDS review process, we conducted regulatory and technical analysis on inquiries from the authority, developed targeted response strategies, drafted response documents and revised filing materials, to support timely and accurate responses to all review concerns.
The approval of NS-342’s Phase I clinical trial protocol in South Korea marks another successful practice of BLA in international registration projects for innovative biologics. Going forward, BLA will continue to leverage its cross-regulatory expertise to provide professional support for the global clinical development and registration of innovative biopharmaceutical companies.
About NovaSpira Biotherapeutics
NovaSpira Biotherapeutics is a U.S.-based innovative biotechnology company focused on the development of innovative immunotherapies for GPC3-positive solid tumors, with an emphasis on bispecific T-cell-activating agents for refractory tumors such as liver cancer and lung cancer. Leveraging its cutting-edge bispecific antibody technology platform, the company focuses on high-clinical-value targets and boasts a highly differentiated pipeline. NS-342 is its lead clinical-stage candidate under priority development.
About BLA Regulatory
Awarded “Top 10 Emerging Pharmaceutical Consulting Firms of 2022”
BLA Regulatory is a full-service pharmaceutical regulatory consulting firm headquartered in Maryland, U.S.A. While focusing on the U.S. market, BLA also provides regulatory consulting services for pharmaceutical and medical device R&D in other major global markets.
We offer innovative drug developers strategy development and execution services for regulatory registration from IND through to BLA/NDA marketing applications. For medical device and in vitro diagnostic (IVD) developers, we provide strategic and execution support covering Q-Sub, 510(k), De Novo, IDE and PMA filings, as well as applications for approved medical devices to enter national and local reimbursement systems. Our mission is to help innovative biopharmaceutical and medical device companies advance their products from clinical development to marketing authorization efficiently and effectively.
BLA’s consulting team consists of former FDA reviewers and R&D experts from leading international pharmaceutical companies. Our team has hands-on experience in the review and filing of hundreds of INDs and dozens of NDA/BLA applications, and has achieved outstanding track records in regulatory consulting for medical device and IVD approvals. We have particularly deep expertise in large molecule drugs, small molecule drugs, gene therapy, tissue therapy and cell therapy.
Our capabilities span pharmaceutical sciences, preclinical research, clinical development, biostatistics, clinical pharmacology, regulatory affairs, medical writing and project management. We bring full-cycle drug development experience across a broad range of therapeutic areas, including oncology, respiratory diseases, substance use disorders, autoimmunity, infectious diseases, cardiovascular diseases and endocrine disorders.