HC Biosciences Showcases Global Innovation Leadership at 2025 China Biopharma Alliance Annual Conference

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The 2025 CBA-China Biopharmaceutical Conference, organized by Meihua Medicine, will be grandly held at the Suzhou International Expo Center from June 27 to 28, 2025. This annual conference focuses on cutting-edge topics such as global regulatory trends, AI technological innovation, advanced therapy development, and international strategies. It brings together top scholars, business leaders, and representatives from regulatory agencies worldwide to explore new pathways for the collaborative development of the biopharmaceutical industry. As a key participant in the conference, the core team of Haichang Biotech will make a significant appearance, showcasing their strategic depth and technical barriers in three core areas—small nucleic acid drug development, complex injectable technology breakthroughs, and global oncology treatment strategies—through keynote speeches, panel discussions, and case sharing.

Regulatory Science and Overseas Strategy: Dr. Xiaobin Zhao Leads the Sharing of Practical Experience

Dr. Xiaobin Zhao, Chairman and Founder of Haichang Biotech, delivered a keynote speech titled *Considerations, Practices, and Case Studies on the Regulatory Strategy for Small Nucleic Acid Drugs* at the "Path to Overseas Markets Forum." The report systematically analyzed key regulatory aspects across the entire lifecycle management of small nucleic acid drugs, including pharmaceutical research, preclinical evaluation, and clinical trial design. Leveraging Haichang Biotech's globally proprietary LNP delivery platform QTsome®, which addresses critical challenges in nucleic acid delivery, the report provided an in-depth analysis of HC0301, a nucleic acid drug targeting the AKT-1 site that has entered Phase II global multicenter clinical trials in China, the U.S., and Hong Kong. The presentation elucidated the full-chain regulatory science from early-stage R&D to global commercialization, offering strategic guidance for innovative Chinese pharmaceutical companies seeking to "go global." In the context of rapidly evolving regulatory frameworks, only by deeply integrating technological innovation with a global perspective can companies truly transition from "New in China."”To“Global New”A leap forward.

Clinical Development Aligns with International Standards: Dr. Men Yuxin’s Dual-Track Drive for Innovative Dialogue

Dr. Men Yuxin, Chief Medical Officer of Haichang Biotech and current president of CBA, participated deeply in the conference with dual identities. As the general planner of the sub-forum on innovative drug clinical development strategies, Dr. Men led the design of the oncology drug development session and hosted the roundtable discussion on "Challenges and Opportunities in the Development of Innovative Oncology Drugs." Focusing on global innovation in oncology drugs from...R&D Strategy, Clinical Trial Design, Global Clinical Operations and Regulatory AffairsHot topics in various fields, especiallyDifficulties in Cross-Cultural Implementation of Multiregional Clinical Trials (MRCT)Unfold the discussion. Differences in ethical norms, data regulations, and medical practices across countries require enterprises to build a "culture-ethics-regulations" three-dimensional synergy capability. Haichang Biotech shared its practical experience in reducing cross-regional ethical conflict risks by dynamically adjusting enrollment criteria and implementing localized communication strategies.

At the "Path to Overseas Expansion Forum," Dr. Men Yuxin focused onE21: Guideline on the Inclusion of Pregnant and Breastfeeding Women in Clinical TrialsIn-depth Interpretation. She combined the latest FDA guideline framework with clinical practice cases from Haichang Biotech, emphasizing the need to establish a standardized risk assessment system for medication use in pregnant women, to scientifically balance the improvement of drug accessibility with ethical safety guarantees for special populations. The current global R&D collaboration still faces challenges such as data silos and differences in ethical standards. She called for regulatory agencies, enterprises, and research institutions to work together to shift clinical research design from "exclusionary thinking" to "inclusive innovation," providing more precise evidence-based support for medication use in special populations.

In the roundtable discussion on "New Trends in International Regulatory Dynamics for Innovative Drug Clinical Trials," Dr. Zhao Xiaobin, as the moderator, joined hands with industry experts such as Dr. Men Yuxin to deeply analyze the challenges of global regulatory collaboration. Using Haichang Biotech's HC0301 project as a case study—developed simultaneously in the U.S., China, and Hong Kong—they proposed a "start with the end in mind" global development strategy, emphasizing the need to consider regional regulatory differences from the initial stages of trial design. From a medical strategic perspective, they also interpreted global practices in accelerated approval pathways for rare disease drugs, sharing how early patient involvement can optimize clinical endpoint design. This provided an innovative model for communication between multinational pharmaceutical companies and regulatory agencies, offering multidimensional insights into resolving international development challenges and building a global R&D system.

Technical Barriers and Commercial Breakthroughs: In-depth Analysis of Complex Injectable Development by Pan Xin

At the "Modified New Drugs & High-Technical Barrier Generic Drugs" forum, Pan Xin, Vice President of Production at Haichang Biotech, delivered a keynote speech titled "Experience Sharing on CMC of Complex Injectables" and participated in a roundtable discussion, systematically breaking down the core logic of the entire chain of high-end formulation development.

At the technical research level,In-depth analysis of the core challenges in controlling the nanoscale particle size, enhancing encapsulation efficiency, and ensuring long-term stability of injectables. Combined with Haichang Biotech's self-developed QTsome® delivery system, it reveals how to achieve the critical leap from laboratory to industrialization for high-end formulations through iterative process modeling and real-time quality control technology.Global Compliance Level,Compare the differentiated requirements of major global regulatory agencies for CMC studies of complex injectables, and propose a "modular development + regional adaptation" global registration strategy to provide an efficient pathway for cross-border submissions.In terms of commercial implementation,Using Haichang Biotech's already marketed products as examples, the business logic of "building market competitiveness through technical barriers" is validated. This provides a practical reference framework for the industry to break through the bottlenecks of complex formulation development and build a full value chain advantage.

Frontier Exploration of Nucleic Acid Drugs: Dr. Bai Jun Reveals the Heavyweight Secrets of HC016 Molecular Design

Dr. Bai Jun, Head of the Small Nucleic Acid Drug Department at Haichang Biotech's New Drug Research and Development Center, presented the report "Antitumor Oligonucleotide Drug HC016" at the "Nucleic Acid Drug Development" session. Leveraging AI algorithm-optimized sequence screening and chemical modification strategies to enhance drug stability and targeting, the multidimensional efficacy models validated the single-agent and combination potential of HC016 in solid tumors, laying a solid foundation for clinical development. This showcases Haichang Biotech's original innovation capabilities in the small nucleic acid drug field and provides the industry with an end-to-end paradigm from target discovery to clinical translation for exploring next-generation antitumor therapies.

Sailing with Innovation, Empowering the Globalization of China's Pharmaceutical Industry.

Through the 2025 AmeriChina Pharma Biomedical Science and Technology Conference,HaichangBiologicalNot only showcased innovative achievements in the fields of small nucleic acid drug delivery technology, complex formulation development, and precise tumor treatment, highlighting the company's technology-driven development path, but also actively built an exchange platform for industry-university-research collaboration to promote industry-wide innovation. Looking ahead, the company will continue to advance technological innovation and global cooperation, accelerate the clinical translation of innovative therapies, and deepen collaboration with partners across the industrial chain, providing sustained momentum toward the realization of the "Healthy China 2030" goals.

About Haichang Biotech

Haichang Biotech, located in the China Medical Valley in Hangzhou, is a national-level specialized and innovative "little giant" enterprise that integrates research, production, and sales, with biopharmaceutical technology innovation as its core driving force. The company adheres to the core values of "sharing, progress, truth-seeking, and pragmatism," focusing on the technical development and industrial application of drug delivery systems. Its product pipeline covers multiple fields, including anti-tumor, tumor immunotherapy, pain relief, and infectious disease prevention.
Haichang Biotech's self-developed QTsome® technology platform has successfully broken through the international patent barriers of nucleic acid delivery systems, overcoming key "bottleneck" technologies. HC0301, a small nucleic acid innovative drug for primary liver cancer developed based on this platform, has entered Phase II of international multi-center clinical trials in China and the US, becoming one of the fastest progressing pipelines in the global field of precise small nucleic acid tumor treatment. In the high technical barrier and high value-added complex injectables field, the company's core product, albumin-bound paclitaxel for injection, has been approved for marketing in nearly 40 countries including China, the EU, the UK, and Peru. The company is the first domestic enterprise to obtain EU marketing authorization through centralized review and has passed the EU GMP on-site inspection at two production sites simultaneously, leading the trend of high-end formulations "going overseas." HC016 lipid complex injection, the world’s first TLR9 agonist based on lipid nanoparticle (LNP) delivery technology, has received IND approval from both China and the US. HC009, an mRNA COVID-19 vaccine booster, has obtained clinical approval from the US FDA, becoming the first Chinese-produced mRNA vaccine product to receive US clinical approval. The company has also received support from the "First Batch of Projects for the National Development and Reform Commission's 2024 Key Product Innovation and Application Demonstration Project in Biomanufacturing," reflecting its technological accumulation and industrialization capabilities in small nucleic acid innovative drugs and complex formulations.