Apexelsin® (Albumin-bound Paclitaxel for Injection) Receives Marketing Approval in Peru, Marking Entry into Latin American Market

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Recently, the injectable paclitaxel (albumin-bound) (Apexelsin®, hereinafter referred to as "nab-paclitaxel") independently developed by Haichang Biotech has officially received marketing approval from Peru's Institute for the Evaluation, Control and Monitoring of Drugs and Medical Products (DIGEMID). This milestone marks the successful expansion of the product into the Latin American market following its launch in nearly 40 countries, including the EU and the UK. Its innovative technology platform based on albumin nanoparticle delivery has once again gained recognition from international regulatory authorities, injecting strong momentum into the company’s global strategic layout.

Technical Breakthrough: Innovative Delivery System Solves Clinical Challenges

Apexelsin® Utilizes Haichang Biotech's Self-developed High Drug-loading Albumin Nanoparticle Technology to Achieve Efficient Paclitaxel Delivery Through a Biocompatible Albumin Carrier. Compared with Traditional Paclitaxel Formulations, This Product Effectively Solves Technical Challenges Such as Low Solubility and High Toxicity of Paclitaxel, Significantly Enhances the Targeted Accumulation of the Drug in Tumor Tissues, While Reducing the Exposure Risk to Non-target Tissues, Offering Patients with Metastatic Breast Cancer, Metastatic Pancreatic Cancer, and Non-small Cell Lung Cancer a More Efficacious and Safer Treatment Option.

    Quality Foundation: International Standards Safeguard Global Supply

To meet the global market's demand for high-quality pharmaceuticals, Haichang Biotech and Sinovac Biotech have jointly established a facility compliant with EU standards.An intelligent production line meeting GMP standards passed an on-site inspection by the European Medicines Agency (EMA) in May 2024. During the registration process in Peru, the product obtained approval just two months after the submission of registration documents, shortening the conventional process by five months, thanks to a complete international quality management system. This fully demonstrates the team's professional capabilities and execution efficiency in global pharmaceutical registration.

   Strategic Depth: Technology Output Drives Global Accessibility

Access to the Peruvian market isKey milestones in the globalization journey of Apexelsin®. In the future, Haichang Biotech will continue to deepen its strategic cooperation with Sinovac Biotech, focusing on the proprietary QTsome® technology platform. It aims to accelerate the technical transformation and commercialization of innovative formulations in emerging markets, while building a full-process solution covering R&D, production, and registration. This effort will promote the global accessibility of advanced formulation technologies, ultimately achieving the strategic goal of "enabling patients worldwide to share in China's innovative achievements."

This approval not only demonstrates Haichang Biotech's R&D strength in the field of nanodelivery technology but also provides a valuable reference for the international expansion of innovative pharmaceutical products from China. With the continuous improvement of the technical platform and quality management system,Apexelsin® is expected to play a broader role in the field of cancer treatment.

About Haichang Biotech

Haichang Biotech, located in China Medical Valley, Hangzhou, is a national-level specialized and innovative "little giant" enterprise driven by the core momentum of biopharmaceutical technology innovation. The company integrates research, production, and sales, adhering to the core values of "sharing, progress, truth-seeking, and pragmatism." It focuses on the technical development and industrial application of drug delivery systems, with a product pipeline covering multiple fields including anti-cancer, cancer 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 United States, becoming one of the fastest progressing pipelines in the global field of precise small nucleic acid tumor treatment. In the highly technical and high value-added complex injectables sector, 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 via centralized review, with two production sites simultaneously passing EU GMP inspections, leading the trend of high-end formulations going global. HC016 lipid complex injection, the world’s first TLR9 agonist based on lipid nanoparticle (LNP) delivery technology, has received IND approval in both China and the United States. HC009, an mRNA COVID-19 vaccine booster, has received clinical approval from the U.S. FDA, making it the first Chinese-produced mRNA vaccine product to gain clinical approval in the United States. It has also received support from the "National Development and Reform Commission's Key Product Innovation and Application Demonstration Project in Biomanufacturing for the First Batch of Projects in 2024," demonstrating the company’s technological accumulation and industrialization capabilities in small nucleic acid innovative drugs and complex formulations.