HISUN(SH:600267) Xin Hua Cai Jing·2025-10-11 02:12Core Insights - The total value of licensing and strategic cooperation transactions by Chinese pharmaceutical companies reached a historic high of $48.5 billion in the first half of 2025, driven by internationalization, technological breakthroughs, and strategic transformations [1] Group 1: Company Overview - Zhejiang Huazhong Pharmaceutical Co., Ltd. (Huazhong Pharma) has been actively promoting its internationalization strategy, entering a deeper phase of internationalization 2.0, and establishing a more robust global value chain [1] - In 2025, Huazhong Pharma's wholly-owned subsidiary, Huazhong USA, successfully launched three new products in the U.S. market, achieving net profitability in the first year of launch, validating the effectiveness of its internationalization strategy [1] Group 2: Huazhong USA's Development - Established in November 2009 in Princeton, New Jersey, Huazhong USA initially served as a front-line observation window for the international pharmaceutical market, leveraging local geographical and talent advantages [2] - In 2018, Huazhong USA underwent a strategic transformation to build a formulation sales platform, successfully pushing the parent company's oral and injectable products into the U.S. market, achieving significant business transformation [2] - Huazhong USA has developed a mature generic drug formulation sales platform, with complete registration, sales, and service capabilities, covering North America, South America, Europe, the Middle East, Africa, Southeast Asia, and Russia [2] Group 3: Internationalization Strategy - Huazhong Pharma's internationalization process emphasizes a global perspective of "bringing in and going out," seeking cooperation with advanced overseas platforms while actively expanding into international markets [3] - After establishing a foothold in the U.S. market, Huazhong Pharma announced plans to invest in a subsidiary in Brazil in August 2025, further expanding its business reach in the Americas [3] - The company’s core product in the animal health sector, "Hailiwang," successfully entered the Vietnamese market, while its active pharmaceutical ingredient business continues to expand in South America, the CIS, and the Middle East [3] Group 4: Industry Empowerment - Huazhong Pharma is gradually transforming into a comprehensive service platform for Chinese pharmaceutical companies going abroad, having signed exclusive licensing and cooperation agreements for four products with three large domestic pharmaceutical companies in 2024 [4] - The company has accumulated nearly 40 ANDA approvals in key therapeutic areas since obtaining its first U.S. ANDA in 2009, showcasing its systematic international registration capabilities [4] - In April 2025, Huazhong Pharma became the first Chinese pharmaceutical company to complete an FDA submission under the eCTD 4.0 international standard, significantly improving submission efficiency and quality [5] Group 5: Service System and Quality Management - Huazhong USA has built a comprehensive service capability covering the entire lifecycle of drug export, providing complete solutions that comply with local regulations [5] - The company’s internationalization strategy is supported by a quality management system built to the highest global standards, with production bases passing audits from global authorities like the FDA, EMA, and WHO [5] - Huazhong Pharma's development model signifies a shift from "product export" to "empowering outbound," establishing a mature international pathway for Chinese pharmaceutical companies [5]