According to industry analysis firm IQVIA data, in the first half of 2025, Chinese pharmaceutical companies' overseas licensing and strategic cooperation transactions totaled $48.5 billion, reaching a historic high. Driven by accelerated internationalization, innovative technology breakthroughs, and corporate strategic transformations, Chinese pharmaceutical companies going overseas has become an unstoppable trend.
As a pioneer that has been deeply cultivating the internationalization field for over 30 years, Zhejiang Hisun Pharmaceutical Co.,Ltd. (hereinafter referred to as "Hisun Pharmaceutical") has proactively embraced change, driving its internationalization strategy toward deeper development and entering the era of deep internationalization 2.0, constructing a more stable global value chain. In 2025, the company's wholly-owned subsidiary Hisun USA successfully launched three new products in the US market, including actinomycin injection and large-specification daunorubicin injection, achieving net profitability in the first year of launch. This achievement fully validates the effectiveness of Hisun Pharmaceutical's internationalization strategy.
**From "Frontier Window" to "Comprehensive Platform": Hisun USA's Localization Evolution**
In November 2009, Hisun Pharmaceutical established Hisun USA in Princeton, New Jersey, launching a key layout of its internationalization strategy. In its early stages, Hisun USA was positioned as a frontier observation window for international pharmaceutical markets, fully utilizing local geographical and talent advantages to continuously track the latest industry developments, actively introducing cooperation projects for the parent company, and significantly enhancing the parent company's compliance management level and R&D innovation capabilities by attracting returnee talent. Meanwhile, Hisun USA also undertook the parent company's API sales functions in the US.
2018 marked an important turning point for Hisun USA's strategic transformation, as it focused on building a formulation sales platform, gradually introducing the parent company's oral formulations and injection products to the US market, achieving significant results in business transformation. Currently, Hisun USA has built a mature generic drug formulation sales platform with complete registration, sales, and service capabilities, with business spanning North America, South America, Europe, the Middle East, Africa, Southeast Asia, Russia, and other countries and regions.
Hisun USA's core competitive advantage lies in its professional team, composed of senior professionals with an average of over 30 years of experience in US generic drug sales, possessing deep industry expertise. Currently, Hisun USA has obtained sales qualifications issued by the US government and over 40 states, established stable supply relationships with major wholesalers, GPOs, and government procurement agencies, with a sales network covering the entire United States. In 2024, Hisun USA achieved profitability for the first time, marking a breakthrough that opened new prospects for Hisun Pharmaceutical's expansion in international formulation markets.
**From Single-Point Breakthrough to Multi-Dimensional Expansion: Multi-Polar Expansion of Hisun's Internationalization Strategy**
Since first obtaining FDA certification in 1992 to enter European and American markets, to establishing the Hisun USA subsidiary in 2009, Hisun Pharmaceutical's 30+ year internationalization process has consistently emphasized "bringing in + going out" under a global perspective. The company not only seeks cooperation with advanced overseas platforms but also actively deploys in international markets, including establishing overseas subsidiaries and building marketing systems compliant with local regulations, aiming to achieve autonomous international operations. After successfully establishing itself in the US market, in August 2025, Hisun Pharmaceutical further announced investment in establishing a subsidiary in Brazil, continuously expanding its business reach in the Americas market, developing markets locally and serving customers seamlessly. Simultaneously, its animal health business's core product "Hailewang" successfully entered the Vietnamese market, while its API business continues expanding new customers in South America, the CIS, and Middle East regions, jointly constructing Hisun Pharmaceutical's new strategic pattern of multi-regional, multi-sector coordinated overseas expansion.
Currently, Hisun USA has upgraded from a single market touchpoint to a key node supporting the group's global sales integration strategy. Leveraging the professional advantages of its localized team, Hisun USA not only promotes formulation product commercialization in the US but also comprehensively empowers the parent company's overseas human API and formulation, veterinary API and formulation, CMO, non-pharmaceutical nutrition, and cross-border health product e-commerce businesses, forming an international operation network of "point-to-surface, full-domain coordination."
**Industry Empowerment: Building "Infrastructure" for Chinese Pharmaceutical Companies Going Overseas**
With accumulated advantages in quality management systems, market expansion, and overseas localization operations, Hisun Pharmaceutical is gradually transforming into a comprehensive service platform for Chinese pharmaceutical companies going overseas. In 2024, Hisun USA signed exclusive licensing and cooperative development agreements for 4 products with three major domestic pharmaceutical companies. In 2025, the first imported product it represents achieved a 21% market share in the US market in the second quarter, fully demonstrating its mature platform service capabilities and efficient commercialization implementation abilities.
Hisun Pharmaceutical's core competitiveness is rooted in its systematic international registration capabilities. Since obtaining its first US ANDA approval in 2009, the company has accumulated nearly 40 US ANDA approvals and dozens of other overseas market formulation registration certificates across key therapeutic areas including oncology, cardiovascular, and anti-infection. In April 2025, Hisun Pharmaceutical pioneered the industry by becoming the first Chinese pharmaceutical company to complete a US FDA submission under the eCTD (Electronic Common Technical Document) 4.0 international standard. eCTD 4.0, as the new international standard for electronic common technical documents for pharmaceuticals, can significantly improve submission efficiency and quality. This breakthrough benefited from its forward-looking deployment—initiating technical evaluation work in 2023 and completing domestic software system deployment in 2024, setting a benchmark for the industry.
In service system construction, Hisun USA has gradually built service capabilities covering the full lifecycle of pharmaceutical overseas expansion, from early product market research and analysis, ANDA submission guidance, to quality system compliance recommendations, pharmacovigilance management, and logistics warehousing and channel services, providing Chinese pharmaceutical companies with complete solutions compliant with local regulatory requirements. Its full-chain service capabilities make Hisun USA a trusted partner for Chinese pharmaceutical companies going overseas.
Hisun Pharmaceutical's international layout is also significantly supported by its quality management system built to global highest standards. The company's three major production bases in Taizhou, Fuyang, and Nantong, along with Hisun USA, have all successfully passed audits by globally authoritative institutions including FDA, EMA, and WHO, providing solid guarantees for overseas business expansion.
The development model of Hisun USA marks that Hisun Pharmaceutical's internationalization strategy has evolved from "product export" to "empowerment for overseas expansion." It is not only an output platform for proprietary products but also provides escort services for Chinese pharmaceutical companies going overseas by building mature international channels. In the future, Hisun Pharmaceutical will continue leading industry trends, advancing its "Deep Internationalization 2.0" strategy, and opening new chapters in international development.
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