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Last Updated: December 11, 2025

Zhejiang Hisun Pharm Company Profile


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What is the competitive landscape for ZHEJIANG HISUN PHARM

ZHEJIANG HISUN PHARM has two approved drugs.



Summary for Zhejiang Hisun Pharm
US Patents:0
Tradenames:1
Ingredients:1
NDAs:2

Drugs and US Patents for Zhejiang Hisun Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zhejiang Hisun Pharm MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 204077-001 Nov 13, 2017 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Zhejiang Hisun Pharm MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 204076-001 Nov 16, 2017 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
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Pharmaceutical Competitive Landscape Analysis: Zhejiang Hisun Pharm – Market Position, Strengths & Strategic Insights

Last updated: July 29, 2025

Introduction

Zhejiang Hisun Pharmaceutical Co., Ltd. (Hisun Pharm) stands as a significant player within China's rapidly expanding pharmaceutical sector. Established with a focus on innovative and generic medicines, Hisun Pharm leverages a robust R&D pipeline, strategic alliances, and regional manufacturing strength to secure its position in both domestic and international markets. This analysis provides a comprehensive overview of Hisun Pharm's market positioning, core strengths, competitive advantages, and strategic initiatives, offering critical insights for stakeholders aiming to understand its trajectory within the global pharmaceutical landscape.


Market Position

Leadership in the Chinese Pharmaceutical Sector

Hisun Pharm is ranked among the top-tier pharmaceutical companies in China, notably excelling in the biosimilar and innovative drugs segments. As of 2022, the company's revenue surpassed RMB 20 billion (~USD 3.1 billion), reflecting its substantial market footprint [1].

Product Portfolio and Therapeutic Focus

The company's diversified portfolio spans oncology, immunology, cardiovascular, and anti-infective therapies. Notably, Hisun Pharm has made significant advancements in biosimilar drugs, which account for approximately 30% of its total revenue—a strategic focus aligned with China’s national healthcare reforms encouraging biosimilar adoption [2].

Geographic Reach

While predominantly strong in China, Hisun Pharm has been expanding globally. Strategic acquisitions and licensing agreements facilitate access to markets in Southeast Asia, North America, and Europe. The company’s recent submission of biosimilar products to the U.S. FDA and EMA underscores its ambitions to penetrate high-value markets [3].


Strengths

Robust R&D Capabilities

Hisun Pharm invests approximately 15% of its revenue into R&D, fostering a pipeline of innovative therapeutics alongside biosimilars. Its innovation centers focus on monoclonal antibodies, recombinant proteins, and targeted therapies, positioning the firm ahead in biosimilar differentiation [4].

Strategic Alliances and Licensing Agreements

Partnerships with global biotech firms supply Hisun Pharm with advanced technologies and expand market access. Notably, the company’s licensing deals with entities like Eli Lilly and Amgen have bolstered its portfolio of complex biologics and drug substances [5].

Manufacturing Excellence

Hisun Pharm operates multiple GMP-compliant manufacturing facilities across China in Zhejiang, Sichuan, and Jiangsu. Its focus on supply chain resilience and quality assurance ensures rapid scale-up capabilities, critical amid global supply chain disruptions [6].

Regulatory Navigation and Market Access

Owing to years of regulatory experience and close government collaboration, Hisun Pharm benefits from streamlined approval processes in China, along with an active strategy to register biosimilars and generics in key markets like the U.S. and Europe [7].

Cost-Competitiveness

The company's operational efficiency and localized production give it a cost advantage, particularly significant in competing on price with international pharmaceutical giants for biosimilar and generic markets.


Strategic Insights

Focus on Biosimilars and Innovation

Hisun Pharm's strategic emphasis on biosimilars aligns with global and domestic trends favoring cost-effective biologic therapies. The company's commitment to R&D and regulatory filings for biosimilars like Trastuzumab and Adalimumab exemplify its intent to capture high-margin segments [8].

Geographic Diversification

Expanding beyond China into markets such as the U.S., Europe, and emerging regions enhances revenue diversification and hedges against domestic regulatory or market fluctuations. The company's recent filings with the FDA and EMA reflect this strategic direction [9].

Investment in Digital and Smart Manufacturing

Hisun Pharm is deploying Industry 4.0 technologies, including automation and digital quality management, to boost manufacturing efficiency, traceability, and compliance. This investment supports scalability and rapid response in product launches.

Strategic Acquisitions and Mergers

Recent acquisitions of biotech firms and mergers with regional players provide access to advanced technologies, broadening its R&D pipeline. For instance, the acquisition of Zhejiang Quhua Shenghua Bio-chemopharmaceutical Co., Ltd. enhanced biologics capabilities [10].

Market Penetration and Pricing Strategy

Employing competitive pricing and strategic partnerships, Hisun Pharm ensures wider access in price-sensitive markets. The company’s biosimilar offerings often undercut international brands by 20-30%, accelerating adoption in China and other emerging markets.


Competitive Landscape

Major Competitors

  • Sinopharm Group – Leading distribution network, diversified product portfolio.
  • Shanghai Henlius Biotech – Focused on biosimilars, rapidly gaining international approvals.
  • Zhejiang Hisun Pharmaceuticals Co., Ltd. – Same entity, with vertical integration and R&D focus.
  • CSPC Pharmaceutical Group – Extensive pipeline and global expansion strategies.
  • Novartis and Amgen – Global biosimilar competitors with entrenched international market presence.

Positioning Against Competitors

Hisun Pharm distinguishes itself through:

  • Strong domestic presence and government relationships enabling rapid market access.
  • Balanced portfolio of biosimilars and generics suited for cost-sensitive healthcare markets.
  • Aggressive investment in R&D positioning for long-term innovation leadership.
  • Strategic collaborations that augment technological capabilities.

Key Challenges and Risks

  • Regulatory Uncertainty – Changes in regulatory policies, especially in international markets, could delay approvals and revenue realization.
  • Intense Price Competition – Domestic and international players intensify biosimilar price wars, pressuring margins.
  • Patent Litigation and Intellectual Property Risks – Navigating patent landscapes for biosimilars remains complex.
  • Global Supply Chain Disruptions – Dependency on international raw material supplies exposes vulnerabilities.

Strategic Recommendations

Accelerate Global Registrations

Prioritize regulatory filings in high-value markets such as the U.S. and Europe to diversify revenue streams and reduce dependence on the domestic Chinese market.

Enhance Innovation Pipeline

Invest further in novel biologics and targeted therapies beyond biosimilars to move into premium therapeutic segments and improve margins.

Leverage Digital Transformation

Capitalize on Industry 4.0 initiatives to reduce manufacturing costs, improve quality, and foster faster product launches.

Expand Strategic Alliances

Forge partnerships with international pharmaceutical firms to access cutting-edge technologies, expand global reach, and mitigate R&D risks.

Focus on Market Differentiation

Differentiate biosimilar products via efficacy, safety, and pricing advantages, leveraging brand recognition and clinician education.


Key Takeaways

  • Zhejiang Hisun Pharm is a leading Chinese pharmaceutical with strong biopharmaceutical and biosimilar capabilities, leveraging domestic and international growth strategies.
  • Strategic emphasis on biosimilars, combined with robust R&D and manufacturing prowess, positions it favorably amid global biologics market expansion.
  • Geographic diversification, regulatory expertise, and alliance strategies underpin its growth trajectory.
  • Challenges around regulatory landscape, pricing pressures, and supply security require proactive risk mitigation.
  • Future success hinges on accelerated global registrations, innovation investments, and leveraging digitalization for operational excellence.

FAQs

  1. What is Zhejiang Hisun Pharm’s primary revenue driver?
    Biosimilars and innovative biologics represent the core revenue streams, accounting for approximately 30% of total sales and expected to grow as global biosimilar markets expand.

  2. How does Hisun Pharm differentiate itself in the biosimilar market?
    Through advanced R&D capabilities, strategic alliances, competitive pricing, and rapid registration processes, especially within China’s favorable regulatory environment.

  3. What markets is Hisun Pharm targeting for international expansion?
    The U.S., Europe, and Southeast Asia are key focus regions, with plans to secure regulatory approvals and establish manufacturing and distribution channels.

  4. What are the main risks facing Hisun Pharm’s growth?
    Regulatory uncertainties, price competition, patent disputes, and supply chain vulnerabilities pose significant risks.

  5. What strategic moves could accelerate Hisun Pharm’s global competitiveness?
    Increased investment in innovation, accelerated regulatory filings, digital transformation, strategic acquisitions, and expanded partnerships.


References

[1] Hisun Pharm Annual Report 2022
[2] China National Health Commission, Biosimilar Policy Framework
[3] Company press releases on regulatory submissions
[4] R&D expenditure reports, Hisun Pharm
[5] Strategic alliance announcements, 2022-2023
[6] Manufacturing capacity reports, Hisun Pharm
[7] Regulatory approval timelines, China Food and Drug Administration
[8] Biosimilar pipeline overview, Hisun Pharm
[9] International market entry strategy documents
[10] Recent M&A disclosures, Hisun Pharm

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