How Does Shenzhen Hepalink Pharmaceutical Group Co. Company Work?

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How does Shenzhen Hepalink Pharmaceutical Group Co. operate?

Shenzhen Hepalink Pharmaceutical Group Co., Ltd. is a global biopharmaceutical company focused on the heparin industry. It's involved in research, development, manufacturing, and sales of heparin sodium APIs and low molecular weight heparin preparations, operating in over 40 countries.

The company achieved a significant financial turnaround in 2024, reporting a net profit of RMB 646.7 million, a substantial improvement from a net loss the previous year. This recovery was driven by reduced expenses and increased market demand.

Hepalink's operations are vertically integrated, covering everything from sourcing raw materials to producing APIs and marketing finished products like enoxaparin sodium injections. This comprehensive approach allows for strong market leverage and strategic expansion into new therapeutic areas.

Shenzhen Hepalink Pharmaceutical Group Co. focuses its core operations on the heparin industrial chain, demonstrating a vertically integrated approach from raw material sourcing to the production of heparin sodium APIs and enoxaparin sodium injections. This comprehensive control over its supply chain is a significant aspect of the Shenzhen Hepalink business model, ensuring consistent quality and a strong competitive edge in the global pharmaceutical market.

Heparin Business Core

Hepalink's primary strength lies in its fully integrated heparin business. This includes sourcing raw materials, manufacturing heparin sodium APIs, and producing low molecular weight heparin preparations like enoxaparin sodium injections. The company's commitment to quality control throughout this process underpins its value proposition.

Global Reach and Market Penetration

The company's enoxaparin sodium injection has achieved significant global market penetration, with over 540 million doses sold in Europe. It is marketed in more than 40 countries and regions, including the U.S. and the EU, and is covered by national insurance programs in all 13 EU member states, the UK, and Switzerland.

Diversification into Biologics CDMO

Hepalink has strategically expanded into large molecule biologics Contract Development and Manufacturing Organization (CDMO) services through subsidiaries like Cytovance Biologics and SPL. This diversification aims to leverage synergistic effects, consolidate resources, and enhance overall business performance by serving a broader client base more efficiently.

Innovative Drug Development

The company is actively engaged in the research, development, and commercialization of innovative drugs. A key development in 2025 was the first subject enrollment and dosing in a Phase I clinical trial for H1710 injection, an independently developed candidate drug targeting heparanase for advanced solid tumors, demonstrating its commitment to addressing unmet medical needs.

Hepalink's operational effectiveness is further enhanced by its robust global marketing network, which consistently drives sales growth both domestically and internationally. The company actively seeks new market opportunities and strengthens product promotion, as evidenced by its successful market access in Thailand and New Zealand in the first half of 2024. This continuous refinement of its core heparin business, coupled with the rapid enhancement of its CDMO operations and strategic development of innovative drugs, fosters a synergistic relationship across its three main business segments, thereby driving financial performance and future expansion. Understanding the Target Market of Shenzhen Hepalink Pharmaceutical Group Co. is crucial to appreciating its strategic positioning.

Synergistic Business Model

The Shenzhen Hepalink business model is characterized by the synergistic interplay between its heparin business, CDMO services, and innovative drug development. This multi-faceted approach not only broadens its revenue streams but also mitigates risks associated with reliance on a single product line, creating a resilient and growth-oriented enterprise.

• Vertical integration in heparin production
• Global market presence for enoxaparin sodium
• Expansion into biologics CDMO services
• Investment in innovative drug research and development

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Shenzhen Hepalink Pharmaceutical Group Co. operates with a diversified revenue model, primarily driven by its robust heparin supply chain, contract development and manufacturing organization (CDMO) services, and a growing focus on innovative drug development. This multi-faceted approach allows the company to capitalize on different market opportunities within the pharmaceutical sector.

Heparin Supply Chain Dominance

The company's core strength lies in its integrated heparin supply chain. This segment encompasses both active pharmaceutical ingredients (APIs) and finished dose pharmaceutical products, forming the backbone of its revenue generation.

Contract Development and Manufacturing (CDMO) Growth

Hepalink's CDMO business is a significant contributor, experiencing consistent growth. The company focuses on deepening relationships with existing clients and expanding its customer base through targeted marketing efforts.

Innovative Drug Development Pipeline

The company is actively investing in its innovative drugs and innovation segment. This includes advancing the development of new therapeutic agents and exploring diverse commercialization strategies.

Finished Dose Pharmaceutical Products

This segment was the largest revenue generator for the full year ended December 31, 2024. It accounted for approximately 56.8% of the Group's total revenue, with sales reaching approximately RMB 2,986.1 million.

Active Pharmaceutical Ingredients (API)

The API business generated approximately RMB 1,065.7 million in sales revenue for the full year 2024. This segment showed a notable turnaround, achieving a gross profit margin of approximately 38.6%.

CDMO Business Performance

In 2024, the CDMO business contributed approximately RMB 1,033.8 million in sales revenue, a 6.9% year-on-year increase. The gross profit margin for this segment significantly improved to approximately 32.9%.

Hepalink's monetization strategies are geared towards expanding its global reach, particularly for its finished dosage form products. This involves optimizing marketing approaches, increasing market penetration, and enhancing sales share through its established global sales management system, local marketing teams, and strategic business partnerships. For its CDMO operations, the company emphasizes strengthening existing client relationships and actively pursuing new business opportunities. The company also actively pursues opportunities in innovative drugs, such as advancing the development of new drugs for Oregovomab and H1710 injection, and building diversified commercialization capabilities through licensing agreements and collaborations, further detailing its Growth Strategy of Shenzhen Hepalink Pharmaceutical Group Co.

Key Financial Contributions (2024)

The company's financial performance in 2024 highlights the varied contributions of its business segments. These figures underscore the strategic importance of each area to Hepalink's overall revenue and profitability.

• Total Sales Revenue: Approximately RMB 5,258.9 million.
• Finished Dose Pharmaceutical Products Revenue: Approximately RMB 2,986.1 million (56.8% of total revenue), with a gross profit margin of approximately 31.8%.
• API Business Revenue: Approximately RMB 1,065.7 million, with a gross profit margin of approximately 38.6%.
• CDMO Business Revenue: Approximately RMB 1,033.8 million, with a gross profit margin of approximately 32.9%.

First Half 2024 Performance Highlights

The first half of 2024 demonstrated strong performance across Hepalink's key business areas, indicating positive momentum and growth.

• Heparin Injections Business Revenue: RMB 1,454 million, with a gross profit margin of 35.79%.
• CDMO Segment Sales: Approximately RMB 560 million, a 41.73% year-on-year growth.
• API Business Sales: Approximately RMB 748 million, a 7.06% year-on-year increase, with a gross margin of 36.45%.

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Shenzhen Hepalink Pharmaceutical Group Co. has navigated a path of significant growth and strategic adaptation since its inception in 1998. The company's journey is marked by key acquisitions and product approvals that have solidified its position in the global pharmaceutical market. Understanding these milestones and the company's strategic moves is crucial to grasping its competitive edge.

Key Milestones in Hepalink's Growth

Established in 1998, Hepalink's journey includes a dual listing in Hong Kong and mainland China. A significant step was the 2014 acquisition of SPL Acquisition Corp. in the U.S., bolstering its heparin sodium API supply and expanding into the pancreatin market.

Vertical Integration and Market Penetration

The 2018 acquisition of Duopule and Techdow completed Hepalink's vertical integration of the heparin industrial chain. In 2020, its enoxaparin sodium injection (Prolongin®) in China was the first to pass the Bioavailability Equivalence Evaluation.

Global Expansion and Innovation Pipeline

Recent achievements include the 2024 EMA new manufacturer authorization and South African marketing approval for its enoxaparin sodium injection. A January 2025 partnership aims to commercialize Gabapentin capsules in the U.S., while the July 2025 completion of the first subject dosing for its anti-tumor drug H1710 injection highlights its R&D focus.

Navigating Industry Challenges

Despite challenges like the 2023 heparin industry destocking impacting API prices, Hepalink adapted by increasing API sales volume, achieving a positive gross profit margin for API in 2024. Its CDMO business saw a significant Q4 2023 revenue increase, counteracting earlier declines.

Hepalink's Competitive Edge

Hepalink's competitive advantages are built on its strong brand recognition, technological leadership, and significant economies of scale. The company's fully integrated heparin industrial chain offers a robust defense against competitors, ensuring stringent quality control throughout its Mission, Vision & Core Values of Shenzhen Hepalink Pharmaceutical Group Co..

• Brand Strength: Established reputation in the pharmaceutical sector.
• Technological Leadership: Investment in advanced manufacturing and R&D.
• Economies of Scale: Efficient production capabilities due to large-scale operations.
• Vertical Integration: End-to-end control over the heparin supply chain.
• Global Reach: Extensive marketing network and regulatory approvals across international markets.
• R&D Investment: Focus on innovative drugs and biologics to diversify its product portfolio.

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Shenzhen Hepalink Pharmaceutical Group Co. holds a commanding position in the global heparin market, underpinned by its comprehensive, vertically integrated operations. The company's enoxaparin sodium finished dose products have seen substantial worldwide sales, surpassing 110 million units by mid-2024, demonstrating its leadership in key markets including Europe, the US, and China. This strong market presence is further bolstered by its strategic acquisitions, which have expanded its international reach and capabilities in the biologics sector.

Industry Position

Hepalink Pharmaceutical Group is a global leader in the heparin industry, distinguished by its complete vertical integration across the entire heparin production chain. Its enoxaparin sodium injection is recognized worldwide and distributed in over 40 countries.

Key Strengths

The company's strategic acquisitions, such as Cytovance Biologics, have been crucial in establishing an international presence and acquiring expertise in biologics. This diversification strengthens its overall market standing and operational capabilities.

Identified Risks

The pharmaceutical sector, including Hepalink operations, faces risks from global economic slowdowns, varied inflation rates, and geopolitical instability. The heparin market specifically is vulnerable to raw material price volatility and increasing competition, as evidenced by price declines in crude heparin and API in 2023.

Future Outlook

Hepalink aims to enhance profitability through continued internationalization and market penetration. The company plans to optimize marketing strategies, expand its customer base in the CDMO business, and advance its innovative drug pipeline, including Oregovomab and H1710 injection.

Strategic Growth Initiatives

Hepalink Pharmaceutical Group is focused on expanding its global footprint and brand influence within the heparin industry. The company is also committed to prudent financial management to ensure liquidity and operational efficiency.

• Deepen internationalization strategy and accelerate global presence.
• Optimize marketing strategies and increase market penetration.
• Consolidate existing client relationships and develop new customer groups in the CDMO business.
• Advance development of innovative drugs like Oregovomab and H1710 injection.
• The company's revenue is projected to grow at an average of 6.3% annually over the next three years.
• This growth is compared to an 11% growth forecast for the broader Chinese Pharmaceuticals industry.

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