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Last Updated: December 11, 2025

Shandong Company Profile


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Summary for Shandong
International Patents:29
US Patents:5
Tradenames:13
Ingredients:13
NDAs:15

Drugs and US Patents for Shandong

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shandong TADALAFIL tadalafil TABLET;ORAL 216279-002 Dec 4, 2024 AB1 RX No No ⤷  Get Started Free ⤷  Get Started Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-003 Jan 13, 2023 RX Yes No 10,098,882 ⤷  Get Started Free Y ⤷  Get Started Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-002 Jan 13, 2023 RX Yes Yes 10,098,882 ⤷  Get Started Free Y ⤷  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

Supplementary Protection Certificates for Shandong Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 CR 2014 00048 Denmark ⤷  Get Started Free PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
2101777 93081 Luxembourg ⤷  Get Started Free PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0521471 03C0043 France ⤷  Get Started Free PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Shandong – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Shandong Province, a powerhouse in China’s pharmaceutical industry, holds a pivotal role in both the domestic and global healthcare markets. With its rich pharmaceutical heritage, burgeoning R&D capabilities, and robust manufacturing ecosystem, Shandong has evolved into a strategic hub for pharmaceutical innovation and production. This analysis provides a comprehensive overview of Shandong’s pharmaceutical landscape, detailing market positioning, core strengths, competitive dynamics, and strategic considerations for industry stakeholders.

Market Position in China's Pharmaceutical Sector

Shandong is recognized as one of China’s leading pharmaceutical provinces, contributing approximately 8-10% to the national output (per China National Pharmaceutical Industry Information Center). The province's pharmaceutical sector spans traditional Chinese medicine (TCM), chemical drugs, biopharmaceuticals, and advanced medical devices.

The local government’s proactive policies aim to accelerate industry upgrades, foster innovation, and expand global market reach. Major cities like Jinan, Qingdao, and Yantai serve as bustling hubs, hosting a concentration of significant pharmaceutical companies, research institutes, and biotech startups.

While Shanghai and Guangdong lead in terms of innovation and market size, Shandong's strategic focus on integrating manufacturing and R&D enhances its competitive position, especially within the biopharmaceutical segment.

Core Strengths of Shandong’s Pharmaceutical Industry

1. Rich Traditional Chinese Medicine (TCM) Heritage

Shandong’s longstanding tradition in TCM provides a foundational advantage. The region boasts a comprehensive supply chain, from raw herb sourcing to formulation science. Companies like Shandong Buchang Pharmaceuticals capitalize on this legacy, integrating TCM with modern pharmaceutical techniques.

2. Robust Manufacturing Infrastructure

The province's advanced manufacturing facilities support high-volume production of both chemical and biological drugs, adhering to international standards like GMP (Good Manufacturing Practice). Leading firms such as Hisun Pharmaceutical and Shandong Xinhua Pharmaceutical benefit from state-of-the-art production lines, enhancing quality and efficiency.

3. Government Support and Policy Incentives

Shandong government actively promotes pharmaceutical innovation through financial incentives, tax breaks, and infrastructure development. Notable initiatives include the "Shandong Pharmaceutical Innovation Project" and special economic zones tailored for biotech startups.

4. Growing Biopharmaceutical Sector

The biopharmaceutical segment is expanding rapidly, driven by local research institutions and private investment. The province's focus on translational research and collaboration with academia fosters a conducive environment for innovative drug development.

5. Strategic Location and Logistics

Situated along China’s eastern coast, Shandong benefits from superior logistics infrastructure, including ports like Qingdao and Yantai. This facilitates efficient distribution domestically and exports globally.

Competitive Dynamics and Key Industry Players

Market Leaders

  • Hisun Pharmaceuticals: A leading integrated producer specializing in oncology, cardiovascular, and autoimmune drugs, with significant R&D investments in biosimilars.
  • Shandong Xinhua Pharmaceutical: Focuses on antibiotics, NSAIDs, and traditional Chinese medicines, with extensive domestic distribution networks.
  • Weifang Binyu Pharmaceutical: Known for its biosimilar portfolio and active R&D pipeline in biologics.

Emerging Innovators and Startups

  • Diverse startups and biotech firms are increasingly engaging in novel drug discovery, leveraging Shandong’s academic collaborations.
  • Investment from venture capital (VC) and private equity (PE) firms accelerates innovative startups’ growth trajectories.

Partnerships and Alliances

Strategic collaborations between academia, pharmaceutical giants, and government agencies underpin the industry’s innovation pipeline. Notably, partnerships with universities such as Shandong University facilitate translational research and talent acquisition.

Strategic Insights for Stakeholders

1. Embracing Innovation and Biologics

To sustain growth, companies should prioritize biologics R&D, leveraging Shandong’s strengths in biopharmaceuticals. Investment in advanced platforms like mRNA technology and cell therapies could foster differentiation.

2. Expanding Global Footprint

Internationalization remains critical. Firms should navigate regulatory pathways effectively, especially in the U.S. and Europe, capitalizing on Shandong’s strategic proximity to ports and export hubs.

3. Digital Transformation and Supply Chain Optimization

Digital tools such as AI-driven R&D, process automation, and supply chain digitization can reduce costs, enhance quality, and accelerate time-to-market.

4. Local R&D Ecosystem Development

Fostering collaborations with academic institutions and incentivizing startups through incubators and funding will spur innovation and diversify the local portfolio.

5. Navigating Regulatory and Market Risks

Compliance with evolving Chinese and international regulatory standards, including data integrity and quality management, remains paramount. Engaging proactively with regulatory agencies ensures smoother approvals and market access.

Future Outlook and Trends

  • Innovation Hub Emergence: Shandong is positioning itself as an innovation-driven hub, emphasizing biotech R&D clusters and industrial parks.
  • Increased Biopharma Investment: The biopharmaceutical sector is poised for exponential growth with government backing and private sector involvement.
  • International Collaborations: More alliances with global pharma players aim to enhance innovation, licensing, and market penetration.
  • Regulatory Reforms: China's continued reform of drug approval pathways (e.g., ICH guidelines alignment) will benefit Shandong’s companies seeking global expansion.
  • Sustainable and Ethical Production: Growing emphasis on green manufacturing practices and ethical sourcing aligns with global ESG standards.

Key Takeaways

  • Shandong’s entrenched TCM heritage, robust manufacturing infrastructure, and strategic location position it as a critical hub within China's pharmaceutical sector.
  • Industry leaders are pivoting toward biologics, global expansion, and digital transformation to sustain competitive advantage.
  • Public-private partnerships and government incentives are vital drivers of innovation and industry growth.
  • Stakeholders must navigate complex regulatory landscapes while leveraging Shandong’s local strengths, fostering collaboration, and seizing emerging global opportunities.
  • The province's commitment to fostering an innovation ecosystem signals long-term growth potential in biopharmaceuticals and advanced therapies.

FAQs

1. How does Shandong's pharmaceutical industry compare to other Chinese provinces?

Shandong ranks among China’s top pharmaceutical provinces due to its extensive manufacturing capacity, historical TCM expertise, and strategic government support. However, provinces like Guangdong and Shanghai lead in innovation and biotech R&D. Shandong compensates with scale and integration of traditional and modern medicine.

2. What are the primary growth drivers for Shandong’s biotech sector?

Key drivers include government initiatives promoting innovation, increased R&D investments, academia-industry collaborations, and the rising global demand for biologics and personalized medicine. The province’s infrastructure and talent pool further bolster growth.

3. Which segments are attracting the most foreign investment in Shandong?

Biopharmaceuticals, especially biosimilars and innovative biologics, see substantial foreign interest. Traditional Chinese medicine exports and contract manufacturing are also key areas attracting international capital.

4. What regulatory changes are influencing Shandong’s pharmaceutical landscape?

China’s reforms, including the implementation of ICH guidelines and accelerated approval pathways, enhance market access for innovative drugs developed in Shandong. Localization of clinical trials and quality standards also impact operational strategies.

5. How can companies leverage Shandong's logistics network for global expansion?

Access to major ports like Qingdao enables efficient export logistics. Companies should integrate digital supply chain solutions, optimize manufacturing footprints, and develop compliance frameworks aligned with international standards to expand globally.

References

[1] China National Pharmaceutical Industry Information Center, 2022.
[2] Shandong Provincial Government Reports, 2021.
[3] GlobalData. "Shandong Province Biopharmaceutical Outlook," 2022.
[4] China Food and Drug Administration (CFDA) Regulatory Guidelines, 2023.
[5] Industry Expert Insights, 2023.

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