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Last Updated: April 22, 2025

Shandong Luye Company Profile


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Summary for Shandong Luye
International Patents:29
US Patents:5
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Shandong Luye

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-003 Jan 13, 2023 RX Yes No 10,098,882 ⤷  Try for Free Y ⤷  Try for Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-001 Jan 13, 2023 RX Yes No 9,446,135 ⤷  Try for Free Y ⤷  Try for Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-004 Jan 13, 2023 RX Yes No 9,532,991 ⤷  Try for Free Y ⤷  Try for Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-002 Jan 13, 2023 RX Yes Yes 10,406,161 ⤷  Try for Free Y ⤷  Try for Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-003 Jan 13, 2023 RX Yes No 10,406,161 ⤷  Try for Free Y ⤷  Try for Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-002 Jan 13, 2023 RX Yes Yes 10,098,882 ⤷  Try for Free Y ⤷  Try for Free
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-001 Jan 13, 2023 RX Yes No 10,098,882 ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

International Patents for Shandong Luye Drugs

CountryPatent NumberEstimated Expiration
European Patent Office 3772354 ⤷  Try for Free
European Patent Office 2701687 ⤷  Try for Free
Japan 5728128 ⤷  Try for Free
Russian Federation 2586306 ⤷  Try for Free
South Korea 101932207 ⤷  Try for Free
South Korea 20140026481 ⤷  Try for Free
Spain 2855349 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for Shandong Luye Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0196132 94C0008 Belgium ⤷  Try for Free PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 1 of 1 entries
Similar Applicant Names
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Shandong Luye Pharmaceutical: A Comprehensive Analysis of Market Position, Strengths, and Strategic Insights

Shandong Luye Pharmaceutical, also known as Luye Pharma Group, has emerged as a significant player in the global pharmaceutical industry. This article delves into the company's market position, strengths, and strategic insights, providing a comprehensive analysis of its competitive landscape.

Company Overview

Luye Pharma Group, founded in 1994, has grown from a small local pharmaceutical company to an international pharmaceutical powerhouse[1]. The company focuses on four key therapeutic areas: oncology, cardiovascular, metabolism, and central nervous system (CNS)[1]. With a global presence spanning China, Germany, the United States, Switzerland, Japan, Malaysia, and Singapore, Luye Pharma has positioned itself as a formidable competitor in the pharmaceutical industry[1].

Market Position

Luye Pharma has established a strong market position, particularly in its home market of China. The company's portfolio includes around 30 market-approved products, with 21 approved in China and seven in international markets[1]. Several of its products are market leaders in their respective categories:

  • Lipusu: 35% market share
  • Xuezhikang: 97% market share
  • Maitongna: 66% market share
  • CMNa: Full market share[2]
According to the company, Lipusu ranked number one in market share with 35% market share; Xuezhikang had 97% share; Maitongna accounted for 66%, and CMNa occupied the full market.[2]

This dominant market position in key products has contributed significantly to Luye Pharma's growth and success.

Financial Performance

Luye Pharma has demonstrated strong financial performance in recent years. In the first half of 2023, the company reported:

  • An 18.7% increase in product sales revenue to RMB2,784.5 million
  • A 1.9% increase in total revenue to RMB2,904.1 million[6]

These figures indicate robust growth and financial health, positioning Luye Pharma favorably in the competitive pharmaceutical landscape.

Market Growth Potential

The pharmaceutical market in China, Luye Pharma's primary market, shows promising growth potential. The market size increased from RMB1,551.2 billion in 2018 to RMB1,763.9 billion in 2023, with a CAGR of 2.6%[4]. This growth trajectory suggests a favorable environment for Luye Pharma's continued expansion.

Key Strengths

1. Diverse Product Portfolio

Luye Pharma's product portfolio spans four of the fastest-growing therapeutic areas: oncology, cardiovascular, metabolism, and central nervous system[1]. This diversification helps mitigate risks associated with market fluctuations in any single therapeutic area.

2. Strong R&D Capabilities

The company has invested heavily in research and development, with over 400 employees engaged in R&D activities[1]. Luye Pharma has established a Laboratory for Long-acting and Targeting Drug Delivery Systems, focusing on developing novel drug delivery technologies[5].

3. Global Presence

With production facilities and R&D centers in China and Germany, as well as offices in several countries, Luye Pharma has established a truly global footprint[1]. This international presence allows the company to tap into diverse markets and talent pools.

4. Strategic Acquisitions and Collaborations

Luye Pharma has pursued strategic acquisitions and collaborations to strengthen its market position. Notable examples include:

  • Acquisition of Seroquel from AstraZeneca[2]
  • Collaboration with AstraZeneca to promote Xuezhikang globally[10]
  • Acquisition of Shandong Boan Biological Technology Co., Ltd. to expand into biopharmaceuticals[10]

Strategic Insights

1. Focus on Innovation

Luye Pharma's strategy is heavily focused on innovation. The company has over 40 drug candidates in China and over 10 in international markets[10]. This robust pipeline positions Luye Pharma for future growth and market expansion.

2. Internationalization

The company has adopted an "internationalisation" development strategy[6]. This approach aims to expand Luye Pharma's global footprint and reduce dependence on any single market.

3. Expansion into Biopharmaceuticals

With the acquisition of Shandong Boan Biological Technology Co., Ltd., Luye Pharma has signaled its intent to expand into the biopharmaceutical sector[10]. This move diversifies the company's portfolio and opens up new growth opportunities.

4. Strategic Partnerships

Luye Pharma has leveraged strategic partnerships to enhance its market position. The collaboration with AstraZeneca for Xuezhikang has resulted in impressive growth for the product[10].

Competitive Landscape

While Luye Pharma has established a strong position in the Chinese pharmaceutical market, it faces competition from both domestic and international players. The company's focus on innovation and internationalization helps differentiate it from many domestic competitors, while its strong local market position provides an advantage over international pharmaceutical giants.

Competitive Advantages

  1. Market leadership in key products
  2. Strong R&D pipeline
  3. Global presence
  4. Diversified product portfolio
  5. Strategic partnerships and acquisitions

Future Outlook

Luye Pharma's future outlook appears promising, driven by several factors:

  1. Robust pipeline of drug candidates
  2. Expansion into biopharmaceuticals
  3. Growing Chinese pharmaceutical market
  4. Increasing international presence
  5. Focus on high-growth therapeutic areas

Challenges and Risks

Despite its strong position, Luye Pharma faces several challenges:

  1. Intense competition in the pharmaceutical industry
  2. Regulatory hurdles in international markets
  3. Potential pricing pressures, especially in China's volume-based procurement system
  4. Need for continuous innovation to maintain market leadership

Key Takeaways

  1. Luye Pharma has established a strong market position, particularly in China, with several market-leading products.
  2. The company's focus on innovation and R&D has resulted in a robust pipeline of drug candidates.
  3. Strategic acquisitions and collaborations have strengthened Luye Pharma's market position and expanded its capabilities.
  4. The company's internationalization strategy aims to reduce market dependence and drive global growth.
  5. Expansion into biopharmaceuticals represents a significant growth opportunity for Luye Pharma.
  6. While facing challenges, Luye Pharma's diverse portfolio, strong R&D capabilities, and strategic focus position it well for future growth.

FAQs

  1. Q: What are Luye Pharma's main therapeutic areas of focus? A: Luye Pharma focuses on four key therapeutic areas: oncology, cardiovascular, metabolism, and central nervous system (CNS).

  2. Q: How has Luye Pharma expanded its global presence? A: Luye Pharma has expanded globally through strategic acquisitions, collaborations, and establishing offices and R&D centers in multiple countries, including China, Germany, the United States, Switzerland, Japan, Malaysia, and Singapore.

  3. Q: What is Luye Pharma's strategy for future growth? A: Luye Pharma's strategy for future growth focuses on innovation, internationalization, expansion into biopharmaceuticals, and strategic partnerships.

  4. Q: How does Luye Pharma's market position in China compare to other pharmaceutical companies? A: Luye Pharma holds strong market positions in China for several of its key products, with market shares ranging from 35% to 97% for products like Lipusu, Xuezhikang, and Maitongna.

  5. Q: What recent acquisitions has Luye Pharma made to strengthen its position? A: Notable recent acquisitions include Seroquel from AstraZeneca and Shandong Boan Biological Technology Co., Ltd., which has expanded Luye Pharma's capabilities in the biopharmaceutical sector.

Sources cited: [1] https://www.luyepharma.eu/en/about-us/luye-pharma-group [2] https://img3.gelonghui.com/pdf201811/pdf20181127082343144.pdf [4] https://www1.hkexnews.hk/app/sehk/2025/107116/a122093/sehk25012700736.pdf [5] https://www.luye.cn/lvye_en/aboutUS.php [6] https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0928/2023092802119.pdf [10] https://www.luye.com/en/info.php?id=282

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