Home PharmaGend: A Chinese Pharma’s 'New Globalization' Blueprint for Overseas Expansion

PharmaGend: A Chinese Pharma’s 'New Globalization' Blueprint for Overseas Expansion

Jun 24, 2024 07:59 CST Updated 08:00
PharmaGend Global Medical Services

Contract Development and Manufacturing Organization

As the only developed country in Southeast Asia, Singapore is known as the “City of Wealth” and stands as the fourth-largest international financial center after New York, London, and Hong Kong, China. In recent years, Singapore has attracted numerous multinational corporations to establish their presence, with one-third of Fortune Global 500 companies choosing to set up their Asian headquarters there. Major international pharmaceutical companies have also established manufacturing facilities in Singapore, leading some entrepreneurs to refer to the city-state as the “Capital of Southeast Asia.”

 

With the accelerated development of Chinese pharmaceutical companies, expanding overseas has become a strategic imperative. Since last year, domestic biopharmaceutical firms such as Junshi Biosciences, WuXi AppTec, GenScript Biotech, and Fosun Pharma have successively established their presence in Singapore. It is evident thatThe “new globalization” closed-loop model, in which Chinese new drugs utilize Singapore as a formulation manufacturing base before being sold to global markets, is gradually taking shape.

 

Not long ago, the “2024 HIEA Overseas Industrial Park Tour – Southeast Asia Opportunities and Global Expansion Prospects,” jointly organized by Legend Capital and the Healthcare Innovation Ecosystem Alliance (HIEA), was successfully held. During the event, leading Chinese healthcare companies engaged in in-depth exchanges and matchmaking with Singaporean government agencies and local enterprises, aiming to further explore business collaboration opportunities for Chinese medical firms in Southeast Asia and facilitate the global expansion of China’s healthcare innovation industry.


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The event was held at the PharmaGend facility in the Tuas Biomedical Park, Singapore, where attendees had the opportunity to tour the plant. PharmaGend is jointly invested in by CMS MEDICAL VENTURE PTE. LTD., a wholly-owned subsidiary of China Medical System (CMS) Holdings Ltd.; Rxilient Health (Kanglianda Health), a non-wholly-owned subsidiary; Pharmaron; and Legend Capital. The company acquired the Singaporean factory to launch its contract manufacturing organization (CMO) business for finished pharmaceutical products in Southeast Asia. Seizing this opportunity,VCBeat Conducted an Exclusive Interview with Han Yinglin, CEO of PharmaGend, and Zhu Danian, President of PharmaGend.


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(Second from left: Han Yinglin, CEO of PharmaGend; second from right: Zhu Danian, President of PharmaGend)


The following is a transcript of the interview:

 

VCBeat: What advantages does the “Made in Singapore” label offer?

 

Zhu Danian: PharmaGend was founded with the mission of advancing the pharmaceutical industry through cutting-edge science and technology. The company’s shareholders recognized a market demand for high-quality, reliable pharmaceutical manufacturing services that comply with stringent international standards. By establishing its operational hub in Singapore, PharmaGend aims to leverage the country’s robust regulatory framework and global reputation for quality to solidify the foundation of its overseas operations.

 

The “Made in Singapore” label is a significant asset for Chinese pharmaceutical companies. Singapore’s stringent regulatory standards and rigorous quality control measures enhance product credibility and market competitiveness. This label facilitates easier access to international markets for Chinese pharmaceutical firms, as “Made in Singapore” signifies reliability and high quality. Furthermore, products manufactured in Singapore typically command higher market valuations, offering a competitive edge in the global pharmaceutical market.


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VCBeat: How is PharmaGend's business performance?

 

Han Yinglin: PharmaGend’s CMO operations in Singapore encompass a broad range of pharmaceutical manufacturing services, with the company aiming to commence production of its first commercialized product by the end of this year. Its facility located in Tuas Biomedical Park is designed to meet the highest standards of quality and efficiency:

1. Production Capacity: The factory boasts world-class production capabilities, with existing facilities capable of producing 1 billion tablets and hard/gelatin capsules annually. This high throughput is enabled by advanced machinery and an integrated quality system.

2. Technological Advancement: The facilities are equipped with world-class technologies, including multi-layer coating machines, high-capacity blister packaging lines, and comprehensive serialization capabilities. These technologies ensure the precision and efficiency of the production process. Meanwhile, through deep collaboration with shareholders, the company has reached the forefront of the industry in formulation R&D, laying a solid foundation for its future business development.

3. Regulatory Certifications: The factory has obtained certifications from multiple regulatory agencies and is expected to secure approvals from the HSA, FDA, and NMPA within the year. These certifications demonstrate that the facility complies with stringent international quality standards, enabling PharmaGend to serve multiple global markets.

4. Integrated Quality Management System (QMS): PharmaGend’s operations are built upon an integrated QMS, ensuring consistent product quality and compliance with regulatory requirements. The system incorporates real-time monitoring, data integrity controls, and electronic quality management tools.

5. Future Expansion: PharmaGend plans to expand its manufacturing capacity through a two-phase construction project, adding new production lines. This expansion includes a new packaging center with seven new packaging lines and seven new production lines for specialized dosage forms—such as nasal sprays, creams, ointments, eye drops, and injectables—each equipped with an independent air handling system. Some of these new production lines are expected to be completed as early as 2025. These expansions will further enhance the company’s ability to meet diverse market demands.

 

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PharmaGend Tablet Coating Machine


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PharmaGend Blister Cartoner Machine

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PharmaGend Tablet Compression Machine


VCBeat: How will PharmaGend ensure supply chain stability and logistics timeliness?

 

Han Yinglin: Singapore is one of the world’s logistics hubs, with 24 of the top 25 global logistics companies establishing a presence there, including 10 that specialize in providing logistics solutions for the biopharmaceutical industry. PharmaGend ensures supply chain stability and logistical timeliness, while guaranteeing that products comply with international and Chinese quality standards and regulatory requirements, through the following measures:

1. Diversified Supply Chain: PharmaGend establishes a diversified supply chain network to ensure multi-channel sourcing of raw materials and critical components, thereby mitigating risks associated with reliance on a single supplier.

2. Real-Time Logistics Management: PharmaGend leverages an advanced logistics management system to track shipments in real time and optimize transportation routes, ensuring efficient and timely delivery.

3. Rigorous Quality Control: PharmaGend implements strict quality control measures throughout the production process to ensure that its products comply with both international and Chinese quality standards.

4. Regulatory Compliance: PharmaGend maintains close engagement with international and Chinese regulatory authorities to ensure that its products and manufacturing processes remain in full compliance with the latest regulatory requirements.

5. Continuous Improvement: PharmaGend is committed to the continuous improvement of its quality management system, conducting regular internal audits and training to ensure ongoing enhancement of product quality and compliance.

 

VCBeat: In future collaborations with Chinese pharmaceutical companies, which areas or types of drug R&D and manufacturing will you primarily focus on and support?

 

Zhu Danian: In its collaborations with Chinese pharmaceutical companies, PharmaGend will focus on and support drug research and development as well as manufacturing in the following areas:

1. Innovative Drug R&D: PharmaGend will support its Chinese partners in the development and production of innovative drugs. The company’s advanced manufacturing capabilities and compliance with Good Manufacturing Practice (GMP) standards across multiple countries enable efficient, high-quality production while facilitating simultaneous drug registration in multiple jurisdictions.

2. Biopharmaceutical Fill-Finish: PharmaGend plans to leverage its advanced biopharmaceutical fill-finish facilities and technologies to assist Chinese pharmaceutical companies in completing the final fill-finish stage of biologics production.

3. Efficient Generic Drug Production: PharmaGend will support the R&D and production of efficient generic drugs, helping Chinese pharmaceutical companies launch high-quality generic drug products in the global market.

4. Complex Formulation Development: PharmaGend will assist in the development of complex formulations, such as extended-release tablets, controlled-release capsules, nasal sprays, and pre-filled syringes, to meet market demand for diverse drug delivery forms.

5. Supplementing and Enhancing the Overseas Supply Chain: PharmaGend will serve as a critical link in the overseas supply chain for pharmaceuticals imported into mainland China, acting as an alternative to overseas manufacturing facilities and becoming a key overseas production base for drugs imported into the mainland.


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 PharmaGend Bottle Primary Packing Machine


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PharmaGend Bottle Secondary Packing Machine


VCBeat: What are PharmaGend’s specific development plans and goals for the coming years?

 

Han Yinglin: In the coming years, PharmaGend's specific development plans and objectives include:

1. Expand Production Capacity: PharmaGend plans to further enhance its production capacity by adding new production lines and expanding existing facilities to meet growing market demand.

2. Increase R&D Investment: PharmaGend will increase its investment in research and development to drive the development of novel formulations and technological upgrades of existing ones, thereby maintaining its technological leadership.

3. Deepening International Cooperation: PharmaGend plans to deepen its collaboration with global pharmaceutical companies, expand into international markets, and enhance its global competitiveness.

4. Enhance Brand Influence: Through continuous marketing and customer relationship management, PharmaGend will enhance its brand influence and establish an image as an industry leader.

5. Sustainable Development: PharmaGend will advance green manufacturing and sustainable development strategies to reduce environmental impact and fulfill its corporate social responsibility.


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Zhu Danian: In the long term, PharmaGend's long-range objectives include:

1. To Become a Globally Leading CDMO: By continuously enhancing its technical capabilities and service standards, PharmaGend strives to become a globally leading contract development and manufacturing organization.

2. Driving Innovation in the Pharmaceutical Industry: PharmaGend is committed to advancing innovation within the pharmaceutical sector by developing more innovative drugs that benefit human health.

3. Building a Global Supply Chain Network: PharmaGend plans to establish a global supply chain network to ensure rapid and efficient delivery of products worldwide.

4. Achieving Sustainable Growth: PharmaGend will achieve long-term sustainable growth by optimizing operations, enhancing efficiency, and expanding market share, thereby maintaining its industry leadership.


Conclusion


As decoupling between China and the United States accelerates and Chinese innovative drugs urgently require market commercialization, Singapore has emerged as a strategic beachhead for global expansion, serving as a “second battlefield” for Chinese pharmaceutical companies. From an industry development perspective, recouping R&D investments and achieving premium pricing for products are essential to fueling further novel drug development and continuously exploring and addressing more unmet clinical needs.

 

PharmaGend, a representative formulation CDMO, is becoming a "shortcut" for Chinese pharmaceutical companies going global, leveraging its professional expertise in drug development and manufacturing, international service network, and flexible cooperation models. By providing one-stop customized services—including but not limited to drug formulation development, process scale-up, and commercial manufacturing—PharmaGend offers robust support for the internationalization strategies of Chinese pharmaceutical enterprises. As the global pharmaceutical market continues to integrate and develop, PharmaGend is poised to play an even more significant role in the global expansion of Chinese pharmaceutical companies.