EirGenix Leverages Dual Engines of CDMO and Biosimilars to Capitalize on Global Biopharma Supply Chain Realignment

As geopolitical tensions, the U.S. Biosecure Act, and reshoring initiatives reshape global pharmaceutical manufacturing, Taiwan-based EirGenix is positioning itself at the intersection of CDMO growth and biosimilar expansion. In an exclusive interview with GeneOnline, Dr. Portia Lin, Senior Vice President and Chief Business Officer at EirGenix, discussed how the company is navigating supply chain transformation, evolving customer demands, and emerging opportunities in biologics manufacturing.

From Globalization to Regionalization: Supply Chain Security Becomes a Strategic Imperative

The global pharmaceutical industry is undergoing a profound transformation. What was once a highly globalized ecosystem focused primarily on efficiency is increasingly shifting toward a regionalized model centered on supply security, resilience, and geopolitical risk mitigation.

According to Dr. Lin, this transition began years before the COVID-19 pandemic. Trade disputes and tariff wars had already prompted multinational companies to reassess supply chain strategies. The pandemic merely exposed vulnerabilities that many governments could no longer ignore.

“Increasingly, countries recognize that medicines are not just commercial products. They are strategic assets tied directly to public health and national security,” said Lin.

As governments elevate pharmaceutical supply chains to a national security priority, policy-driven changes are reshaping the entire industry. This shift is also redefining the role of contract development and manufacturing organizations (CDMOs).

Historically, CDMOs primarily provided manufacturing services. Today, however, customers expect far more. Drug developers increasingly seek partners capable of supporting multiple stages of product development and commercialization.

Many biotech startups operate under significant financial constraints. As a result, they look for CDMOs that can help overcome early development and financing challenges rather than simply execute manufacturing tasks.

“Many CDMOs are no longer focused solely on fee-for-service models,” Lin explained. “They are exploring more diversified collaboration structures that create mutual value.” She pointed to the investment-driven business model pioneered by companies such as WuXi AppTec. Under this approach, CDMOs invest in promising biotech startups, support development and manufacturing activities, and potentially participate in downstream licensing or commercialization revenues.

“EirGenix adopted similar thinking early on,” Lin said. “We collaborate with investment funds and biotech companies. If a program demonstrates strong potential, we may deepen our involvement or even consider acquisitions. At the same time, these partnerships provide greater visibility into future manufacturing demand and reduce operational uncertainty.”

As a result, modern CDMOs must develop capabilities that extend well beyond manufacturing. Regulatory expertise, flexible capacity management, accelerated development timelines, and global business networks are becoming equally important competitive advantages.

Different Customers, Different Priorities: Speed Versus Risk Mitigation

Customer expectations vary significantly depending on company size.

For emerging biotech companies, speed and cost efficiency remain paramount. The current financing environment has become increasingly challenging as capital continues to flow toward artificial intelligence investments.

Many biotech startups need critical data as quickly as possible to support subsequent fundraising efforts. Lin noted that resource-constrained companies often favor highly flexible, stepwise development strategies instead of committing to full end-to-end development programs.

“Some clients only require cell line development,” she explained. “Their immediate goal may simply be to demonstrate biological activity. In certain cases, they are not even ready to establish a stable cell line.” For these companies, successfully advancing a program toward Investigational New Drug (IND) submission often represents a major milestone.

Large pharmaceutical companies have very different priorities.

Rather than focusing primarily on cost, multinational pharmaceutical firms place greater emphasis on technical maturity, regulatory compliance, manufacturing reliability, and risk management. Most large pharmaceutical companies maintain substantial internal manufacturing capabilities. However, they frequently outsource selected projects because of the breadth of their development pipelines.

Breaking into these supply chains is extremely challenging.

Lin revealed that CDMOs must typically pass three critical evaluations before even entering consideration: technical audits, GMP audits, and environmental health and safety (EHS) assessments. Even after passing these reviews, suppliers face extensive additional scrutiny.

“Many large pharmaceutical companies outsource early-stage programs or selected development activities,” Lin explained. “However, once programs reach late-stage clinical development or commercial production, companies often prefer bringing manufacturing back in-house to maintain greater control and reduce supply risks.”

Although some mature products remain outsourced for economic reasons, major pharmaceutical companies generally prioritize top-tier CDMOs with deep technical expertise and proven execution capabilities. “For large pharma, minimizing development risk and ensuring timelines are met are often more important than price,” she added.

EirGenix’s Dual Strategy: Biosimilars and CDMO Operations Create Mutual Synergies

EirGenix occupies a unique position within Taiwan’s biotechnology sector. The company simultaneously operates a biosimilar development business and a CDMO platform. This dual-business model occasionally raises concerns regarding potential conflicts of interest. Lin believes the two businesses are highly complementary.

Biosimilar development requires substantial capital, advanced technical capabilities, and long-term commitment. Historically, developers often needed to complete both Phase I and Phase III clinical trials before securing regulatory approval. Without significant financial resources, sustaining biosimilar development can be difficult.

Lin noted that one of EirGenix Chairman Dr. Roger Liu’s original motivations for founding the company was to increase patient access to affordable biologic therapies. “Making high-quality biologics more accessible remains part of our core mission,” she said.

However, biosimilar development involves more than scientific and manufacturing challenges. Innovator companies frequently employ extensive patent litigation and lifecycle management strategies to delay market entry by competitors.

“Every additional day of patent exclusivity can represent millions of dollars in revenue for the originator company,” Lin noted. “That creates substantial uncertainty for biosimilar developers.”

This reality makes CDMO operations an attractive complement to biosimilar development. “CDMO services provide stable cash flow and help maximize facility utilization,” Lin explained. “That supports our long-term biosimilar strategy.” Regarding competitive concerns, EirGenix maintains strict internal safeguards. “We simply do not accept projects that overlap with our own proprietary biosimilar programs,” she said.

The company’s biosimilar portfolio currently focuses on selected oncology targets, while CDMO projects span a broad range of therapeutic areas and technologies.

To reinforce separation, EirGenix operates its BioPharma and BioManufacturing divisions as independent business units. Project management, regulatory affairs, manufacturing operations, and capacity planning are all managed separately.

“We even separate them by floor,” Lin said with a laugh. Before accepting new CDMO projects, EirGenix conducts detailed resource and capacity assessments to ensure sufficient personnel and manufacturing availability.

Navigating Geopolitical Uncertainty Through Global Diversification

Geopolitical tensions have become one of the defining challenges for global pharmaceutical manufacturing. The proposed U.S. Biosecure Act and broader policy initiatives supporting domestic production have prompted pharmaceutical companies to reassess sourcing strategies.

Lin believes the “Made in USA” movement could significantly influence future manufacturing decisions. Some customers continue to express concerns about geopolitical risks across Asia, even though Taiwan is not subject to the same restrictions facing China. As a result, EirGenix has adopted an early-engagement strategy in the United States.

The company primarily collaborates with startups, academic institutions, and hospital-based programs during early development stages. Current projects focus on molecule development and proof-of-concept-to-IND activities.

EirGenix also maintains dedicated business development resources in the United States to support client engagement. For longer-term expansion, the company remains open to acquiring manufacturing facilities in the U.S. to address evolving localization requirements.

Japan represents another key market. According to Lin, Japan lacks sufficient large-scale commercial biologics drug substance manufacturing capacity. Many Japanese pharmaceutical companies prefer licensing partnerships rather than investing heavily in new manufacturing infrastructure.

EirGenix has already established a strong presence in the market. The company currently supplies two commercialized customer products to Japan and expects two additional customer products to pursue regulatory approvals across multiple countries beginning in 2027.

At the same time, EirGenix continues to explore additional partnerships in Japan and other international markets. Another emerging opportunity comes from evolving biosimilar regulations. Global regulatory agencies are increasingly moving toward reducing or eliminating certain Phase III clinical trial requirements for biosimilars.

Lin considers this trend could attract more traditional generic drug manufacturers into the biosimilar market. Many of these companies lack biologics development and CMC expertise, creating additional opportunities for experienced CDMOs.

Capacity Secured Through 2030 as EirGenix Expands Its Global Manufacturing Vision

Biologics manufacturing remains one of the most capital-intensive sectors within the pharmaceutical industry. Building facilities, obtaining GMP certifications, and securing global regulatory approvals require years of investment and execution. These barriers create substantial competitive advantages for established manufacturers.

Lin disclosed that EirGenix’s Hsinchu facility currently operates two manufacturing lines, each equipped with six 2,000-liter bioreactors. Based on current projections, available capacity should be sufficient through 2030. However, several internally developed biosimilars are expected to approach commercialization around that timeframe. Consequently, EirGenix has already begun planning its next growth phase.

The company has reserved land in Kaohsiung’s Qiaotou Science Park for potential future expansion. It is also evaluating acquisition and partnership opportunities involving existing biologics manufacturing facilities in the United States and other international locations. Such strategies could significantly shorten facility construction timelines while reducing geopolitical exposure.

Hybrid CDMO Models Create New Value Beyond Manufacturing

Looking ahead, Lin believes the future of CDMO services lies in hybrid business models that extend beyond traditional contract manufacturing.

EirGenix already leverages its regulatory expertise to support customer submissions. The company also helps clients identify commercialization opportunities and potential market partners. “Future CDMO relationships will not be limited to simple manufacturing transactions,” she said.

One example is cross-border licensing facilitation.

A European biotechnology company may engage EirGenix to develop a biologic product while simultaneously seeking commercialization partners in Asia or Japan. Through its established regional network, EirGenix can help identify licensing partners, creating additional revenue opportunities for clients while generating future manufacturing business.

Another model involves exchanging market rights for development services.

Taiwan’s National Drug Resilience Program actively supports domestic biosimilar development. When international clients possess products with strategic relevance to Taiwan’s healthcare system, EirGenix may negotiate local commercialization rights as part of broader collaboration agreements. “It is a flexible structure that can benefit all stakeholders,” Lin emphasized.

From the “Two Trillions, Twin Stars” Initiative to the Next National Economic Pillar

Despite ongoing discussions about geopolitics, capacity expansion, and global competition, Lin identified talent as the industry’s greatest long-term challenge.

Having spent more than 25 years in pharmaceutical development, she has witnessed Taiwan’s biotechnology sector evolve from its early beginnings through the Two Trillion and Twin Star initiative and into today’s ambitions of becoming the country’s next strategic industry.

“The semiconductor and AI industries exert tremendous attraction for talent,” she said. “That pressure affects every other sector, including biotechnology.”

While government support remains important, Lin believes companies must ultimately attract and retain talent through strong execution, meaningful career opportunities, and long-term growth prospects. EirGenix currently manages four to five Process Performance Qualification (PPQ) projects annually as multiple programs advance toward commercialization. Although PPQ activities are highly demanding, they also provide valuable opportunities for teams to accumulate real-world experience.

As the interview concluded, construction continued outside the windows of the rapidly expanding Hsinchu Biomedical Science Park. Lin reflected on Taiwan’s position within the global CDMO landscape.

“Some people are optimistic, while others remain cautious,” she said. “But I believe Taiwan’s CDMO industry has meaningful advantages.” She highlighted Taiwan’s reputation for integrity, flexibility, and responsiveness.

“Many clients tell us they are impressed by EirGenix’s communication efficiency and service quality.”

As global pharmaceutical supply chains continue to evolve, Taiwan’s biotechnology industry is searching for its next defining growth engine. With a dual focus on biosimilars and CDMO services, EirGenix is positioning itself to play a meaningful role in that future while remaining committed to its original mission of improving patient access to biologic medicines.

Author

Steven Chung

紅杏枝頭春意鬧固然是眾人所追求的風景，但我願意說，青蘿拂行衣更能湧生感嘆。 願在海量晦澀的生醫資訊中，為您點亮一座心燈塔。鐘煌翔