Bora Pharmaceuticals Co., Ltd.

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Bora Pharmaceuticals, Taiwan's Leading CDMO: Model of Globalization for Taiwanese Biotech Industry Expanding from Local to Global Markets

Over the last decade, Bora Pharmaceuticals has swiftly grown through strategic mergers and acquisitions. Combined with solid integration and execution capabilities, Bora is able to become Taiwan's largest CDMO and compete with global players. This expansion has accelerated the development and distribution of new drugs at more accessible prices, invigorating the biopharmaceutical industry both in Taiwan and the world to bring forth more possibilities. Bora exemplifies through concrete actions that innovation is not only just crucial for boosting their competiveness as a company, but also a vital role in advancing enhancing human health and well-being.

The biopharmaceutical sector in Taiwan has evolved over decades. According to the 2023 Biotechnology Industry in Taiwan report by the Ministry of Economic Affairs, there are now 193 certified biopharmaceutical companies in Taiwan, collectively offering 492 products. Despite being a key component of the nation's industrial strategy, Taiwan's biotech industry, particularly in pharmaceuticals, has consistently faced several challenges.

Taiwanese biopharma companies are predominantly dedicated to new drug development. While the exact investment by various firms is hard to quantify, the drug development process - from research and development, pre-clinical trials, clinical trials, and to market approval - is notoriously lengthy, often spanning a decade or more. This process requires substantial financial outlay and has a high burn rate, which can stifle projects before they reach fruition. Companies also face decisions about whether to construct their in-house manufacturing facilities.

"The pharmaceutical sector in Taiwan grapples with the challenge of a small domestic market. The limited local demand for pharmaceuticals and health products creates a bottleneck, leading to market saturation for the traditional pharmaceutical sector. Expanding into international markets becomes imperative to overcoming these challenges," said Bobby Sheng, Bora Group CEO & Chairman. To address these challenges, Bobby Sheng initiated his "targeted therapy" strategy ten years ago.

Under Bobby Sheng's management, Bora has been methodically enhancing its capabilities as a CDMO (Contract Development and Manufacturing Organization), achieving both vertical and horizontal integration from distribution to developing and manufacturing.

In essence, a CDMO provides outsourced research, development, and manufacturing services for pharmaceutical companies. "By utilizing CDMO services, new drug developers can concentrate on innovation and brand management. This not only reduces costs but also speeds up product launches, allowing Taiwanese developers to gain an edge and showcase their capabilities globally," explained Bobby Sheng.

Forging New Paths to Establish a World-Class CDMO

A decade ago, recognizing the talent experiences and service ethos of Taiwan's OEM manufacturing sector, Bobby Sheng saw the potential for establishing a global CDMO service in Taiwan and chose to take the road no one took. The subsequent success of Bora has validated his foresight.

Since 2013, under Bobby Sheng's leadership, Bora has executed eight domestic and international mergers and acquisitions (M&As), becoming Taiwan's largest and most recognized CDMO in the biopharma industry. Bora now operates nine production facilities: For small molecule facilities, there are five in Taiwan, two in the United States, one plant in Canada, and a large molecule biopharma facility.

In 2023, Bora’s small molecule manufacturing facilities produced around 1.4 billion doses, encompassing six commercial products. Meanwhile, the large molecule facility successfully completed 14 commissioned development projects. Regarding new business expansion, Bora secured a total of 40 commissions on large/small molecule products and new business ventures in 2023. In 2022, its revenue surpassed the NT$10 billion (~US$310 million) mark, and in 2023, it climbed further to NT$14.2 billion (~US$441 million).

Driving Innovation: Embracing the Crucial Role of Manufacturing in Accelerating Drug Development

Bora is revolutionizing Taiwan's biopharmaceutical industry by transforming manufacturing responsibilities through its CDMO services. Offering one-stop support from clinical batches to commercial production, Bora challenges the conventional Taiwanese biotech model of a single company managing research, manufacturing, and sales. This approach enables drug developers to rapidly bring their products to market and capitalize on the critical patent period. A prime example is the collaboration between Shine-On BioMedical and Bora.

In early 2023, Bora began its collaboration with Shine-On BioMedical on their groundbreaking Nanobody-based Double Immune Checkpoints Trispecific T Cell Engager, Nano-TriTE (SOA101). Within just one year, Bora and Shine On successfully completed and optimized the process development, analytical method development, with verification and cGMP production for clinical trials. Shine-On has received favorable feedback from the US FDA, highlighting the success of this partnership with Bora.

Founded in April 2021, Shine-On is dedicated to the innovative development of targeted exosome cancer therapies and trispecific T cell engaging antibodies, aiming to provide patients with highly effective cancer treatment options. "Antibody technology is rapidly advancing, and multispecific antibodies are increasingly prominent in new drug development. Yet, globally, no trispecific antibody drugs have been successfully developed and marketed. We recognized a critical opportunity to be pioneers in this field, and Bora has been instrumental in our efforts to consistently deliver results on schedule," said Jennifer Ho, Deputy General Manager of Shine-On.

Shine-On selected Bora from numerous CDMOs primarily for its expertise in manufacturing bispecific antibody drugs and its rigorous quality control system, which adheres to both US FDA and EU standards. "Simply having a GMP (Good Manufacturing Practice) facility isn't enough, as this is standard across all CDMOs. The true foundation of successful collaboration lies in the team's experience, professional knowledge, and strong international communication skills," emphasized Jennifer Ho.

Additionally, the development and production of trispecific antibodies present unique challenges due to the absence of prior benchmarks. The complex structure of these antibodies poses unprecedented challenges in maintaining protein stability during scaling and purification processes. It is essential for CDMO providers to be equipped to address these novel challenges. For Shine-On, a positive attitude and strong problem solving capabilities are particularly crucial. "Whenever we present issues, the teams at both Bora and Shine-On collaborate to address them, with additional prompt support from Shine On's consultants in the US," noted Jennifer Ho. "Bora consistently resolves issues quickly, devising and implementing solutions within the scheduled timeframe." After more than a year of collaboration, Shine-On regards Bora as a partner rather than just a contractor.

It's noteworthy that partnering with Bora has enabled Shine-On to effectively manage the costs associated with early clinical trials. Looking forward, there is optimism that the cost structure will be further optimized during the mass production phase. "Using the analytical method validation and GMP drug production for SOA101's drug process development as an example, Bora has helped us ensure drug quality, suitable costs, and fast development timelines. This serves as a compelling case for addressing the ongoing challenges in Taiwan's biopharmaceutical industry," concluded Jennifer Ho.

Precise Evaluations and Valuing Talent: Keys to Successful Integration

In a mere decade, Bora has significantly expanded its production capacity and technological scale, establishing itself as a leading manufacturing partner for new drug development at home and abroad. How did Bora manage to achieve such remarkable growth? The answer is: eight successful M&As over the past decade. "The key to Bora's success lies in its focus on professional contract manufacturing and its knack for strategic M&As. This strategy has propelled rapid growth, with every M&A bringing substantial benefits," said Alex Shih, Chairman of Taishin Securities Venture Capital Investment Co., Ltd. The partnership between Taishin Securities Venture Capital Investment and Bora encompasses Bora's IPO, fundraising, transition from OTC to the Taiwan Stock Exchange, and the establishment of a health fund, highlighting their strong relationship.

Bobby Sheng, who evaluates around 80 cases annually, explained his approach to ensuring precision in M&As: "Before pursuing an M&A, it's crucial to first understand your company, clearly define its development direction, and use that understanding to choose suitable targets. Choosing the wrong target from the start can complicate the process, hinder the execution, and potentially lead to future challenges if pursued forcefully." To ensure precision in his assessments, he has established standard operating procedures (SOPs) to evaluate the target company's condition, the capabilities of its management team, and other critical factors.

Moreover, Bobby Sheng emphasized that the most crucial aspect of successful M&As is a focus on talent. "With each M&A, the most valuable assets we obtain are not the facilities or equipment, but the international-level biotech professionals," he stated. From an observer’s perspective, Shih greatly admires Bora for its strong focus on personnel and corporate cultural integration during M&As. "This approach not only turns the employees involved into valuable assets for the company, but it also builds a strong reputation for Bora. It instills confidence in international pharmaceutical companies like GSK to entrust their facilities to Bora," Shih noted.

Unlocking Global Opportunities: Gaining Unique Insights into International Markets

Bora's transformative journey into M&As started with the 2013 purchase of the Tainan facility from Eisai, a Japanese pharmaceutical company. This move marked Bora's transition from a sales agency to a CDMO, making it the first traditional drug agency in Taiwan to venture into the CDMO sector. In 2014, UNION CHEMICAL & PHARMACEUTICAL, a prominent Taiwanese pharmaceutical company, approached Bobby Sheng with an offer to sell its manufacturing plant and 185 drug licenses to Bora.

In 2017, facing declining revenues from generic drugs, the U.S. Nasdaq-listed company Impax Laboratories decided to sell its Taiwan branch in Zhunan Science Park to raise funds. However, high operating expenses and insufficient production capacity at Impax Laboratories Taiwan made many established pharmaceutical companies hesitant to take it over.

Bobby Sheng had an innovative idea. Impax Laboratories Taiwan's Zhunan facility had an annual capacity of 2 billion tablets and capsules. At that time, it was the only pharmaceutical company in Taiwan that exports all of its drugs to the United States, also approved by the US FDA, UK MHRA, and TFDA. "Acquiring this facility offers us a golden opportunity as a stepping stone to the US pharmaceutical market," remarked Bobby Sheng. Reflecting on his bold decision, Bobby Sheng recognized that he was right, as evidenced by the outcomes. Bora became the first pharmaceutical company in Taiwan to successfully step out of the Asian market with a business model centered on CDMO services.

Acquisition of Renowned Pharmaceutical Company Shocks Global Biotech Industry

The acquisition of Impax Laboratories Taiwan was significant news in the biotechnology industry, but the subsequent merger and acquisition were truly groundbreaking. In December 2020, Bora, with annual revenues of less than NT$2 billion (~US$62 million), officially acquired the Canadian facility of GlaxoSmithKline (GSK), taking over a satellite facility from a company with revenues exceeding US$40 billion at the time. This bold move also marked the establishment of Bora's North American headquarters in Canada.

The task of acquiring a much larger company presented numerous challenges, as one might expect. Bobby Sheng recalled: "Initially met with skepticism, I personally flew to their UK headquarters to meet with them, communicated persistently, and leveraged our track record of past M&As to convince them." Bobby Sheng showcased Bora's strong execution capabilities, demonstrated through the success of several past M&As. These efforts effectively improved the output efficiency and cost advantages of assets, consistently creating a win-win for both the buyer and seller. Furthermore, Bora's commitment to high-quality contract manufacturing, including focus on customer service, and solid reputation in the global pharmaceutical industry were key factors that ultimately sealed the deal.

Despite further challenges in the facility takeover later due to the pandemic, the effort proved worthwhile. Bobby Sheng guided Bora to make history once again, as it became the first Taiwanese company to successfully acquire a world class pharmaceutical facility. Consequently, Bora uniquely positioned itself among the global top ten pharmaceutical supply chains.

s 2022 unfolded amidst the ongoing COVID-19 pandemic, Bora completed two M&As. One was TWi Pharmaceuticals, including its BPO facility. "For Taiwanese ophthalmic drugs to reach the international market, it was necessary to have a pharmaceutical manufacturing facility approved by the US FDA. Therefore, our team collaborated with American consultants to enhance the quality system, and refine the SOPs, and in 2023, we passed the FDA inspection, becoming the only ophthalmic pharmaceutical company in Taiwan that could export to the US," Bobby Sheng explained the significance of acquiring TWi Pharmaceuticals.

Expanding into Large Molecule Drugs:Broadening Its CDMO Footprint

Bora also transitioned from small molecule to large molecule through M&A, marking a pivotal expansion in Bora's CDMO operations. Large molecule drugs, often referred to as biologics, are created using biotechnology in microorganisms, as well as animal and plant cells. These include substances like insulin, monoclonal antibodies, protein drugs, and nucleic acid drugs, primarily used to treat chronic diseases, cancer, and other serious illnesses. The CDMO market for biologics is experiencing a growth rate of over 11.5%, outpacing the global CDMO market's compound annual growth rate of 7%, indicating biologics as a significant driver of future growth in the biotech industry. Once the opportunity arose to enter the biologics market, Bobby Sheng did not miss it.

Leveraging Bobby Sheng's convincing communication and negotiation skills, Bora acquired the assets of Eden Biologics, including its teams, projects, and equipment to establish a molecular biopharmaceutical facility in Zhubei. This move officially marked Bora's entry into the fields of large molecule antibody drugs, successfully entering into the supply chain of biologics CDMO.

This acquisition established Bora as the first and only CDMO in Taiwan capable of providing a comprehensive range of both large and small molecule drugs. Bora is also actively evaluating opportunities to integrate various advanced technologies and future applications such as the field of cell and gene therapy. Bobby Sheng noted, "Although these next-generation technologies and related applications are still in their initial stages, they are definitely among the main drivers of future industry growth. If we can establish an early presence and prepare in advance, we are confident in overcoming the challenges from customization to mass production."

The global CDMO market is growing and competition is intensifying. "This is a field where production volume and technical scale are crucial, so our aim is to break into the top ten CDMOs worldwide and strive to prevail in the competition among the major players," Bobby Sheng explained. In the global CDMO ecosystem, developed countries in Europe, America, along with Asian nations like China, South Korea, and Japan have traditionally led

the way. Bora is demonstrating with its capabilities that Taiwan will emerge as a formidable contender.

Advancing towards its goal of joining the top ten CDMOs globally, Bora is continuing its M&A strategy. Earlier this year (2024), the company successfully acquired Upsher-Smith, an American pharmaceutical company jointly owned by Japanese pharmaceutical company Sawai Group Holdings Co., Ltd., and Sumitomo Corporation Group. Following this acquisition, the facility will not only serve as Bora's initial stronghold in the US domestic market, but will also position Bora as one of the largest manufacturers of oral solid dosage forms in the United States. Bora plans to utilize this larger-scale production facility base to further expand into the global CDMO market, accelerating the company’s expansion and growth in the global market.

Robust Fundraising Capabilities: Building a Solid Cushion for Bora

Andrew Fuh, Bora's CPA and Managing Partner at Ernst & Young Taiwan, has witnessed Bora's growth firsthand. Ernst & Young has fully committed to supporting Bora's M&As. "Honestly, raising funds in Taiwan's biopharmaceutical industry

is quite challenging. However, Bora has navigated these hurdles through a well-rounded strategy that includes private/institutional investments, bank financing, and various funding avenues like IPOs," he explained.

Fuh credits Bobby Sheng's charismatic leadership and communication skills as key elements to Bora's fundraising successes. "His sharp insight into industry trends is remarkable," Fuh noted. "He accurately foresaw the trend towards shortening supply chains and strategically expanded production bases from Taiwan to America, achieving the goal of localized manufacturing."

Looking ahead, Bobby Sheng outlines two primary objectives for Bora. The first is numbers, focusing on continuous revenue growth. The second is mission-oriented: "We aim to boost Taiwan's presence in the global pharmaceutical market, showcasing Taiwan's capacity to produce high-quality drugs that can benefit the global community," he explained. As a leading figure in Taiwan's pharmaceutical CDMO industry, Bora Pharmaceuticals remains committed to innovation and aspires to become among the top ten CDMOs globally.

Mantra for Success

• By moving beyond traditional pharmaceutical business model and targeting the global CDMO market, Bora Pharmaceuticals has completed eight domestic and international mergers and acquisitions in ten years. This expansion across different dosage forms and markets has made Bora the largest CDMO in Taiwan, leading the globalization of the domestic pharmaceutical industry.
• With eight small molecule drug facilities and a biologics plant, Bora stands as the only CDMO in Taiwan capable of providing both large and small molecule drugs. It supplies to over 100 countries worldwide, showcasing strong international competitiveness.
• A small player taking over a giant, Bora Pharmaceuticals successfully acquired GlaxoSmithKline's Canadian facility, becoming the first Taiwanese biotech company to acquire a world-class pharmaceutical plant. This achievement uniquely positioned Bora within the supply chain of the world's top ten pharmaceutical companies.
• Bora has formed a CDMO community in Taiwan that supports domestic pharmaceutical R&D companies in shortening submission schedules, entering the international market, and showcasing Taiwan-made drugs to the world.

得獎感言－Bora Pharmaceuticals Co., Ltd. Bobby Sheng CEO of Bora

To remain competitive, especially in the manufacturing sector, enterprises must achieve certain economies of scale and capital market cap.

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• Date of announcement：2024/12/02
• Last updated： 2026/07/22
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