From Laboratory to Deal-making Table: Navigating Challenges in Global Business Development and Due Diligence

According to analysis by Global Information, the global immuno-oncology market is projected to expand from $125.9 billion in 2024 to $634.1 billion by 2034, representing a compound annual growth rate of approximately 17.5%. Competition within the market is also intensifying, giving rise to multiple billion-dollar transactions in recent years, ranging from licensing agreements for drugs or technologies, co-development partnerships, to product or company acquisitions.

As a global player in this enormous market, HanchorBio has leveraged its proprietary FBDB™ technology platform to develop the fusion protein-based HCB101. Subsequently, the company started tackling the challenging development of tri-specific biologics, creating the first-in-class HCB301 and HCB303. For this reason, the Taipei-based clinical-stage biotech has garnered attention from several big pharma companies, and is actively seeking regional and international partners for its drug candidates. Following the signing of an exclusive licensing agreement with Henlius for HCB101 in Greater China, Southeast Asia as well as the Middle East and North Africa (MENA) in June 2025, further licensing negotiations are underway in Japan, Korea and Europe. In some cases, the company has also signed confidential disclosure agreements (CDA) with potential partners and already entered the due diligence phase.

GeneOnline is honored to feature an exclusive interview with Dr. Yuehua Cong, Hanchor’s Chief Business Officer (CBO). During the conversation, she not only shared her invaluable experience in life science business development (BD) and investment across the US, Europe and Greater China, but also discussed Hanchor’s BD and licensing strategies, the logic behind deal evaluations, and priorities in due diligence.

Toward a BD Strategy Balancing Scientific Innovations and Business Realities

After earning her doctorate in organic chemistry in Germany, Dr. Cong joined the founding scientific team at UK-based PolyTherics, where she participated in the development of its first-generation ADCs. She later transitioned into life sciences BD and investment, holding positions at PolyTherics, F-star Biotech, and China’s Simcere Pharmaceutical before joining HanchorBio. In these roles, she led the BD operations for these companies, closing multiple international licensing deals with total values ranging from USD 400 million to 1.2 billion.

Having personally witnessed two defining industry cycles—the innovation growth phase in the US and EU (2007–2016) and the accelerated globalization phase of China’s biotech ecosystem (2016–2025),  Dr. Cong noted that these cross-regional and cross-functional experiences have equipped her with both technical expertise and familiarity with the decision-making process and investment logic of global pharmas. This foundation has enabled her to effectively lead Hanchor’s BD team, which can be summarized in three key elements: global vision, core values, and scientific narrative – all aimed at creating long-term synergies for both sides.

Among innovative drugs approved globally, at least half of them come from emerging biopharma companies like HanchorBio. “We are in a ‘global knockout race’, where challenges and competitions come globally,” said Dr. Cong. Recognizing this, she emphasized that Hanchor has embraced a global vision since its inception, aspiring to “develop world-class innovative drugs and serve patients worldwide.” Only by targeting global patients can the company access vast international markets and achieve greater commercial returns.

Despite navigating market and policy fluctuations over the past five years, Dr. Cong remains steadfast in her belief that only through robust and powerful evidence can the company’s scientific innovations gain recognition and acceptance from the market. She also reiterated that patients’ well-being is always at the core of the biopharma industry, and all innovations must ultimately deliver tangible benefits to patients. Having established this core value, she believes the BD team is not merely tasked with securing individual deals. Rather, they must deliver a clear and compelling scientific narrative for each product, enabling potential partners to appreciate its uniqueness and clinical value, thus differentiating it within the highly competitive immuno-oncology landscape. In essence, clinical science establishes a product’s value, while business development makes that value visible.

Dr. Cong’s philosophy outlines a well-defined BD logic, on one hand pursuing the international advancement of promising scientific deliverables like HCB101, while on the other hand mitigating risks through a BD process that balances scientific innovation with business realities. Furthermore, the BD team must select like-minded partners to “grow the pie together,” thus amplifying commercial success and achieving long-term mutual benefits.

Keys to Global Relevance: Data, Proactivity and Deal Readiness

Speaking on ways for Taiwanese biopharma companies to enhance their visibility on the global stage and position themselves as potential collaboration partners for the major players, Dr. Cong drew upon her own experiences to propose a concrete and actionable methodology, not only for HanchorBio, but also for other biotech start-ups or SMEs to follow. This encompasses three key elements: world-class scientific data, a proactive and mature BD team, and cross-departmental deal readiness.

In Dr. Cong’s observation, many pharmas are not short on innovative ideas, yet the ability to provide authentic evidence of quality sufficient for deal-making is a totally different question. Robust research data definitely lay the foundation for all collaborations. However, she added: “Even the most compelling scientific principles and experimental data struggle to gain traction in the market unless they are consistently and clearly communicated across international platforms.” Therefore, biopharma companies must establish professional and proactive BD teams, which consistently and persistently engage on various platforms to effectively tell the company’s story and highlight the scientific value of their products.

“Deal readiness” was a key concept Dr. Cong stressed repeatedly throughout the interview. In her remarks, she emphasized that preparing for potential deals is not solely the role of the BD team, but rather a company-wide effort requiring cross-functional collaboration. This enables the company to deliver a complete, ready-to-use data package at the right moment, thus boosting the efficiency of subsequent licensing negotiations.

Taking HanchorBio as an example, prior to generating formal data packages, they create an internal virtual data room (VDR), a cloud-based platform designed for secure storage, sharing, and management of confidential documents. Through structured data organization, gap analysis, and cross-departmental calibration, the company gains a good grasp of the strengths and weaknesses of its data before entering formal negotiations and due diligence. This also allows them to proactively address areas that may be questioned by potential license partners.

Another example of how Hanchor enhances deal readiness is the international presence of their R&D professionals. Whether participating in major academic conferences with abstract presentations, publishing high-impact research in world-class journals (such as the recent feature in the Journal of Hematology & Oncology), or hosting R&D days, these efforts collectively build the company’s brand identity and scientific narrative, elevating Hanchor’s visibility and credibility within both academic and business sectors.

Perspective-taking in Handling Due Diligence

Due diligence is always an essential step for successful deal-making. Therefore, effectively navigating the process is essential for biopharma companies preparing for potential deals. Dr. Cong reminded, “Due diligence is not initiated at the point when the potential partner enters the data room. It kicks off at the moment both parties sign the CDA. From that day on, they will keep evaluating whether we are trustworthy enough to be their partner.” The entire process only concludes when the final agreement is signed and the VDR is closed.

She further pointed out that due diligence encompasses multiple dimensions including technology, legal compliance, business operations, and intellectual property (IP), each being core pieces of information highly valued by partners. Among these, the completeness of IP protection is often a major focus. For example, HCB101 has been granted full patent protection in the US, rather than remaining in the “patent application pending” stage. The levels of protection involved are very different, and this directly impacts partners’ confidence in the fusion protein.

Regarding technical data preparation, Dr. Cong proposed a simple yet critical benchmark: “Can our partners seamlessly take over our data package and replicate our results in their labs and clinical trials?” Guided by this principle, Hanchor’s team consistently takes the collaborator’s perspective, considering whether missing data might create operational gaps or hinder regulatory communications. This process involves cross-departmental simulations, anticipating potential questions from partners, developing Q&A lists, and conducting internal rehearsals. The goal is to prepare thoroughly, ensuring a smoother due diligence process and accelerating the deal-making process.

Proving the Promise: Addressing Market Skepticism with Concrete Scientific Data

As Hanchor’s current lead drug candidate, HCB101 is the most advanced compound in the company’s extensive oncology pipeline, currently progressing through a Phase 1b/2 clinical trial with ongoing multi-center enrollment across the US, China, and Taiwan. Given this, HCB101 becomes the center of attention during licensing discussions and due diligence by international pharmas.

Speaking on ways to prove HCB101’s potential as a best-in-class anti-SIRPα-CD47 drug to potential partners, Dr. Cong highlighted HanchorBio’s vision: “Design every product with the goal of achieving first-in-class or best-in-class status.” Nevertheless, she acknowledged that given the CD47 pathway’s history—a global buzz followed by a string of setbacks, with many international pharma giants discontinuing their candidates due to disappointing clinical results—convincing potential partners of HCB101’s anti-tumor efficacy during licensing discussions is no easy feat.

“Why do you think HCB101 can succeed when all previous candidates failed?” is a question Hanchor faces in nearly every negotiation. Confronting this historical burden, Dr. Cong took a head-on approach, outlining Hanchor’s three-tiered response: biological mechanism, preclinical evidence, and clinical data. At a biological level, the team would first return to the core of the CD47-SIRPα pathway, explaining that the pathway itself was fundamentally sound. The issue lies in the molecular design of previous competitors failing to fully harness the anti-tumor activity of innate immunity. HCB101’s molecular design specifically addresses the reasons for such failure, efficiently activating both innate and adaptive immune responses simultaneously to eliminate tumor cells.

In the pre-clinical phase, Hanchor has conducted multiple head-to-head comparisons between HCB101 and its competitors. Both in vitro and animal studies have generated directly comparable efficacy and safety data, clearly demonstrating HCB101’s significant lead over its counterparts. Clinically, Dr. Cong acknowledged that many would question HCB101’s status as it remains in the early Phase 2 stage, making definitive conclusions premature. Yet, based on current clinical results, HCB101 has already outperformed its competitors. Therefore, in the first chapter of external presentations, Hanchor will fully disclose comparative safety and efficacy data, using scientific evidence to address any potential concerns.

Overcoming Geographical and Policy Challenges: Every Detail Matters

Reflecting on years of business negotiations in the biopharma industry, Dr. Cong believes that the journey from initial contact to final contract signing is essentially a trust-building process. What truly propels a deal forward is the principles and execution demonstrated by the company throughout the process. Every meeting, every response, and every effort made in deal preparation shapes potential partners’ perception and trust in the company. All of these are decisive for whether due diligence and the deal itself can ultimately succeed.

Dr. Cong then recalled a major collaboration accomplished during the COVID-19 pandemic, where in-person due diligence was impossible. In face of such difficulty, she led her BD team to reconstruct the “on-site” scenario step by step—from equipment models and instrument configurations to operational procedures—through video recordings and online discussions, striving to overcome geographical barriers. Their efforts ultimately paid off, as the deal was successfully finalized, later leading to further partnership deals. This example highlights the importance for BD teams to think outside the box and take every possible step to win trust in the rapidly changing, highly uncertain global business landscape.

Beyond force majeure events like COVID-19, the BD team often faces diverse challenges in licensing negotiations with pharmas worldwide. For instance, some large players suffer from “paralysis by analysis” when confronting policy or regulatory shifts due to complex internal processes and conservative corporate cultures. Moreover, frequent changes in US policies in recent years, coupled with the FDA’s evolving requirements for drug manufacturing locations and supply chains, create uncertainties that often hinder timely decision-making. Furthermore, even for the same indication, disease prevalence, patient demographics, standards of care, clinical trial designs, and regulatory requirements can vary significantly across different regions.

Dr. Cong pointed out that the biopharma industry is characterized by high regulatory barriers, and all decisions regarding deals should be driven by patient interests and deliver value to patients. Therefore, when designing deal structures, the BD team should tailor them to local contexts and thoroughly understand the actual needs of patients in each region. Faced with a multitude of challenges, while Hanchor cannot eliminate concerns for potential partners, they can think from the partner’s perspective, anticipate details that might cause concern, and offer transparency and real-time data sharing to expedite the decision-making process.

Facilitating Mutual Trust Through Function-to-function Communication

Successful licensing partnerships not only feature cutting-edge technology and therapeutically proven drugs, but also require effective teamwork. Bearing this in mind, Dr. Cong and the entire company have established channels for seamless cross-departmental communication. Apart from biweekly formal meetings, team members can raise ideas, questions, and concerns when necessary. This approach keeps the entire company prepared to step forward, effectively communicate Hanchor’s scientific and business narrative, and pursue every potential collaboration opportunity.

During licensing negotiations, Dr. Cong mentioned Hanchor’s practice of getting functional department heads of both sides acquainted early on to initiate direct conversations promptly. Also, the company organizes formal “department-to-department” discussions where the counterpart prepares questions in advance, which are then addressed one by one by the corresponding in-house teams. 

While members of the BD team are present throughout the process, they are deliberately positioned as facilitators rather than direct responders. They work behind the scenes, stepping in only when necessary to provide additional information or coordinate follow-up actions. She firmly believes that the earlier functional teams from both companies build mutual trust, the smoother subsequent collaboration and due diligence will proceed.

Embracing Flexible Partnership Models for Long-term Mutual Benefits

Closing the interview, Dr. Cong stressed that developing innovative drugs inherently involves “three highs and one long”—high risk, high investment, high returns, and a long cycle. With the emergence of generative AI and its rapid advancement, she is confident that AI will become a crucial tool for mitigating risks and shortening development cycles. With the emergence of generative AI and its rapid advancement, she is confident that AI will become a crucial tool for mitigating risks and shortening development cycles. Meanwhile, Hanchor has actively adopted AI with data-enabled solutions since its inception to accelerate clinical R&D and operational decision-making. 

Regarding the company’s focus on immuno-oncology and autoimmune diseases, Dr. Cong acknowledged intense market competition but expressed optimism that Hanchor’s differentiated technology platform and fusion protein candidates will secure a competitive position in the long run. “The FBDB™ platform enables the development of bispecific or multispecific fusion proteins and is therapeutic area-agnostic,” stated Dr. Cong. This advantage opens up vast possibilities for BD and licensing discussions.

Beyond platform or product licensing, Hanchor can tailor-make deals to meet the specific needs of prospective partners. Taking HCB101 as an example, considering this fusion protein’s applicability across multiple tumor indications and its ability to deliver “single-agent efficacy,” the company currently prioritizes preserving as many of its key benefits as possible rather than prematurely licensing the product to other biopharma companies. 

Under this overarching consideration, possible partnership models include co-development, platform partnerships, equity investments, licensing, and more. In essence, beyond maximizing Hanchor’s own interests, the company seeks to identify like-minded partners to “grow the pie” together, creating long-term value and achieving mutual success.

Author

Richard Chau

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