Can the 'In Global for Global' Model Create the Next Genmab Amid the Biopharma Winter?

Currently, in the post-pandemic era, the complex, volatile, and uncertain environment of the pharmaceutical industry has cast a shadow of anxiety across the entire sector. In the secondary market, pharmaceutical stocks have experienced repeated turbulence; in the primary market, startups are grappling with financing difficulties. The pharmaceutical industry is once again enduring a capital winter.

In the face of the current downturn in the pharmaceutical industry, what development paths should Chinese biopharmaceutical companies pursue to navigate market cycles? How can they leverage global trends to find breakthroughs amidst emerging challenges and dilemmas?

Reviewing the Past, Analyzing the Present, and Envisioning the Future.

For a considerable period, China’s pharmaceutical market was dominated by generic drugs, with significant deficiencies in R&D investment and experience for innovative medicines. In recent years, to foster a favorable environment for innovation-driven development, China has introduced a series of proactive policies, including priority review and approval, the Marketing Authorization Holder (MAH) system, drug consistency evaluations, and incentives for high-quality innovative drugs to align with international standards. These measures have accelerated the development of the entire pharmaceutical industry chain.

Propelled by favorable policy winds, pharmaceutical companies of all types have actively experimented with their business models, identifying those best suited to thrive in this environment while fully leveraging their competitive advantages. These models can be primarily categorized into the following three types:

In China for China：Such companies can be described as engaging in gap-filling innovation. Their original intent was to bring new drugs to Chinese patients. Leveraging strong local manufacturing and commercialization capabilities, they offer products at relatively low prices with high accessibility, thereby commanding significant influence in the domestic market. However, as their focus has been primarily on the domestic market, these enterprises are gradually exploring transformation amid the impact of the evolving innovative drug era, continuously enhancing their independent R&D and innovation capabilities. Established listed pharmaceutical companies such as Hengrui Medicine and Chia Tai Tianqing are exemplary representatives of this category.

From Global for China：Such companies bring global innovative drugs to Chinese patients through “license-in” arrangements, pursuing clinical trials in China that are synchronized with international studies, with the aim of delivering internationally leading innovative medicines to Chinese patients more rapidly. They have made significant contributions to the rapid development of innovative drugs in China. These companies primarily serve the Chinese market. However, they need to continuously introduce new projects to sustain innovation-driven growth. Amid intensifying industry competition, license-in project prices have risen sharply, and many companies often have to pay high premiums to secure attractive assets, which still carry certain development risks. Zai Lab and Everest Medicines are outstanding representatives of this type of company.

In China for Global：These companies are seeking to expand overseas, aiming to bring domestically developed novel drugs to global patients through “license-out” arrangements. They possess strong capabilities in drug development and pharmaceutical manufacturing. Since drug development and manufacturing are primarily conducted in China, these companies benefit from lower drug costs and can support global supply. Compared with the two aforementioned categories of enterprises, this type may demonstrate stronger source innovation capabilities. However, because clinical trial data for some of these companies are derived from Chinese populations (i.e., using a complete set of Chinese drug development and clinical development documentation to apply for overseas product approvals), they face significant challenges in securing global transactions or partnerships. CSPC Pharmaceutical Group and Kelun-Biotech are outstanding representatives of this category.

The three aforementioned corporate models exhibit distinct advantages and characteristics, each possessing core competencies in areas such as market positioning, R&D, and operations. Regardless of the model adopted, companies at this stage are already leveraging cutting-edge international innovations to expand into broader global markets. However, truly embarking on and sustaining a path toward globalization is by no means an easy endeavor.

To leverage cutting-edge international innovations to address the unmet needs of patients worldwide and efficiently expand into broader global markets in response to the uncertain risks of the current VUCA era, higher capabilities are undoubtedly required of domestic biotech companies—such as possessing comprehensive global innovation capabilities, conducting international clinical trials, executing global commercial expansion, and formulating development strategies with a global market perspective.

So, how should this true path of global exploration be pursued?

Perhaps we can draw some inspiration from successful international biotech companies.

First,Genmab, founded in 1999 and rooted in the small Nordic country of Denmark, this company began as a European spin-off of the U.S. biotechnology firm Medarex. A decade later, it completed its initial public offering (IPO) on the Copenhagen and Frankfurt stock exchanges, raising DKK 1.56 billion (approximately USD 226 million) and setting a record for IPO fundraising among European biotechnology companies at that time.But what this company is more renowned for is that, after its IPO, Genmab faced a life-or-death crisis and was nearly forced to shut down, but ultimately made a remarkable recovery, listing on the NASDAQ ten years later (in 2019).Honored as the 2019 European IPO of the Year by Life Stars, it has become a leading enterprise in international antibody drug development. Furthermore, Genmab is one of the few biotech companies in the biopharmaceutical industry to achieve profitability, having recorded profits for nine consecutive years, with a market capitalization of approximately $23.8 billion.

Genmab, emerging from the small nation of Denmark, weathered significant turbulence on its path to the international stage. Ultimately, by leveraging its distinctive development strategy, it has secured a central position globally, becoming a leading enterprise in international antibody drug development. Its growth trajectory offers valuable lessons for China’s current biotech sector.

By analyzing Genmab’s global development capabilities, we summarize them into the following aspects:

First, build a world-class team.From a Danish company to a leading global developer of antibody-based therapeutics, one of the core reasons behind Genmab’s rise lies in its cross-border strategy of building a globalization-ready team capable of tackling tough challenges. On one hand, Genmab’s R&D team, with its global background, not only possesses deep expertise in antibody technologies but, more importantly, leverages its global perspective to drive project initiation and conduct international multi-center clinical trials worldwide, laying the foundational groundwork for its emergence on the international stage. On the other hand, Genmab’s global operations team has successfully overcome cultural barriers to forge business partnerships around the world, which has been key to enabling the company to repeatedly turn crises into opportunities.

Second, refine the proprietary technology platform.The secret to continuously building a robust pipeline of high-quality antibody drugs lies in Genmab’s core technology platforms. Genmab boasts four antibody R&D technology platforms: DuoBody®, which is used for the discovery and development of therapeutic bispecific antibodies, offering flexible solutions for various dual-targeting applications; HexaBody®, which enhances antibody binding efficacy by inducing the formation of antibody hexamers; DuoHexaBody®, which combines the bispecific targeting capability of DuoBody® with the hexamerization-enhancing power of HexaBody® to construct bispecific antibodies with enhanced hexamerization; and HexElect®, Genmab’s novel proprietary technology that combines two HexaBody® molecules to selectively target cells co-expressing two specific targets. These four proprietary technology platforms constitute the “engine” of Genmab’s sustainable innovation.

Finally, establish a global cooperation alliance.A key factor behind Genmab’s ability to achieve profitable operations with substantial margins for nine consecutive years lies in its distinctive external collaboration model. Genmab categorizes its product pipeline into two types: proprietary products, in which the company holds at least a 50% equity stake (Genmab Proprietary Products); and partnered products, which leverage Genmab’s technology and innovation engine but are led by partners in development and commercialization (Partnered Products).By co-developing its pipeline with partners, Genmab not only shares the risks associated with pipeline development and accelerates pipeline progress through partner enablement, but also generates substantial collaboration revenue (including upfront payments, milestone payments, and sales royalties from collaborative pipelines).

Building a world-class team, refining its proprietary technology platform, and expanding its global collaboration network—these three strategic pillars serve as Genmab’s “three carriages,” propelling the company to successfully transcend national borders, navigate market volatility, and reach the pinnacle of the international stage.

Coincidentally, another international company with a similar situation to Genmab is Ionis Pharmaceuticals, a leader in RNA-targeted therapies, which confirms the development advantages brought by such global capabilities.

Ionis is a leader in the discovery and development of RNA-targeted therapies and the company with the most approved drugs in this field.

It can even be said that the development trajectory of Ionis nearly mirrors the evolution and transformation of antisense oligonucleotide technology. During the advancement of this field, the emergence of RNA interference (RNAi) technology in 1998 delivered a profound shock, virtually reshaping the industry landscape at the time. Amidst this “avalanche,” numerous antisense oligonucleotide companies were abandoned, struggling to survive and gradually collapsing. However, Ionis managed not only to secure its survival but also to achieve a remarkable turnaround, thanks to its distinctive development model.

Since its founding in 1989, Ionis has successfully launched numerous drugs, including Spinraza, Tegsedi, and Waylivra, and has built a robust R&D pipeline. Currently, there are 40 drug candidates in development, covering therapeutic areas such as cardiovascular, metabolic, neurological, and respiratory diseases.Similar to Genmab, establishing an extensive global partnership network is also a hallmark of Ionis—of the 40 clinical-stage assets in Ionis’s pipeline, 68% (27 candidates) are being developed through collaborations.From 2019 to 2021, Ionis’s core business revenues were $1.122 billion, $729 million, and $810 million, respectively, with licensing-derived revenue accounting for over 50% of the total in each of the past three years. Under its distinctive commercial development model, similar to Genmab, Ionis maintains very healthy cash flows. Currently, Ionis has a market capitalization of approximately $5.6 billion, while its cash holdings amount to around $2.1 billion.Ionis’s similar talent profile to Genmab, its robust proprietary technology platform, and the establishment of an extensive global collaboration network have not only helped Ionis weather its most challenging developmental years but also laid the foundation for ushering in a new chapter in the field of antisense oligonucleotide therapeutics.

It is not difficult to observe that Genmab and Ionis, both having started as biotechnology startups, independently turned to globalization in the face of their respective development challenges, leveraging global resources to mitigate growth risks. For domestic biotech companies currently grappling with similar difficulties, this globalization model may serve as a valuable reference for exploring pathways to breakthroughs.

Shifting to a domestic perspective, compared with overseas markets, achieving true globalization to break through the current impasse faces numerous obstacles due to various factors. However, thanks to the leapfrog development of globalization explorations in China, many innovative Chinese pharmaceutical companies have gradually acquired the capability to explore global operations. It is evident that an increasing number of enterprises positioning themselves for global development models are emerging.

Among these emerging biotech companies, VCBeat has identified numerous specialized development models. These include Harbour BioMed, which emphasizes global operations; Antengene, which positions itself as a driver of global innovation; and those advocating an “In Global, For Global”l“Biosion’s development model... Regardless of the approach, each has yielded rich experience and thought-provoking directions in the pursuit of globalization.”

According to reports, in April, Harbour BioMed announced a global licensing agreement with AstraZeneca for the development and commercialization of HBM7022, a CLDN18.2xCD3 bispecific antibody. In July, Antengene held a launch event in China for Xpovio (selinexor), its first commercially launched innovative anti-cancer drug. The drug has received marketing approval in mainland China, South Korea, Singapore, and Australia. Similarly, Biosion entered into a licensing agreement with Pyxis in March and announced in August the appointment of Dr. Steven Knapp as its Chief Regulatory Affairs and Quality Officer... These companies have already achieved significant results in their globalization efforts this year, thanks to their forward-looking strategic positioning.

However, although many Chinese biopharmaceutical companies have attempted to position themselves globally, significant differences remain. Take Biosion as an example: as a company dedicated to developing next-generation innovative antibody drugs for patients worldwide, Biosion focuses on continuous breakthroughs and innovation in the two major fields of oncology and autoimmune diseases. Since its inception, the company has been actively exploring an “In Global, For Global” development strategy.

According to the company’s official website, Biosion’s executive management team, which operates in both China and the United States, comprises former senior executives from Johnson & Johnson, AbbVie, Bristol Myers Squibb, and other leading pharmaceutical companies. The drug development team is led by Dr. Hugh Davis, former Global Vice President of Innovative Biologics Development at Janssen Pharmaceuticals, ensuring that the entire process—from project initiation and molecular discovery to preclinical development and clinical trial applications—is implemented in accordance with a globally positioned model. Additionally, its international advisory team consists of renowned experts from top-tier research institutions, including Memorial Sloan Kettering Cancer Center (MSKCC), the Pancreatic Cancer Precision Medicine Center at Johns Hopkins University (PMCEJH), and George Washington University.Biosion’s drug pipeline has been strategically designed from the outset with consideration of global distribution, competitive landscape, and other multifaceted factors.

Meanwhile, Biosion’s three leading antibody discovery platforms—the highly competitive H³ Antibody Discovery Platform, the SynTracer™ ADC Antibody Internalization Screening Platform, and the FlexiBody™ Bispecific Antibody Technology Platform—enable the company to continuously generate differentiated innovative antibodies during early-stage drug discovery.Leveraging its three core technology platforms, Biosion has currently developedOver 20 ModelsDifferentiated drug pipeline,3 productsThe product has entered the clinical stage. The self-developed product BSI-045B (anti-TSLP monoclonal antibody) is undergoing Phase II clinical trials in China for severe asthma and Phase I clinical trials abroad for atopic dermatitis, with an Investigational New Drug (IND) application for Phase II clinical trials in the United States imminent. Furthermore, two additional pipeline products are expected to file IND applications in the United States this year.

In building global collaborations, Biosion has established business development initiatives and industrial alliances targeting the global pharmaceutical market, leveraging global resources to mitigate its own risks.Although Biosion is headquartered in Nanjing, Jiangsu Province, it has established subsidiaries in the United States, Australia, and other regions to support international multi-center clinical trials for its global antibody drug development and worldwide business expansion. To this end, in the first half of this year, Biosion successively recruited senior executives, including Joel Edwards, former Vice President of Ionis Pharmaceuticals, and Dr. Ye Xinliang, former Vice President of CStone Pharmaceuticals, to lead its team in driving global business development. Their management expertise has empowered Biosion to advance smoothly in its global business expansion efforts. Currently, Biosion has entered into nine strategic collaborations with pharmaceutical companies both in China and abroad. In the future, the company will pursue additional global drug development partnerships leveraging its core technology platforms and drug asset portfolio.

As can be seen, the benefits of Biosion’s multiple global collaborative deals are already becoming apparent. As a biotech company, Biosion has successfully built a truly globalized, cross-cultural international team, enabling the simultaneous development of over 20 drug pipelines and the conduct of global clinical trials. By leveraging the resources of its global partners, Biosion is not only advancing its drug pipelines rapidly and efficiently but also mitigating development risks. Through strategic collaborations, the company has secured substantial revenue, allowing for a more stable financing rhythm compared to typical biotech firms. These globalization advantages have endowed the Biosion team with exceptional resilience in today’s complex, volatile, and uncertain market environment.

The slogan “In Global, For Global” has been ingrained in the development of this biotech company. However, whether globally positioned biopharmaceutical enterprises such as Biosion, Harbour BioMed, and Antengene can truly forge an innovative development path distinct from their domestic peers, or even emerge as the next Genmab to break through the current industry impasse, remains to be seen.

In conclusion, we return to the question posed at the beginning: In the current era, how should biopharmaceutical companies navigate global trends and find breakthroughs amidst emerging challenges and dilemmas? Cases of international biotech firms such as Genmab and Ionis offer insights into globalization strategies, while domestic enterprises like Biosion are already exploring the path of “In Global for Global” development for biopharmaceutical companies. We believe that global expansion reflects a new model for Chinese biopharmaceutical companies to pioneer fresh opportunities.