In the dynamic and ever-evolving landscape of global biopharmaceuticals, one company is steering its course into an ambitious new era of internationalizationAccording to DrZhu Jun, Executive Director and CEO of Fuhong Hanlin, the company is plunging into what he calls the "deep waters" of globalization 2.0. Following a remarkable trajectory since its inception, Fuhong Hanlin is setting out to become a pioneer as it partners with diverse nations and regions and focuses on enhancing its localization capabilities.

Founded 14 years ago, Fuhong Hanlin (2696.HK) stands tall among Chinese biopharmaceutical companies as a notable success storyIts innovative approach has continually captured the industry's attention, often through unexpected means.

In a notable milestone for 2023, Fuhong Hanlin emerged as the first Chinese biopharmaceutical company to achieve comprehensive profitability through product sales on the Hong Kong Stock Exchange's 18A listing

This achievement is particularly impressive given the challenging environment of a capital winter affecting the healthcare and pharmaceutical sectorsOn November 19, 2024, just a year later, Fuhong Hanlin secured its place in Forbes China’s 2024 list of "30 & 30 Globalization Trailblazers" as the only biopharmaceutical company honored.

Just ten days after the announcement from Forbes China, Fuhong Hanlin's self-developed and manufactured biosimilar trastuzumab, Hanquyou® (marketed as HERCESSI™ in the USA and Zercepac® in Europe), was dispatched from its Shanghai Songjiang base, marking the company's first commercial supply to the North American marketThis shipment symbolizes a significant stepping stone in the company's global strategic framework.

Pioneering the path to global markets, Fuhong Hanlin's journey is underscored by both determination to conquer global challenges and a genuine commitment to understanding patients' needs throughout the life cycle of their products.

With an ethos centered around empathy, Fuhong Hanlin has built a comprehensive integrated platform for biopharmaceutical research, production, and sales since its founding in 2010. Currently, the company has six products on the market, addressing areas such as oncology, autoimmune diseases, and ophthalmology, benefitting over 700,000 patients in the process

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Notably, the company's flagship product, Hanquyou® (trastuzumab), has garnered approvals in multiple regions, including the United States and Europe, making it the first domestically produced monoclonal antibody biosimilar to do soMoreover, its PD-1 monoclonal antibody, Hanzhuang® (slurilumab), is the first of its kind approved for first-line treatment of small cell lung cancer, gaining five indications in China and becoming the first PD-1 monoclonal antibody approved in Southeast Asia.

On the research front, the company has established an efficient global innovation center which has facilitated numerous international, multi-center clinical trials across the US, EU, Australia, Southeast Asia, and JapanStringent adherence to international Good Manufacturing Practices (GMP) governs their production and quality management effortsWith collaborations involving over 20 global partners, Fuhong Hanlin's commercial reach extends across more than 50 countries and regions, effectively completing the groundwork for its earlier globalization phase.

The landscape of biopharmaceuticals is fraught with intricate challenges and fierce competition

Yet, Fuhong Hanlin has carved a niche, demonstrating that a combination of strategic foresight and an unyielding commitment to creating affordable, high-quality biopharmaceuticals can render significant outcomesDrZhu Jun, prior to his leadership role at Fuhong Hanlin, accumulated extensive experience collaborating with over 70 local pharmaceutical companies and conducting more than 100 clinical trial designsHis unique blend of entrepreneurial spirit and global perspective positions the company favorably in a diverse and competitive global arena.

DrZhu delineates that the intrinsic nature of biopharmaceuticals inherently lends itself to a global market, driven by universal health needs and treatments applicable to various populationsAt the heart of this innovative field lies the augmented potential for growth, with globalization presenting companies with unprecedented opportunities.

According to principles of economics, Dr

Zhu asserts that expanding a drug's reach from a singular market to a multitude of markets incurs limited additional costs post-developmentWith a successful global commercial strategy, the potential for enhancing pharma portfolios is immenseHe emphasizes that each additional global market represents not just one, but potentially two to three revenue streams for a product.

This transformative journey has not been without its challengesFor instance, Hanquyou® and Hanzhuang®, among others, engaged in rigorous trials to secure approvals in a host of countriesEach product holds stories of triumph, marking milestones as they overcome the barriers to international acceptance.

For instance, Hanquyou® has received approvals in 51 countries, making it the most widely accepted domestically produced monoclonal antibody biosimilarIts efficacy has positively impacted over 225,000 patients worldwide

In Southeast Asia, Hanzhuang® achieved a notable accolade in December 2023 as the first localized PD-1 monoclonal antibody approved for treating extensive-stage small cell lung cancer in Indonesia, diverging from conventional treatment methods and representing a significant breakthrough.

Moreover, Hanlikang®, another one of the company's star products, is celebrated as China's first biosimilar and has since expanded its reach with the approval of various indicationsIt officially made its debut in the Peruvian market in May 2024, further advancing Fuhong Hanlin's ambitions in South America.

Establishing a robust framework for globalization has been no straightforward taskDrZhu splits Fuhong Hanlin's evolution into three distinct stagesThe initial phase vitalized the company with an unwavering commitment to delivering affordable, high-quality biopharmaceuticals and establishing a brand with a strong international presence

This led to strategic alliances with overseas partners and set the foundation for a cohesive operational model.

As the second stage unfolded, the company focused on enhancing its global strategy through a dual approach of developing both biosimilars and innovative drugsThis phase was marked by meticulous adjustments to clinical protocols and regulatory compliance, solidifying their positioning in international marketsWith a portfolio extending across more than 50 molecular and development platforms, encompassing a wide variety of drug formats, Fuhong Hanlin expanded its operational capabilities significantly.

Entering into the present third phase, the company is poised to elevate its internationalization efforts, addressing the complexities that accompany deeper market penetrationDrZhu mentions, “Newer, faster, and more comprehensive internationalization” are the keywords of this ambitious interim phase

To achieve substantive growth, Fuhong Hanlin aims to enhance its proprietary innovation pipelines and solidify a strong international team.

The goal is to seamlessly transition from a licensing focus to a more self-sustained operational approach, which requires an in-depth understanding of local cultures to forge enduring relationships with consumers across different territoriesThis necessity lends itself to the realization that effective globalization is not merely a logistical implementation, but also requires profound cultural comprehension.

Driven by innovative principles, Fuhong Hanlin boasts over 600 regulatory submissions and over 500 approvals across regions such as China, the US, EU, and JapanThe FDA approval process stands out as a premier accomplishment for the companyBetween 2020 and 2021, Fuhong Hanlin submitted their Hanquyou® for registration in the US, which gained acceptance from the FDA in February 2023, opening the doors to worldwide commercial collaborations.

The potential for growth has been reflected in Fuhong Hanlin's impressive revenue trajectory

In 2023, the company surpassed RMB 5.394 billion in annual revenue, representing a staggering 67.8% year-on-year increase, and they achieved a net profit of RMB 546 million—their first-ever full-year profitabilityBy the first half of 2024, revenues surged approximately 9.8% from the previous year, totaling around RMB 2.746 billion, with net profits escalating by 61%.

Key product lines such as Hanquyou® saw significant performance growth as well, with half-year revenues in 2024 reaching roughly RMB 1.474 billion—a 15.5% growthThe company reported an impressive sales division income of about RMB 0.0682 billion, notably growing by 79.1%. International collaborations have expanded aggressively, now covering around 70 countries, suggesting an astonishing potential revenue exceeding billions of dollars.

However, with great rewards come significant risksBalancing scientific inquiry with commercialization remains a Herculean task, and Dr

Zhu's experiences have illuminated the pitfalls many companies face, caught in the snare of sunk costs during clinical developmentsHe counters prevalent pessimism in the industry by asserting that optimism drives forward momentum, advocating for nuanced decision-making rooted in actual clinical needs and financial returns.

Fundamentally, pipeline development takes precedence in Fuhong Hanlin’s strategyDrZhu emphasizes the importance of concentration and selectivity in decision-making processesIn a strategic departure from typical global business logic, Fuhong Hanlin purposefully streamlines its efforts, channeling resources towards products with the highest potential returns.

DrZhu articulates that if a product's prospective market size falls below RMB 10 billion, it may likely be sidelined during globalization pursuitsHe adds that each line of products vying for global introductions should ideally cater to numerous patient demographics—not merely localized solutions

Attention to the minutiae of resource allocation at every stage remains critical for maximizing the overall effectiveness of their offerings.

The company’s trajectory encapsulates the earnest values shared among its members, many of whom bring a wealth of experience from multinational pharmaceutical firms before joining Fuhong HanlinBeyond business objectives, there remains a shared aspiration to improve lives through innovation, providing patients not just with medication, but also with hope.

For DrZhu, the transition from physician to pharmaceutical innovator encapsulates a deeper acknowledgment of impactWhile definite cures for illnesses like cancer remain aspirations, he observes notable advancements in treatment paradigms, allowing for the possibility of prolonged patient survival and enhanced quality of life through innovative therapies.

As the company forges ahead, with over 700,000 patients already benefitting from its products, the story of Fuhong Hanlin exemplifies a future where bridging gaps in healthcare catalyzes significance