Humadx: From 'Riding the Ship' to 'Building Our Own Vessel'—Driving Dual-Engine Global Expansion

Amid intensifying competition and increasing market saturation in China’s in vitro diagnostics (IVD) industry, expanding overseas has become the preferred strategy for many IVD companies to break through. According to the 2023 Edition of the Chinese IVD Company Directory, the number of registered IVD manufacturing enterprises in China exceeded 2,000 as of 2023. Meanwhile, driven by multiple factors including centralized procurement, the implementation of DRG/DIP policies, and market cyclical fluctuations, going global has become a critical strategic imperative that numerous IVD companies must consider.

However, due to significant differences in cultural practices, market access barriers, and laws and regulations across various overseas destinations, as well as the need to contend with regional market competition and supply chain challenges, IVD companies often face severe tests in their localization strategies when expanding globally, leading many to encounter setbacks.

Among IVD companies that have made overseas expansion their top strategic priority,VCBeat has observed a Chinese IVD company that originated from a foreign-funded IVD enterprise and operates independently based on its self-developed technologies—Nanjing Human Zhizao Technology Co., Ltd. (hereinafter referred to as “Human Zhizao”).

The origins of Human Zhizao date back to 2009, when HUMAN Diagnostics (hereinafter referred to as “HUMAN”) from Germany established a representative office in China. With resource support from HUMAN and the continuous enhancement of its independent research and development capabilities, Human Zhizao officially began independent operations in 2021.Currently, Nanjing Human Zhizao Technology Co., Ltd. has established a full industry chain layout for flow fluorescence technology, ranging from raw materials to finished products, and has participated in the drafting of industry standards for flow fluorescence array instruments. The company has filed more than 50 patent applications, holds nearly 20 NMPA product registration certificates, and has obtained 177 CE product certifications.

The HumaPlex1200 fully automated flow fluorescence detection platform, independently developed by Human Zhizao, achieves a testing speed of 3,000 tests per hour and enables “sample-in, result-out” within 40 minutes. It has received China’s first invention patent authorization for fully automated flow fluorescence equipment and has been successfully deployed in multiple batches of key hospitals across the country.

Beyond its flow fluorescence technology platform, Nanjing Human Zhizao Technology Co., Ltd. has opened up a new growth curve—its overseas expansion strategy. By solidifying its growth foundation in the domestic market and actively expanding its overseas business, the company is driving its dual-track development.

Reflecting on the history of Human Zhizao’s independent operations, its founder, Li Dongqi, had much to share. “After many years in the industry, I began to develop more ideas about starting a venture in the diagnostics sector. However, as one of HUMAN’s subsidiaries, we actually had limited autonomy.” In 2014, enthusiasm for technological innovation in China’s IVD industry remained high, with domestic substitution already underway across multiple IVD technology tracks. That year, Li Dongqi made up his mind and traveled to HUMAN’s German headquarters with a project proposal spanning dozens of pages, filled with fresh ideas tailored to the Chinese market.

“China is a major market for IVD, and relying solely on the arbitrage model of reselling products is insufficient. To truly cultivate the Chinese market, the first step is to establish manufacturing facilities in China and encourage R&D.” This was the primary strategy outlined by Li Dongqi in his project proposal. Furthermore, he presented a bold decision to HUMAN: reducing his annual salary to one yuan in exchange for the rights to independently develop products. Subsequently, Li Dongqi returned to China to found Eurasia Pioneer Biotechnology Investment (Beijing) Co., Ltd. (hereinafter referred to as “Eurasia Pioneer”), becoming a long-term commercial partner for multiple European IVD companies in China and leveraging its systematic marketing capabilities to facilitate the localization of their products. In 2023, Eurasia Pioneer was integrated into Nanjing Human Zhizao Technology Co., Ltd. and merged into its Marketing Center.

It is now evident that both strategic decisions outlined in the project proposal have yielded favorable outcomes. In terms of market performance, Nanjing Human Zhizao Technology Co., Ltd. has partnered with over 100 distributors in China, and its products have reached hundreds of leading hospitals.

In terms of R&D, Nanjing Human Zhizao Technology Co., Ltd. has mastered multiple core technologies, including multiplex magnetic encoding microsphere technology and fully automated flow fluorescence detection platforms. The company has filed dozens of patents centered on flow fluorescence technology, with products covering two major testing areas: autoantibodies and cytokines. Its multiplex-encoded magnetic microspheres enable the stable preparation of 40-plex codes. Notably, the HumaPlex 1200 fully automated flow fluorescence detection platform, independently developed by Nanjing Human Zhizao, achieves a testing speed of 3,000 tests per hour, enabling “sample-in, result-out” within 40 minutes. It has received China’s first invention patent authorization for fully automated flow fluorescence equipment and has been successfully deployed in multiple batches of key hospitals.

As global competition intensifies, a considerable number of European in vitro diagnostics (IVD) companies are facing pressure from declining product competitiveness. With slow product iteration cycles, persistently high labor and supply chain costs, and the approaching deadline for compliance with the In Vitro Diagnostic Regulation (IVDR), European firms are also seeking new pathways forward.

Collaboration with the German company HUMAN has enabled Human Zhizao to develop a distinctive overseas expansion model. “It is fair to say that we are not expanding overseas; we are already present in international markets and are simply further implementing our globalization strategy,” said Li Dongqi, founder of Human Zhizao.

HUMAN was founded in 1972. It currently boasts 13 diagnostic product lines with over 400 products, maintains offices in dozens of countries worldwide, and sells its products to more than 160 countries. Starting from HUMAN’s Chinese subsidiary, Nanjing Human Zhizao Technology Co., Ltd. has established robust bidirectional import/export channels over years of operation. The company has not only introduced HUMAN’s and other European enterprises’ products into the Chinese market and built a nationwide sales network, but also accumulated substantial practical expertise through a deep understanding of global market demands, distribution systems, and end-customers.

For HUMAN, Li Dongqi pointed out, “In the face of challenges such as fierce market competition and differences in product demand and regulations across various countries and regions, HUMAN not only needs to continuously innovate and explore incremental markets with new products; at the same time, its existing 13 product lines also face the need for cost reduction and product upgrades.”

Nanjing Human Zhizao, now operating independently, maintains strong ties with HUMAN—a relationship reflected in its current organizational structure, where several former HUMAN executives serve as employees or business consultants. Leveraging this robust partnership, Nanjing Human Zhizao has begun to integrate HUMAN’s global resources in reverse, rapidly establishing channels for international expansion.

Specifically,Leveraging its independently developed technology platform and robust local manufacturing capabilities, Human Zhizao researches and produces high-quality IVD products that meet international standards for HUMAN, enabling rapid product upgrades and market responsiveness. In turn, HUMAN utilizes its global distribution network spanning over 160 countries and more than 50 years of industry experience to successfully introduce Human Zhizao’s innovative products to the international market.

According to reports, Human Zhizao’s overseas expansion model encompasses the entire process, from product R&D and registration, international adaptation and upgrading, to market sales and supply chain operations. “It must be emphasized that Human Zhizao is not merely a ‘porter’ of products; rather, it needs to fully leverage its own R&D and creative capabilities to effectively address every practical challenge encountered in the process of taking products global,” said Li Dongqi.

“Judging from Human Zhizao’s ‘battle map’ for overseas expansion, ‘currently about 75% of HUMAN’s products can meet clinical needs in different countries and regions through upgrades and modifications, including POCT, rapid testing, and chemiluminescence. Through this overseas expansion model, supply chain costs will be reduced by 30%, creating greater profit margins for end-users in the international market; furthermore, global resources integrated through reverse fusion provide a better pathway for products to enter overseas markets and achieve rapid volume growth,’ added Meng Zekai, Head of the Overseas Business Division at Human Zhizao.”

According to reports, through a systematic overseas expansion strategy, Nanjing Human Zhizao Technology Co., Ltd. has successfully launched its fluorescence POCT product line internationally and plans to expand multiple other product lines, including urine testing and rapid diagnostics, within this year. Among these, the flagship product, the HumaFIA Time-Resolved Fluorescence Immunoassay Analyzer, has gained regulatory approval and been officially launched in dozens of countries across the Middle East, Latin America, Africa, and other regions, achieving remarkable sales performance.

In the journey of internationalization,Human ZhizaoNanjing Human Zhizao Technology Co., Ltd. is nearing the completion of its transition from “leveraging existing platforms” to “building independent capabilities,” demonstrating the company’s resilience and innovative capacity. By gaining deep insights into the genuine needs of customers across global regions and conducting secondary product development, Human Zhizao has successfully enhanced the international adaptability of its products. Meanwhile, the company is actively collaborating with global marketing channels to accelerate market expansion. Looking ahead, Human Zhizao plans to further build a comprehensive overseas ecosystem, achieving a strategic shift from relying on external resources to independently constructing its own platforms, thereby strengthening its competitiveness in the global market.

Nanjing Human Zhizao Technology Co., Ltd. has chosen to seek breakthroughs in overseas markets, marking another strategic extension of its independent R&D capabilities. This move has established a dual-growth pattern characterized by “flow fluorescence driving domestic growth and an overseas expansion strategy unlocking new markets.” By combining its technological advantages with international market demands, Nanjing Human Zhizao not only enhances its own market competitiveness but also provides high-quality in vitro diagnostic products to more countries and regions.

Looking ahead, Nanjing Human Zhizao Technology Co., Ltd. will continue to deepen technological innovation and market expansion under the synergistic effect of its dual growth curves, continuously unleashing its innovative potential. As its overseas business advances steadily, the company will significantly enhance its brand’s international influence, achieving a win-win situation in both domestic and global markets. Meanwhile, with an open mindset, Nanjing Human Zhizao will join hands with small and medium-sized enterprises (SMEs) in China to jointly promote the construction of an international platform, integrate upstream and downstream resources, and foster complementary advantages, striving for long-term growth amidst fierce international competition.