Pharma Safety Digital SaaS Provider Dongxi Network Secures Tens of Millions in Series A+ Funding to Accelerate Global Expansion

VCBeat has learned that Beijing Holox Network Co., Ltd. (“Holox”) completed a tens-of-millions-yuan Series A+ financing round at the end of 2022, with investor details yet to be disclosed. The company previously received early-stage investment from Zhonghai Investment. The proceeds from this round will be allocated to the research and development of new strategic product lines and to accelerating its internationalization efforts.

Holox, established in 2016, specializes in pharmaceutical safety. Adopting a model of “digital SaaS for the entire lifecycle and full industrial chain of pharmaceutical safety, combined with highly specialized vertical safety services,” the company provides pharmacovigilance and risk management services covering the entire lifecycle from clinical trials to post-marketing stages for the pharmaceutical industry. Currently, the company has launched Holox^®Clinical、Holox^®Pharma、Holox^®Vaccin、Holox^®Four Major RWE SaaS Platforms, Serving International Clinical Pharmacovigilance, Post-Marketing Pharmacovigilance, Vaccine Safety Surveillance, and Real-World Study Scenarios, and Enabling Data Management through Integration with International Electronic Gateways such as the U.S. FDA and the European EMA.

Furthermore, while leveraging the aforementioned big data platform to provide compliant, standardized, and process-driven services, Holox has established a deeply specialized, full-lifecycle, and whole-industry-chain pharmaceutical safety service system designed to meet customers’ deeper needs. This system encompasses services such as outsourced pharmacovigilance, system establishment, specialized audits, medical evaluations, retrospective studies and labeling revisions, and real-world studies. As founder Liu Xinyi stated, “Holox maintains a very clear strategic positioning: it knows what it wants and what it does not, clearly defines the boundaries of its business, focuses on its objectives, and pursues differentiated positioning. By concentrating on deeply specialized services centered around the broad safety of drugs and medical devices, we adopt a strategy of building strong foundations, fighting methodical battles, and avoiding premature claims to leadership.”

In 2017, China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), marking an acceleration in aligning its drug registration management system with international standards and further promoting the improvement and internationalization of its drug regulatory framework. In recent years, with the promulgation of the Drug Administration Law of the People's Republic of China and the issuance of a series of policy documents, including the Good Clinical Practice for Drug Trials, the Good Pharmacovigilance Practice, the Provisions on the Administration of Annual Drug Reports, and the Guidelines for Pharmacovigilance Inspections, China has entered a new era of comprehensive drug safety.

However, compared with developed countries in Europe and the United States, China’s pharmacovigilance activities remain relatively lagging. There is a substantial gap between China and these developed nations in terms of investment by new drug sponsors and marketing authorization holders (MAHs) in R&D and management related to overall drug safety. Currently, most MAHs primarily focus on routine compliance management for drug safety regulation. Meanwhile, clinical safety, proactive risk management, post-marketing safety re-evaluation and research, as well as digitalization in R&D and management, require sustained, long-term investment and improvement. According to Liu Xinyi, founder of Holox, this situation presents both opportunities and challenges for third-party service providers specializing in pharmacovigilance and risk management services.

The opportunity lies in the fact that, with the introduction of new regulations, many enterprises are starting from scratch, and there is an urgent market need for professional third-party support and guidance. This presents a significant market opportunity for specialized third-party service providers like Holox. For instance, the promotion of ERP systems in China during the last century was also driven by national policies at the time.

Liu Xinyi told VCBeat, “Following the introduction of new laws and regulations, many pharmaceutical companies were uncertain about how to proceed with their operations—specifically, how to establish quality management systems, form Pharmacovigilance Committees (PVCs), manage risk signals and commercial emergencies, and conduct post-marketing research, among other tasks. Addressing these market pain points presents an opportunity for innovative enterprises. Holox has explored and developed a service model combining a ‘full-lifecycle safety digital platform’ with ‘intensive professional services,’ providing one-stop, full-lifecycle support to sponsors, Marketing Authorization Holders (MAHs), and CXOs. This approach has earned the company a strong reputation among users in the market.”

Liu Xinyi stated, “Our B2B SaaS services operate on an annual subscription model. Although the initial sunk costs for market education are relatively high, our customer repurchase rate is nearly 100%, which serves as the strongest validation of our business model and is clearly reflected in the company’s financial data. Furthermore, leveraging our professional security service quality and customer trust, the majority of clients entrust Holox with the delivery of related value-added security services.”

Currently, market share and service penetration have gradually formed a moat for Holox against market competition. The company has provided services to over 500 high-quality enterprises, including China National Biotec Group, CR Sanjiu, Jimin Kexin, Yunnan Baiyao, and HuiSun. As of February 2023, more than half of the Top 100 traditional Chinese medicine companies and over one-third of the Top 100 pharmaceutical companies have partnered with Holox. Its foreign clients span Japan, South Korea, India, the European Union, and the United States. Additionally, Holox enables domestic enterprises to conduct multinational multi-center clinical trials and provides regulatory registration and market launch services for global expansion.

In terms of professional service excellence, Liu Xinyi, founder of Holox, is a senior expert in the field of pharmacovigilance in China and an expert in computer distributed systems. He participated in the testing and revision of China’s first international standard, the “Telecommunications 3G Standard,” and was involved in the development and management of multiple national-level projects, including the digitalization initiatives for the pharmaceutical safety industry under the National Medical Products Administration (NMPA) and the Beijing Medical Products Administration. He has served as an expert for regulatory authorities and provincial-level scientific research projects in various provinces, and has held positions as a specialist committee member and standing committee member of pharmacovigilance societies in several provinces. Technical and pharmaceutical safety professionals constitute 85% of Holox’s workforce. The technical team is responsible for the continuous research, development, and innovation of the SaaS platform, while the pharmaceutical safety professional team, composed of experts in medicine, pharmacy, epidemiology, statistics, and related fields, is dedicated to building the safety service system and ensuring high-quality services. Holox has gained favor from investors and established a strong reputation in the industry by steadfastly adhering to its strategic positioning, prioritizing user-centric services, and building a robust talent pipeline. This core competitive advantage in human capital has gradually become the fundamental guarantee for Holox’s sustainable development.

In terms of service breadth, the company’s offerings meet the safety and risk management needs throughout the entire drug lifecycle. Meanwhile, with financing secured, Holox will further expand its service scope into the fields of medical device vigilance and risk management, while accelerating its internationalization strategy. Liu Xinyi stated, “Only innovation-driven enterprises will truly usher in a golden era! Therefore, in 2018, Holox proposed its ‘Three No-Financing’ principles: no financing before product launch, no financing before closed-loop validation of the business model, and no financing before the company achieves profitability and sustainability. Over the next three to five years, only B2B enterprises that can achieve profitability, ensure survival, create genuine value, and provide in-depth services will truly welcome the arrival of spring for China’s B2B sector!”