Dongxi Network Files IPO Prospectus: AI-Powered SaaS Platform for End-to-End Pharmacovigilance and Medical Device Safety

Recalling his entrepreneurial journey over the past decade, Liu Xinyi, CEO and founder of Holox, told VCBeat, “We are those who wait for the wind, not those who chase it.” Before establishing Holox, Liu had two prior internet-related startup experiences: providing software development and data analysis services related to medical devices for drug regulatory authorities, and offering value-added cloud computing services focused on pharmaceutical and medical device safety for enterprises and government agencies. With a background as a product manager, he possesses unique insights into products and markets. “However, in the internet industry, success is not guaranteed merely by having superior technology or high-quality products and services. To expand and strengthen our market presence, we must not only add but also know how to subtract,” said Liu Xinyi.

In early 2016, prior to the establishment of Holox, Liu Xinyi assembled a team of experts to form an advisory committee. The committee was tasked with discussing the R&D direction of the company’s products, launching them into the market for validation, and analyzing development trends in the pharmaceutical and medical device safety industries. “At that time, we believed that the pharmaceutical and medical device safety sector would enter a period of rapid growth within the next two to three years. Therefore, it was imperative for us to strategically position ourselves in advance and establish an end-to-end industry chain for SaaS-based safety services covering the entire lifecycle of pharmaceuticals and medical devices,” stated Liu Xinyi.

These forward-looking assessments were later validated. In June 2017, the National Medical Products Administration (NMPA) formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and became a member of its Management Committee in June 2018. In May 2016, the General Office of the State Council issued the Pilot Program for the Marketing Authorization Holder (MAH) System. The comprehensive implementation of the MAH system and China’s accession to the ICH represent significant steps toward aligning China’s drug regulatory framework with international standards. From 2017 to 2019, the national authorities successively issued guidelines related to Good Pharmacovigilance Practice (GVP), adverse drug reaction monitoring, and clinical trial data safety. These guidelines also reflect the state’s emphasis on the safety of pharmaceuticals and medical devices.

In April 2016, shortly after its establishment in Beijing, Holox rapidly assembled an R&D team and recruited partners. Leveraging its technological expertise in AI and big data within the field of pharmaceutical and medical device safety, along with its client base from providing cloud computing services to provincial and municipal drug administrations, Holox achieved rapid growth over three years. In 2017, Holox completed its angel financing rounds with CCB International Healthcare and Zhonghai Investment. In June 2018, Holox launched its independently developed HoloX platform. The name “Holo” signifies insight and penetration, while “X” represents a series. The HoloX platform’s business scope covers both clinical and post-marketing stages:

HoloX® PV™ Pharmacovigilance Platform; HoloX® IN™ AI Platform for Real-World Studies; HoloX® AIMonitor™ One-Stop Active Monitoring Service Platform for MAHs; HoloX® Safte™ AI-Powered Public Opinion Monitoring Platform for MAHs; HoloX® eMobile™ Mobile Terminal Platform; and HoloX® Standard™ International Standards and Certification Platform.

“HoloX is China’s first SaaS platform leveraging artificial intelligence, big data, and cloud computing to provide comprehensive, one-stop, full-lifecycle pharmacovigilance system services for Chinese Marketing Authorization Holder (MAH) pharmaceutical companies and medical device enterprises,” stated Liu Xinyi. With this platform, the company secured second place in the national “Haichuang Cup” AI Top 10 Finals. In November 2018, Holox signed its first contract, completing the validation of its commercial closed-loop model. In 2019, Holox’s HoloX platform achieved commercial validation of its GVP SOP system, obtained US FDA and EU CE certifications, and contracted with over 100 enterprises, including more than one-third of the Top 100 listed companies. As an internet company only three years old, it achieved break-even for the first time in August.

“From the outset, our objective has been to integrate the entire pharmaceutical and medical device safety industry chain, positioning our business around four core pillars: post-marketing clinical safety monitoring for drugs and medical devices, active surveillance, re-evaluation, and extensive real-world studies,” stated Liu Xinyi. “Over the next three to five years, Holox will deliver premium AI-powered real-world study services to pharmaceutical companies worldwide. All our strategic early investments are aimed at capitalizing on the emerging opportunities two years from now, rather than merely chasing trends once they have already gained momentum.”

Since its launch, the HoloX platform has undergone four version iterations. Its business operations are primarily divided into two segments: a SaaS platform for full-lifecycle pharmacovigilance services and an AI-powered value-added service segment for real-world studies. The SaaS platform offers pharmacovigilance services for both clinical-stage and post-marketing phases, along with features such as certification integration for multiple developed countries worldwide and AI-driven risk signal early warning. The SaaS platform supports mobile data terminals including mobile apps, WeChat Official Accounts, and mainstream web browsers, with the entire monitoring system compliant with ICH international standards.

The AI-powered value-added services platform offers comprehensive real-world study AI solutions, including key monitoring, safety re-evaluation, new indication discovery, and automated label updates. It also assists Marketing Authorization Holders (MAHs) in establishing GVP SOP systems that comply with EU and NMPA standards, and provides robust GAMP5 validation services for automated production practice verification. The platform currently serves multiple pharmaceutical companies engaged in new drug R&D and global operations.

Post-marketing AI research services are one of the core offerings provided by Holox. The company aligns with ICH international standards at the foundational level, establishes an international knowledge graph, and performs cleaning, annotation, and mapping of massive big data. By leveraging neural network algorithms such as Bayesian networks, Holox has independently developed the HoloX® DL™ deep learning platform to continuously train and track signals throughout their entire lifecycle. This approach enables the system to closely approximate real-world scenarios, safeguarding corporate and product safety through timely warnings and effective early mitigation of potential safety risks.

Holox Platform

Since its inception, Holox has taken only about two years to launch its core products. However, the company’s core team boasts extensive accumulated experience in the field of pharmaceutical and medical device safety. Liu Xinyi, the CEO, has over a decade of experience in product development and management within the internet-based pharmaceutical safety industry. Possessing a multidisciplinary background spanning technology, marketing, and management, he is an expert in pharmacovigilance in China and a specialist in distributed computing systems. He has participated in and led the development and management of multiple national-level projects. Dr. Li Angsheng, the Chief Scientist, is a renowned mathematician and computer scientist, a researcher at a Key Laboratory of the Chinese Academy of Sciences (CAS), a selectee of the CAS “Hundred Talents Program,” and a recipient of the National Science Fund for Distinguished Young Scholars. Other core members of the company include experts in drug safety and risk control, as well as senior executives in internet product research and development.

“Unlike traditional pharmacovigilance (PV), the full-lifecycle service system for drug and medical device safety covers a broader scope,” explained Liu Xinyi. “Good Vigilance Practices (GVP) primarily focus on ensuring that the safety of drugs and medical devices developed and manufactured by enterprises complies with relevant regulatory monitoring and supervision requirements. In contrast, our platform offers enterprise-wide SaaS solutions for drug and medical device safety, along with AI-powered real-world study services. Based on this, CRO companies providing PV services are not our competitors but rather our strategic collaboration partners.”

Currently, Holox serves over 100 MAH pharmaceutical and medical device companies, multiple provincial Food and Drug Administrations, and has established strategic partnerships with several CRO firms. The company is currently advancing its Series A financing round, with the funds to be allocated toward market promotion, R&D of innovative product lines, and global business expansion. In-depth discussions are already underway with several top-tier enterprises.

“Holox was born in the depths of winter, unafraid of the bitter cold. At our 2019 Shareholders’ Meeting and Board of Directors Meeting, we put forward the philosophy: ‘Survive, and the last one standing will reign supreme.’” When asked by a reporter why such a pessimistic outlook, CEO Liu Xinyi replied, “No, it is optimism! It is a judgment and decision made based on insights into and perceptions of macroeconomic trends. Companies that went through the high-valuation internet era from 2013 to 2015 raised substantial funds by spinning narratives, but their biggest problem was that capital came too easily. They lacked clarity on how to survive and return to the essence of business. Now, as the internet dividend fades and there is no disruptive technological innovation to sustain rapid growth in the tech sector, macroeconomic development has entered a normal phase. The era has shifted from expanding the pie to dividing up the existing one. Only companies that can survive effectively, create commercial value, and are driven by innovation will truly see their spring. Therefore, in 2018, Holox proposed its ‘Three No-Fundraising’ principles: no fundraising without product launch, no fundraising without closed-loop validation of the business model, and no fundraising until the company achieves profitability and ensures survival. In the next three to five years, only B2B enterprises that can generate profits, survive, truly create value, and provide genuine services will usher in the real spring!”