Macrowing Pharma Files IPO Prospectus: Empowering End-to-End Data Lifecycle Compliance for Over 300 Life Science Enterprises

On August 8, 2023, the U.S. FDA issued 12 warning letters for alleged violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals, sparking widespread attention within the industry.

12 Warning Letters. Image source: www.fda.gov

Meanwhile, more than 30 pharmaceutical companies, including Xinhua Pharmaceutical, Hengrui Medicine, Taiji Group, Foci Pharmaceutical, Teyi Pharmaceutical, BeiGene, 3SBio, and Fangsheng Pharmaceutical, have successively issued statements on various platforms addressing hot-button issues in the pharmaceutical sector, such as kickback-driven sales, compliance, and anti-corruption.

Whether in China or abroad, “compliance” has become one of the most closely watched topics in the global pharmaceutical industry. In particular, since the 18th National Congress of the Communist Party of China, deepening healthcare reform has been integrated into the coordinated advancement of comprehensive reforms, with regulatory oversight steadily intensifying and regulatory tools becoming increasingly sophisticated. As a result, the compliance ecosystem of the pharmaceutical industry is undergoing renewal and transformation.

However, the process of drug development and commercialization involves numerous stages, each generating massive amounts of information and data. Therefore, regardless of the stage a pharmaceutical company is in, it is crucial to understand the current status, identify and mitigate risks, evaluate the effectiveness of compliance management, and implement continuous improvements based on these evaluations. This is essential for achieving compliant, healthy, and sustainable corporate development.

In response, Shanghai Hongyi Medical Information Technology Co., Ltd. (hereinafter referred to as “Hongyi Medical”), the “Life Sciences Data Compliance Management Expert” under MACROWING (Shanghai Hongwing Software Technology Co., Ltd., hereinafter referred to as “Hongwing Software”), has helped more than 300 pharmaceutical companies establish compliance systems and achieve high-quality compliant operations. Its clients include leading pharmaceutical enterprises such as WuXi AppTec, Yangtze River Pharmaceutical Group, Qilu Pharmaceutical, and Fosun Pharma.

One cannot help but ask: Why is Hongyi Medical hailed as the “Expert in Compliant Data Management”? And why has it earned the favor of more than 300 pharmaceutical companies?

Hongyi Medical’s “Compliance Journey” begins with the story of Hongyi Software, dating back to the company’s founding.

MACROWING is a leading domestic provider of enterprise content management (ECM), low-code application platform (LCAP), and intelligent big data management software, with 23 years of specialization in content management. Having served over 5,000 enterprise and government clients, MACROWING has participated in and initiated multiple national standards for data management, empowering organizations to achieve excellence by elevating their data capabilities from content to knowledge and ultimately to intelligence.

Specifically, MACROWING centers on unstructured data management capabilities, leveraging end-to-end technologies for data acquisition, storage, management, utilization, and security, alongside next-generation high-efficiency, agile low-code technologies, and leading AI technologies such as data analytics, deep learning, and knowledge graphs. This integrated approach delivers full-stack, all-scenario content management solutions covering documents, archives, knowledge, EPC engineering design management, and GMP pharmaceutical quality system management.

“Hongyi Medical originated as the pharmaceutical division of MACROWING, initially responsible for developing solutions and promoting technologies for the pharmaceutical industry within MACROWING,” said Tang Liang, General Manager of Hongyi Medical.

Tang Liang, General Manager of Hongyi Medicine

So, what are the historical background and strategic considerations behind MACROWING’s spin-off of its independent pharmaceutical business unit? According to Tang Liang, a decade ago in China, digital data management platforms were almost exclusively supplied by overseas vendors. This homogeneous market landscape led to persistently high software prices. Moreover, many Chinese pharmaceutical companies deal with localized medicinal materials, such as traditional Chinese medicine (TCM), for which the standardized solutions offered by overseas vendors were poorly suited.

Subsequently, around 2015, a large private pharmaceutical enterprise, then ranked among the top three nationwide, was planning to leverage digitalization to enhance management efficiency and drive product upgrades.

After thoroughly evaluating numerous products on the market, this pharmaceutical company found that mainstream imported software solutions were not only prohibitively expensive but also incompatible with its needs.Thus, upon engaging with the team at MACROWING, both parties quickly reached a consensus and resolved to develop a localized digital solution better suited for Chinese pharmaceutical enterprises, thereby achieving domestic substitution.

Of course, it is undeniable that at a time when imported systems had already reached full maturity, although MACROWING already had the foundation of a mature data management platform, it still faced numerous challenges in aligning the platform with the high standards and stringent regulatory requirements of the pharmaceutical industry.

In response, MACROWING made a decisive move to engage a leading team then providing consulting services to multinational pharmaceutical companies. With the formal onboarding of this specialized team in quality compliance auditing and consulting for the pharmaceutical industry, a tripartite alliance was formed among the team, large pharmaceutical enterprises, and MACROWING, turning the vision of “Hongyi Pharma” into reality.

“Since then, amidst the surging wave of digital transformation in China’s pharmaceutical industry, a superior platform better suited to the domestic market has emerged, truly achieving import substitution with domestically produced alternatives.”“Tang Liang stated. Today, after more than a decade of development, Hongyi Medical has established a professional team composed of leading talents from specialized fields around the world.”

From the perspective of team composition,General Manager Tang LiangDeeply engaged in the digitalization of the life sciences industry, with nearly two decades of experience in this field. Previously served as General Manager of IBM China’s Global Business Services Greater West Region and Deputy General Manager of NNIT China Ltd.Zhou Zongbao, Founding Partner and Chief Architect of MACROWINGLed the design and development of Hongyi Medical’s integrated quality management platform, embedding industry best practices into the GxP² platform.

Hongyi Medical currently boasts a professional technical and service team of over 100 members, with more than 70% dedicated to R&D and technical services. Headquartered in Shanghai, the company has established four R&D centers across China. Furthermore, to deliver data services to users more efficiently and with higher quality, Hongyi Medical has set up service centers and offices in more than twenty provinces and municipalities nationwide, ensuring direct access to its clientele.

Under the support and leadership of the team, in early 2023, Hongyi Medical successfully completed its Pre-A financing round, exclusively invested by the Xiya Si Fund managed by Sinopharm CICC.

Sinopharm Capital commented on this matter, stating that it is an inevitable trend for pharmaceutical manufacturers to adopt information technology solutions to record all data generated during production and testing processes. Sinopharm Capital is optimistic about Hongyi Medical’s entry into various stages of the life sciences workflow, comprehensively empowering life sciences companies across multiple processes—from R&D and clinical trials to production and market launch. This approach helps clients manage production and R&D data, shorten time-to-market, and precisely target customers.

Pharmaceuticals are a special category of commodity, the quality of which directly impacts public life and health. Throughout the entire lifecycle of pharmaceutical products, each stage is governed by distinct quality assurance regulations to ensure safety and efficacy.GxP is a collective term for quality assurance regulations relevant to various stages of pharmaceuticals, representing different disciplines or fields such as manufacturing, packaging and warehousing, quality control, research and development, clinical trials, sales, and transportation, covering the entire lifecycle of pharmaceutical products.

GxP²(GxP Platform) The GxP Platform is the core product of Hongyi Pharmaceutical, aiming to streamline lifecycle data management in the life sciences sector and become an industry-leading, document-content-driven process management engine.

Under the premise of compliance with domestic and international GxP regulations, fully unlock the value of data, empower industry innovation, and facilitate the digital transformation of the life sciences industry.

Data serves as the raw material for humans to acquire information about the world; in its native state, it lacks systematic structure and cannot be classified as knowledge. Therefore, it is essential to interpret data through a specific hierarchical framework to unlock its value. To this end, the platform integrates MACROWING’s DIKW model, enabling data to evolve hierarchically and yield progressively deeper insights.

The DIKW Wisdom Model consists of four layers: starting from the data management foundation—the Content Management Capability Service Platform; progressing to the business system application layer—Pharmaceutical Full Lifecycle Solutions; then to the Knowledge Aggregation and Management Layer; and culminating in the current core of large-model intelligence for the pharmaceutical industry. This framework integrates AI intelligence from concept into business scenarios, elevating the hierarchy of data value management capabilities and advancing from initial data management toward intelligent enterprise management.

To elaborate, the advantages can be categorized into the following three points:

Strengthen the ECM data foundation to accelerate digital transformation in the life sciences industry.Tang Liang stated, “As an expert in life sciences data management capabilities, Hongyi Medical has accumulated years of experience in digital intelligence. Currently, we are more focused on solidifying our digital foundation to truly empower the industry’s digital transformation.”

Hongyi Medical’s digital foundation is built upon MACROWING’s ECM platform. With over two decades of specialization in unstructured data, MACROWING possesses extensive data resources, enabling AI models to be continuously trained and refined using real-world business data.

  Hongyi Pharma: One Core, Three Platforms

Complete and traceable data, connecting the entire lifecycle of pharmaceutical products.In the pharmaceutical industry, information systems are emerging at every stage; however, how to aggregate and leverage data from disparate platforms and in various formats, as well as how to safeguard vast amounts of sensitive business and privacy data, remain critical pain points in enterprises’ digital transformation and upgrading.

In this regard, GxP²The platform enables enterprises to efficiently manage and utilize business documents, quality documents, and archival records generated during operations, while meeting the information management needs for training and various quality activities—all in compliance with domestic and international GxP regulations. By doing so, it helps accelerate drug R&D, enhance production execution efficiency, and improve quality compliance management, thereby fully unlocking the value of data.

Data + Algorithms + Computing Power: Empowering Intelligent Enterprise Upgrades.Leveraging years of accumulated industry data and a profound understanding of global regulations, Hongyi Medical has partnered with world-leading algorithm and computing power collaborators to develop InWise, a vertical, specialized, and independently controllable large-model AI platform.

Hongyi Medical: AI-Empowered Path to Smart Product Upgrades

By leveraging massive industry data and training on nearly 10 billion parameters, InWise not only achieves intelligent AIGC applications in specialized fields but also can be embedded into various customer business systems to provide dedicated services. Specifically, it offers functions such as intelligent knowledge Q&A, automated summarization and analysis, traceable and verifiable business consultation assistance, and intelligent writing, helping enterprises reduce costs and increase efficiency.

Since its establishment, with the support of MACROWING and the efforts of its R&D team, the company’s data capability management platform has undergone six major version iterations, processed over 100 million documents, and served more than 160,000 pharmaceutical enterprise users. The platform has also proven robust across both temporal and spatial dimensions; notably, it has operated continuously for nearly a decade and successfully passed more than 20 external audits.

Hongyi Medical serves over 300 clients, including leading enterprises across multiple sub-sectors such as pharmaceuticals, medical devices, CROs, CDMOs, and CGT. Notable clients include Yangtze River Pharmaceutical Group, Qilu Pharmaceutical, Fosun Pharma, WuXi AppTec, Joinn Laboratories, Johnson & Johnson MedTech, Sinocare, Zhifei Biological Products, WuXi Jienuo, and Chimeric Biologics.

Tang Liang introduced to VCBeat that Hongyi Medical is currently expanding into other sectors of the life sciences industry, building on its drug lifecycle data management platform. This initiative comprehensively empowers life sciences companies across multiple processes—from R&D and clinical trials to production and market launch—helping clients manage production and R&D data, shorten time-to-market, and precisely target customers.

Undoubtedly, as the industry ecosystem continues to evolve, “compliance” has become a critical determinant of survival for pharmaceutical distributors in the marketplace. However, the path to compliance in the pharmaceutical and even the broader life sciences industry is arduous and long, particularly given that the life sciences sector is itself a highly regulated and government-involved comprehensive field.

Therefore, when confronted with intricate data processing scenarios and diverse data types, enterprises require the support of professional teams to establish compliance management organizational structures, define the scope of compliance management, and build and refine their compliance management systems.

At the conclusion of the interview, Tang Liang stated, “Drawing on our continuous exploration, learning, and understanding of the industry and technology, Hongyi Pharmaceutical has defined a product design pathway that is data-driven and intelligence-oriented. Our goal is to leverage the various business domains of life sciences and enterprise data management capabilities as complementary dimensions, enabling organizations at different stages and across diverse business segments to access functionalities tailored to their current needs, along with future-ready upgrade paths, thereby empowering innovation in the industry.”