Frost & Sullivan Released Report: "Healthnice: Building an Integrated, End-to-End R&D and Manufacturing Service Platform with Innovative R&D and High-End Preparation Technologies"

Shanghai, China--(Newsfile Corp. - February 11, 2025) - Frost & Sullivan released a report, titled, " Healthnice: Building an Integrated, End-to-End R&D and Manufacturing Service Platform with Innovative R&D and High-end Preparation Technologies." The report delves into the development trends of high-end preparations and highlights how Healthnice, by closely following industry development trends and precisely positioning itself in the field of high-end preparations and modified new drugs, continuously enhances its competitiveness in the pharmaceutical industry. This is achieved through the establishment of a dual-track business model, integrated full-industry-chain service capabilities, a quality-first approach, and a strategy of deep domestic roots with an international outlook, thereby providing high-quality and efficient R&D and production services to global clients.

I. Aligning with Industry Trends: Healthnice Advances Step by Step

Amid the global pharmaceutical industry's evolution, high-end preparations have become a mainstream trend in drug development. In 2016, China's Ministry of Industry and Information Technology identified high-end preparations as a key development area, recognized for their superior compliance, safety, and convenience. This category includes novel injectable delivery systems like liposomes and nanoformulations, as well as immediate-release oral dosage forms and transdermal drug delivery systems.

To address the escalating market competition, strategies such as outsourcing R&D and manufacturing services or directly acquiring technological achievements are becoming essential for improving R&D quality and accelerating development timelines.

Healthnice has recognized these industry trends, building momentum and gradually evolving into a comprehensive CXO pharmaceutical company with independent project development at its core. The company specializes in high-end preparations and modified new drugs, focusing on high-value and high-potential products while actively exploring new opportunities. Through sustained technological expertise and R&D investments, Healthnice has established a fully integrated, end-to-end R&D and manufacturing system. This closed-loop industry chain spans innovative drug and high-end preparation development, custom manufacturing, and commercial production. Empowering the pharmaceutical industry with high-quality services, Healthnice has provided approximately 700 multi-mode, end-to-end R&D and manufacturing solutions to approximately 300 clients worldwide.

Healthnice's development journey showcases its innovative capabilities and stands as a microcosm of the pharmaceutical industry's transformation. Starting with early exploration in generic drug pharmaceutical research in 2001, the company pivoted toward a specialization transformation in 2007, following the introduction of the Measures for the Administration of Drug Registration (No.28). Keeping pace with industry trends, Healthnice transitioned from a single quality research service model to a strategic, diversified business model, systematically developing parallel services alongside quality research. Through strategic product selection and forward-looking project planning, Healthnice has successfully established a comprehensive pharmaceutical research system, built a professional R&D team, and accumulated a rich portfolio of projects.

Over the past decade, Healthnice has developed a fully integrated service chain. In 2009, the company initiated its independent R&D projects. Guided by a scientific and forward-looking product selection system, Healthnice has focused on unmet clinical needs, identifying high-value products and launching independent R&D projects. In 2016, the company formally established its CDMO business segment. With the integration of critical functions such as production, clinical research, and bioanalysis services, Healthnice gradually shaped its comprehensive service chain, reaching a mature development stage in 2019.

Healthnice has strategically focused on high-end preparations and modified new drugs, intensifying its market expansion efforts since 2020. The successful approval of several proprietary products and the transfer of marketing authorizations for self-developed products have significantly enhanced the company's efficiency in translating research into practice.

II. Integrated, End-to-End Full Industry Chain Services Provide High-Quality, Efficient R&D and Manufacturing Services to Clients

Dual-Track Model: A Unique Model to Unlock New Expansion Opportunities

Healthnice has implemented a dual-track business model that integrates parallel pathways: entrusted R&D services and the transfer of self-developed projects, further enhanced by an equity-sharing mechanism. Under this model, the company achieves a win-win relationship with its clients. For clients, Healthnice's proprietary project transfer services ensure a high-quality R&D process, effectively enhancing research efficiency and accelerating new drug launches. Moreover, clients can entrust their selected projects to Healthnice, benefiting from its full-chain, one-stop high quality services from R&D to production and its extensive development expertise to achieve "ready-to-market" convenience. For Healthnice, the dual-track approach lays the foundation for a diversified business model.

Service Chain Innovation: Building a Fully Integrated, End-to-End Industry Chain

While the industry races toward integrated and seamless models, Healthnice has prioritized business innovation from its early stages. The company has actively explored new development models and directions, achieving a fully integrated pharmaceutical R&D and production service chain.

Today, Healthnice operates under an "Integrated tripartite model" comprising pharmaceutical research, clinical studies, and manufacturing. By enabling seamless integration across all stages and parallel processing of multiple steps, Healthnice's end-to-end, integrated service model aims to offer clients efficient, convenient, and comprehensive pharmaceutical R&D and production solutions.

Driving Innovation: Strengthening R&D in high-end preparations and Expanding Competitive Product Portfolios

Healthnice has established a multidimensional, comprehensive technology platform matrix encompassing "APIs + preparations" and "R&D + clinical + manufacturing." The company now operates five key technology platforms: preparation R&D, API R&D, high-end preparation technology transfer and validation, clinical research, and bioanalytical testing. These platforms are supported by 11 core technologies, including polymer coating-based taste-masking microsphere delivery systems and solid dispersion solubilization techniques.

As drug development enters the era of preparation innovation, high-end preparations have become the strategic focus for pharmaceutical companies. However, R&D for high-end preparations involves high technical barriers, complex manufacturing processes, and stringent quality control requirements. Broadly, the main challenges in this process can be summarized into three key aspects: First, maintaining strict quality control of excipients remains a significant challenge. Second, high-end preparations demand highly stringent control over process parameters. Finally, the complexity of bioequivalence evaluation for high-end preparations has substantially increased. An industrialization platform that integrates solutions to these challenges is critical for achieving independent innovation. Supported by its 5 key platforms and 11 core technologies, Healthnice has established an innovative preparation industrialization research platform capable of addressing complex technical issues during product development. This platform provides comprehensive support to both generic and innovative pharmaceutical companies entering the high-end preparation sector.

Quality as Priority: Building a Production System That Balances Compliance and Scalability, Enhancing the Quality of Back-End Manufacturing Services

Healthnice has transformed its extensive R&D and production experience into a solid foundation for expanding its manufacturing services. The company's production system integrates efficient manufacturing with comprehensive risk management. In terms of regulation compliance, Healthnice adheres to regulatory standards from China, the US, and Europe, while actively advancing digital transformation. By adopting advanced online management systems, it ensures real-time monitoring of the entire production process, provides instant tracking of contract manufacturing projects, and dynamically manages potential risks. Moreover, Healthnice continues to expand and strengthen its quality control team, further broadening and deepening the scope of its quality management system.

Healthnice is also advancing its production capacity to enhance service resilience. Under careful planning for both approved and pipeline products, the company initiated Phase II base construction expansion to mitigate the risks associated with product co-production.

III. Deepening Roots Domestically While Expanding Globally

Healthnice strengthens its industry competitiveness through a balanced focus on both domestic and global growth. Domestically, the company continues to strengthen its core business and expand service offerings. Globally, it is committed to providing comprehensive, one-stop services for the entire lifecycle of high-end preparations and innovative drugs, covering both R&D and manufacturing.

"Focusing on Refinement": Aiming to Lead in High-End Transdermal Preparations

Healthnice aims to deepen its presence in high-end preparation fields such as sustained and controlled release, transdermal, inhalable, ophthalmic, and peptide-based formulations.

"Layering Foundations and Achieving New Growth": Advancing the Industrialization of APIs and Preparations

To address challenges in cost control, stable supply of APIs, and controlled sourcing of key excipients, Healthnice is actively strengthening its R&D efforts for APIs and its excipients. By adopting a flexible collaboration model, the company invests in early-stage R&D and partners with high-quality API manufacturers for subsequent production and registration. Additionally, Healthnice is working to establish its own API production base to enhance its industrial capabilities.

Global Expansion: Strategic International Market Development

The internationalization of preparations is crucial for upgrading China's API industry and optimizing its export structure. Developing high-end preparations represents a critical step for China's pharmaceutical sector in global expansion. Healthnice adopts a phased expansion strategy, advancing from APIs to preparations. The company initially targets markets in Southeast Asia, South America, and Africa with APIs, establishing a strong foundation for future expansion into the U.S. and European markets. Meanwhile, the company actively engages in the international CDMO business for advanced intermediates, further expanding its global market presence. Building on its success in API expansion, Healthnice is dedicated to securing FDA and EMA certifications for its preparation production facilities and product lines. This will enable the company to launch high-technology, differentiated preparations in overseas markets through registration and approval processes. Ultimately, Healthnice aims to establish an integrated strategy covering key intermediates, APIs, and high-end preparations, achieving full coverage of the pharmaceutical value chain.

The full content can also be viewed on the Frost & Sullivan global official website: https://www.frost.com/news/press-releases/building-an-integrated-end-to-end-rd-and-manufacturing-service-platform-with-innovative-rd-and-high-end-preparation-technologies/

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