HopeMedica Files for IPO, Offering Affordable Customized Global Expansion Solutions for Over 30 Chinese Pharma and MedTech Projects

In recent years, the continuous emergence of innovative pharmaceutical companies in China has led to an increasingly crowded landscape, signaling to the industry that China’s pharmaceutical production capacity is expanding at a rapid pace. Driven by volume-based procurement (VBP) and the pandemic, intense competition within the sector has continued to escalate. With companies’ R&D aspirations and market-oriented expectations remaining unmet, there is an urgent need for broader markets. To sustainably expand their influence and achieve long-term, stable growth, domestic pharmaceutical enterprises are progressively transitioning toward global expansion, both in terms of product internationalization and corporate globalization.

Meanwhile, China's pharmaceutical production capacity, amid rapid growth and high-quality transformation, is seeking to expand overseas.

MDCE CRO is a global consulting firm specializing in the international expansion of Chinese pharmaceuticals and medical devices, dedicated to providing comprehensive, flexible, and customized solutions for global market entry.“The core mission we are committed to is helping Chinese enterprises expand their production capacity globally, enabling them to cross the threshold of international expansion with faster and more affordable solutions,” said Deng Xiaoyu, founder of MDCE CRO, in a recent interview with VCBeat.

Chinese pharmaceutical companies expanding overseas face three major challenges: overseas product registration, international clinical trials and R&D collaboration, and overseas market expansion and commercialization strategy. This is a meticulous and complex process of resource alignment. Pharmaceutical enterprises often struggle with limited overseas resources, insufficient understanding of foreign market policies, and compliance issues related to clinical trials and regulatory registration.

Challenges Faced by Chinese Enterprises Expanding Overseas (Photo provided by interviewee)

In the past, Chinese pharmaceutical companies often opted for large global contract research organizations (CROs) to support their international expansion. However, since these global CROs primarily serve leading multinational pharmaceutical companies, their operational models and communication practices are tailored to the organizational structures and business processes of established multinational corporations. This mismatch often results in significant expenditures of time, capital, effort, and opportunity costs. A more pressing issue is that global CROs command substantially higher fees. Faced with internationalization services characterized by long timelines, high costs, and low compatibility, many companies find themselves overwhelmed even before embarking on their global expansion journey.

Deng Xiaoyu, who has worked at global CROs for many years, identified the crux of the issue: “Chinese companies often present customized demands, such as more sophisticated designs, shorter timelines, greater agility, and lower budgets. However, global CROs are often unwilling to adapt their global business structures and models. As a result, Chinese companies going global are forced to make painful compromises to meet the various requirements of their vendors.”

“Today, the scale and production capacity of China’s pharmaceutical industry are sufficiently large to warrant its own solutions.”“But there is a lack of solutions in China that specifically address the pain points Chinese enterprises face when expanding overseas,” introduced Deng Xiaoyu. “In countries with active outbound pharmaceutical R&D, such as Japan, South Korea, and India, there are many similar organizations. These entities provide targeted assistance to their domestic pharmaceutical and medical device companies in their overseas expansion.”

Distribution of MDCE CRO’s Medical Service Segments (Image provided by interviewee)

Centered on the unique characteristics of Chinese pharmaceutical companies expanding globally, MDCE CRO has established a comprehensive organizational structure and business model to provide clients with “affordable Global CRO” services.Full-cycle, integrated solutions covering everything from strategic consulting and clinical trials to post-launch market expansion and commercialization services.

“Whether in terms of flexibility, timing, speed, budget, or product type, our customized solutions can better meet the needs of Chinese enterprises,” introduced Deng Xiaoyu. Tailored global expansion strategies are more efficient and precise, enabling companies toReduce risks, shorten cycles, save costs, and accelerate overseas market expansion。

Specifically, a major challenge for Chinese companies in overseas registration, clinical trials, and market expansion lies in resource alignment and project management. When geographical distances are vast, globalized resources and local implementation teams become crucial.MDCE CRO pools global resources to establish a localization strategy driven by the synergistic interplay of three key pillars: government relations, hospital collaborations, and localized teams.

MDCE CRO has successfully implemented clinical trials across four continents, including Europe, the United States, ASEAN countries, Australia, the Middle East, and Africa. It has established multi-level collaborations with government agencies in Australia, Singapore, Latvia, Bulgaria, the United Kingdom, Thailand, and Malaysia. Globally, it currently boasts over 20 partners and a network of 2,000 global consultants and experts.

MDCE CRO’s Clinical Operations Team Spanning Four Continents (Photo provided by the interviewee)

On the other hand, MDCE CRO helps Chinese companies establish a presence in overseas markets and connect with core, leading expert resources. “This is not only an important strategy to help companies successfully complete projects, but also reflects our genuine commitment to standing in their shoes. We aim to help them build connections with local KOLs, expand their international influence, and lay the foundation for future commercialization,” said Deng Xiaoyu.

“There are no shortcuts to establishing partnerships with hospitals; the only thing we can do is negotiate with each one individually and sign agreements one by one.” In this way, MDCE CRO has built a hospital resource network spanning four continents.

Some Overseas Top-Tier Hospitals and Research Centers Partnered with MDCE CRO (Photo Provided by Interviewee)

Deng Xiaoyu emphasized, “In practice, we directly hire local staff and build teams to work alongside local hospitals and their personnel. This approach significantly reduces the costs associated with intermediary communication and resource coordination, ultimately helping Chinese enterprises achieve their goals of cost reduction, accelerated project implementation, and capturing a larger share of the global market.”

Leveraging extensive overseas resources and execution expertise, MDCE CRO’s international team has successfully delivered nearly 40 pharmaceutical and medical device global expansion projects, helping client companies increase their total market capitalization by over RMB 30 billion and boost profits by more than RMB 16 billion.

Deng Xiaoyu has observed that overseas practitioners—including physicians, hospitals, and research centers—that have partnered with MDCE CRO are already perceiving the progress and transformations in China’s pharmaceutical industry. While executing projects to facilitate the global expansion of Chinese pharmaceutical companies, MDCE CRO’s efforts are also helping to enhance overseas markets’ awareness and understanding of Chinese pharmaceutical and medical device products.

Meanwhile, the landscape of overseas expansion projects is also evolving, with more products from emerging sectors beginning to explore international markets.“For example, gene therapy projects involve high operational complexity, significant biosafety risks, and stringent regulatory oversight across countries. The MDCE CRO team has collaborated with numerous clinical experts worldwide to overcome challenges related to regulations, regulatory compliance, logistics, drug administration, and biosafety protection.” Currently, MDCE CRO is managing more than five gene therapy projects, with implementations in regions including the United States, Southeast Asia, Africa, and the Middle East.

In terms of domain distribution, MDCE CRO has deployed expert resources and medical teams across 12 fields, including gene therapy, oncology, rare diseases, cardiovascular disease, electrophysiology, and medical aesthetics, to build a comprehensive framework for global expansion.

"Beyond its multi-sector presence, MDCE CRO adheres to high-standard operational principles, facilitating the entry of Chinese projects into the global market and achieving sustainable development."“For us, upholding fundamental principles while pursuing innovative excellence means executing all documentation to high standards and aligning with the comprehensive quality systems and operational specifications of global CROs in Europe and the United States. This approach ensures the data quality of clinical trials and secures recognition from authoritative global regulatory agencies, thereby facilitating entry into the more strictly regulated European and American markets in subsequent development stages.”

Deng Xiaoyu emphasized, “Collaborating with leading global institutions—including cutting-edge scientific experts, universities, governments, and research institutes—is also essential to ensuring high-quality standards.” The project oversight and quality control system is jointly composed of more than 800 SOPs and quality control documents, 170,000 project files, an on-site monitoring team, and a self-established audit and quality control team.

MDCE CRO believes that China’s abundant pharmaceutical production capacity will effectively compensate for the shortfall in global pharmaceutical supply, serving as a critical safeguard for the worldwide pharmaceutical product supply chain. Today, this process is continuing to unfold rapidly.

The pandemic has created significant growth opportunities for Chinese healthcare companies to expand overseas. From epidemic prevention supplies and viral testing products to vaccine exports, domestic R&D enterprises have secured substantial overseas orders, exporting to over a hundred countries and regions, thereby achieving multi-fold revenue growth.

This opportunity has led to increased recognition of Chinese medical and healthcare products in overseas markets. The influx of substantial orders and capital has temporarily made “going global” a widely discussed keyword within the industry.In the post-pandemic era, the destination countries and product categories for the overseas expansion of pharmaceuticals and medical devices are gradually shifting. Chinese enterprises are ushering in a new era of global expansion and exploring new pathways.

“Currently, the advantages of Chinese pharmaceutical companies in going global still lie in their high cost-effectiveness and high R&D efficiency,” said Deng Xiaoyu. He noted that the transition toward innovation, differentiation, and high quality remains a challenging process. Achieving this transformation will depend on the strength of companies’ products; only truly superior products can change the overall perception within the medical community.

Looking to the future, MDCE CRO will advance steadily and faithfully serve as a companion for Chinese pharmaceuticals and medical devices going global.