Dr. Liu Feng, Chairman of Guangzhou DiQi Pharmaceutical Technology Co., Ltd.
From a senior scientist at MacroMed (now BTG Healthcare) and Perrigo Company to a senior manager at Aptuit (now Catalent Pharma Solutions Inc), he left behind familiar work environments to embark on a new journey as an entrepreneur starting from scratch. How did he break the monopoly of high-end formulation giants and become a pioneer in this field? Pharma Intelligence Media conducted an exclusive interview with Dr. Liu Feng to hear his story about pioneering high-end pharmaceutical formulation entrepreneurship.
1 Staying true to my original aspiration, I resolutely returned to China to pursue my dream of developing pharmaceutical formulations.”
Reporter: As an overseas high-level talent, what was your academic journey like?
Dr. Liu Feng:
I received my Bachelor's and Master's degrees in Chemistry from Sun Yat-sen University in 1985 and 1988, respectively. In 1993, I earned my Ph.D. in Polymer Science from the Department of Chemistry at Wuhan University. That same year, I began postdoctoral research at the Beijing Institute of Chemistry, Chinese Academy of Sciences, focusing on polymer composite materials. In 1995, I was invited by the late Professor Sung Wan Kim, a renowned expert in drug delivery systems and a member of both the National Academy of Sciences and the National Academy of Engineering, to conduct postdoctoral research at the Department of Pharmacy, College of Pharmacy, University of Utah. In 2010, I earned a Master of Business Administration degree from the Henry B. Black School of Business and Management at the University of Missouri-Kansas City.
Reporter: After graduation, which pharmaceutical companies abroad have you worked for?
Dr. Liu Feng:
1997–2002: Senior Scientist at MacroMed (now BTG Healthcare), where he participated in and led the synthesis and scale-up of ReGel, the world's first biodegradable thermosensitive hydrogel (delivery system). 2003-2004: Senior Manager at Pharmadigm Inc., leading the development and scale-up of manufacturing processes for an innovative asthma treatment that completed Phase I/II clinical trials. 2004-2007: Served as Senior Scientist at Perrigo Company, then the world's largest tablet manufacturer, leading and participating in the development and industrialization of four marketed products. 2007-2010: Senior Manager at Aptuit Inc. (later acquired by Catalent Pharma Solutions, the largest pharmaceutical services company in the U.S.), where he led the development and industrialization of ribavirin immediate-release tablets, the formulation process development and clinical batch production (Phase I/II clinical trials) of a sustained-release anti-heart failure drug, and the formulation development and clinical batch production for over ten Phase I, II, and III clinical drugs.
Reporter: Why did you give up favorable conditions abroad to return to China and begin exploring and developing in the high-end pharmaceutical formulation field?
Dr. Liu Feng:
Entrepreneurship has always been my dream. I aspire to use a company as a vehicle to complete the entire journey of a technology—or a suite of technologies—from concept, through R&D and industrialization, to market launch. This journey aims to free humanity from suffering and extend longevity. Simultaneously, I wish to impart my accumulated expertise in R&D and industrialization to the younger generation without reservation, witnessing their growth into professionals who contribute meaningfully to society. Ultimately, I aim to realize the entire journey of building a company from scratch—from its inception and growth to its eventual public listing.
In fact, entrepreneurship differs from employment. It requires not only talent and technology, but also indispensable support from national policies. As the saying goes, favorable timing, advantageous location, and harmonious people are all essential. In 2010, research into novel high-end formulations had become the frontier of international drug innovation, and Chinese pharmaceutical companies were facing a critical juncture in their development. At this moment, I chose to return to China to start my own business, setting the vision for DiQi's development as “developing and manufacturing high-quality, highly effective, long-acting, and highly compliant medicines that are affordable for the general public.” Coincidentally, Chinese pharmaceutical companies were also on the eve of significant transformation.
In 2011, at the Fourth Session of the 11th National People's Congress, the national “Twelfth Five-Year Plan” designated biomedicine as a strategic industry, signaling major reforms in pharmaceutical regulations and market policies. In 2016, at the Fourth Session of the 12th National People's Congress, the national “13th Five-Year Plan” incorporated the development of high-end pharmaceutical formulations into the national development blueprint. Subsequently, the newly issued drug classification system designated innovative formulations as Category II innovative drugs. These national policies have charted a clear course for the advancement of the high-end pharmaceutical formulation industry.
2 The road ahead is long and arduous, Only the forward-thinkers will prevail.
Reporter: What distinguishes drug approval processes in regulated markets in Europe and the United States from those in China?
Dr. Liu Feng:
Since 2015, China's drug regulations and approval processes have increasingly aligned with those in Europe and the United States, and communication with the CDE has become increasingly smooth.
Regarding dosage form innovation and modification, domestic regulations differ somewhat from those in Europe and the United States, with greater emphasis placed on efficacy and convenience. For instance, converting a medication requiring multiple daily doses to once-daily administration or a once-every-four-weeks injection clearly offers significant advantages in terms of compliance. However, under current regulations, it is difficult to find supporting rationale for changing a formulation from a standard tablet to a standard capsule or dispersible tablet. Nevertheless, pharmaceuticals are ultimately commodities, and patients should have the right to choose between tablets, capsules, or dispersible tablets based on their preferences.
Reporter: As a formulation R&D expert with over 20 years of experience, how do you view the current development of formulation processes for solid dosage forms and injectables in China?
Dr. Liu Feng:
The development and production of generic drugs in China have undergone a qualitative transformation in philosophy, shifting from a market-driven approach to a patient-needs-driven one. This shift has brought significant changes in product selection, dosage form choices, as well as production, management, and inspection practices. Such changes have rapidly narrowed the technological and quality gap between domestic and international formulation industries.
In the development of Category II innovative drugs, we still face certain challenges, primarily manifested in shortages of talent, equipment, and available raw materials and excipients. While these issues are less pronounced in solid dosage forms, they remain particularly acute in injectables, especially high-end formulations. To support the development of proprietary long-acting injectables and meet the demands of the high-end formulation market, DiQi submitted applications for two specifications of PLGA excipients—PLGA8515 and PLGA7525—in 2020. The company plans to file applications for three additional PLGA excipient specifications in 2021. DiQi hopes these efforts will contribute to the advancement of China's high-end formulation sector.
Reporter: Regarding the current development of prescription manufacturing processes in China, how are you adjusting your company's development strategy?
Dr. Liu Feng:
The development of an enterprise must be forward-looking, and this foresight is achieved by comprehensively analyzing industry policies, current development status, and future trends. Continuous technological and product innovation has always been the technical foundation for corporate development. Building upon this foundation, technical services generate cash flow for the enterprise, reduce financial risks associated with development, and simultaneously enhance the company's technological competitiveness. Technology licensing, technical cooperation, product collaboration, and marketing authorization holders form the basis for the company's sustainable development. These three elements are mutually dependent and form a strategic triangle. Focusing on high-end formulation development, DiQi has established six proprietary technology platforms: Targeted Nanotechnology Platform, Long-Acting Formulation Technology Platform, Pegylation Technology Platform, Controlled-Release Formulation Technology Platform, High-End Excipient Technology Platform; DiQi possesses GMP-compliant production facilities for oral formulations, injectables, and excipients, supporting the manufacturing of preclinical and clinical products.
3 Leverage talent advantages and survive on quality
Reporter: Three-fifths of your management team consists of overseas returnees. How do you think pharmaceutical companies should structure their talent pipelines?
Dr. Liu Feng:
Recruiting talent is one of the effective means for pharmaceutical companies to achieve rapid development, and it is also a common strategy employed by many such enterprises. However, without corresponding technical talent planning, technological capabilities, and product development, even after attracting top talent, companies may fail to enable these individuals to reach their full potential. This not only wastes valuable resources but can also generate negative consequences. Therefore, a company's strategic planning extends beyond merely recruiting senior talent. It must also encompass the cultivation of corporate culture, the establishment of shared values, and the development of robust systems. Only when the environment is properly cultivated will recruited talent remain, enabling them to leverage their strengths and allowing the company's strategic vision to be fully realized.
Reporter: In your view, how should the commercial attributes of pharmaceuticals be addressed?
Dr. Liu Feng:
Undoubtedly, drug development must prioritize patient-centered approaches. However, pharmaceuticals are ultimately commodities, and as such, they possess inherent characteristics of goods. Therefore, during the development of different dosage forms, emphasis should not solely focus on clinical advantages. Pharmaceutical companies should also be encouraged to develop patient-friendly formulations—such as tablets, capsules, orally disintegrating tablets, dispersible tablets, oral liquids, and other acceptable forms—while ensuring efficacy and quality. This approach accommodates the diverse needs of patients. Amidst national policies like volume-based procurement and generic drug consistency evaluation, competition among pharmaceutical companies will intensify. It is hoped that pharmaceutical professionals will stay true to their original aspirations, developing and manufacturing high-quality, effective, long-acting, and highly compliant medicines that are affordable for the general public. China can also take the lead in international innovation, particularly in high-end formulations.
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