Raffles Pharma Secures Over RMB 100 Million in Series A Funding to Build Global CDMO Platform
CDMO (Contract Development and Manufacturing Organization), i.e., Contract Research and Manufacturing Organization, this modelBy leveraging the dual advantages of custom R&D and manufacturing capabilities, we can commercialize innovative drugs with maximum efficiency.. Moreover, CDMOs enjoy business advantages such as high technological value-added, substantial profit margins, and significant growth potential.
As a specialized segment within the pharmaceutical industry, Contract Development and Manufacturing Organizations (CDMOs) are poised to become an inevitable trend in industrial division of labor, driven by the increasing specialization of pharmaceutical development.Globally, China’s advantages—including lower comprehensive costs, a vast talent pool, and a more complete industrial chain—have led the CDMO industries in Europe and the United States to shift toward China in recent years. As a result, China’s CDMO sector has experienced rapid development and gained increasing recognition from international clients.
From a domestic perspective, with policy reforms and incentives for pharmaceutical innovation, China’s innovative drugs are currently experiencing explosive growth, which has also led to a surge in local demand for CDMO services.According to the Annual Statistical Report on Drug Supervision and Administration (2020) released by the National Medical Products Administration, a total of 1,096 clinical varieties of innovative drugs and 20 manufacturing varieties of innovative drugs were approved in 2020. Based on relevant data, it is projected that China’s innovative drug market will exceed $150 billion in 2021.
Guangdong Raffles Pharmatech Co., Ltd. (hereinafter referred to as “Raffles”) is a CDMO company committed to the mission of “innovating pharmaceutical technologies, serving drug development, and advancing human health.” Established in August 2011 and led by Dr. Ye Weiping, Raffles is a national high-tech enterprise.
Prior to founding Raffles Pharmatech, Dr. Ye worked at GlaxoSmithKline for four years and at Pfizer for two years. During this period, he was responsible for process development of two global innovative drugs, green process innovation for eight original patented drugs, and global outsourced supply. Dr. Ye has led multiple global project teams and registered new suppliers in over 180 countries worldwide.
Their combined expertise in technology and business laid the foundation for Dr. Ye’s establishment of Raffles Pharmatech. Additionally, Dr. Ye’s wife, a professional in a related field and recipient of the U.S. Presidential Green Chemistry Challenge Award, played a key role in the company’s early development. During the initial phase of Raffles Pharmatech, Dr. Ye was responsible for R&D and market operations, while his wife oversaw technical affairs and internal management.
As the startup gained momentum, a series of partners with extensive experience in pharmaceutical R&D and industrialization joined the team. These include Dr. Andrew Phillis, former Senior Researcher and Project Manager at GlaxoSmithKline, who has cumulatively led or participated in the development of manufacturing processes for nine marketed innovative drugs; and Dr. Zhangtao Zhou, formerly with HEC Group and Lonza Group (Switzerland), who specializes in innovative route design, Quality by Design (QbD) R&D, and process scale-up technologies.
The addition of partners has enabled Raffles to achieve more comprehensive technical coverage and a broader scope of business development.
Under the leadership and management of the founders,Leveraging its core competencies in innovative processes, the company systematically integrates advanced process engineering technologies—including enzymatic catalysis, organocatalysis, and continuous-flow microreaction—to achieve reduced production costs, significant minimization of waste (wastewater, exhaust gas, and solid waste), enhanced production safety, and improved R&D efficiency, thereby meeting multifaceted requirements for industrialization, drug registration, safety, and environmental protection.
Raffles Pharmatech, while centering on craftsmanship and prioritizing customers, is comprehensively building a premier one-stop service platform.
InIn terms of process capabilities, Raffles Pharmatech is capable of conducting various specialized reactions, including cryogenic reactions, asymmetric synthesis, high-temperature and high-pressure reactions, transition metal-catalyzed reactions, and fluorination reactions.By leveraging extensive GMP-compliant industrial production experience, the manufacturing facility is utilized with flexible, multi-purpose functionality to scale up projects from kilogram-scale to ton-scale production lines. These capabilities provide favorable conditions for the continuous optimization of various commercial manufacturing projects, effectively reducing delivery lead times.
Meanwhile, Raffles also maintains a robust quality system, which is reflected in five specific aspects:Implement supplier screening controls within the material system, along with rigorous testing and control of materials; establish packaging and labeling procedures, and review packaging records and labels. Within the QC system, perform review of analytical records, conduct Out-of-Specification (OOS) investigations, and carry out method validation. The quality system encompasses document management, CAPA management, complaint handling and product recalls, process/cleaning validation, and quality-related training. The production system includes batch record review, change control, deviation investigation, and cleaning validation/verification.
In terms of information and intellectual property protection, Raffles Pharmatech safeguards clients' trade secrets and enhances corporate competitiveness by encrypting critical data through software and blocking channels for data leaks. Furthermore, the company achieves standardized management across the entire project lifecycle by implementing a vertical system where principal investigators lead R&D projects, complemented by horizontal oversight from the Customer Project Management Department.
Ultimately, by leveraging an experienced team to develop innovative processes, we have established a one-stop service from laboratory to commercialization, striving to ensure timely delivery of high-quality products in full compliance with regulatory and safety requirements. To this end, Raffles Pharmatech has summarizedA core set ofDOT-CERAQ®Service Philosophy: Deliver on Time with Compliance & EHS, in the Right Amount & Quality.
Raffles Pharmatech has achieved steady growth underpinned by comprehensive R&D capabilities and a robust management system. With over nine years of experience in new drug development, the company currently employs more than 200 staff members, including 17 PhDs and 40 master’s degree holders. The workforce is projected to expand to 300 employees by year-end as the company continues to scale. The growing R&D team has evolved into two specialized units: the Process Development Team and the Analytical Development Team.
The Process Development team is primarily responsible for the design, selection, optimization, and scale-up of manufacturing processes; development of new processes and continuous cost optimization; process safety testing, stability studies, and technology transfer. The Analytical Development team is primarily responsible for the development, qualification, and validation of analytical methods; ICH stability studies; and support for CMC regulatory submissions.
The team members each perform their respective duties, with close collaboration from universities.Completed over 700 molecular synthesis process assessments, accumulated experience in more than 200 process development projects, secured 11 new process patents and filed 32 patent applications, with over 40% featuring innovative process route designs and more than 80% of processes achieving commercial-scale production.
These growing achievements have gradually earned Raffles Pharmatech a strong reputation in the industry, leading to an increasing number of collaborative projects. To accommodate the rising demand for project collaborations, Raffles is actively expanding its infrastructure beyond its existing R&D base in Pingshan, the R&D base in Daya Bay, Huizhou, and the pilot-scale platform in Huizhou.Huizhou Dayawan GMP API CDMO Plant, Expected to Start Production in July This Year.
The Huizhou Dayawan GMP-compliant manufacturing facility is located within a national-level chemical industrial park on the east bank of the Pearl River, adjacent to Pingshan, Shenzhen. Designed around core concepts that comply with international GMP and EHS standards, the facility employs a state-of-the-art Emerson automation control system. It features two multi-purpose workshops meeting international GMP and OHSAS requirements, along with Class A warehouses, Class C comprehensive warehouses, raw material tank farms, utility systems, a three-waste treatment center, and supporting facilities including a Quality Center, R&D building, and office building.
The new factory’s departmental quality management philosophy, as well as its software and hardware configurations, are all designed in accordance with the requirements of the NMPA, FDA, EMA, and other regulatory authorities. Official certifications from China, the United States, and Europe are scheduled to be obtained sequentially in the second half of 2022.
To date, Raffles Pharmatech has secured over RMB 100 million in total financing. In March this year, the company launched its Series B funding round, which is expected to raise between RMB 100 million and RMB 150 million. The Series B round is scheduled to close in June this year, with the proceeds primarily allocated to the construction of Phase II of Raffles’ new manufacturing facility and the integration of AI technologies into its R&D platform alongside its traditional technology platforms.
Going forward, Raffles Pharmatech will continue to integrate R&D with industrialization, establishing multiple R&D and manufacturing platforms across East China, North China, Europe, and the United States. The company is committed to providing small-molecule drug clients with one-stop services spanning R&D, manufacturing, and regulatory filings—from preclinical studies through to commercialization—thereby facilitating the development and industrialization of innovative medicines worldwide.